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The Annals of Pharmacotherapy Oct 2023To review the available literature regarding the treatment effects and efficacy of benzonatate needed to better inform patients, providers, and regulators evaluating its... (Review)
Review
OBJECTIVE
To review the available literature regarding the treatment effects and efficacy of benzonatate needed to better inform patients, providers, and regulators evaluating its role in modern medical therapies.
DATA SOURCES
Comprehensive literature searches were conducted in PubMed, Embase (Elsevier), Cochrane Library, and Scopus for original research articles evaluating the effectiveness, tolerability, and safety profile of benzonatate from January 1956 through August 2022.
STUDY SELECTION AND DATA EXTRACTION
The identified studies were screened for relevance and then assessed for inclusion through a full-text review, data extraction, and quality assessment by multiple reviewers using the online software Covidence.
DATA SYNTHESIS
The selection process resulted in 37 articles consisting of 21 cohort studies, 5 experimental studies, and 11 case studies and series. Initial clinical studies exploring potential therapeutic benefits collected data from very small populations and limited clinical settings. Safety is primarily assessed in terms of toxicity due to overdose or inappropriate use. Quality assessment raised concerns for high degrees of biases primarily related to the limited sample size, data collection, generalizability, and study design.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
This review reveals substantial limitations within existing evidence pertaining to the safety and clinical effectiveness of benzonatate and thus, a need for large observational studies or randomized trials to better characterize its role and value in modern medical practice.
CONCLUSIONS
Rising safety concerns should bring closer scrutiny upon the prescription of benzonatate whose approval is founded upon evidence that would not stand up to current regulatory review.
Topics: Humans; Butylamines; Drug Overdose; Text Messaging
PubMed: 36688284
DOI: 10.1177/10600280221135750 -
Journal of Clinical Nursing Sep 2023Medication administration errors (MAEs) cause preventable patient harm and cost billions of dollars from already-strained healthcare budgets. An emerging factor... (Review)
Review
BACKGROUND
Medication administration errors (MAEs) cause preventable patient harm and cost billions of dollars from already-strained healthcare budgets. An emerging factor contributing to these errors is nurse fatigue. Given medication administration is the most frequent clinical task nurses undertake; it is vital to understand how fatigue impacts MAEs.
OBJECTIVE
Examine the evidence on the effect of fatigue on MAEs and near misses by registered nurses working in hospital settings.
METHOD
Arksey and O'Malley's scoping review framework was used to guide this review and PAGER framework for data extraction and analysis. The PRISMA checklist was completed. Four electronic databases were searched: CINAHL, PubMed, Scopus and PsycINFO. Eligibility criteria included primary peer review papers published in English Language with no date/time limiters applied. The search was completed in August 2021 and focussed on articles that included: (a) registered nurses in hospital settings, (b) MAEs, (c) measures of sleep, hours of work, or fatigue.
RESULTS
Thirty-eight studies were included in the review. 82% of the studies identified fatigue to be a contributing factor in MAEs and near misses (NMs). Fatigue is associated with reduced cognitive performance and lack of attention and vigilance. It is associated with poor nursing performance and decreased patient safety. Components of shift work, such as disruption to the circadian rhythm and overtime work, were identified as contributing factors. However, there was marked heterogeneity in strategies for measuring fatigue within the included studies.
RELEVANCE TO CLINICAL PRACTICE
Fatigue is a multidimensional concept that has the capacity to impact nurses' performance when engaged in medication administration. Nurses are susceptible to fatigue due to work characteristics such as nightwork, overtime and the requirement to perform cognitively demanding tasks. The mixed results found within this review indicate that larger scale studies are needed with particular emphasis on the impact of overtime work. Policy around safe working hours need to be re-evaluated and fatigue management systems put in place to ensure delivery of safe and quality patient care.
Topics: Humans; Pharmaceutical Preparations; Patient Safety; Hospitals; Fatigue; Menthol; Nurses
PubMed: 36707921
DOI: 10.1111/jocn.16620 -
Nursing Reports (Pavia, Italy) Sep 2023With the increasingly demanding healthcare environment, patient safety issues are only becoming more complex. This urges nursing leaders to adapt and master effective... (Review)
Review
BACKGROUND
With the increasingly demanding healthcare environment, patient safety issues are only becoming more complex. This urges nursing leaders to adapt and master effective leadership; particularly, transformational leadership (TFL) is shown to scientifically be the most successfully recognized leadership style in healthcare, focusing on relationship building while putting followers in power and emphasizing values and vision.
AIM
To examine how transformational leadership affects nurses' job environment and nursing care provided to the patients and patients' outcomes.
DESIGN
A systematic literature review was conducted. From 71 reviewed, 23 studies were included (studies included questionnaire surveys and one interview, extracting barriers and facilitators, and analyzing using qualitative synthesis).
RESULT
TFL indirectly and directly positively affects nurses' work environment through mediators, including structural empowerment, organizational commitment, and job satisfaction. Nurses perceived that managers' TFL behavior did not attain excellence in any of the included organizations, highlighting the necessity for additional leadership training to enhance the patient safety culture related to the non-reporting of errors and to mitigate the blame culture within the nursing environment.
CONCLUSION
Bringing more focus to leadership education in nursing can make future nursing leaders more effective, which will cultivate efficient teamwork, a quality nursing work environment, and, ultimately, safe and efficient patient outcomes. This study was not registered.
PubMed: 37755351
DOI: 10.3390/nursrep13030108 -
Rheumatology (Oxford, England) Nov 2023To evaluate the effectiveness and safety of current treatment strategies for the vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome.
OBJECTIVES
To evaluate the effectiveness and safety of current treatment strategies for the vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome.
METHODS
A protocolized systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was performed. Three databases were searched for reports on treatment strategies for VEXAS. Data from the included publications was extracted and a narrative synthesis was performed. Treatment response was recorded as complete (CR), partial (PR) or none (NR) depending on changes in clinical symptoms and laboratory parameters. Patient characteristics, safety data and previous treatments were analysed.
RESULTS
We identified 36 publications with a total of 116 patients; 113 (98.3%) were male. The identified reports included azacytidine (CR 9/36, 25%; PR 14/36, 38.9%), Janus kinase inhibitors (JAKi) (CR 11/33, 33%; PR 9/33, 27.3%), tocilizumab (CR 3/15, 20%; PR 6/15, 40%), allogeneic stem cell transplantation (CR 6/7, 85.7%; one patient died), anakinra (CR 4/5, 80%; NR 1/5, 20%), canakinumab (CR 1/2, 50%; PR 1/2, 50%) and glucocorticoid monotherapy (CR 1/6, 16.7%; PR 4/6, 66.7%). Individual reports were available for TNF inhibitors, rituximab and MTX. Data on adverse events were available for 67 patients (67/116, 57.8%) and included: pneumonia (12/67, 17.9%), other infections (9/67, 13.4%), venous thromboembolisms (6/67, 8.9%), cytopenias (4/67, 5.9%), and acute (4/67, 5.9%) and chronic graft-vs-host-disease (2/67, 2.9%).
CONCLUSION
Current data on VEXAS treatment are limited and inhomogeneous. Treatment decisions should be individualized. For the devolvement of treatment algorithms clinical trials are needed. Adverse events remain a challenge, especially an elevated risk for venous thromboembolism associated to JAKi treatment should be carefully considered.
Topics: Humans; Male; Female; Algorithms; Azacitidine; Bronchiolitis Obliterans Syndrome; Databases, Factual; Janus Kinase Inhibitors; Mutation
PubMed: 37233149
DOI: 10.1093/rheumatology/kead240 -
Journal of Drugs in Dermatology : JDD Jul 2023This article describes the clinical trial, safety, and efficacy of ruxolitinib 1.5% cream or repigmentation in patients with vitiligo.
BACKGROUND
This article describes the clinical trial, safety, and efficacy of ruxolitinib 1.5% cream or repigmentation in patients with vitiligo.
DATA SOURCES
A systematic review was done using ruxolitinib or Opzelura in MEDLINE (PubMed) and EMBASE.
CLINICALTRIALS
gov was used to identify ongoing or unpublished studies.
STUDY SELECTION AND DATA EXTRACTION
Studies included were written in English and relevant to pharmacology, clinical trials, safety, and efficacy.
DATA SYNTHESIS
In two 52-week phase 3 trials, 52.0% of subjects had at least 75% improvement in their Facial Vitiligo Area Scoring Index (F-VASI).
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Ruxolitinib is a topical Janus kinase (JAK) inhibitor newly approved by the US Food and Drug Administration for repigmentation in patients with vitiligo.
CONCLUSION
Topical ruxolitinib is the first medication approved for repigmentation in patients with vitiligo. It is a safe and effective treatment; however, cost may be a barrier to some patients when prescribing this medication. Trials to compare the efficacy and side effect profile of topical ruxolitinib with other topical treatments are still needed. Grossmann MC, Haidari W, Feldman SR. A Review on the use of topical ruxolitinib for the treatment of vitiligo. J Drugs Dermatol. 2023;22(7):664-667. doi:10.36849/JDD.7268.
Topics: Humans; Vitiligo; Pyrimidines; Nitriles; Pyrazoles; Treatment Outcome; Janus Kinase Inhibitors
PubMed: 37410047
DOI: 10.36849/JDD.7268 -
International Braz J Urol : Official... 2023bladder based on a systematic review and network meta-analysis approach. (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
bladder based on a systematic review and network meta-analysis approach.
METHODS
Pubmed, Embase, Web of Science, and the Cochrane Register of Clinical Trials databases were systematically searched. The search time frame was from database creation to June 2, 2022. Randomized controlled double-blind trials of oral medication for overactive bladder were screened against the protocol's entry criteria. Trials were evaluated for quality using the Cochrane Risk of Bias Assessment Tool, and data were statistically analyzed using Stata 16.0 software.
RESULT
A total of 60 randomized controlled double-blind clinical trials were included involving 50,333 subjects. Solifenacin 10mg was the most effective in mean daily micturitions and incontinence episodes, solifenacin 5/10mg in mean daily urinary urgency episodes and nocturia episodes, fesoterodine 8mg in urgency incontinence episodes/d and oxybutynin 5mg in voided volume/micturition. In terms of safety, solifenacin 5mg, ER-tolterodine 4mg, mirabegron, vibegron and ER-oxybutynin 10mg all showed a better incidence of dry mouth, fesoterodine 4mg, ER-oxybutynin 10mg, tolterodine 2mg, and vibegron in the incidence of constipation. Compared to placebo, imidafenacin 0.1mg showed a significantly increased incidence in hypertension, solifenacin 10mg in urinary tract infection, fesoterodine 4/8mg and darifenacin 15mg in headache.
CONCLUSION
Solifenacin showed better efficacy. For safety, most anticholinergic drugs were more likely to cause dry mouth and constipation, lower doses were better tolerated. The choice of drugs should be tailored to the patient's specific situation to find the best balance between efficacy and safety.
Topics: Humans; Urinary Bladder, Overactive; Solifenacin Succinate; Tolterodine Tartrate; Network Meta-Analysis; Double-Blind Method; Constipation; Xerostomia; Treatment Outcome; Muscarinic Antagonists; Randomized Controlled Trials as Topic
PubMed: 37506033
DOI: 10.1590/S1677-5538.IBJU.2023.0158 -
Journal of Bodywork and Movement... Jul 2023More than two-thirds of pregnant women experience low back pain during pregnancy. This condition increases with advancing pregnancy, interfering with work, daily... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
More than two-thirds of pregnant women experience low back pain during pregnancy. This condition increases with advancing pregnancy, interfering with work, daily activities and sleep.
OBJECTIVE
To assess the efficacy of the Pilates method in comparison to prenatal care on the control of lower back pain in pregnant women.
SEARCH METHODS
Electronic searches were carried out with no language or year of publication restriction in the databases Medline via Pubmed, Embase, CINAHL, LILACS, PEDro, and SPORTDiscus on 20 March 2021. The keywords "Pilates" and "Pregnancy" were applied and the search strategies, adapted to each databank.
SELECTION CRITERIA
Randomized clinical trials with pregnant women with muscle pain symptoms and Pilates as an intervention method in comparison to conventional prenatal care were considered.
DATA COLLECTION AND ANALYSIS
two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The critical evaluation was done using the Risk of Bias tool assess the quality and GRADE to assess the certainty of evidence. We conducted a meta-analysis for the main outcome "pain".
RESULTS
through our searches, 687 papers were identified, but only two fulfilled the inclusion criteria and were included in this review. Only two studies compared Pilates with a control group without physical exercise for pain in the short term. In the meta-analysis, there was a significant difference for pain in the comparison between the Pilates group and the control group without exercise; the mean difference (MD) was -23.09 (95% CI), from -31.07 to -15.10, p = 0.001, for 65 individuals (33 in the Pilates group and 32 in the conventional group). Limitation found was the lack of blinding of therapists and participants and the small sample size of individual studies. In addition, no adverse effects were reported.
CONCLUSION
There is moderate-quality evidence that Pilates exercise may reduce pregnancy-related low-back pain more than usual prenatal or no exercise. Prospero registration number CRD42021223243.
Topics: Pregnancy; Female; Humans; Quality of Life; Low Back Pain; Exercise Therapy; Exercise Movement Techniques; Exercise
PubMed: 37330773
DOI: 10.1016/j.jbmt.2023.04.076 -
The Cochrane Database of Systematic... Oct 2023Concerns exist regarding antibiotic prescribing for respiratory tract infections (RTIs) owing to adverse reactions, cost and antibacterial resistance. One proposed... (Review)
Review
BACKGROUND
Concerns exist regarding antibiotic prescribing for respiratory tract infections (RTIs) owing to adverse reactions, cost and antibacterial resistance. One proposed strategy to reduce antibiotic prescribing is to provide prescriptions, but to advise delay in antibiotic use with the expectation that symptoms will resolve first. This is an update of a Cochrane Review originally published in 2007, and updated in 2010, 2013 and 2017.
OBJECTIVES
To evaluate the effects on duration and/or severity of clinical outcomes (pain, malaise, fever, cough and rhinorrhoea), antibiotic use, antibiotic resistance and patient satisfaction of advising a delayed prescription of antibiotics in respiratory tract infections.
SEARCH METHODS
From May 2017 until 20 August 2022, this was a living systematic review with monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL and Web of Science. We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov on 20 August 2022. Due to the abundance of evidence supporting the review's key findings, it ceased being a living systematic review on 21 August 2022.
SELECTION CRITERIA
Randomised controlled trials involving participants of all ages with an RTI, where delayed antibiotics were compared to immediate or no antibiotics. We defined a delayed antibiotic as advice to delay the filling of an antibiotic prescription by at least 48 hours. We considered all RTIs regardless of whether antibiotics were recommended or not.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures.
MAIN RESULTS
For this 2022 update, we added one new trial enrolling 448 children (436 analysed) with uncomplicated acute RTIs. Overall, this review includes 12 studies with a total of 3968 participants, of which data from 3750 are available for analysis. These 12 studies involved acute RTIs including acute otitis media (three studies), streptococcal pharyngitis (three studies), cough (two studies), sore throat (one study), common cold (one study) and a variety of RTIs (two studies). Six studies involved only children, two only adults and four included both adults and children. Six studies were conducted in primary care, four in paediatric clinics and two in emergency departments. Studies were well reported and appeared to provide moderate-certainty evidence. Randomisation was not adequately described in two trials. Four trials blinded the outcome assessor, and three included blinding of participants and doctors. We conducted meta-analyses for pain, malaise, fever, adverse effects, antibiotic use and patient satisfaction. Cough (four studies): we found no differences amongst delayed, immediate and no prescribed antibiotics for clinical outcomes in any of the four studies. Sore throat (six studies): for the outcome of fever with sore throat, four of the six studies favoured immediate antibiotics, and two found no difference. For the outcome of pain related to sore throat, two studies favoured immediate antibiotics, and four found no difference. Two studies compared delayed antibiotics with no antibiotic for sore throat, and found no difference in clinical outcomes. Acute otitis media (four studies): two studies compared immediate with delayed antibiotics - one found no difference for fever, and the other favoured immediate antibiotics for pain and malaise severity on Day 3. Two studies compared delayed with no antibiotics: one found no difference for pain and fever severity on Day 3, and the other found no difference for the number of children with fever on Day 3. Common cold (two studies): neither study found differences for clinical outcomes between delayed and immediate antibiotic groups. One study found delayed antibiotics were probably favoured over no antibiotics for pain, fever and cough duration (moderate-certainty evidence).
ADVERSE EFFECTS
there were either no differences for adverse effects or results may have favoured delayed over immediate antibiotics with no significant differences in complication rates (low-certainty evidence). Antibiotic use: delayed antibiotics probably resulted in a reduction in antibiotic use compared to immediate antibiotics (odds ratio (OR) 0.03, 95% confidence interval (CI) 0.01 to 0.07; 8 studies, 2257 participants; moderate-certainty evidence). However, a delayed antibiotic was probably more likely to result in reported antibiotic use than no antibiotics (OR 2.52, 95% CI 1.69 to 3.75; 5 studies, 1529 participants; moderate-certainty evidence). Patient satisfaction: patient satisfaction probably favoured delayed over no antibiotics (OR 1.45, 1.08 to 1.96; 5 studies, 1523 participants; moderate-certainty evidence). There was probably no difference in patient satisfaction between delayed and immediate antibiotics (OR 0.77, 95% CI 0.45 to 1.29; 7 studies, 1927 participants; moderate-certainty evidence). No studies evaluated antibiotic resistance. Reconsultation rates and use of alternative medicines were similar for delayed, immediate and no antibiotic strategies. In one of the four studies reporting use of alternative medicines, less paracetamol was used in the immediate group compared to the delayed group.
AUTHORS' CONCLUSIONS
For many clinical outcomes, there were no differences between prescribing strategies. Symptoms for acute otitis media and sore throat were modestly improved by immediate antibiotics compared with delayed antibiotics. There were no differences in complication rates. Delaying prescribing did not result in significantly different levels of patient satisfaction compared with immediate provision of antibiotics (86% versus 91%; moderate-certainty evidence). However, delay was favoured over no antibiotics (87% versus 82%). Delayed antibiotics achieved lower rates of antibiotic use compared to immediate antibiotics (30% versus 93%). The strategy of no antibiotics further reduced antibiotic use compared to delaying prescription for antibiotics (13% versus 27%). Delayed antibiotics for people with acute respiratory infection reduced antibiotic use compared to immediate antibiotics, but was not shown to be different to no antibiotics in terms of symptom control and disease complications. Where clinicians feel it is safe not to prescribe antibiotics immediately for people with RTIs, no antibiotics with advice to return if symptoms do not resolve is likely to result in the least antibiotic use while maintaining similar patient satisfaction and clinical outcomes to delayed antibiotics. Where clinicians are not confident in not prescribing antibiotics, delayed antibiotics may be an acceptable compromise in place of immediate prescribing to significantly reduce unnecessary antibiotic use for RTIs, while maintaining patient safety and satisfaction levels. Further research into antibiotic prescribing strategies for RTIs may best be focused on identifying patient groups at high risk of disease complications, enhancing doctors' communication with patients to maintain satisfaction, ways of increasing doctors' confidence to not prescribe antibiotics for RTIs, and policy measures to reduce unnecessary antibiotic prescribing for RTIs.
Topics: Child; Adult; Humans; Common Cold; Anti-Bacterial Agents; Cough; Respiratory Tract Infections; Pharyngitis; Otitis Media; Fever; Pain
PubMed: 37791590
DOI: 10.1002/14651858.CD004417.pub6 -
BMC Gastroenterology Jan 2024To comprehensively evaluate the efficacy, safety, patient symptoms, and quality-of-life (QoL) of lubiprostone, linaclotide, and elobixibat as treatment for chronic... (Comparative Study)
Comparative Study Meta-Analysis
Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm.
OBJECTIVE
To comprehensively evaluate the efficacy, safety, patient symptoms, and quality-of-life (QoL) of lubiprostone, linaclotide, and elobixibat as treatment for chronic constipation (CC).
DESIGN
Systematic literature review (SLR) and meta-analysis (MA). Literature searches were conducted on PubMed and Embase using the Ovid platform.
METHODS
SLR including randomized controlled trials (RCTs) and observational studies was conducted to identify the overall efficacy and safety of lubiprostone, linaclotide, and elobixibat. Thereafter, MA was performed using only RCTs. The number needed to treat (NNT) and number needed to harm (NNH) analyses were additionally conducted.
PRIMARY AND SECONDARY OUTCOME MEASURES
The primary outcome was efficacy regarding change in spontaneous bowel movements. Secondary outcomes included safety, constipation-related symptoms, and QoL.
RESULTS
Twenty-four studies met the inclusion criteria for the SLR: 17 RCTs, 4 observational studies, and 3 single-arm trials. Feasibility assessment for the MA resulted in 14 studies available for safety data analysis, and 8 available for efficacy analysis, respectively. Three drugs showed similar efficacy in the MA and NNT analysis. However, the NNH analysis revealed distinct safety profiles: lubiprostone, linaclotide, and elobixibat were linked to the highest risk of nausea, diarrhea, and abdominal pain, respectively.
CONCLUSION
The current study provides an updated overview of the efficacy, safety, patient symptoms, and QoL of the three drugs with different mechanisms of action for CC treatment.The findings could help physicians adopt an individualized approach for treating patients with CC in clinical practice.
Topics: Humans; Constipation; Lubiprostone; Peptides; Treatment Outcome
PubMed: 38166671
DOI: 10.1186/s12876-023-03104-8 -
Social Psychiatry and Psychiatric... Nov 2023This systematic review of systematic reviews aims to provide the first global picture of the prevalence and correlates of perinatal depression, and to explore the... (Review)
Review
PURPOSE
This systematic review of systematic reviews aims to provide the first global picture of the prevalence and correlates of perinatal depression, and to explore the commonalities and discrepancies of the literature.
METHODS
Seven databases were searched from inception until April 2022. Full-text screening and data extraction were performed independently by two researchers and the AMSTAR tool was used to assess the methodological quality.
RESULTS
128 systematic reviews were included in the analysis. Mean overall prevalence of perinatal depression, antenatal depression and postnatal depression was 26.3%, 28.5% and 27.6%, respectively. Mean prevalence was significantly higher (27.4%; SD = 12.6) in studies using self-reported measures compared with structured interviews (17.0%, SD = 4.5; d = 1.0) and among potentially vulnerable populations (32.5%; SD = 16.7, e.g. HIV-infected African women) compared to the general population (24.5%; SD = 8.1; d = 0.6). Personal history of mental illness, experiencing stressful life events, lack of social support, lifetime history of abuse, marital conflicts, maternity blues, child care stress, chronic physical health conditions, preeclampsia, gestational diabetes mellitus, being exposed to second-hand smoke and sleep disturbance were among the major correlates of perinatal depression.
CONCLUSION
Although the included systematic reviews were all of medium-high quality, improvements in the quality of primary research in this area should be encouraged. The standardisation of perinatal depression assessment, diagnosis and measurement, the implementation of longitudinal designs in studies, inclusions of samples that better represent the population and better control of potentially confounding variables are encouraged.
Topics: Female; Humans; Pregnancy; Child; Depression; Prevalence; Systematic Reviews as Topic; Depression, Postpartum; Pregnancy Complications
PubMed: 36646936
DOI: 10.1007/s00127-022-02386-9