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Journal of Clinical Pharmacy and... Dec 2021Despite the large body of evidence demonstrating equivalent efficacy and safety for branded drugs and their generic counterparts, some patients and providers have the...
WHAT IS KNOWN AND OBJECTIVES
Despite the large body of evidence demonstrating equivalent efficacy and safety for branded drugs and their generic counterparts, some patients and providers have the perception that generics may be less safe and effective than branded agents. Authorized generics (AGs) are a category of generic drugs defined by the United States Food and Drug Administration (FDA) as being the same as the brand-name drug without the brand's name on the label and which may have minor differences, such as tablet or capsule markings for identification. Studies in which AGs are considered along with other generics may increase our understanding of factors that may influence perceptions about generics and shed light on areas where education may be impactful. The objectives of this paper are to provide information about AGs, review studies in which they have been evaluated and explore the role that AGs may fill in the individualized treatment of patients.
METHODS
A literature review was conducted on 30 September 2019 with follow-up search on 4 March 2020. The search was focussed on published papers and meeting abstracts that provided information on AGs with respect to medical and health outcomes of therapy as well as switching in individuals receiving branded, AG, or other generic agents. Information about patients' perceptions of generic medications and adherence to therapy was also included. Additional information, including relevant government sources, such as the FDA website and the Federal Trade Commission Report, was included as appropriate.
RESULTS
The literature specific to AGs is limited, but available data clearly highlight the importance of patient perception of generics as well as medication appearance as factors that may affect adherence and potentially more frequent switchbacks to branded agents from generics or AGs.
WHAT IS NEW AND CONCLUSION
To our knowledge, this is the first narrative review to provide a summary of the published evidence about AGs with respect to clinical and health outcomes and switching. There is a need for more research and education regarding the use of AGs in clinical practice if they are to become more recognized as a potential treatment choice for patients. Generic medications play an important role in the healthcare system, and AGs may be able to provide an option to meet the specific needs of individual patients.
Topics: Drug Utilization; Drugs, Generic; Excipients; Health Knowledge, Attitudes, Practice; Health Resources; Health Services; Humans; Patient Preference; Therapeutic Equivalency; United States; United States Food and Drug Administration
PubMed: 33829528
DOI: 10.1111/jcpt.13426 -
Journal of Affective Disorders Dec 2022The offspring of parents with Anxiety Disorders (AD) are at high risk for different types of psychopathology, including AD. However, little is known about how parental... (Review)
Review
BACKGROUND
The offspring of parents with Anxiety Disorders (AD) are at high risk for different types of psychopathology, including AD. However, little is known about how parental anxiety during pregnancy and/or the postnatal period might result in alterations in behavior or neurodevelopmental changes in offspring. To examine the effect of parental AD on offspring behavior and neurodevelopment, we conducted a systematic review.
METHODS
Following PRISMA guidelines, we searched the Web of Science, PubMed, and PsycINFO databases.
RESULTS
Forty-seven articles met the inclusion criteria for the systematic review. Prenatal maternal anxiety is related to negative temperament, increased attention to fearful vocalizations, decreased alertness, and impaired psychomotor and cognitive development in early and middle childhood. AD during the postnatal period is associated with greater negative temperament, internalizing symptoms, and anxiety symptoms in early childhood, middle childhood, and adolescence.
CONCLUSION
Our review is the first to demonstrate that prenatal and postnatal AD symptoms impact offspring. Future research should explore the mediating and moderating factors leading to the development of psychopathology in the offspring of parents with AD.
Topics: Adolescent; Pregnancy; Female; Child; Child, Preschool; Humans; Anxiety Disorders; Psychopathology; Parents; Child of Impaired Parents; Temperament
PubMed: 36174782
DOI: 10.1016/j.jad.2022.09.049 -
Archives of Physical Medicine and... Mar 2017To examine the state of psychometric validation in the health-related work outcome literature. (Review)
Review
OBJECTIVE
To examine the state of psychometric validation in the health-related work outcome literature.
DATA SOURCES
We searched PubMed, PubMed Central, CINAHL, Embase (plus Embase Classic), and PsycINFO from inception to January 2016 using the following search terms: stroke, multiple sclerosis, epilepsy, spinal cord injury, brain injury, musculoskeletal disease, work, absenteeism, presenteeism, occupation, employment, job, outcome measure, assessment, work capacity evaluation, scale, and questionnaire.
STUDY SELECTION
From the 22,676 retrieved abstracts, 597 outcome measures were identified. Inclusion was based on content analysis. There were 95 health-related work outcome measures retained; of these, 2 were treated as outliers and therefore are discussed separately. All 6 authors individually organized the 93 remaining scales based on their content.
DATA EXTRACTION
A follow-up search using the same sources, and time period, with the name of the outcome measures and the terms psychometric, reliability, validity, and responsiveness, identified 263 unique classical test theory psychometric property datasets for the 93 tools. An assessment criterion for psychometric properties was applied to each article, and where consensus was not achieved, the rating delivered by most of the assessors was reported.
DATA SYNTHESIS
Of the articles reported, 18 reporting psychometric data were not accessible and therefore could not be assessed. There were 39 that scored <20% of the maximum achievable score, 106 scored between 20% and 40%, 82 scored between 40% and 60%, 15 scored between 60% and 80%, and only 1 scored >80%. The 3 outcome measures associated with the highest scoring datasets were the Sheehan Disability Scale, the Fear Avoidance Beliefs Questionnaire, and the assessment of the Subjective Handicap of Epilepsy. Finally, only 2 psychometric validation datasets reported the complete set of baseline psychometric properties.
CONCLUSIONS
This systematic review highlights the current limitations of the health-related work outcome measure literature, including the limited number of robust tools available.
Topics: Humans; Musculoskeletal Diseases; Nervous System Diseases; Outcome Assessment, Health Care; Physical Therapy Modalities; Psychometrics; Reproducibility of Results; Work Capacity Evaluation
PubMed: 27424293
DOI: 10.1016/j.apmr.2016.06.013 -
Neurosurgical Focus Feb 2015OBJECT Cushing's disease (CD) can lead to significant morbidity secondary to hormonal sequelae or mass effect from the pituitary tumor. A transsphenoidal approach to... (Review)
Review
OBJECT Cushing's disease (CD) can lead to significant morbidity secondary to hormonal sequelae or mass effect from the pituitary tumor. A transsphenoidal approach to resection of the adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma is the first-line treatment. However, in the setting in which patients are unable to undergo surgery, have acute hypercortisolism, or have recurrent disease, medical therapy can play an important role. The authors performed a systematic review to highlight the efficacy of medical treatment of CD and discuss novel molecular insights that could guide the development of future medical treatments of CD. METHODS A search on current medical therapies for CD was performed. After individual medical therapeutic agents for CD were identified, each agent underwent a formal systematic search. The phrase "(name of agent) and Cushing's" was used as a search term in PubMed for all years up to 2014. The abstract of each article was reviewed for studies that evaluated the efficacy of medical treatment of CD. Only studies that enrolled at least 20 patients were included in the review. RESULTS A total of 11 articles on 6 individual agents were included in this review. Specific medical therapies were categorized based on the level of action: pituitary directed (cabergoline and pasireotide), adrenal/steroidogenesis directed (ketoconazole, metyrapone, and mitotane), and end-tissue directed/cortisol receptors (mifepristone). The studies identified consisted of a mix of retrospective reviews and small clinical trials. Only pasireotide and mifepristone have undergone Phase III clinical trials, from which they garnered FDA approval for the treatment of patients with CD. Overall, agents targeting ACTH secretion and steroidogenesis were found to be quite effective in reducing urine free cortisol (UFC) to levels near normal. A significant reduction in UFC was observed in 45%-100% of patients and a majority of patients gained clinical improvement. Similarly, inhibition at the end-tissue level led to clinical improvement in 87% of patients. However, side-effect rates associated with these drugs are high (up to 88%). Ketoconazole has been shown to enhance tumor appearance on MRI to facilitate pituitary resection. Promising molecular targets have been identified, including epidermal growth factor receptor, retinoic acid receptors, and cyclin dependent kinases. These pathways have been linked to the regulation of pro-opiomelanocortin expression, ACTH secretion, and tumor growth. CONCLUSIONS Despite encouraging Phase III clinical trials leading to FDA approval of 2 agents for treatment of patients with CD, no agent has yet produced results comparable to resection. As a result, the molecular insights gained into CD pathogenesis will need to continue to be expanded until they can lead to the development of medical therapies for CD with a favorable side-effect profile and efficacy comparable to resection. Ideally these agents should also reduce tumor size, which could potentially permit their eventual discontinuation.
Topics: Clinical Trials as Topic; Drug Delivery Systems; Female; Forecasting; Humans; Male; Mitotane; Pituitary ACTH Hypersecretion; Receptors, Retinoic Acid; Retrospective Studies; Somatostatin
PubMed: 25639313
DOI: 10.3171/2014.10.FOCUS14700 -
Clinical Interventions in Aging 2017Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness... (Review)
Review
BACKGROUND
Research on crisis teams for older adults with dementia is limited. This scoping review aimed to 1) conduct a systematic literature review reporting on the effectiveness of crisis interventions for older people with dementia and 2) conduct a scoping survey with dementia crisis teams mapping services across England to understand operational procedures and identify what is currently occurring in practice.
METHODS
For the systematic literature review, included studies were graded using the Critical Appraisal Skills Programme checklist. For the scoping survey, Trusts across England were contacted and relevant services were identified that work with people with dementia experiencing a mental health crisis.
RESULTS
The systematic literature review demonstrated limited evidence in support of crisis teams reducing the rate of hospital admissions, and despite the increase in number of studies, methodological limitations remain. For the scoping review, only half (51.8%) of the teams had a care pathway to manage crises and the primary need for referral was behavioral or psychological factors.
CONCLUSION
Evidence in the literature for the effectiveness of crisis teams for older adults with dementia remains limited. Being mainly cohort designs can make it difficult to evaluate the effectiveness of the intervention. In practice, it appears that the pathway for care managing crisis for people with dementia varies widely across services in England. There was a wide range of names given to the provision of teams managing crisis for people with dementia, which may reflect the differences in the setup and procedures of the service. To provide evidence on crisis intervention teams, a comprehensive protocol is required to deliver a standardized care pathway and measurable intervention as part of a large-scale evaluation of effectiveness.
Topics: Aged; Crisis Intervention; Dementia; England; Female; Hospitalization; Humans; Mental Health Services
PubMed: 29042760
DOI: 10.2147/CIA.S142341 -
Current Problems in Cardiology Oct 2023Twelve CCI patients were studied with confirmed or suspected COVID-19 infection. The majority of these patients were males (83.3%) with a median age of 55 years from... (Review)
Review
Twelve CCI patients were studied with confirmed or suspected COVID-19 infection. The majority of these patients were males (83.3%) with a median age of 55 years from three geographical locations, constituting the Middle East (7), Spain (3), and the USA (1). In 6 patients, IgG/IgM was positive for COVID-19, 4 with high pretest probability and 2 with positive RT-PCR. Type 2 DM, hyperlipidemia, and smoking were the primary risk factors. Right-sided neurological impairments and verbal impairment were the most common symptoms. Our analysis found 8 (66%) synchronous occurrences. In 58.3% of cases, neuroimaging showed left Middle Cerebral Artery (MCA) infarct and 33.3% right. Carotid artery thrombosis (16.6%), tandem occlusion (8.3%), and carotid stenosis (1%) were also reported in imaging. Dual antiplatelet therapy (DAPT) and anticoagulants were conservative therapies (10). Two AMI patients had aspiration thrombectomy, while three AIS patients had intravenous thrombolysis/tissue plasminogen activator (IVT-tPA), 2 had mechanical thrombectomy (MT), and 1 had decompressive craniotomy. Five had COVID-19-positive chest X-rays, whereas 4 were normal. four of 8 STEMI and 3 NSTEMI/UA patients complained chest pain. LV, ICA, and pulmonary embolism were further complications (2). Upon discharge, 7 patients (70%) had residual deficits while 1 patient unfortunately died.
Topics: Female; Humans; Male; Middle Aged; Anticoagulants; COVID-19; Infarction, Middle Cerebral Artery; Stroke; Thrombectomy; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome; Case Reports as Topic
PubMed: 37209804
DOI: 10.1016/j.cpcardiol.2023.101814 -
Genetics in Medicine : Official Journal... Apr 2024Rare genetic neurodevelopmental disorders associated with intellectual disability require lifelong multidisciplinary care. Clinical practice guidelines may support... (Review)
Review
PURPOSE
Rare genetic neurodevelopmental disorders associated with intellectual disability require lifelong multidisciplinary care. Clinical practice guidelines may support healthcare professionals in their daily practice, but guideline development for rare conditions can be challenging. In this systematic review, the characteristics and methodological quality of internationally published recommendations for this population are described to provide an overview of current guidelines and inform future efforts of European Reference Network ITHACA (Intellectual disability, TeleHealth, Autism, and Congenital Anomalies).
METHODS
MEDLINE, Embase, and Orphanet were systematically searched to identify guidelines for conditions classified as "rare genetic intellectual disability" (ORPHA:183757). Methodological quality was assessed using the Appraisal of Guidelines, Research, and Evaluation II tool.
RESULTS
Seventy internationally published guidelines, addressing the diagnosis and/or management of 28 conditions, were included. The methodological rigor of development was highly variable with limited reporting of literature searches and consensus methods. Stakeholder involvement and editorial independence varied as well. Implementation was rarely addressed.
CONCLUSION
Comprehensive, high-quality guidelines are lacking for many rare genetic neurodevelopmental disorders. Use and transparent reporting of sound development methodologies, active involvement of affected individuals and families, robust conflict of interest procedures, and attention to implementation are vital for enhancing the impact of clinical practice recommendations.
Topics: Humans; Intellectual Disability; Quality Improvement; Evidence-Based Medicine; Neurodevelopmental Disorders; Consensus
PubMed: 38224026
DOI: 10.1016/j.gim.2024.101071 -
Obesity Research & Clinical Practice 2023The association between early-life exposure to antibiotics and overweight/obesity is unclear. We conducted a systematic review and meta-analysis to address this issue.
BACKGROUND
The association between early-life exposure to antibiotics and overweight/obesity is unclear. We conducted a systematic review and meta-analysis to address this issue.
METHODS
We searched PubMed, Web of Science, Scopus, and grey literature from inception to August 10, 2022, for cohort studies investigating the association between early-life exposure to antibiotics and weight outcomes. Two independent reviewers screened studies for eligibility, extracted data, assessed risk of bias, and examined the certainty of the evidence. Random-effects meta-analyses was used for pooling the data. The review was registered in PROSPERO, CRD42021265417.
RESULTS
We included 42 studies and data from 28 of them were pooled in the quantitative synthesis. Overall antenatal (OR 1.10, 95% CI 1.04-1.16; 518,095 children, very low certainty) and second trimester (OR 1.11, 95% CI 1.08-1.14, 248,469 children, low certainty) exposure to antibiotics were associated with increased risk of overweight/obesity in childhood/adolescence. Overall early postnatal antibiotic exposure was also associated with increased likelihood of overweight/obesity in childhood/adolescence (OR 1.09, 95% CI 1.05-1.12, 1,488,316 children, very low certainty). The magnitude of the association increased from exposure to one (OR 1.07, 95% CI 1.00-1.15, 512,954 children) to four or more courses of antibiotics (OR 1.31, 95% CI 1.17-1.46, 543,627 children).
CONCLUSION
Antenatal and early postnatal exposure to antibiotics is associated increased likelihood of overweight/obesity, although the findings are limited by the very low certainty of evidence. We highlight the need for homogeneous prospective studies addressing potential confounding factors to further explore the link between exposure to antibiotics and the risk of excess body weight.
PubMed: 37573229
DOI: 10.1016/j.orcp.2023.07.001 -
Asian Journal of Surgery Jan 2023Autologous lipotransfer is an essential component of soft tissue reconstruction. However, it is not widely applied or accepted by surgeons due to its unstable survival... (Meta-Analysis)
Meta-Analysis Review
Autologous lipotransfer is an essential component of soft tissue reconstruction. However, it is not widely applied or accepted by surgeons due to its unstable survival rate and uncertain efficacy. The cell-assisted fat transfer (CAL) is a promising technique that increases the fat survival rate. However, it is controversial based on various clinical studies. Here, we assessed the fat survival and complication rates of CAL, compared to the conventional autologous lipotransfer. To conduct our research, two reviewers independently screened related articles published in Medicine (via PubMed), EMBASE, Cochrane Library, and Web of Science. The combined effect estimates for efficacy evaluation was performed by the Review Manager software (RevMan 5.4.1). In total, 14 articles were included in our analysis (n = 722). Based on our analysis, the survival rate of the fat graft in CAL was significantly higher than the conventional fat grafting group (non-CAL group) (SMD = 2.81, 95%CI [1.54, 4.08], P < 0.01). In the subgroup, the fat retention of CAL in the facial filling was higher than the conventional one (SMD = 3.01, 95%CI [1.68, 4.33], P < 0.01). After breast augmentation, however, the difference between the experimental and control group was not statistically significant (SMD = 1.80, 95%CI [-0.31, 3.91], P = 0.09). Moreover, the CAL group exhibited comparable complications as the non-CAL group. Based on our analysis, the CAL group was significantly better than the conventional lipotransfer in terms of fat survival, particularly, during facial filling. However, it failed to reduce the complication rate, compared to the non-CAL group.
Topics: Humans; Mammaplasty; Face
PubMed: 35504778
DOI: 10.1016/j.asjsur.2022.04.031 -
Journal of the American Board of Family... 2021Substance use disorders (SUDs) are complex interactions between various genetic, environmental, developmental, and social factors. Yoga is recommended as a nonmainstream...
INTRODUCTION
Substance use disorders (SUDs) are complex interactions between various genetic, environmental, developmental, and social factors. Yoga is recommended as a nonmainstream treatment for many health conditions, including SUDs.
METHODS
Five databases were searched for randomized controlled trials (RCTs) that evaluated yoga as an intervention in adults with any type of substance use disorder. The interventions being studied included Hatha yoga, Sudarshan Kriya yoga, breathing yoga exercises, and meditation. Studies, where yoga was combined with other interventions were excluded. The effect of yoga as an intervention was analyzed using primary outcomes such as anxiety, pain, and craving. Eight RCTs met the eligibility criteria, and quality analysis was conducted using the Cochrane criteria.
RESULTS
Among the 8 final studies eligible for quality analysis, 2 had undefined substance use, while the others were focused on tobacco, alcohol, or opioids. Seven out of 8 studies showed significant results and improved primary outcomes such as anxiety, pain, or substance use. Seven out of the 8 studies showed significant positive outcomes using yoga in conjunction with other pharmacological treatment modalities like opioid substitution therapy.
CONCLUSIONS
Six out of 8 studies showed low concerns, while 2 studies showed some concerns about the risk of bias judgment. Although the results look encouraging, RCTs with larger sample size are needed to better evaluate the effectiveness of yoga as a treatment modality for substance use.
Topics: Adult; Anxiety; Anxiety Disorders; Humans; Meditation; Substance-Related Disorders; Yoga
PubMed: 34535521
DOI: 10.3122/jabfm.2021.05.210175