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Steele CM, Burdick RJ, Dallal-York J, Shapira-Galitz Y, Abrams SW. EQUATOR Network Mapping Review for Dysphagia Research. AMERICAN JOURNAL OF SPEECH-LANGUAGE PATHOLOGY 2024; 33:2207-2219. [PMID: 39151057 DOI: 10.1044/2023_ajslp-23-00306] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/18/2024]
Abstract
PURPOSE The EQUATOR Network is an international initiative aimed at improving published health research through use of reporting guidelines. We conducted a review to determine the extent to which EQUATOR Network guidelines contain recommendations relevant for dysphagia research in human subjects. METHOD We downloaded all 542 EQUATOR Network guidelines on November 8, 2022. Each guideline was reviewed by two independent raters and judged for relevance to dysphagia and related fields (e.g., otolaryngology, gastroenterology). Dysphagia-relevant guidelines pertaining to quantitative human subjects research were further inspected to identify reporting guidance regarding (a) general research elements (e.g., data collection, statistical methods), (b) participant characteristics (e.g., demographics, accrual, randomization), (c) screening and clinical/noninstrumental assessments, (d) videofluoroscopic examinations, (e) flexible endoscopic examinations, (f) other instrumentation in swallowing research, (g) dysphagia treatment, (h) patient-/care provider-reported outcome measures, and (i) any other narrowly specified focus relevant for research on swallowing. Discrepancies were resolved by consensus. RESULTS Of 542 guidelines, 156 addressed quantitative research in human subjects relevant to dysphagia. Of these, 104 addressed general research elements and 108 addressed participant characteristics. Only 14 guidelines partially addressed the other topics of interest, and none addressed elements relevant to reporting videofluoroscopic or endoscopic assessments of swallowing. CONCLUSIONS We were unable to find guidelines with specific relevance to reporting key methods in dysphagia research. This lack of guidance illustrates a gap that hinders the critical appraisal of research quality in the field of dysphagia. Our review highlights the need to develop dysphagia-specific tools for critical appraisal and guidance regarding adequate research reporting. SUPPLEMENTAL MATERIAL https://doi.org/10.23641/asha.25014017.
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Affiliation(s)
- Catriona M Steele
- Swallowing Rehabilitation Research Laboratory, KITE Research Institute, University Health Network, Toronto, Ontario, Canada
- Rehabilitation Sciences Institute, Temerty Faculty of Medicine, University of Toronto, Ontario, Canada
- Canada Research Chair in Swallowing and Food Oral Processing, Canada Research Chairs Secretariat, Ottawa, Ontario, Canada
| | - Ryan J Burdick
- Swallowing and Salivary Bioscience Lab, Department of Medicine, Division of Geriatrics and Gerontology, Department of Communication Sciences and Disorders, University of Wisconsin-Madison
| | - Justine Dallal-York
- Laboratory for the Study of Upper Airway Dysfunction, Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY
| | - Yael Shapira-Galitz
- Department of Otolaryngology-Head and Neck Surgery, Kaplan Medical Center, Rehovot, Israel
- Hadassah School of Medicine, Hebrew University of Jerusalem, Israel
| | - Sophia Werden Abrams
- Aging Swallow Research Laboratory, School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada
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Jamshidi S, Hashemi S, Valipoor S. Adapting to Change: A Systematic Literature Review of Environmental Flexibility in Emergency Departments. HERD-HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 2024; 17:326-343. [PMID: 38264992 DOI: 10.1177/19375867231224904] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2024]
Abstract
PURPOSE This study aimed to offer a comprehensive analysis of distinct design strategies identified, evaluated, or discussed in the existing literature that promote environmental flexibility in the context of emergency departments (EDs). BACKGROUND EDs are subject to constant changes caused by several factors, including seasonal disease trends, the emergence of new technologies, and surges resulting from local or global disasters, such as mass casualty incidents or pandemics. Thus, integrating flexibility into ED design becomes crucial to effectively addressing these evolving needs. METHODS A systematic search was conducted in four databases: CINAHL, MEDLINE, PubMed, and ScienceDirect, in addition to a hand search. A two-stage review process was employed to determine the final list of included articles based on the inclusion criteria. Included studies were evaluated for quality, and findings were categorized using a hybrid deductive and inductive coding approach. RESULTS From the initial yield of 900 records, 22 studies met the inclusion criteria and were included in the final full-text review. The identified design strategies were organized into five categories: modifiability (n = 13 articles), versatility (n = 8 articles), tolerance (n = 6 articles), convertibility (n = 4 articles), and scalability (n = 7 articles). Specific design strategies under each category are reported in detail. CONCLUSIONS Our findings suggest that most flexibility design solutions are based on anecdotal evidence or descriptive studies, which carry less weight in terms of reliable support for conclusions. Therefore, more studies employing quantitative, relational, or causal designs are recommended.
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Affiliation(s)
- Saman Jamshidi
- School of Architecture, University of Nevada, Las Vegas, NV, USA
| | - Seyedehnastaran Hashemi
- School of Architecture, University of Nevada, Las Vegas, NV, USA
- Department of Design, College of Human Sciences, Texas Tech University, TX, USA
| | - Shabboo Valipoor
- Department of Interior Design, College of Design, Construction and Planning, University of Florida, Gainesville, FL, USA
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Jamshidi S, Pati D. Hierarchy of Evidence: An Appraisal Tool for Weighting the Evidence in Healthcare Design Research Based on Internal Validity. HERD-HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 2023; 16:19-38. [PMID: 38374648 DOI: 10.1177/19375867231175916] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/21/2024]
Abstract
PURPOSE This inquiry aims to develop an appraisal tool to offer greater granularity in weighing evidence in the field of healthcare design research. BACKGROUND In evidence-based design (EBD), the goal is to implement interventions that result in a meaningful and optimal effect based on current best evidence. Although multiple appraisal tools (many adopted from medical disciplines) have been instrumental in evaluating studies in the field of healthcare design research to identify the best evidence, they do not necessarily consider the unique contexts of healthcare design research, and methodologies appropriate to the field. METHODS Five basic types of studies are ranked based on the level of confidence that they offer regarding the estimate of an effect: (1) meta-analysis studies, (2) causal studies, (3) correlational studies, (4) descriptive studies, and (5) anecdotal evidence. Causal studies are further divided into four levels based on the interaction of two factors: (1) type of intervention and (2) groups' equivalency and extraneous variable control. RESULTS An eight-level hierarchy of evidence for healthcare design research is proposed that is expected to improve upon previous hierarchies in three major ways: (a) including research methods that are more relevant to healthcare design research, (b) enhancing evaluation accuracy and reliability by providing a clearer definition of studies based on their key components rather than using study labels alone, and (c) distinguishing different levels of evidence, particularly in causal studies. CONCLUSIONS The proposed appraisal tool is developed specifically for EBD by reflecting on the unique context of healthcare design research and practice.
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Affiliation(s)
- Saman Jamshidi
- School of Architecture, University of Nevada, Las Vegas, NV, USA
| | - Debajyoti Pati
- Department of Design, College of Human Sciences, Texas Tech University, Lubbock, TX, USA
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Ørstavik R. Who should write a case report? TIDSSKRIFT FOR DEN NORSKE LEGEFORENING 2022; 142:22-0295. [PMID: 35510449 DOI: 10.4045/tidsskr.22.0295] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022] Open
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5
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Lawson DO, Mellor K, Eddy S, Lee C, Kim KH, Kim K, Mbuagbaw L, Thabane L. Pilot and Feasibility Studies in Rehabilitation Research: A Review and Educational Primer for the Physiatrist Researcher. Am J Phys Med Rehabil 2022; 101:372-383. [PMID: 34091466 DOI: 10.1097/phm.0000000000001797] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
ABSTRACT Pilot and feasibility studies are conducted early in the clinical research pathway to evaluate whether a future, definitive study can or should be done and, if so, how. Poor planning and reporting of pilot and feasibility studies can compromise subsequent research efforts. Inappropriate labeling of studies as pilots also compromises education. In this review, first, a systematic survey of the current state of pilot and feasibility studies in rehabilitation research was performed, and second, recommendations were made for improvements to their design and reporting. In a random sample of 100 studies, half (49.5%) were randomized trials. Thirty (30.0%) and three (3.0%) studies used "pilot" and "feasibility" in the study title, respectively. Only one third (34.0%) of studies provided a primary objective related to feasibility. Most studies (92.0%) stated an intent for hypothesis testing. Although many studies (70.0%) mentioned outcomes related to feasibility in the methods, a third (30.0%) reported additional outcomes in the results and discussion only or commented on feasibility anecdotally. The reporting of progression plans to a main study (21.0%) and progression criteria (4.0%) was infrequent. Based on these findings, it is recommended that researchers correctly label studies as a pilot or feasibility design based on accepted definitions, explicitly state feasibility objectives, outcomes, and criteria for determining success of feasibility, justify the sample size, and appropriately interpret and report the implications of feasibility findings for the main future study.
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Affiliation(s)
- Daeria O Lawson
- From the Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (DOL, LM, LT); Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom (KM); Institute of Population Health Sciences, Queen Mary University of London, London, United Kingdom (SE); Department of Medicine, McMaster University, Hamilton, Ontario, Canada (CL, KHK, KK); and Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada (LM, LT)
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Richards GC, Aronson JK, Heneghan C. Coroners' concerns to prevent harms: a series of coroners' case reports to serve patient safety and educate the public, clinicians and policy-makers. BMJ Evid Based Med 2021; 26:37-38. [PMID: 33262123 DOI: 10.1136/bmjebm-2020-111567] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/24/2020] [Indexed: 12/13/2022]
Affiliation(s)
- Georgia C Richards
- Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
| | - Jeffrey K Aronson
- Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK
| | - Carl Heneghan
- Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
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Lehmkuhl G, Holtmann M. „Learning from Stories“: Die Bedeutung von Fallgeschichten für Diagnostik und Therapie. ZEITSCHRIFT FUR KINDER-UND JUGENDPSYCHIATRIE UND PSYCHOTHERAPIE 2021; 49:89-91. [PMID: 33666496 DOI: 10.1024/1422-4917/a000776] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Affiliation(s)
- Gerd Lehmkuhl
- Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters der Universität zu Köln
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Seguel-Moraga P, Onetto JE, E Uribe S. Reporting quality of case reports about dental trauma published in international journals 2008-2018 assessed by CARE guidelines. Dent Traumatol 2020; 37:345-353. [PMID: 33222392 DOI: 10.1111/edt.12630] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2020] [Revised: 10/28/2020] [Accepted: 10/29/2020] [Indexed: 11/30/2022]
Abstract
BACKGROUND/AIMS The diagnosis and treatment of dental trauma are based primarily on observational evidence and case reports. The aim of this research is to assess the quality of reporting of case reports published from 2008 to 2018 in dental selected journals using the Care Report (CARE) guideline and to assess whether there was a change after publication of the CARE guidelines. METHODS A descriptive study of the publications available on PubMed from specialist journals was conducted. Searches were made for MESh and free keywords associated with dental trauma and tooth injuries. One calibrated evaluator (kappa-intra = 0.87) using the CARE guidelines (max = 30 points) evaluated all case reports published from 2008 to 2018 in relevant journals. The average score before and after 2013 was compared by t-test and regression modeling, and the description of each CARE item was analyzed. RESULTS The search found 201 relevant articles published in Dent Traumatol 141 (70.1%), Eur Arch Paediatr Dent 10 (5.0%), Int J Clin Pediatr Dent 16 (8.0%), J Clin Pediatr Dent 19 (9.5%), and Pediatr Dent 15 (7.5%). The mean quality (± standard deviation) was 14.3 (±2.6), and range from 7 to 20. The number and mean (±SD) before the CARE guidelines were n = 171, mean = 14.3 (±2.6) and after the CARE guidelines were n = 30, mean = 14.7 (±2.7), (P = .39, t-test). No significant differences per journal or origin of the first author were found. CONCLUSIONS The reporting quality of case reports about dental trauma in five international dental journals has not improved since the publication of the CARE guidelines. The lack of reporting of essential items in case reports suggests that journals could enhance their quality by requiring authors to adhere to the CARE guidelines or similar reporting guidelines.
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Affiliation(s)
| | - Juan E Onetto
- Faculty of Dentistry, University of Valparaiso, Valparaiso, Chile
| | - Sergio E Uribe
- Faculty of Dentistry, University of Valparaiso, Valparaiso, Chile.,Department of Conservative Dentistry and Oral Health, Bioinformatics Research Unit, Riga Stradins University, Riga, Latvia.,School of Dentistry, Universidad Austral de Chile, Valdivia, Chile
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Yang KL, Lu CC, Sun Y, Cai YT, Wang B, Shang Y, Tian JH. How about the reporting quality of case reports in nursing field? World J Clin Cases 2019; 7:3505-3516. [PMID: 31750332 PMCID: PMC6854409 DOI: 10.12998/wjcc.v7.i21.3505] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/16/2019] [Revised: 08/27/2019] [Accepted: 09/09/2019] [Indexed: 02/05/2023] Open
Abstract
BACKGROUND As a significantly important part of clinical practice, the professional nursing process can be advanced in many ways. Despite the fact that case reports are regarded to be of a lower quality grade in the hierarchy of evidence, one of the principles of evidence-based medicine is that decision-making should be based on a systematic summary of evidence. However, the evidence on the reporting characteristics of case reports in the nursing field is deficient.
AIM To use the CARE guidelines to assess reporting quality and factors influencing the quality of case reports in the nursing field.
METHODS Nursing science citation indexed (SCI-indexed) journals were identified from the professional website. Each of the identified journals was searched on their website for articles published before December 2017. Twenty-one sub-items on the CARE checklist were recorded as “YES”, “PARTLY”, or “NO” according to information reported by the included studies. The responses were assigned corresponding scores of 1, 0.5, and 0, respectively. The overall score was the sum of the 21 sub-items and was defined as “high” (more than 15), “medium” (10.5 to 14.5), and “low” (less than 10). The means, standard deviations, odds ratios (OR), and the associated 95% confidence interval (CI) were determined using Stata 12.0 software.
RESULTS Ultimately, 184 case reports from 16 SCI-indexed journals were identified, with overall scores ranging from 6.5 to 18 (mean = 13.6 ± 2.3). Of the included case reports, 10.3% were regarded low-quality, 52.7% were considered middle-quality, and 37% were regarded high-quality. There were statistical differences in the mean overall scores of the included case reports with funding versus those without funding (14.2 ± 1.7 vs 13.6 ± 2.4, respectively; P = 0.4456) and journal impact factor < 1.8 versus impact factor ≥ 1.8 (13.3 ± 2.3 vs 13.6 ± 2.4, respectively; P = 0.4977). Five items from the CARE guidelines, 5a (Patient), 6 (Clinical findings), 8c (Diagnostic reasoning), 9 (Therapeutic intervention), and 11d (The main take-away lessons) were well-reported (Reporting rate more than 90%) in most of the included case reports. However, only three items, 2 (Keywords, OR = 0.42, 95%CI: 0.19-0.92, P = 0.03), 4 (Introduction, OR = 0.35, 95%CI: 0.15-0.83, P = 0.017), and 11b (The relevant medical literature, OR = 0.19, 95%CI: 0.06-0.56, P = 0.003) were considered better-reported after the CARE guidelines published in 2013.
CONCLUSION The reporting quality of case reports in the nursing field apparently has not improved since the publication of the CARE guidelines.
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Affiliation(s)
- Ke-Lu Yang
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou 730000, Gansu Province, China
| | - Cun-Cun Lu
- Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, Gansu Province, China
| | - Yue Sun
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou 730000, Gansu Province, China
| | - Yi-Tong Cai
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou 730000, Gansu Province, China
| | - Bo Wang
- Gansu Province Hospital Rehabilitation Center, Lanzhou 730000, Gansu Province, China
| | - Yi Shang
- Lanzhou University Second Hospital, Lanzhou University, Lanzhou 730000, Gansu Province, China
| | - Jin-Hui Tian
- Evidence-Based Nursing Center, School of Nursing, Lanzhou University, Lanzhou 730000, Gansu Province, China
- Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, Gansu Province, China
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Yang KL, Lu CC, Sun Y, Cai YT, Wang B, Shang Y, Tian JH. How about the reporting quality of case reports in nursing field? World J Clin Cases 2019. [DOI: 10.12998/wjcc.v7.i21.3488] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023] Open
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Moore N, Berdaï D, Blin P, Droz C. Pharmacovigilance - The next chapter. Therapie 2019; 74:557-567. [PMID: 31623850 DOI: 10.1016/j.therap.2019.09.004] [Citation(s) in RCA: 128] [Impact Index Per Article: 21.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2019] [Accepted: 09/24/2019] [Indexed: 12/11/2022]
Abstract
The discovery and quantification of adverse drug reactions has long relied on the careful analysis of spontaneously reported cases. Causality assessment (imputation) was a fundamental feature of individual case report analysis. This was complemented by analysis of aggregated cases, and of disproportionality analyses in spontaneous reports databases. In the absence of more specific information sources, these have resulted in the discovery of many new adverse reactions, altering drug information. It has led to the withdrawal from the market of many drugs, but its use for risk quantification remains fraught with uncertainty. The recent access to population-wide claims or electronic health records databases have confirmed for spontaneous reporting a predominant role in hypothesis generation for serious adverse drug reactions, notably those that result in hospital admission or death. In these cases, the events are identifiable at the population level, and can be quantified precisely using the tools of modern pharmacoepidemiology, to generate specific benefit-risk analyses. Spontaneous reporting remains irreplaceable in signal and alert generation in drug safety, despite its inherent limitations. For signal strengthening and assessment, more systematic and quantitative methods should be sought, such as claims databases for reactions resulting in hospital admissions.
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Affiliation(s)
- Nicholas Moore
- Inserm CIC1401, Bordeaux PharmacoEpi, université de Bordeaux, 33076 Bordeaux, France.
| | | | - Patrick Blin
- Inserm CIC1401, Bordeaux PharmacoEpi, université de Bordeaux, 33076 Bordeaux, France
| | - Cécile Droz
- Inserm CIC1401, Bordeaux PharmacoEpi, université de Bordeaux, 33076 Bordeaux, France
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Kim TH, Kang JW. Acupuncture for symptoms management in Korean breast cancer survivors: a prospective pilot study. Acupunct Med 2019; 37:164-174. [DOI: 10.1177/0964528419832610] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Background: There is an unmet need for effective treatment of the various treatment-related symptoms experienced by breast cancer survivors. These symptoms could be alleviated by acupuncture. Although several lines of evidence in Western countries suggest that acupuncture has a beneficial effect on symptoms in breast cancer survivors, few relevant studies have been conducted in Korean patients. This pilot study assessed the feasibility of acupuncture for a variety of treatment-related symptoms in Korean breast cancer survivors. Method: From October 2015 to March 2016, we recruited patients who had undergone treatment for breast cancer and subsequently reported symptoms, including aromatase inhibitor-related knee pain, vasomotor symptoms, insomnia, sexual dysfunction and post-mastectomy pain in the chest wall or shoulder. The women received 4 weeks of symptom-specific acupuncture followed by a further 4 weeks of follow-up to evaluate the feasibility of acupuncture for this indication, and its impact on common and symptom-specific outcome variables. Results: Eight study participants were recruited over a period of 6 months, six of whom completed the planned acupuncture treatment and follow-up assessments. A total of 78 acupuncture sessions were performed. We found that acupuncture was feasible, with only six minor self-limiting acupuncture-related adverse events. Most of the women felt that they had benefitted from participation in the study. The preliminary analysis indicated improvement in common symptom-specific outcomes. Conclusion: Our findings suggest that acupuncture is feasible, but low recruitment rates should be considered when considering future acupuncture research in Korean breast cancer survivors. Rigorous evaluation of this symptomatic treatment strategy is now needed in the Korean population.
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Affiliation(s)
- Tae-Hun Kim
- Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, South Korea
| | - Jung Won Kang
- Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
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Bradley PJ. Guidelines to authors publishing a case report: the need for quality improvement. AME Case Rep 2018; 2:10. [PMID: 30264006 DOI: 10.21037/acr.2018.04.02] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/14/2018] [Accepted: 03/21/2018] [Indexed: 11/10/2022]
Affiliation(s)
- Patrick J Bradley
- Department of Otorhinolaryngology, Head and Neck Surgery, University of Nottingham, Nottingham, UK
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Murad MH, Sultan S, Haffar S, Bazerbachi F. Methodological quality and synthesis of case series and case reports. BMJ Evid Based Med 2018; 23:60-63. [PMID: 29420178 PMCID: PMC6234235 DOI: 10.1136/bmjebm-2017-110853] [Citation(s) in RCA: 1502] [Impact Index Per Article: 214.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/04/2018] [Indexed: 12/13/2022]
Abstract
Case reports and case series are uncontrolled study designs known for increased risk of bias but have profoundly influenced the medical literature and continue to advance our knowledge. In this guide, we present a framework for appraisal, synthesis and application of evidence derived from case reports and case series. We propose a tool to evaluate the methodological quality of case reports and case series based on the domains of selection, ascertainment, causality and reporting and provide signalling questions to aid evidence-based practitioners and systematic reviewers in their assessment. We suggest using evidence derived from case reports and case series to inform decision-making when no other higher level of evidence is available.
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Affiliation(s)
| | - Shahnaz Sultan
- Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Center for Chronic Diseases Outcomes Research, Minneapolis Veterans Affairs Healthcare System, Minneapolis, Minnesota, USA
| | - Samir Haffar
- Digestive Center for Diagnosis and Treatment, Damascus, Syrian Arab Republic
| | - Fateh Bazerbachi
- Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
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Murad MH, Sultan S, Haffar S, Bazerbachi F. Methodological quality and synthesis of case series and case reports. BMJ Evid Based Med 2018. [PMID: 29420178 DOI: 10.1136/bmjebm-2017-110853]] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
Case reports and case series are uncontrolled study designs known for increased risk of bias but have profoundly influenced the medical literature and continue to advance our knowledge. In this guide, we present a framework for appraisal, synthesis and application of evidence derived from case reports and case series. We propose a tool to evaluate the methodological quality of case reports and case series based on the domains of selection, ascertainment, causality and reporting and provide signalling questions to aid evidence-based practitioners and systematic reviewers in their assessment. We suggest using evidence derived from case reports and case series to inform decision-making when no other higher level of evidence is available.
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Affiliation(s)
| | - Shahnaz Sultan
- Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, Center for Chronic Diseases Outcomes Research, Minneapolis Veterans Affairs Healthcare System, Minneapolis, Minnesota, USA
| | - Samir Haffar
- Digestive Center for Diagnosis and Treatment, Damascus, Syrian Arab Republic
| | - Fateh Bazerbachi
- Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
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An GH, Tang XT, Chen YL, Zhao Y. Reporting characteristics of case reports of acupuncture therapy with CARE guidelines. Chin J Integr Med 2017; 24:56-63. [PMID: 29181732 DOI: 10.1007/s11655-017-2902-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2015] [Indexed: 12/20/2022]
Abstract
OBJECTIVE To investigate the reporting characteristics of case reports of acupuncture therapy with CAse Report (CARE) guidelines, and to explore the applicability of the guidelines for these case reports. METHODS Case reports published from January 1, 2011 to December 31, 2013, were identified by searching PubMed and the China Biomedicine Database by using MeSH terms. Screening and data extraction of case reports were conducted by two independent researchers. Assessments based on CARE guidelines and data analysis were conducted by using Excel 2003 and RevMan 5.0. RESULTS A total of 61 case reports published in 19 journals were identified, which involved 16 major types of diseases. Fifteen (24.6%) case reports declared no conflict of interests, and 5 (8.2%) reported funding sources. None of these case reports met all items of CARE guidelines, and only 6 subordinate items were fully reported among 50% of the case reports. Subgroup analysis indicated that case reports published in English or those that did not have competing interests had higher reporting quality. CONCLUSIONS The reporting quality of case reports of acupuncture therapy is rather low. The reason might be a lack of awareness among authors and the poor dissemination of information regarding CARE guidelines in China. More evaluation studies are needed to promote and improve adherence to CARE guidelines. Moreover, an extended version of CARE guidelines should be developed for cases reports of special interventions such as acupuncture or adverse events caused by interventions.
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Affiliation(s)
- Guang-Hui An
- College of Acupuncture-Moxibustion and Massage, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China
| | - Xiao-Ting Tang
- Wanggang Community Health Service Center, Shanghai, 201201, China
| | - Yao-Long Chen
- Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China
| | - Yi Zhao
- College of Acupuncture-Moxibustion and Massage, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
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Riley DS, Barber MS, Kienle GS, Aronson JK, von Schoen-Angerer T, Tugwell P, Kiene H, Helfand M, Altman DG, Sox H, Werthmann PG, Moher D, Rison RA, Shamseer L, Koch CA, Sun GH, Hanaway P, Sudak NL, Kaszkin-Bettag M, Carpenter JE, Gagnier JJ. CARE guidelines for case reports: explanation and elaboration document. J Clin Epidemiol 2017; 89:218-235. [PMID: 28529185 DOI: 10.1016/j.jclinepi.2017.04.026] [Citation(s) in RCA: 982] [Impact Index Per Article: 122.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/09/2017] [Revised: 04/14/2017] [Accepted: 04/27/2017] [Indexed: 02/07/2023]
Abstract
BACKGROUND Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011-2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. OBJECTIVES This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. ARTICLE DESIGN AND SETTING Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. RESULTS AND CONCLUSION This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.
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Affiliation(s)
- David S Riley
- Integrative Medicine Institute, 2437A NW Overton Street, Portland, OR 97210, USA; Helfgott Research Institute, 2220 SW 1st Ave, Portland, OR 97201, USA.
| | - Melissa S Barber
- Integrative Medicine Institute, 2437A NW Overton Street, Portland, OR 97210, USA
| | - Gunver S Kienle
- Senior Research Scientist, University of Freiburg, Fahnenbergplatz, 79085 Freiburg im Breisgau, Germany; Senior Research Scientist, Institute for Applied Epistemology and Medical Methodology at the University of Witten-Herdecke, Zechenweg 6, 79111 Freiburg im Breisgau, Germany
| | - Jeffrey K Aronson
- University of Oxford, Nuffield Department of Primary Care Health Sciences, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK
| | - Tido von Schoen-Angerer
- Department of Pediatrics, Centre médical de La Chapelle, Chemin de Compostelle 7, 1212 Grand-Lancy, Genève, Switzerland; ACIM Institute, Filderklinik, Im Haberschlai 7, 70794 Filderstadt-Bonlanden, Germany
| | - Peter Tugwell
- Department of Medicine University of Ottawa, 451 Smyth Rd, Ottawa, ON, Canada K1H 8M5
| | - Helmut Kiene
- Senior Research Scientist, Institute for Applied Epistemology and Medical Methodology at the University of Witten-Herdecke, Zechenweg 6, 79111 Freiburg im Breisgau, Germany
| | - Mark Helfand
- Departmenty of Medical Informatics and C linical Epidemiology, 3710 SW US Veterans Hospital Rd, Portland, OR 97239, USA
| | - Douglas G Altman
- University of Oxford, Center for Statistics - Botnar Research Centre, Windmill Road, Oxford OX3 7LD, UK
| | - Harold Sox
- Professor Medicine and of The Dartmouth Institute, Geisel School of Medicine at Dartmouth, 31 Faraway Lane, West Lebanon, NH 03784-4401, USA
| | - Paul G Werthmann
- Senior Research Scientist, Institute for Applied Epistemology and Medical Methodology at the University of Witten-Herdecke, Zechenweg 6, 79111 Freiburg im Breisgau, Germany
| | - David Moher
- Senior Scientist, Ottawa Methods Centre, Ottawa Hospital Research Institute, 501 Smythe Road, Ottawa, ON, Canada K1H 8L6
| | - Richard A Rison
- PIH Health Hospital-Whittier, Neurology Consultants Medicine Group, University of Southern California Keck School of Medicine, 12291 Washington Blvd # 303, Whittier, CA 90606, USA
| | - Larissa Shamseer
- Senior Scientist, Ottawa Methods Centre, Ottawa Hospital Research Institute, 501 Smythe Road, Ottawa, ON, Canada K1H 8L6
| | - Christian A Koch
- Professor of Medicine, Director - Endocrinology at the University of Mississippi Medical Center, 2500 N. State Street, Jacson, MS 39216, USA
| | - Gordon H Sun
- Medical Director of Inpatient Services at Rancho Los Amigos National Rehabilitation Center, 7601 Imperial Highway, Downey, CA 90242, USA
| | - Patrick Hanaway
- Cener for Functional Medicine, Cleveland Clinic, Mail Code H-18, 9500 Euclid Avenue, Cleveland, OH, 44195, USA
| | - Nancy L Sudak
- Essentia Health - Duluth, 420 East First Street, Duluth, MN 55805-1951, USA
| | | | - James E Carpenter
- Department Chair, Orthopaedic Surgery, 24 Frank Lloyd Wright Drive, Lobby A, Ann Arbor, MI 48106, USA
| | - Joel J Gagnier
- Department of Orthopaedic Surgery, 24 Frank Lloyd Wright Drive, Lobby A, Ann Arbor, MI 48106, USA; Department of Epidemiology, School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109-2029, USA
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Scholl JH, van de Ven PM, van Puijenbroek EP. Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs. J Clin Epidemiol 2015; 68:1423-31. [DOI: 10.1016/j.jclinepi.2015.03.001] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/22/2014] [Revised: 02/04/2015] [Accepted: 03/03/2015] [Indexed: 10/23/2022]
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Aronson JK. Toward standardized reporting of drug interactions: the READI checklist for anecdotal reports. Expert Rev Clin Pharmacol 2015; 8:399-409. [PMID: 26018632 DOI: 10.1586/17512433.2015.1049598] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Anecdotal reports contribute 30% of the literature on adverse drug reactions and interactions. However, the quality of such reports has not been uniformly high. Standardized reporting of clinical studies is of increasing interest, including the CARE guidelines on reporting anecdotal cases in general. Although there are guidelines on evaluating and managing drug-drug interactions, there are none recommending methods for reporting suspected drug interactions. Here, based on published guidelines for reporting suspected adverse drug reactions, I propose a checklist for reporting details of suspected drug interactions, the REporting Anecdotal Drug Interactions (READI) checklist, hoping to stimulate discussion and improve reporting of suspected drug interactions. The checklist includes items relating, among others, to the patient affected, the drugs involved, and the outcome.
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Affiliation(s)
- Jeffrey K Aronson
- University of Oxford, Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK
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Hung BT, Long NP, Hung LP, Luan NT, Anh NH, Nghi TD, Van Hieu M, Trang NTH, Rafidinarivo HF, Anh NK, Hawkes D, Huy NT, Hirayama K. Research trends in evidence-based medicine: a joinpoint regression analysis of more than 50 years of publication data. PLoS One 2015; 10:e0121054. [PMID: 25849641 PMCID: PMC4388379 DOI: 10.1371/journal.pone.0121054] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2014] [Accepted: 01/27/2015] [Indexed: 11/18/2022] Open
Abstract
Background Evidence-based medicine (EBM) has developed as the dominant paradigm of assessment of evidence that is used in clinical practice. Since its development, EBM has been applied to integrate the best available research into diagnosis and treatment with the purpose of improving patient care. In the EBM era, a hierarchy of evidence has been proposed, including various types of research methods, such as meta-analysis (MA), systematic review (SRV), randomized controlled trial (RCT), case report (CR), practice guideline (PGL), and so on. Although there are numerous studies examining the impact and importance of specific cases of EBM in clinical practice, there is a lack of research quantitatively measuring publication trends in the growth and development of EBM. Therefore, a bibliometric analysis was constructed to determine the scientific productivity of EBM research over decades. Methods NCBI PubMed database was used to search, retrieve and classify publications according to research method and year of publication. Joinpoint regression analysis was undertaken to analyze trends in research productivity and the prevalence of individual research methods. Findings Analysis indicates that MA and SRV, which are classified as the highest ranking of evidence in the EBM, accounted for a relatively small but auspicious number of publications. For most research methods, the annual percent change (APC) indicates a consistent increase in publication frequency. MA, SRV and RCT show the highest rate of publication growth in the past twenty years. Only controlled clinical trials (CCT) shows a non-significant reduction in publications over the past ten years. Conclusions Higher quality research methods, such as MA, SRV and RCT, are showing continuous publication growth, which suggests an acknowledgement of the value of these methods. This study provides the first quantitative assessment of research method publication trends in EBM.
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Affiliation(s)
- Bui The Hung
- University of Medicine and Pharmacy, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
- Online Research Club, http://onlineresearchclub.org
| | - Nguyen Phuoc Long
- University of Medicine and Pharmacy, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
- Online Research Club, http://onlineresearchclub.org
| | - Le Phi Hung
- University of Medicine and Pharmacy, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
- Online Research Club, http://onlineresearchclub.org
| | - Nguyen Thien Luan
- University of Medicine and Pharmacy, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
- Online Research Club, http://onlineresearchclub.org
| | - Nguyen Hoang Anh
- Online Research Club, http://onlineresearchclub.org
- School of Medicine, Vietnam National University, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
| | - Tran Diem Nghi
- Online Research Club, http://onlineresearchclub.org
- School of Medicine, Vietnam National University, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
| | - Mai Van Hieu
- Online Research Club, http://onlineresearchclub.org
- School of Medicine, Vietnam National University, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
| | - Nguyen Thi Huyen Trang
- Online Research Club, http://onlineresearchclub.org
- University of Medicine and Pharmacy at Hue City, Hue, 53000, Vietnam
| | - Herizo Fabien Rafidinarivo
- Online Research Club, http://onlineresearchclub.org
- Nagasaki University Graduate School of Pharmaceutical Sciences, Nagasaki, 852–8523, Japan
| | - Nguyen Ky Anh
- University of Medicine and Pharmacy, Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam
- Online Research Club, http://onlineresearchclub.org
| | - David Hawkes
- Online Research Club, http://onlineresearchclub.org
- The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, Victoria, 3010, Australia
- * E-mail: (NTH); (DH); (KH)
| | - Nguyen Tien Huy
- Online Research Club, http://onlineresearchclub.org
- Department of Clinical Product Development, Institute of Tropical Medicine (NEKKEN), Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852–8523, Japan
- * E-mail: (NTH); (DH); (KH)
| | - Kenji Hirayama
- Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852–8523, Japan
- * E-mail: (NTH); (DH); (KH)
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Affiliation(s)
- Karen Farchaus Stein
- Karen Farchaus Stein, PhD, RN, FAAN, University of Rochester, Rochester, NY, USA
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23
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Nissen T, Wynn R. The clinical case report: a review of its merits and limitations. BMC Res Notes 2014; 7:264. [PMID: 24758689 PMCID: PMC4001358 DOI: 10.1186/1756-0500-7-264] [Citation(s) in RCA: 346] [Impact Index Per Article: 31.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2014] [Accepted: 04/17/2014] [Indexed: 11/16/2022] Open
Abstract
Background The clinical case report has a long-standing tradition in the medical literature. While its scientific significance has become smaller as more advanced research methods have gained ground, case reports are still presented in many medical journals. Some scholars point to its limited value for medical progress, while others assert that the genre is undervalued. We aimed to present the various points of view regarding the merits and limitations of the case report genre. We searched Google Scholar, PubMed and select textbooks on epidemiology and medical research for articles and book-chapters discussing the merits and limitations of clinical case reports and case series. Results The major merits of case reporting were these: Detecting novelties, generating hypotheses, pharmacovigilance, high applicability when other research designs are not possible to carry out, allowing emphasis on the narrative aspect (in-depth understanding), and educational value. The major limitations were: Lack of ability to generalize, no possibility to establish cause-effect relationship, danger of over-interpretation, publication bias, retrospective design, and distraction of reader when focusing on the unusual. Conclusions Despite having lost its central role in medical literature in the 20th century, the genre still appears popular. It is a valuable part of the various research methods, especially since it complements other approaches. Furthermore, it also contributes in areas of medicine that are not specifically research-related, e.g. as an educational tool. Revision of the case report genre has been attempted in order to integrate the biomedical model with the narrative approach, but without significant success. The future prospects of the case report could possibly be in new applications of the genre, i.e. exclusive case report databases available online, and open access for clinicians and researchers.
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Affiliation(s)
| | - Rolf Wynn
- Department of Clinical Medicine, University of Tromsø, N-9038 Tromsø, Norway.
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Talat B, Mayers A, Baldwin DS. Quality of case reports of adverse drug reactions with psychotropic drugs: a 25-year review. Hum Psychopharmacol 2013; 28:413-20. [PMID: 23754771 DOI: 10.1002/hup.2329] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2012] [Accepted: 04/29/2013] [Indexed: 12/26/2022]
Abstract
Case reports of adverse reactions with psychotropic drugs can be useful in raising hypotheses, to be tested with more rigorous study designs. However such reports have significant methodological drawbacks, making it hard to determine causality. We undertook a systematic assessment of the quality of case reports and small case series published within Human Psychopharmacology over 25 years. For reports of adverse drug reactions, modified Bradford Hill criteria for causality (for consistency, strength, specificity, temporal relationship and plausibility) were used to ascertain the quality of the account. Reports which had been cited at least 10 times by December 2010 were examined in detail, to assess their overall contribution in extending understanding and influencing clinical practice. Of 40 reports of adverse drug reactions, only seven were sufficiently robust for confidence in probable or possible causality. Nine reports had been cited more than 10 times: the five most frequently cited reports of adverse drug reactions described movement disorders, suicidal thoughts and discontinuation symptoms with SSRIs: clinical relevance was high, but their quality was not markedly greater than less frequently cited reports. Nearly all reports of adverse drug reactions, published in a single journal over 25 years, were insufficiently robust to demonstrate probable causality. Reports that are cited frequently become influential because of their potential clinical relevance, rather than due to their methodological quality.
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Affiliation(s)
- Bilal Talat
- Avon and Wiltshire Mental Health Partnership NHS Trust, Bristol, UK; Faculty of Medicine, University of Southampton, Southampton, UK
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Ramasamy SN, Korb-Wells CS, Kannangara DRW, Smith MWH, Wang N, Roberts DM, Graham GG, Williams KM, Day RO. Allopurinol Hypersensitivity: A Systematic Review of All Published Cases, 1950–2012. Drug Saf 2013; 36:953-80. [DOI: 10.1007/s40264-013-0084-0] [Citation(s) in RCA: 127] [Impact Index Per Article: 10.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
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Selvaraj SA, Chairez E, Wilson LM, Lazarev M, Bass EB, Hutfless S. Use of case reports and the Adverse Event Reporting System in systematic reviews: overcoming barriers to assess the link between Crohn's disease medications and hepatosplenic T-cell lymphoma. Syst Rev 2013; 2:53. [PMID: 23826928 PMCID: PMC3710465 DOI: 10.1186/2046-4053-2-53] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2013] [Accepted: 06/24/2013] [Indexed: 01/03/2023] Open
Abstract
BACKGROUND To identify demographic and clinical characteristics associated with cases of hepatosplenic T-cell lymphoma (HSTCL) in patients with Crohn's disease, and to assess strength of evidence for a causal relationship between medications and HSTCL in Crohn's disease. METHODS We identified cases of HSTCL in Crohn's disease in studies included in a comparative effectiveness review of Crohn's disease medications, through a separate search of PubMed and Embase for published case reports, and from the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS). We used three causality assessment tools to evaluate the relationship between medication exposure and HSTCL. RESULTS We found 37 unique cases of HSTCL in patients with Crohn's disease. Six cases were unique to the published literature and nine were unique to AERS. Cases were typically young (<40 years of age) and male (86%). The most commonly reported medications were anti-metabolites (97%) and anti-tumor necrosis factor alpha (anti-TNFa) medications (76%). Dose and duration of therapy were not consistently reported. Use of aminosalicylates and corticosteroids were rarely reported, despite the high prevalence of these medications in routine treatment. Using the causality assessment tools, it could only be determined that anti-metabolite and anti-TNFa therapies were possible causes of HSTCL in Crohn's disease based on the data contained in the case reports. CONCLUSION Systematic reviews that incorporate case reports of rare lethal events should search both published literature and AERS, but consideration should be given to the limitations of case reports. In this study, establishing a causative effect other than 'possible' between anti-metabolite or anti-TNFa therapies and HSTCL was not feasible because case reports lacked data required by the causality assessments, and because of the limited applicability of causality assessment tools for rare irreversible events. We recommend minimum reporting requirements for case reports to improve causality assessment and routine reporting of rare life-threatening events, including their absence, in clinical trials to help clinicians determine whether rare adverse events are causally related to a medication.
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Affiliation(s)
- Saranya A Selvaraj
- Johns Hopkins University School of Medicine, 733 North Broadway, Baltimore, MD 21205-2196, USA.
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Abstract
Open-access publishing, which removes monetary and legal restrictions from Internet reading, provides benefits for readers and publishers alike. Radiology Case Reports has used an open-access publishing model from its inception.
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Strum SC. Darwin's monkey: Why baboons can't become human. AMERICAN JOURNAL OF PHYSICAL ANTHROPOLOGY 2012; 149 Suppl 55:3-23. [DOI: 10.1002/ajpa.22158] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/06/2012] [Accepted: 09/07/2012] [Indexed: 11/07/2022]
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Rumack B, Heard K, Green J, Albert D, Bucher-Bartelson B, Bodmer M, Sivilotti MLA, Dart RC. Effect of therapeutic doses of acetaminophen (up to 4 g/day) on serum alanine aminotransferase levels in subjects consuming ethanol: systematic review and meta-analysis of randomized controlled trials. Pharmacotherapy 2012; 32:784-91. [PMID: 22851428 DOI: 10.1002/j.1875-9114.2012.01122.x] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
STUDY OBJECTIVE To quantify the effect of therapeutic doses of acetaminophen on serum alanine aminotransferase (ALT) levels in subjects who consumed ethanol. DESIGN Systematic review of six randomized placebo-controlled trials, of which five were included in a meta-analysis. SUBJECTS Subjects included in the meta-analysis were those who consumed ethanol and received acetaminophen in doses up to 4 g/day (551 subjects) or placebo (350 subjects). MEASUREMENTS AND MAIN RESULTS A comprehensive literature search of the MEDLINE, EMBASE, and International Pharmaceutical Abstracts databases and the Cochrane Central Register of Controlled Trials was performed to identify randomized, placebo-controlled trials that enrolled subjects who consumed ethanol, received acetaminophen in therapeutic doses up to 4 g/day, and had serum ALT level measurements. A total of 184 articles were identified; six articles met all criteria. Five of the six articles reported ALT levels on study day 4 for both groups of subjects who received acetaminophen or placebo. Thus, for the meta-analysis, we used the primary outcome of mean change in serum ALT level from baseline to day 4 in the acetaminophen groups compared with the placebo groups. We found that the difference in mean change from baseline ALT levels between the acetaminophen and placebo groups on day 4 was 0.0 U/L (95% confidence interval -0.2-0.1 U/L). There were no reports of liver dysfunction, liver failure, or death in any of the trials. CONCLUSION In randomized, placebo-controlled trials of subjects who consumed ethanol, no elevation of ALT level on study day 4 was noted when subjects ingested up to 4 g/day of acetaminophen.
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Affiliation(s)
- Barry Rumack
- Denver Health and Hospital Authority Rocky Mountain Poison and Drug Center, Denver, Colorado 80204, USA
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Abstract
Case reports remain an invaluable resource in the literature, and they continue to serve an equally important role in scientific advancement. They record discoveries, report the unexpected, and spark further research. Preparation of a case report can be a great learning experience, especially for medical students, residents, and young physicians. It serves as an excellent introduction to academic writing, familiarizing them with all aspects of publishing, from a structured case presentation and literature review to submitting and revising a manuscript. It can also stimulate an interest in a specific topic and gradually lead to more involved and complex academic endeavors.
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Hung SK, Hillier S, Ernst E. Case reports of adverse effects of herbal medicinal products (HMPs): a quality assessment. PHYTOMEDICINE : INTERNATIONAL JOURNAL OF PHYTOTHERAPY AND PHYTOPHARMACOLOGY 2011; 18:335-343. [PMID: 20739165 DOI: 10.1016/j.phymed.2010.07.007] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/13/2009] [Revised: 05/07/2010] [Accepted: 07/12/2010] [Indexed: 05/29/2023]
Abstract
BACKGROUND Case reports provide essential information on adverse effects. Yet there is little consistency in the quality and format of reporting them. AIM In this study, we aimed to assess the quality of case reports of adverse effect of herbal medicinal products (HMPs) published during three time periods, 1986-1988, 1996-1998, and 2006-2008. METHODS We conducted literature searches in four major databases: Medline, EMBASE, AMED, and CINALH. Each case report was subject to specific inclusion criteria related to the intervention (i.e. herbal medicine) and outcome measurement (i.e. adverse effect). A 21-item scale was used to assess the quality of all included reports. Each report was categorised into low quality (score between 0 and 14), lower medium quality (score between 15 and 21), upper medium quality (score between 22 and 28), and high quality (score between 29 and 42). RESULTS In total, 137 case reports were included. The percentage of high quality case reports rose from 0% in 1986-1988 to 27.9% in 1996-1998 and 34.2% in 2006-2008; conversely, the percentages of low quality case reports dropped from 13.3% in 1986-1988 to 0% in 1996-1998 and 2.5% in 2006-2008. CONCLUSION These findings are consistent with the notion that the quality of case reports is improving. However, due to several caveats, our data should be interpreted with caution.
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Affiliation(s)
- Shao Kang Hung
- Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK.
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Impicciatore P, Mucci M. Completeness of published case reports on suspected adverse drug reactions: evaluation of 100 reports from a company safety database. Drug Saf 2010; 33:765-73. [PMID: 20701409 DOI: 10.2165/11537500-000000000-00000] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND Case reports of suspected adverse drug reactions (ADRs) are common in the biomedical literature. Standards for authors and editors for writing, submitting and publishing ADR case reports have been empirically established since the 1980s; however, these recommendations have not been widely disseminated or incorporated into practice. Comprehensive and standardized guidelines on good publication practice have recently been proposed. No study has been performed so far to assess the adherence of published ADR case reports to these guidelines. OBJECTIVE To describe the current situation with regards to the reliability and completeness of published ADR case reports. METHODS A random sample of 100 single ADR case reports published between 2005 and 2008 (25 for each year) was retrieved from Pfizer's pharmacovigilance database. Reliability and completeness were assessed by comparing the relevant information contained in the retrieved ADR case reports against the recommendations prescribed by the guidelines. Descriptive statistics and correlation analysis using the Statistical Package for Social Science (SPSS) were undertaken. RESULTS The patient's medical history relevant to the ADR was reported in 92% of the case reports. Concerning the suspected drug, 11% of the reports included the proprietary name; duration, dosage, route and formulation were reported in 87%, 85%, 37% and 21% of the reports, respectively. Information on concomitant therapies was included in 71% of the reports. The description of the ADR contained details on management (99%), time-course (97%) and diagnostic tests (95%), while final outcome and seriousness were reported in 73% and 52% of the reports, respectively. A discussion on the possible mechanism for the ADR was present in 70% of the case reports. The possible implications for clinical practice of the reported drug-event association were described in 75% of the cases. Causality assessment was reported in 81%, and rating scales to support the causal link were used in 20% of the reports. The major predictive factor for the presence of an objective causality assessment was found to be publication in specialized pharmacoepidemiology or clinical pharmacology journals: 47% specialized versus 11% non-specialized (odds ratio = 6.93; 95% CI 2.37, 20.26). CONCLUSIONS The findings of this study show that published ADR case reports, especially those coming from non-specialized journals, still lack important information necessary for comprehensive evaluation. As published ADR case reports are expected to be reported to regulatory authorities using the same approach as for spontaneous cases, it is paramount for their effective integration in the pharmacovigilance system that pharmaceutical companies and learned societies actively promote a culture of good publication practices.
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Affiliation(s)
- Piero Impicciatore
- Safety Evaluation and Reporting, Worldwide Safety & Regulatory Operations, Pfizer Medical, Milan, Italy.
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Abstract
There are few controlled clinical trials in medical toxicology to guide treatment decisions. Given the relative paucity of definitive data, we determined the types of evidence used to support treatment recommendations given in three major toxicology textbooks. One author reviewed the acetaminophen, tricyclic antidepressant, calcium channel blocker plus any relevant antidote chapters in three textbooks: Goldfranks Toxicologic Emergencies, Critical Care Toxicology, and Medical Toxicology. We identified statements that gave a treatment recommendation and classified the citation using the following system: No citation, general review article, in vitro study, animal study, case reports (n<3), case series (n>2), retrospective study, prospective observational study, and controlled clinical trial. Proportions for each type of citation with 95% confidence intervals were determined. We identified 469 treatment recommendations. We could not classify 57/742 citations. A large number of statements were not referenced (14%, 95% CI 12-17%). The most common citation types were case reports (28%, 95% CI 25-31%) and animal studies (18%, 16-21%). The proportions for the remaining types of citations were: review article (9%, 7-11%), clinical trials (9%, 7-11%), retrospective studies (8%, 6-10%), prospective observational studies (5%, 3-6%), and case series (4%, 3-6%). There is a need for more systematic studies of poisoned patients. As case reports are commonly used to support treatment recommendations, they should be held to rigorous scientific standards and include information to assess the validity of the conclusions. Case reports and animal studies are commonly used as evidence to support treatment recommendations in medical toxicology textbooks.
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Affiliation(s)
- Ryan Chuang
- Rocky Mountain Poison & Drug Center, 777 Bannock St. MC-0180, Denver, CO 80204-4507, USA.
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Maignen F, Hauben M, Tsintis P. Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation. Drug Saf 2010; 33:417-34. [PMID: 20397741 DOI: 10.2165/11532850-000000000-00000] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022]
Abstract
BACKGROUND It has been postulated that the time to onset of adverse drug reactions is connected to the underlying pharmacological (or toxic) mechanism of adverse drug reactions whether the reaction is time dependent or not. OBJECTIVE We have conducted a preliminary study using the parametric modelling of the time to onset of adverse reactions as an approach to signal detection on spontaneous reporting system databases. METHODS We performed a parametric modelling of the reported time to onset of adverse drug reactions for which the underlying toxic mechanism is characterized. For the purpose of our study, we have used the reported liver injuries associated with bosentan, and the infections associated with the use of the tumour necrosis factor (TNF) inhibitors, adalimumab, etanercept and infliximab, which are used in Crohn's disease and rheumatoid arthritis, reported to EudraVigilance between December 2001 and September 2006. RESULTS The main results reflect the fact that the reported time to onset is a surrogate of the true time to onset of the reaction and combines three hazards (occurrence, diagnosis and reporting) that cannot be disentangled. Consequently, the modelling of the time to onset of reactions reported with TNF inhibitors showed differences that could reflect different pharmacological activities, indications, monitoring of the patients or different reporting patterns. These variations could also limit the interpretation of the parametric modelling. CONCLUSIONS Some consistency that was found between the occurrences of the infections with the TNF inhibitors suggests a causal association. There are statistical issues that are important to keep in mind when interpreting the results (the impact of the data quality on the fit of the distributions and the absence of a test of hypothesis linked to the absence of a relevant comparator). The study suggests that the modelling of the reported time to onset of adverse reactions could be a useful adjunct to other signal detection methods.
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Affiliation(s)
- François Maignen
- Pharmacovigilance and Risk Management Sector, European Medicines Agency, London, UK.
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Jullien D, Boulinguez S. [How should one advance the current therapeutic strategies and objectives?]. Ann Dermatol Venereol 2010; 137:5-10. [PMID: 20510179 DOI: 10.1016/s0151-9638(10)70016-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Affiliation(s)
- Denis Jullien
- Service de Dermatologie, Hôpital Edouard Herriot, Lyon, France.
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Wu T, Shang H, Bian Z, Zhang J, Li T, Li Y, Zhang B. Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine. J Evid Based Med 2010; 3:11-7. [PMID: 21349035 DOI: 10.1111/j.1756-5391.2010.01056.x] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
Clearly report adverse effect or adverse event occurred in the clinical practice is very important for understanding the potential risk of using a drug for treatment of diseases, and with other advantages. This document aims to help healthcare providers to organize, report, and publish information on ADR/AE occurrences and to identify the nature of the ADR/AE in TCM and integrative medicine practice. This document provides recommendations on constructing a title, basic factors of writing an abstract and the text of ADR/AE reporting. In each part, there are some samples could be references for the development of a report and ADR/AE. We welcome any comments for improving this recommendation.
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Affiliation(s)
- Taixiang Wu
- Chinese Clinical Trial Registry, West China Hospital, Sichuan University, Chengdu, China
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Moreno RP, Rhodes A, Donchin Y. Patient safety in intensive care medicine: the Declaration of Vienna. Intensive Care Med 2009; 35:1667-72. [PMID: 19697007 PMCID: PMC2749175 DOI: 10.1007/s00134-009-1621-2] [Citation(s) in RCA: 51] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2009] [Accepted: 08/09/2009] [Indexed: 10/31/2022]
Affiliation(s)
- Rui P Moreno
- Unidade de Cuidados Intensivos Polivalente, Hospital de Santo António dos Capuchos, Alameda de Santo António dos Capuchos, 1169-050, Lisbon, Portugal.
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Hochberg AM, Hauben M, Pearson RK, O'Hara DJ, Reisinger SJ, Goldsmith DI, Gould AL, Madigan D. An evaluation of three signal-detection algorithms using a highly inclusive reference event database. Drug Saf 2009; 32:509-25. [PMID: 19459718 DOI: 10.2165/00002018-200932060-00007] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022]
Abstract
BACKGROUND Pharmacovigilance data-mining algorithms (DMAs) are known to generate significant numbers of false-positive signals of disproportionate reporting (SDRs), using various standards to define the terms 'true positive' and 'false positive'. OBJECTIVE To construct a highly inclusive reference event database of reported adverse events for a limited set of drugs, and to utilize that database to evaluate three DMAs for their overall yield of scientifically supported adverse drug effects, with an emphasis on ascertaining false-positive rates as defined by matching to the database, and to assess the overlap among SDRs detected by various DMAs. METHODS A sample of 35 drugs approved by the US FDA between 2000 and 2004 was selected, including three drugs added to cover therapeutic categories not included in the original sample. We compiled a reference event database of adverse event information for these drugs from historical and current US prescribing information, from peer-reviewed literature covering 1999 through March 2006, from regulatory actions announced by the FDA and from adverse event listings in the British National Formulary. Every adverse event mentioned in these sources was entered into the database, even those with minimal evidence for causality. To provide some selectivity regarding causality, each entry was assigned a level of evidence based on the source of the information, using rules developed by the authors. Using the FDA adverse event reporting system data for 2002 through 2005, SDRs were identified for each drug using three DMAs: an urn-model based algorithm, the Gamma Poisson Shrinker (GPS) and proportional reporting ratio (PRR), using previously published signalling thresholds. The absolute number and fraction of SDRs matching the reference event database at each level of evidence was determined for each report source and the data-mining method. Overlap of the SDR lists among the various methods and report sources was tabulated as well. RESULTS The GPS algorithm had the lowest overall yield of SDRs (763), with the highest fraction of events matching the reference event database (89 SDRs, 11.7%), excluding events described in the prescribing information at the time of drug approval. The urn model yielded more SDRs (1562), with a non-significantly lower fraction matching (175 SDRs, 11.2%). PRR detected still more SDRs (3616), but with a lower fraction matching (296 SDRs, 8.2%). In terms of overlap of SDRs among algorithms, PRR uniquely detected the highest number of SDRs (2231, with 144, or 6.5%, matching), followed by the urn model (212, with 26, or 12.3%, matching) and then GPS (0 SDRs uniquely detected). CONCLUSIONS The three DMAs studied offer significantly different tradeoffs between the number of SDRs detected and the degree to which those SDRs are supported by external evidence. Those differences may reflect choices of detection thresholds as well as features of the algorithms themselves. For all three algorithms, there is a substantial fraction of SDRs for which no external supporting evidence can be found, even when a highly inclusive search for such evidence is conducted.
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Kelly W, Arellano F, Barnes J, Bergman U, Edwards R, Fernandez A, Freedman S, Goldsmith D, Huang K, Jones J, McLeay R, Moore N, Stather R, Trenque T, Troutman W, van Puijenbroek E, Williams F, Wise R. Guidelines for Submitting Adverse Event Reports for Publication. Therapie 2009; 64:289-94. [DOI: 10.2515/therapie/2009041] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/30/2009] [Indexed: 11/20/2022]
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Richason TP, Paulson SM, Lowenstein SR, Heard KJ. Case reports describing treatments in the emergency medicine literature: missing and misleading information. BMC Emerg Med 2009; 9:10. [PMID: 19527500 PMCID: PMC2703616 DOI: 10.1186/1471-227x-9-10] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/04/2009] [Accepted: 06/15/2009] [Indexed: 12/03/2022] Open
Abstract
BACKGROUND Although randomized trials and systematic reviews provide the "best evidence" for guiding medical practice, many emergency medicine journals still publish case reports (CRs). The quality of the reporting in these publications has not been assessed. OBJECTIVES In this study we sought to determine the proportion of treatment-related case reports that adequately reported information about the patient, disease, interventions, co-interventions, outcomes and other critical information. METHODS We identified CRs published in 4 emergency medicine journals in 2000-2005 and categorized them according to their purpose (disease description, overdose or adverse drug reactioin, diagnostic test or treatment effect). Treatment-related CRs were reviewed for the presence or absence of 11 reporting elements. RESULTS All told, 1,316 CRs were identified; of these, 85 (6.5%; 95CI = 66, 84) were about medical or surgical treatments. Most contained adequate descriptions of the patient (99%; 95CI = 95, 100), the stage and severity of the patient's disease (88%; 95CI = 79, 93), the intervention (80%; 95CI = 70, 87) and the outcomes of treatment (90%; 95CI = 82, 95). Fewer CRs reported the patient's co-morbidities (45%; 95CI = 35, 56), concurrent medications (30%; 95CI = 21, 40) or co-interventions (57%; 95CI = 46, 67) or mentioned any possible treatment side-effects (33%; 95CI = 24, 44). Only 37% (95CI = 19, 38) discussed alternative explanations for favorable outcomes. Generalizability of treatment effects to other patients was mentioned in only 29% (95CI = 20, 39). Just 2 CRs (2.3%; 95CI = 1, 8) reported a 'denominator" (number of patients subjected to the same intervention, whether or not successful. CONCLUSION Treatment-related CRs in emergency medicine journals often omit critical details about treatments, co-interventions, outcomes, generalizability, causality and denominators. As a result, the information may be misleading to providers, and the clinical applications may be detrimental to patient care.
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Affiliation(s)
| | - Stephen M Paulson
- Denver Health Residency in Emergency Medicine, Denver Health, Denver CO, USA
| | - Steven R Lowenstein
- The Colorado Emergency Medicine Research Center, Division of Emergency Medicine, Department of Surgery, University of Colorado School Denver of Medicine, Aurora CO, USA
| | - Kennon J Heard
- The Colorado Emergency Medicine Research Center, Division of Emergency Medicine, Department of Surgery, University of Colorado School Denver of Medicine, Aurora CO, USA
- Rocky Mountain Poison and Drug Center, Denver Health, Denver CO, USA
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AHRQ series paper 4: assessing harms when comparing medical interventions: AHRQ and the effective health-care program. J Clin Epidemiol 2008; 63:502-12. [PMID: 18823754 DOI: 10.1016/j.jclinepi.2008.06.007] [Citation(s) in RCA: 131] [Impact Index Per Article: 7.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2008] [Revised: 06/21/2008] [Accepted: 06/21/2008] [Indexed: 12/23/2022]
Abstract
Comparative effectiveness reviews (CERs) are systematic reviews that evaluate evidence on alternative interventions to help clinicians, policy makers, and patients make informed treatment choices. Reviews should assess harms and benefits to provide balanced assessments of alternative interventions. Identifying important harms of treatment and quantifying the magnitude of any risks require CER authors to consider a broad range of data sources, including randomized controlled trials (RCTs) and observational studies. This may require evaluation of unpublished data in addition to published reports. Appropriate synthesis of harms data must also consider issues related to evaluation of rare or uncommon events, assessments of equivalence or noninferiority, and use of indirect comparisons. This article presents guidance for evaluating harms when conducting and reporting CERs. We include suggestions for prioritizing harms to be evaluated, use of terminology related to reporting of harms, selection of sources of evidence on harms, assessment of risk of bias (quality) of harms reporting, synthesis of evidence on harms, and reporting of evidence on harms.
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Simera I, Altman DG, Moher D, Schulz KF, Hoey J. Guidelines for reporting health research: the EQUATOR network's survey of guideline authors. PLoS Med 2008; 5:e139. [PMID: 18578566 PMCID: PMC2443184 DOI: 10.1371/journal.pmed.0050139] [Citation(s) in RCA: 163] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/22/2023] Open
Abstract
Iveta Simera and colleagues survey the authors of 37 guidelines on reporting health research.
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Affiliation(s)
- Iveta Simera
- Centre for Statistics in Medicine, Oxford, United Kingdom.
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Smith R. Why do we need Cases Journal? CASES JOURNAL 2008; 1:1. [PMID: 18577237 PMCID: PMC2423473 DOI: 10.1186/1757-1626-1-1] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 04/30/2008] [Accepted: 05/12/2008] [Indexed: 11/24/2022]
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Kelly WN, Arellano FM, Barnes J, Bergman U, Edwards IR, Fernandez AM, Freedman SB, Goldsmith DI, Huang K, Jones JK, McLeay R, Moore N, Stather RH, Trenque T, Troutman WG, van Puijenbroek E, Williams F, Wise RP. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol Drug Saf 2007; 16:581-7. [PMID: 17471601 DOI: 10.1002/pds.1399] [Citation(s) in RCA: 58] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.
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Affiliation(s)
- William N Kelly
- William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA.
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Kelly WN, Arellano FM, Barnes J, Bergman U, Edwards RI, Fernandez AM, Freedman SB, Goldsmith DI, Huang KA, Jones JK, McLeay R, Moore N, Stather RH, Trenque T, Troutman WG, van Puijenbroek E, Williams F, Wise RP. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30:367-73. [PMID: 17472416 DOI: 10.2165/00002018-200730050-00001] [Citation(s) in RCA: 90] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/02/2022]
Abstract
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.
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Affiliation(s)
- William N Kelly
- William N. Kelly Consulting, Inc., Oldsmar, Florida 34677, USA.
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Demonaco HJ, Ali A, Hippel EV. The major role of clinicians in the discovery of off-label drug therapies. Pharmacotherapy 2006; 26:323-32. [PMID: 16503712 DOI: 10.1592/phco.26.3.323] [Citation(s) in RCA: 92] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
OBJECTIVE To determine the role of clinicians in the discovery of off-label use of prescription drugs approved by the United States Food and Drug Administration (FDA). Data Sources. Micromedex Healthcare Series was used to identify new uses of new molecular entities approved by the FDA in 1998, literature from January 1999-December 2003 was accessed through MEDLINE, and relevant patents were identified through the U.S. Patent and Trademark Office. DATA SYNTHESIS AND MAIN FINDING A survey of new therapeutic uses for new molecular entity drugs approved in 1998 was conducted for the subsequent 5 years of commercial availability. During that period, 143 new applications were identified in a computerized search of the literature for the 29 new drugs considered and approved in 1998. Literature and patent searches were conducted to identify the first report of each new application. Authors of the seminal articles were contacted through an electronic survey to determine whether they were in fact the originators of the new applications. If they were, examination of article content and author surveys were used to explore if each new application was discovered through clinical practice that was independent of pharmaceutical company or university research (field discovery) or if the discovery was made by or with the involvement of pharmaceutical company or university researchers (central discovery). Eighty-two (57%) of the 143 drug therapy innovations in our sample were discovered by practicing clinicians through field discovery. CONCLUSION To our knowledge, the major role of clinicians in the discovery of new, off-label drug therapies has not been previously documented or explored. We propose that this finding has important regulatory and health policy implications.
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Affiliation(s)
- Harold J Demonaco
- Massachusetts Institute of Technology-Sloan School of Management, Cambridge, Massachusetts 02114, USA.
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Abstract
Experience of knowledge management initiatives in non-health care organizations can offer useful insights, and strategies, to implement evidence-based practice in health care. Knowledge management offers a structured process for the generation, storage, distribution and application of knowledge in organizations. This includes both tacit knowledge (personal experience) and explicit knowledge (evidence). Communities of practice are a key component of knowledge management and have been recognized to be essential for the implementation of change in organizations. It is within communities of practice that tacit knowledge is actively integrated with explicit knowledge. Organizational factors that limit the development of knowledge management, including communities of practice, in non-health care organizations need to be overcome if the potential is to be achieved within health care.
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Affiliation(s)
- John Sandars
- Evidence for Population Health Unit, University of Manchester, Manchester, UK.
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