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Trials Oct 2018An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China....
Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol.
BACKGROUND
An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outcome measurement instruments has produced little evidence for traditional Chinese medicine in treating NVAF because many trials cannot be included in a meta-analysis. The majority of the trials did not report endpoint outcomes, side effects or other important outcomes for patients, which makes it difficult to evaluate the efficacy and safety of traditional Chinese medicine. Therefore, it is important to develop a core outcome set (COS). Although there are two related COSs for clinical trials of atrial fibrillation, the methodology is limited, and the perspectives of Chinese experts and patients are unclear. Therefore, we will develop a COS and recommend outcome measurement instruments after finishing the COS, which can be used for clinical trials of traditional Chinese medicine in NVAF.
METHODS/DESIGN
The method of the study will include eight stages led by a national multidisciplinary Steering Committee: (1) A systematic review will be developed to identify currently reported outcomes and traditional Chinese medicine syndromes in clinical trials of NVAF, (2) Semi-structured interviews of patients will be conducted to fill gaps in potential outcomes, (3) Traditional Chinese medicine syndrome names will be identified from medical records, (4) A dataset of traditional Chinese medicine syndrome names will be developed, (5) The investigation of traditional Chinese medicine syndromes will be conducted from cross-sectional study, (6) Two rounds of Delphi surveys will be carried out, (7) A consensus meeting will be conducted to develop a COS, and (8) Recommendations of outcome measurement instruments (OMIs), which should be used in the COS, will be developed.
DISCUSSION
The COS will improve the consistency of outcome reporting and reduce the reporting bias in NVAF clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials.
TRIAL REGISTRATION
This study is not a clinical trial, so it is registered in Core Outcome Measures in Effectiveness Trials Initiative (COMET). Registration number: 941 . Registered on 22 December 2016.
Topics: Aged; Atrial Fibrillation; Clinical Trial Protocols as Topic; Clinical Trials as Topic; Consensus; Delphi Technique; Drugs, Chinese Herbal; Endpoint Determination; Female; Humans; Male; Medicine, Chinese Traditional; Middle Aged; Research Design; Treatment Outcome
PubMed: 30290840
DOI: 10.1186/s13063-018-2904-0 -
Campbell Systematic Reviews 2018This review summarizes the evidence from six randomized controlled trials that judged the effectiveness of systematic review summaries on policymakers' decision making,...
UNLABELLED
This review summarizes the evidence from six randomized controlled trials that judged the effectiveness of systematic review summaries on policymakers' decision making, or the most effective ways to present evidence summaries to increase policymakers' use of the evidence. This review included six randomized controlled studies. A randomized controlled study is one in which the participants are divided randomly (by chance) into separate groups to compare different treatments or other interventions. This method of dividing people into groups means that the groups will be similar and that the effects of the treatments they receive will be compared more fairly. At the time the study is done, it is not known which treatment is the better one. The researchers who did these studies invited people from Europe, North America, South America, Africa, and Asia to take part in them. Two studies looked at "policy briefs," one study looked at an "evidence summary," two looked at a "summary of findings table," and one compared a "summary of findings table" to an evidence summary. None of these studies looked at how policymakers directly used evidence from systematic reviews in their decision making, but two studies found that there was little to no difference in how they used the summaries. The studies relied on reports from decision makers. These studies included questions such as, "Is this summary easy to understand?" Some of the studies looked at users' knowledge, understanding, beliefs, or how credible (trustworthy) they believed the summaries to be. There was little to no difference in the studies that looked at these outcomes. Study participants rated the graded entry format higher for usability than the full systematic review. The graded entry format allows the reader to select how much information they want to read. The study participants felt that all evidence summary formats were easier to understand than full systematic reviews.
PLAIN LANGUAGE SUMMARY
It is likely that evidence summaries are easier to understand than complete systematic reviews. Whether these summaries increase the use of evidence from systematic reviews in policymaking is not clear. Systematic reviews are long and technical documents that may be hard for policymakers to use when making decisions. Evidence summaries are short documents that describe research findings in systematic reviews. These summaries may simplify the use of systematic reviews.Other names for evidence reviews are , , , or . The goal of this review was to learn whether evidence summaries help policymakers use evidence from systematic reviews. This review also aimed to identify the best ways to present the evidence summary to increase the use of evidence. This review included six randomized controlled studies. A randomized controlled study is one in which the participants are divided randomly (by chance) into separate groups to compare different treatments or other interventions. This method of dividing people into groups means that the groups will be similar and that the effects of the treatments they receive will be compared more fairly. At the time the study is done, it is not known which treatment is the better one.The researchers who did these studies invited people from Europe, North America, South America, Africa, and Asia to take part in them. Two studies looked at "policy briefs," one study looked at an "evidence summary," two looked at a "summary of findings table," and one compared a "summary of findings table" to an evidence summary.None of these studies looked at how policymakers directly used evidence from systematic reviews in their decision making, but two studies found that there was little to no difference in how they used the summaries. The studies relied on reports from decision makers. These studies included questions such as, "Is this summary easy to understand?"Some of the studies looked at users' knowledge, understanding, beliefs, or how credible (trustworthy) they believed the summaries to be. There was little to no difference in the studies that looked at these outcomes. Study participants rated the graded entry format higher for usability than the full systematic review. The graded entry format allows the reader to select how much information they want to read.. The study participants felt that all evidence summary formats were easier to understand than full systematic reviews. Our review suggests that evidence summaries help policymakers to better understand the findings presented in systematic reviews. In short, evidence summaries should be developed to make it easier for policymakers to understand the evidence presented in systematic reviews. However, right now there is very little evidence on the best way to present systematic review evidence to policymakers. The authors of this review searched for studies through June 2016.
EXECUTIVE SUMMARY/ABSTRACT
Systematic reviews are important for decision makers. They offer many potential benefits but are often written in technical language, are too long, and do not contain contextual details which makes them hard to use for decision-making. Strategies to promote the use of evidence to decision makers are required, and evidence summaries have been suggested as a facilitator. Evidence summaries include policy briefs, briefing papers, briefing notes, evidence briefs, abstracts, summary of findings tables, and plain language summaries. There are many organizations developing and disseminating systematic review evidence summaries for different populations or subsets of decision makers. However, evidence on the usefulness and effectiveness of systematic review summaries is lacking. We present an overview of the available evidence on systematic review evidence summaries. This systematic review aimed to 1) assess the effectiveness of evidence summaries on policy-makers' use of the evidence and 2) identify the most effective summary components for increasing policy-makers' use of the evidence. We searched several online databases (Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Global Health Library, Popline, Africa-wide, Public Affairs Information Services, Worldwide Political Science Abstracts, Web of Science, and DfiD), websites of research groups and organizations which produce evidence summaries, and reference lists of included summaries and related systematic reviews. These databases were searched in March-April, 2016. Eligible studies included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) studies, and interrupted time series (ITS) studies. We included studies of policymakers at all levels as well as health system managers. We included studies examining any type of "evidence summary", "policy brief", or other product derived from systematic reviews that presented evidence in a summarized form. These interventions could be compared to active comparators (e.g. other summary formats) or no intervention.The primary outcomes were: 1) use of systematic review summaries decision-making (e.g. self-reported use of the evidence in policy-making, decision-making) and 2) policymaker understanding, knowledge, and/or beliefs (e.g. changes in knowledge scores about the topic included in the summary). We also assessed perceived relevance, credibility, usefulness, understandability, and desirability (e.g. format) of the summaries. Our database search combined with our grey literature search yielded 10,113 references after removal of duplicates. From these, 54 were reviewed in full text and we included 6 studies (reported in 7 papers, 1661 participants) as well as protocols from 2 ongoing studies. Two studies assessed the use of evidence summaries in decision-making and found little to no difference in effect. There was also little to no difference in effect for knowledge, understanding or beliefs (4 studies) and perceived usefulness or usability (3 studies). Summary of Findings tables and graded entry summaries were perceived as slightly easier to understand compared to complete systematic reviews. Two studies assessed formatting changes and found that for Summary of Findings tables, certain elements, such as reporting study event rates and absolute differences were preferred as well as avoiding the use of footnotes. No studies assessed adverse effects. The risks of bias in these studies were mainly assessed as unclear or low however, two studies were assessed as high risk of bias for incomplete outcome data due to very high rates of attrition. Evidence summaries may be easier to understand than complete systematic reviews. However, their ability to increase the use of systematic review evidence in policymaking is unclear.
PubMed: 37131376
DOI: 10.4073/csr.2018.8 -
Deutsches Arzteblatt International Jun 2018The patient's consent to a medical procedure must be preceded by a pre-procedure discussion with the physician that is documented on a standardized form. Evidence...
BACKGROUND
The patient's consent to a medical procedure must be preceded by a pre-procedure discussion with the physician that is documented on a standardized form. Evidence suggests that these forms lack information that would be relevant for an informed decision.
METHODS
We carried out a systematic literature search up to February 2017 for evidence on the quality and efficacy of informed consent forms. The definition of criteria for the evaluation of meta-information, content, and presentation were derived from current guidelines for evidence-based health information. As an example, we analyzed consent forms currently in use in Germany for 10 medical interventions with regard to decisionally relevant content and intelligibility of format.
RESULTS
Our literature search yielded 14 content analyses, which revealed that even some of the more important evaluative criteria were not always met, including information on benefits (9/14), risks (14/14), alternatives (11/14), the option of doing nothing (6/14), and numerical frequencies (2/14). All analyses indicated deficiencies in the content of the consent forms. We then analyzed 37 consent forms obtained from publishing companies (across Germany) and physician's practices in Hamburg. These forms were found to contain information on: the intervention (37/37), benefits (30/37), risks (37/37), alternatives (26/37), the option of doing nothing (4/37), numerical frequencies (10/37), the names of the authors (17/37), sources of information (0/37), and date of issue (21/37).
CONCLUSION
Both the evidence from foreign countries and our own analysis of the consent forms now in use in Germany revealed deficiencies, particularly in the communication of risks. New standards are needed to promote well-informed decision-making. Structural changes in the process of patient information and decision-making should be discussed.
Topics: Evaluation Studies as Topic; Forms as Topic; Germany; Humans; Informed Consent
PubMed: 29932049
DOI: 10.3238/arztebl.2018.0377 -
European Journal of Clinical... Aug 2018Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current... (Meta-Analysis)
Meta-Analysis
PURPOSE
Unclear labeling has been recognized as an important cause of look-alike medication errors. The aim of this literature review is to systematically evaluate the current evidence on strategies to minimize medication errors due to look-alike labels.
METHODS
A literature search of PubMed and EMBASE for all available years was performed independently by two reviewers. Original studies assessing strategies to minimize medication errors due to look-alike labels focusing on readability of labels by health professionals or consumers were included. Data were analyzed descriptively due to the variability of study methods.
RESULTS
Sixteen studies were included. Thirteen studies were performed in a laboratory and three in a healthcare setting. Eleven studies evaluated Tall Man lettering, i.e., capitalizing parts of the drug name, two color-coding, and three studies other strategies. In six studies, lower error rates were found for the Tall Man letter strategy; one showed significantly higher error rates. Effects of Tall Man lettering on response time were more varied. A study in the hospital setting did not show an effect on the potential look-alike sound-alike error rate by introducing Tall Man lettering. Color-coding had no effect on the prevention of syringe-swaps in one study.
CONCLUSIONS
Studies performed in laboratory settings showed that Tall Man lettering contributed to a better readability of medication labels. Only few studies evaluated other strategies such as color-coding. More evidence, especially from real-life setting is needed to support safe labeling strategies.
Topics: Drug Labeling; Health Personnel; Hospitals; Humans; Medication Errors; Product Labeling; Reaction Time
PubMed: 29754215
DOI: 10.1007/s00228-018-2471-z -
Journal of Managed Care & Specialty... Mar 2018Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Generic drugs are bioequivalent and cost-effective alternatives to brand drugs. In 2014, $254 billion was saved because of the use of generic drugs in the United States.
OBJECTIVE
To critically assess evidence on the association between patient characteristics and generic drug use in order to inform the development of educational outreach for improving generic drug use among patients.
METHODS
We systematically searched the literature between January 2005 and December 2016 using PubMed, Web of Science, Ovid MEDLINE, Google Scholar, and EBSCO IPA-MEDLINE for potentially relevant studies. The titles and abstracts of identified articles were assessed independently by 2 reviewers. Titles and abstracts that were not written in English, were published before 2005, were not empirical, did not contain sociodemographic data, or were not policy or methodologically relevant to generic drug use were excluded. Data were pooled in a meta-analysis using the RStudio software to assess the association of patient-related factors with generic drug use.
RESULTS
Our searches resulted in 11 articles on patient-level factors, and 6 of these articles had sufficient information to conduct meta-analyses in the domains of patients' gender, age, race/ethnicity, and income. Quantitative analysis indicated that no differences in generic drug use existed between subgroups of patients defined by gender, age, or race/ethnicity. However, patients with lower income (i.e., < 200% federal poverty level [FPL]) were more likely to use generic drugs than those with higher income (≥ 200% FPL; pooled OR = 1.32, 95% CI = 1.15-1.52). Heterogeneity was high (I > 75%) for all analyses but income.
CONCLUSIONS
Patients with lower income were more likely to use generic drugs, whereas evidence was heterogeneous regarding an association between generic drug use and gender, age, or race/ethnicity. Educational outreach targeting patients with higher incomes to understand their perspectives in generic drugs may help improve generic drug use within that population.
DISCLOSURES
Funding for this study was made possible, in part, by the U.S. Food and Drug Administration through grant U01FD005486. Hansen has provided expert testimony for Daiichi Sankyo. No other authors have declared a potential conflict of interest. Views expressed in written materials or publications and by speakers do not necessarily reflect the official policies of the U.S. Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the U.S. government. Study concept and design were contributed by Howard, Harris, Kiptanui, Hansen, and Qian. Frank, Mishuk, Howard, Harris, and Kiptanui collected the data, and data interpretation was performed by Mishuk and Hansen, along with Qian, Harris, and Kiptanui. The manuscript was written and revised primarily by Mishuk, along with Qian and Hansen.
Topics: Cost-Benefit Analysis; Drugs, Generic; Humans; Social Class; Therapeutic Equivalency
PubMed: 29485953
DOI: 10.18553/jmcp.2018.24.3.252 -
Archives of Physiotherapy 2018There is a need for psychosocial interventions to address the escalating mental health burden in Sub-Saharan Africa (SSA). Physiotherapists could have a central role in... (Review)
Review
BACKGROUND
There is a need for psychosocial interventions to address the escalating mental health burden in Sub-Saharan Africa (SSA). Physiotherapists could have a central role in reducing the burden and facilitating recovery within the multidisciplinary care of people with mental health problems. The aim of this systematic review was to explore the role of physiotherapists within the current mental health policies of SSA countries and to explore the current research evidence for physiotherapy to improve functional outcomes in people with mental health problems in SSA.
METHODS
The Mental Health Atlas and MiNDbank of the World Health Organization were screened for the role of physiotherapy in mental health plans. Next, we systematically searched PubMed from inception until August 1st, 2017 for relevant studies on physiotherapy interventions in people with mental health problems in SSA. The following search strategy was used: "physiotherapy" OR "physical therapy" OR "rehabilitation" AND "mental" OR "depression" OR "psychosis" OR "schizophrenia" OR "bipolar" AND the name of the country.
RESULTS
The current systematic review shows that in 22 screened plans only 2 made reference to the importance of considering physiotherapy within the multidisciplinary treatment. The current evidence (N studies = 3; n participants = 94) shows that aerobic exercise might reduce depression and improve psychological quality of life, self-esteem, body image and emotional stress in people with HIV having mental health problems. In people with depression moderate to high but not light intensity aerobic exercise results in significantly less depressive symptoms ( = 1, = 30). Finally, there is evidence for reduction in post-traumatic stress symptoms (avoidance and arousal), anxiety and depression following body awareness related exercises (N = 1, = 26).
CONCLUSIONS
Our review demonstrated that physiotherapy is still largely neglected in the mental health care systems of SSA. This is probably due to poor knowledge of the benefits of physiotherapy within mental health care by policymakers, training institutes, and other mental health care professionals in SSA. Based on the current scientific evidence, this paper recommends the adoption of physiotherapy within mental health care services and investment in research and in training of professionals in SSA.
PubMed: 29423279
DOI: 10.1186/s40945-018-0043-2 -
The Cochrane Database of Systematic... Feb 2018The 8-aminoquinoline (8AQ) drugs act on Plasmodium falciparum gametocytes, which transmit malaria from infected people to mosquitoes. In 2012, the World Health... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The 8-aminoquinoline (8AQ) drugs act on Plasmodium falciparum gametocytes, which transmit malaria from infected people to mosquitoes. In 2012, the World Health Organization (WHO) recommended a single dose of 0.25 mg/kg primaquine (PQ) be added to malaria treatment schedules in low-transmission areas or those with artemisinin resistance. This replaced the previous recommendation of 0.75 mg/kg, aiming to reduce haemolysis risk in people with glucose-6-phosphate dehydrogenase deficiency, common in people living in malarious areas. Whether this approach, and at this dose, is effective in reducing transmission is not clear.
OBJECTIVES
To assess the effects of single dose or short-course PQ (or an alternative 8AQ) alongside treatment for people with P. falciparum malaria.
SEARCH METHODS
We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL), published in the Cochrane Library; and the WHO International Clinical Trials Registry Platform (ICRTP) portal using 'malaria*', 'falciparum', 'primaquine', '8-aminoquinoline', and eight 8AQ drug names as search terms. We checked reference lists of included trials, and contacted researchers and organizations. Date of last search: 21 July 2017.
SELECTION CRITERIA
Randomized controlled trials (RCTs) or quasi-RCTs in children or adults, adding PQ (or alternative 8AQ) as a single dose or short course alongside treatment for P. falciparum malaria.
DATA COLLECTION AND ANALYSIS
Two authors screened abstracts, applied inclusion criteria, and extracted data. We sought evidence on transmission (community incidence), infectiousness (people infectious and mosquitoes infected), and potential infectiousness (gametocyte measures assessed by microscopy or polymerase chain reaction [PCR]). We grouped trials into artemisinin and non-artemisinin treatments, and stratified by PQ dose (low, 0.2 to 0.25 mg/kg; moderate, 0.4 to 0.5 mg/kg; high, 0.75 mg/kg). We used GRADE, and absolute effects of infectiousness using trial control groups.
MAIN RESULTS
We included 24 RCTs and one quasi-RCT, comprising 43 arms. Fourteen trials evaluated artemisinin treatments (23 arms), nine trials evaluated non-artemisinin treatments (13 arms), and two trials included both artemisinin and non-artemisinin arms (three and two arms, respectively). Two trial arms used bulaquine. Seven PQ arms used low dose (six with artemisinin), 11 arms used moderate dose (seven with artemisinin), and the remaining arms used high dose. Fifteen trials tested for G6PD status: 11 excluded participants with G6PD deficiency, one included only those with G6PD deficiency, and three included all, irrespective of status. The remaining 10 trials either did not test or did not report on testing.No cluster trials evaluating community effects on malaria transmission met the inclusion criteria.With artemisinin treatmentLow dose PQInfectiousness (participants infectious to mosquitoes) was reduced (day 3 or 4: RR 0.12, 95% CI 0.02 to 0.88, 3 trials, 105 participants; day 8: RR 0.34, 95% CI 0.07 to 1.58, 4 trials, 243 participants; low certainty evidence). This translates to a reduction in percentage of people infectious on day 3 or 4 from 14% to 2%, and, for day 8, from 4% to 1%; the waning infectiousness in the control group by day 8 making the absolute effect smaller by day 8. For gametocytes detected by PCR, there was little or no effect of PQ at day 3 or 4 (RR 1.02, 95% CI 0.87 to 1.21; 3 trials, 414 participants; moderate certainty evidence); with reduction at day 8 (RR 0.52, 95% CI 0.41 to 0.65; 4 trials, 532 participants; high certainty evidence). Severe haemolysis was infrequent, with or without PQ, in these groups with few G6PD-deficient individuals (RR 0.98, 95% CI 0.69 to 1.39; 4 trials, 752 participants, moderate certainty evidence).Moderate dose PQInfectiousness was reduced (day 3 or 4: RR 0.13, 95% CI 0.02 to 0.94; 3 trials, 109 participants; day 8 RR 0.33, 95% CI 0.07 to 1.57; 4 trials, 246 participants; low certainty evidence). Illustrative risk estimates for moderate dose were the same as low dose. The pattern and level of certainty of evidence with gametocytes detected by PCR was the same as low dose, and severe haemolysis was infrequent in both groups.High dose PQInfectiousness was reduced (day 4: RR 0.2, 95% CI 0.02 to 1.68, 1 trial, 101 participants; day 8: RR 0.18, 95% CI 0.02 to 1.41, 2 trials, 181 participants, low certainty evidence). The effects on gametocyte prevalence showed a similar pattern to moderate and low dose PQ. Trials did not systematically report evidence of haemolysis.With non-artemisinin treatmentTrials with non-artemisinin treatment have been conducted only for moderate and high dose PQ. With high dose, infectiousness appeared markedly reduced on day 5 (RR 0.09, 95% CI 0.01 to 0.62; 30 participants, very low certainty evidence), with similar reductions at day 8. For both moderate dose (two trials with 221 people) and high dose (two trials with 30 people), reduction in gametocytes (detected by microscopy) showed similar patterns as for artemisinin treatments, with little or no effect at day 4 or 5, and larger effects by day 8. No trials with non-artemisinin partner drugs systematically sought evidence of severe haemolysis.Two trials comparing bulaquine with PQ suggest bulaquine may have larger effects on gametocytes by microscopy on day 8 (RR 0.41, 95% CI 0.26 to 0.66; 2 trials, 112 participants).
AUTHORS' CONCLUSIONS
A single low dose of PQ (0.25 mg/kg) added to artemisinin-based combination therapy for malaria reduces infectiousness of people to mosquitoes at day 3-4 and day 8, and appears as effective as higher doses. The absolute effect is greater at day 3 or 4, and smaller at day 8, in part because of the lower infectiousness in the control group. There was no evidence of increased haemolysis at 0.25 mg/kg, but few G6PD-deficient individuals were included in the trials. The effect on infectiousness precedes the effect of PQ on gametocyte prevalence. We do not know whether single dose PQ could reduce malaria transmission at community level.
Topics: Adult; Antimalarials; Artemisinins; Child; Chloroquine; Drug Combinations; Glucosephosphate Dehydrogenase Deficiency; Humans; Malaria, Falciparum; Mefloquine; Non-Randomized Controlled Trials as Topic; Plasmodium falciparum; Primaquine; Pyrimethamine; Quinine; Randomized Controlled Trials as Topic; Sulfadoxine; Time Factors
PubMed: 29393511
DOI: 10.1002/14651858.CD008152.pub5 -
BMC Musculoskeletal Disorders Dec 2017The management of acute acromioclavicular (AC) joint injuries depends on the degree of injury diagnosed by the Rockwood classification. Inadequate imaging and not... (Review)
Review
BACKGROUND
The management of acute acromioclavicular (AC) joint injuries depends on the degree of injury diagnosed by the Rockwood classification. Inadequate imaging and not selecting the most helpful imaging protocols can often lead to incorrect diagnosis of the injury. A consensus on a diagnostic imaging protocol for acute AC joint injuries does not currently exist. Therefore we conducted a systematic review of the literature considering three diagnostic parameters for patients with acromioclavicular (AC) joint injuries: 1) Assessment of vertical instability; 2) Assessment of horizontal instability; 3) Benefit of weighted panoramic views.
METHODS
Internet databases were searched in March 2016 using the terms ("AC joint" OR "acromioclavicular joint") AND (MRI OR MR OR radiograph OR X-ray OR Xray OR ultrasound OR "computer tomography" OR "computed tomography" OR CT). Diagnostic, prospective, retrospective, cohort and cross- sectional studies were included to compare their use of different radiological methods. Case reports, cadaveric studies, and studies concerning chronic AC injuries and clinical outcomes were excluded.
RESULTS
This search returned 1359 citations of which 1151 were excluded based on title, 116 based on abstract and 75 based on manuscript. 17 studies were included for review and were analyzed for their contributions to the three parameters of interest mentioned above. The inter- and intra-observer reliability for diagnosing vertical instabilities of the clavicle using x-ray alone show a high level of reproducibility while for horizontal instabilities the values were much more variable. In general, digitally measured parameters seem to be more precise and reliable between investigators than visual classification alone. Currently, evidence for the value of weighted views and other additional diagnostic imaging to supplement standard x-rays is controversial.
CONCLUSION
To date there is no consensus on a gold standard for diagnostic measures needed to classify acute AC joint injuries. The inter- and intra-observer reliability for diagnosing vertical instabilities of the clavicle using bilateral projections show a high level of reproducibility while for horizontal instabilities the results are much more inconsistent. There is currently no clear consensus on a protocol for image-based diagnosis and classification of acute AC joint injuries, leading to a lack of confidence in reproducibility and reliability.
Topics: Acromioclavicular Joint; Humans; Joint Instability; Magnetic Resonance Imaging; Tomography, X-Ray Computed
PubMed: 29216919
DOI: 10.1186/s12891-017-1864-y -
BMC Health Services Research Nov 2017To ensure quality of care delivery clinical supervision has been implemented in health services. While clinical supervision of health professionals has been shown to... (Review)
Review
BACKGROUND
To ensure quality of care delivery clinical supervision has been implemented in health services. While clinical supervision of health professionals has been shown to improve patient safety, its effect on other dimensions of quality of care is unknown. The purpose of this systematic review is to determine whether clinical supervision of health professionals improves effectiveness of care and patient experience.
METHODS
Databases MEDLINE, PsychINFO, CINAHL, EMBASE and AMED were searched from earliest date available. Additional studies were identified by searching of reference lists and citation tracking. Two reviewers independently applied inclusion and exclusion criteria. The quality of each study was rated using the Medical Education Research Study Quality Instrument. Data were extracted on effectiveness of care (process of care and patient health outcomes) and patient experience.
RESULTS
Seventeen studies across multiple health professions (medical (n = 4), nursing (n = 7), allied health (n = 2) and combination of nursing, medical and/or allied health (n = 4)) met the inclusion criteria. The clinical heterogeneity of the included studies precluded meta-analysis. Twelve of 14 studies investigating 38,483 episodes of care found that clinical supervision improved the process of care. This effect was most predominant in cardiopulmonary resuscitation and African health settings. Three of six studies investigating 1756 patients found that clinical supervision improved patient health outcomes, namely neurological recovery post cardiopulmonary resuscitation (n = 1) and psychological symptom severity (n = 2). None of three studies investigating 1856 patients found that clinical supervision had an effect on patient experience.
CONCLUSIONS
Clinical supervision of health professionals is associated with effectiveness of care. The review found significant improvement in the process of care that may improve compliance with processes that are associated with enhanced patient health outcomes. While few studies found a direct effect on patient health outcomes, when provided to mental health professionals clinical supervision may be associated with a reduction in psychological symptoms of patients diagnosed with a mental illness. There was no association found between clinical supervision and the patient experience.
REVIEW REGISTRATION
CRD42015029643 .
Topics: Health Personnel; Health Services; Humans; Mental Disorders; Outcome and Process Assessment, Health Care; Patient Compliance; Patient Satisfaction; Quality of Health Care
PubMed: 29183314
DOI: 10.1186/s12913-017-2739-5 -
Journal of Managed Care & Specialty... Dec 2017Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval... (Review)
Review
BACKGROUND
Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval and, as of August 2017, has been used to approve 5 biosimilars in the United States.
OBJECTIVE
To identify the types and quantities of evidence required by the FDA for biosimilar approval and the corresponding evidence manufacturers have provided in their 351(k) biosimilar approval applications.
METHODS
To collect data for this review, we searched through drug-specific FDA approval documents and approval-related FDA webcasts for approval indications and dates; reference product names; formulations; postmarketing requirements and commitments; evidence used for extrapolation claims; advisory committee votes; and evidence on similarity in analytical and functional characteristics, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity.
RESULTS
All biosimilars approved in the United States provided a large evidence base to demonstrate similarity in analytical and functional characteristics-3 to 5 clinical studies showed similarity in pharmacokinetics and pharmacodynamics, and 1 to 2 clinical studies demonstrated efficacy. Safety and immunogenicity were evaluated across all clinical studies. All biosimilars were compared with either the U.S.-licensed reference product or the reference product licensed by the European Union. Extrapolation allowed biosimilars to be approved for indications in which clinical studies were not conducted. The few indications for which biosimilars did not share approval with the reference product were due to market exclusivity protection. None of the 5 biosimilars have been approved as interchangeable in the United States.
CONCLUSIONS
The approval process for the first 5 biosimilars on the market in the United States provides a baseline understanding of what type and degree of evidence is required for biosimilar approval.
DISCLOSURES
There was no external funding for this study. Hung reports employment as a pharmacist for CVS Health, an AHRQ F32 grant, and meeting/accommodation/travel support from AACP, DIA, and ISPOR, all outside the submitted work. Vu and Mostovoy have nothing to disclose. Study concept and design were contributed by Hung and Mostovoy, along with Vu. Hung and Vu collected the data, and data interpretation was performed primarily by Hung, along with Mostovoy. The manuscript was written by Hung and Vu and revised by all the authors. Some of the study results were previously presented as a poster at the ISPOR 22nd Annual International Meeting; May 20-24, 2017; in Boston, Massachusetts.
Topics: Biosimilar Pharmaceuticals; Clinical Trials as Topic; Drug Approval; Drug Industry; Humans; United States; United States Food and Drug Administration
PubMed: 29172975
DOI: 10.18553/jmcp.2017.23.12.1234