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The Journal of Pain 2020Fibromyalgia is a debilitating condition characterized by chronic widespread pain. It is believed to be caused by dysfunction of the central nervous system (CNS) but... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Fibromyalgia is a debilitating condition characterized by chronic widespread pain. It is believed to be caused by dysfunction of the central nervous system (CNS) but current treatments are largely ineffective. Transcranial direct current stimulation (tDCS), a neuromodulation technique that targets the CNS, may offer a new line of treatment.
OBJECTIVE
To systematically review the most up-to-date literature and perform a meta-analysis of the effects of tDCS on pain intensity in fibromyalgia.
METHODS
The following databases were searched from inception: Medline (Ovid), PsychInfo, CINAHL, Cochrane Library, and Web of Science. Studies were eligible if they were randomized controlled trials, quasi-randomized trials, and nonrandomized. Crossover and parallel-group design studies were included. Risk of bias was assessed for all included studies. Meta-analysis was conducted on studies investigating pain intensity after tDCS in participants with fibromyalgia and analyzed using standardized mean difference and 95% confidence intervals.
RESULTS
Fourteen clinical studies were included. Ten were controlled trials and 4 were within-subjects crossover studies. Meta-analysis of data from 8 controlled trials provides tentative evidence of pain reduction when active tDCS is delivered compared to sham. However, substantial statistical heterogeneity and high risk of bias of primary studies prevent more conclusive recommendations being made.
CONCLUSIONS
tDCS is a safe intervention with the potential to lower pain intensity in fibromyalgia. However, there is a need for more empirical research of the neural target sites and optimum stimulation parameters to achieve the greatest effects before conducting further clinical studies.
PERSPECTIVE
This systematic review and meta-analysis synthesizes current evidence for the clinical effectiveness of tDCS in the treatment of fibromyalgia pain. There is only tentative evidence of pain reduction when active tDCS is compared to sham. High heterogeneity and risk of bias across studies suggest a need for further empirical research.
Topics: Chronic Pain; Clinical Trials as Topic; Fibromyalgia; Humans; Pain Management; Transcranial Direct Current Stimulation; Treatment Outcome
PubMed: 31982685
DOI: 10.1016/j.jpain.2020.01.003 -
The Cochrane Database of Systematic... Feb 2020Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Glaucoma is a multi-factorial optic neuropathy characterized by an acquired loss of retinal ganglion cells at levels beyond normal age-related loss and corresponding atrophy of the optic nerve. Although many treatments are available to manage glaucoma, patients may seek complementary or alternative medicine approaches such as acupuncture to supplement their regular treatment. The underlying plausibility of acupuncture is that disorders related to the flow of Chi (traditional Chinese concept of vital force or energy) can be managed by stimulating relevant points on the body surface.
OBJECTIVES
To assess the effectiveness and safety of acupuncture compared with other treatments, no treatment, or placebo in patients with glaucoma.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Eyes and Vision Trials Register (2018, Issue 11); Ovid MEDLINE; Embase.com; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); the Allied and Complementary Medicine Database (AMED); PubMed; Latin American and Caribbean Literature on Health Sciences (LILACS); ZETOC; the metaRegister of Controlled Trials (mRCT); ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP); and the National Center for Complementary and Alternative Medicine (NCCAM) website. We did not use any language or date restrictions in the search for trials. We last searched electronic databases on November 16, 2018, with the exception of NCCAM, which we last searched on July 14, 2010, and the metaRegister of Controlled Trials (mRCT), which we last searched on January 8, 2013. We handsearched Chinese medical journals at Peking Union Medical College Library in April 2007. We searched the Chinese Acupuncture Trials Register, the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), the Chinese Biological Database (CBM), and the China National Knowledge Infrastructure (CNKI). We last searched Chinese electronic databases on November 19, 2018.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) in which one arm involved acupuncture treatment.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened results, then extracted the data and assessed risk of bias for eligible trials.
MAIN RESULTS
We included three completed trials and one ongoing trial in the 2019 update of this review. The three completed trials, conducted in Taiwan and the United States, included participants with glaucoma or intraocular hypertension. The interventions investigated varied across trials. One trial compared auricular acupressure-a non-standard acupuncture technique-with the sham procedure in 33 patients. Another trial compared transcutaneous electrical nerve stimulation (TENS) with a sham procedure in 82 patients. The third trial compared 12 sessions of acupuncture on eye-points versus on non-eye-points in 22 patients. All three trials were rated at high risk of bias for at least one domain. The certainty of evidence across all outcomes was very low due to high risk of bias in at least one contributing study; substantial clinical heterogeneity and methodological heterogeneity; and imprecision of results. One trial reported change in the visual field from baseline without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. All three trials reported data for estimation of reduction of intraocular pressure (IOP). However, time points of IOP measurement varied. For the trial comparing acupressure to a sham procedure, the difference in IOP reduction (measured in mm Hg) is estimated to be -3.70 (95% confidence interval [CI] -7.11 to -0.29) for the right eye and -4.90 (95% CI -8.08 to -1.72) for the left eye at four weeks, and -1.30 mm Hg (95% CI -4.78 to 2.18) for the right eye and -2.30 mm Hg (95% CI -5.73 to 1.13) for the left eye at eight weeks. For the trial comparing TENS to sham treatment, the difference reduction is estimated to be -2.81 (95% CI -3.8 to -1.84) for the right eye and -2.58 (95% CI -3.36 to -1.80) for the left eye immediately after treatment, -2.93 (95% CI -3.72 to -2.13) for the right eye and -3.56 (95% CI -4.35 to 2.78) for the left eye 30 minutes after treatment, and finally -3.61 (95% CI -4.47 to -2.75) for the right eye and -3.61 (95% -4.47 to -2.74) for the left eye. For the trial that compared acupuncture on eye-points versus non-eye-points, 11 out of 22 (50%) participants did not complete the treatment. One trial reported data for estimation of visual acuity. When acupressure is compared to sham treatment, the difference in uncorrected visual acuity (UCVA, measured in logMAR) is estimated to be -0.01 (95% CI -0.24 to 0.22) for the right eye and -0.04 (95% CI -0.27 to 0.19) for the left eye at four months, and -0.03 logMAR (95% CI -0.27 to 0.21) for the right eye and -0.16 logMAR (95% CI -0.43 to 0.11) for the left eye at eight months. The difference in best corrected visual acuity (BCVA) is estimated to be 0.10 (95% CI -0.06 to 0.26) for the right eye and 0 (95% CI -0.14 to 0.14) for the left eye at four months, and -0.04 logMAR (95% CI -0.09 to 0.17) for the right eye and -0.04 logMAR (95% CI -0.18 to 0.10) for the left eye at eight months. One trial reported progression of optic disc damage or nerve fiber layer loss without any between-group comparison. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret. One trial reported adverse events in two patients (out of 22) who experienced needle sensitivity. However, the study did not report between-group comparisons. Because of the quantity of missing data (50%), we did not calculate a between-group comparison, as the quantitative results are difficult to interpret.
AUTHORS' CONCLUSIONS
At this time, it is impossible to draw reliable conclusions from available data to support the use of acupuncture for treatment of patients with glaucoma. Because of ethical considerations, RCTs comparing acupuncture alone with standard glaucoma treatment or placebo are unlikely to be justified in countries where the standard of care has already been established.
Topics: Acupuncture Therapy; Glaucoma; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Visual Acuity
PubMed: 32032457
DOI: 10.1002/14651858.CD006030.pub4 -
Minerva Medica Oct 2021Asthma is a complex disorder characterized by expiratory airflow limitation, wheeze, shortness of breath, chest tightness and cough, which can vary over time and in...
INTRODUCTION
Asthma is a complex disorder characterized by expiratory airflow limitation, wheeze, shortness of breath, chest tightness and cough, which can vary over time and in intensity. Being highly heterogeneous, asthma was characterized and classified in several asthma phenotypes and endotypes from 1947 until today. The present systematic review aims to summarize and describe evidence that was published in the last ten years in the field of asthma phenotyping and endotyping.
EVIDENCE ACQUISITION
The systematic review resumed high-quality evidence (clinical trials and randomized control trials) retrieved on MEDLINE and EMBASE databanks and involving adult asthmatic populations. Analyses of literature were conducted according to PRISMA and CASP guidelines.
EVIDENCE SYNTHESIS
Querying MEDLINE and EMBASE databanks, 5019 and 12261 entries were retrieved, respectively. Applying limitations for year of publication, age of participants, and type of publication, the search results were reduced to 98 and 132 articles, respectively. After data abstraction and resolution of duplications, only 50 articles were further evaluated. The research products were then classified first in macro-areas of interest (phenotypes or endotypes) and then in detailed micro-areas.
CONCLUSIONS
This systematic review overviews the principal findings available from high-quality literature in the last decade concerning asthma phenotypes and endotypes. Asthma has been described from different points of view, characterizing symptoms, microbiota composition, comorbidities, viral infections, and airway and/or systemic inflammatory status. The comprehension of precise mechanisms underlying asthma pathogenesis is thereby the basis for the development of novel therapeutic strategies, likely essential to the development of precision medicine.
Topics: Adult; Age Factors; Asthma; Biological Products; Clinical Trials as Topic; Comorbidity; Cough; Disease Progression; Drug Resistance; Humans; Microbiota; Obesity; Phenotype; Randomized Controlled Trials as Topic; Respiratory Sounds; Sputum; Steroids; Treatment Outcome
PubMed: 33969960
DOI: 10.23736/S0026-4806.21.07498-X -
Psychiatry Research Oct 2017No systematic reviews and meta-analyses on the use of Z-drug for schizophrenia are available. Randomized, placebo-controlled, or non-pharmacological... (Meta-Analysis)
Meta-Analysis Review
No systematic reviews and meta-analyses on the use of Z-drug for schizophrenia are available. Randomized, placebo-controlled, or non-pharmacological intervention-controlled trials published before 03/20/2017 were retrieved from major healthcare databases and clinical trial registries. A meta-analysis including only randomized, placebo-controlled trials was performed. Efficacy outcomes were measured as improvement in overall schizophrenia symptoms, total sleep time, and wake after sleep onset. Safety/acceptability outcomes were discontinuation rate and individual adverse events. Four trials [1 alpidem placebo-controlled study (n=66), 2 eszopiclone placebo-controlled studies (n=60), and 1 eszopiclone, shallow needling-controlled study (n=96)] were identified. The meta-analysis showed no significant differences in any outcome between pooled Z-drug and placebo treatment groups. For individual studies, alpidem was superior to placebo in improving the overall schizophrenia symptoms. One of the eszopiclone studies showed that eszopiclone was superior to placebo in improving the Insomnia Severity Index scores. Another eszopiclone study showed that eszopiclone did not differ from shallow needling therapy in improving both schizophrenia- and insomnia-related symptoms. Although this study failed to show significant benefits for the use of Z-drug in the treatment of schizophrenia, it showed that short-term use of eszopiclone is an acceptable method for treating persistent insomnia among these patients.
Topics: Adolescent; Adult; Aged; Clinical Trials as Topic; Eszopiclone; Female; Humans; Hypnotics and Sedatives; Imidazoles; Male; Middle Aged; Pyridines; Randomized Controlled Trials as Topic; Schizophrenia; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome; Young Adult
PubMed: 28686934
DOI: 10.1016/j.psychres.2017.06.063 -
The Cochrane Database of Systematic... Nov 2021Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a... (Review)
Review
BACKGROUND
Lamellar macular holes (LMHs) are small, partial-thickness defects of the macula defined by characteristic features on optical coherence tomography (OCT), including a newly recognised type of epiretinal membrane termed 'epiretinal proliferation'. There may be a rationale to recommend surgery for individuals with LMHs, particularly those with functional or anatomical deterioration, or poor baseline vision causing significant disability, to stabilise the LMH and prevent further visual deterioration; however, there is currently no evidence-based consensus.
OBJECTIVES
To assess the effect of surgical interventions on post-operative visual and anatomical outcomes in people with a confirmed LMH.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, Scopus SciVerse, ISRCTN registry, US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched reference lists of included trials to identify other eligible trials which our search strategy may have missed. The date of the search was 20 July 2021.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) involving participants with a confirmed LMH diagnosis which reported one or more surgical intervention(s), alone or in combination, in at least one arm of the RCT.
DATA COLLECTION AND ANALYSIS
We used standard methods as expected by Cochrane. Two study authors independently extracted data and assessed the risk of bias for included trials. Trial authors were contacted for further information and clarification.
MAIN RESULTS
A single RCT was eligible for inclusion. Thirty-six participants were randomised in a 2:1 ratio; 24 were allocated to undergo surgery (pars plana vitrectomy, peeling of the epiretial proliferation followed by fovea-sparing removal of the internal limiting membrane) and 12 (10 following two participant dropouts) to observation. Overall, the certainty of the evidence was low for all outcomes due to selection and detection bias, and the low number of participants enrolled in the study which may affect the accuracy of results and reliability of conclusions. At six-month follow-up, change in vision was better in the surgery group (-0.27 logMAR improvement) than observation (0.02 worsening) (mean difference (MD): -0.29 logMAR, 95% confidence intervals (CI): -0.33 to -0.25). Central retinal thickness increased in the surgery group over 6 months 126 μm increase) compared with observation group (decrease by 11μm) (MD: 137 μm, 95% CI: 125.87 μm to 148.13 μm). Finally, at six-month follow-up, retinal sensitivity was better in the surgery group (3.03 dB increase) compared with the observation group (0.06 dB decrease) (MD: 3.09 dB, 95% CI: 2.07 to 4.11 dB). Vision-related quality of life and metamorphopsia were not reported. No adverse outcomes or complications were reported in the study, however, authors could not provide information on whether any individuals developed deterioration in vision of 0.2 logMAR or worse.
AUTHORS' CONCLUSIONS
The included single trial demonstrated improvements in visual and anatomical outcome measures for participants with a LMH who underwent surgery compared with observation only. Therefore, we can conclude that participants who undergo surgery may achieve superior post-operative best corrected visual acuity and anatomical outcomes compared with observation only. However, the results of a single and small RCT provides limited evidence to support or refute surgery as an effective management option for LMHs. Future RCTs with a larger number of participants and with fewer methodological limitations and biases are necessary to inform future clinical practice.
Topics: Humans; Macula Lutea; Randomized Controlled Trials as Topic; Retina; Retinal Perforations; Visual Acuity; Vitrectomy
PubMed: 34748208
DOI: 10.1002/14651858.CD013678.pub2 -
BMC Musculoskeletal Disorders Jan 2018Dupuytren's disease (DD) is a common and progressive, fibroproliferative disorder of the palmar and digital fascia of the hand. Various treatments have been recommended... (Review)
Review
BACKGROUND
Dupuytren's disease (DD) is a common and progressive, fibroproliferative disorder of the palmar and digital fascia of the hand. Various treatments have been recommended for advanced disease or to retard progression of early disease and to prevent deterioration of the finger contracture and quality of life. Recent studies have tried to evaluate the clinical and cost-effectiveness of therapies for DD, but there is currently no systematic assessment and appraisal of the economic evaluations.
METHODS
A systematic literature review was conducted, following PRISMA guidelines, to identify studies reporting economic evaluations of interventions for managing DD. Databases searched included the Ovid MEDLINE/Embase (without time restriction), National Health Service (NHS) Economic Evaluation Database (all years) and the National Institute for Health Research (NIHR) Journals Library) Health Technology Assessment (HTA). Cost-effectiveness analyses of treating DD were identified and their quality was assessed using the CHEERS assessment tool for quality of reporting and Phillips checklist for model evaluation.
RESULTS
A total of 103 studies were screened, of which 4 met the study inclusion criteria. Two studies were from the US, one from the UK and one from Canada. They all assessed the same interventions for advanced DD, namely collagenase Clostridium histolyticum injection, percutaneous needle fasciotomy and partial fasciectomy. All studies conducting a cost-utility analysis, two implemented a decision analytic model and two a Markov model approach. None of them were based on a single randomised controlled trial, but rather synthesised evidence from various sources. Studies varied in their time horizon, sources of utility estimates and perspective of analysis. The overall quality of study reporting was good based on the CHEERS checklist. The quality of the model reporting in terms of model structure, data synthesis and model consistency varied across the included studies.
CONCLUSION
Cost-effectiveness analyses for patients with advanced DD are limited and have applied different approaches with respect to modelling. Future studies should improve the way they are conducted and report their findings according to established guidance for conducting economic modelling of health care technologies.
TRIAL REGISTRATION
The protocol was registered ( CRD42016032989 ; date 08/01/2016) with the PROSPERO international prospective register of systematic reviews.
Topics: Clinical Trials as Topic; Cost-Benefit Analysis; Databases, Factual; Disease Management; Dupuytren Contracture; Humans
PubMed: 29370792
DOI: 10.1186/s12891-018-1949-2 -
Medicina (Kaunas, Lithuania) Oct 2022: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the... (Meta-Analysis)
Meta-Analysis Review
: The positive implications of using free light chains in diagnosing multiple sclerosis have increasingly gained considerable interest in medical research and the scientific community. It is often presumed that free light chains, particularly kappa and lambda free light chains, are of practical use and are associated with a higher probability of obtaining positive results compared to oligoclonal bands. The primary purpose of the current paper was to conduct a systematic review to assess the up-to-date methods for diagnosing multiple sclerosis using kappa and lambda free light chains. : An organized literature search was performed across four electronic sources, including Google Scholar, Web of Science, Embase, and MEDLINE. The sources analyzed in this systematic review and meta-analysis comprise randomized clinical trials, prospective cohort studies, retrospective studies, controlled clinical trials, and systematic reviews. : The review contains 116 reports that includes 1204 participants. The final selection includes a vast array of preexisting literature concerning the study topic: 35 randomized clinical trials, 21 prospective cohort studies, 19 retrospective studies, 22 controlled clinical trials, and 13 systematic reviews. : The incorporated literature sources provided integral insights into the benefits of free light chain diagnostics for multiple sclerosis. It was also evident that the use of free light chains in the diagnosis of clinically isolated syndrome (CIS) and multiple sclerosis is relatively fast and inexpensive in comparison to other conventional state-of-the-art diagnostic methods, e.g., using oligoclonal bands (OCBs).
Topics: Humans; Oligoclonal Bands; Multiple Sclerosis; Retrospective Studies; Prospective Studies; Immunoglobulin kappa-Chains; Immunoglobulin lambda-Chains; Immunoglobulin Light Chains; Randomized Controlled Trials as Topic
PubMed: 36363469
DOI: 10.3390/medicina58111512 -
The Cochrane Database of Systematic... Jan 2016Discharge planning is a routine feature of health systems in many countries. The aim of discharge planning is to reduce hospital length of stay and unplanned readmission... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Discharge planning is a routine feature of health systems in many countries. The aim of discharge planning is to reduce hospital length of stay and unplanned readmission to hospital, and to improve the co-ordination of services following discharge from hospital.This is the third update of the original review.
OBJECTIVES
To assess the effectiveness of planning the discharge of individual patients moving from hospital.
SEARCH METHODS
We updated the review using the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 9), MEDLINE, EMBASE, CINAHL, the Social Science Citation Index (last searched in October 2015), and the US National Institutes of Health trial register (ClinicalTrials.gov).
SELECTION CRITERIA
Randomised controlled trials (RCTs) that compared an individualised discharge plan with routine discharge care that was not tailored to individual participants. Participants were hospital inpatients.
DATA COLLECTION AND ANALYSIS
Two authors independently undertook data analysis and quality assessment using a pre-designed data extraction sheet. We grouped studies according to patient groups (elderly medical patients, patients recovering from surgery, and those with a mix of conditions) and by outcome. We performed our statistical analysis according to the intention-to-treat principle, calculating risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous data using fixed-effect meta-analysis. When combining outcome data was not possible because of differences in the reporting of outcomes, we summarised the reported data in the text.
MAIN RESULTS
We included 30 trials (11,964 participants), including six identified in this update. Twenty-one trials recruited older participants with a medical condition, five recruited participants with a mix of medical and surgical conditions, one recruited participants from a psychiatric hospital, one from both a psychiatric hospital and from a general hospital, and two trials recruited participants admitted to hospital following a fall. Hospital length of stay and readmissions to hospital were reduced for participants admitted to hospital with a medical diagnosis and who were allocated to discharge planning (length of stay MD - 0.73, 95% CI - 1.33 to - 0.12, 12 trials, moderate certainty evidence; readmission rates RR 0.87, 95% CI 0.79 to 0.97, 15 trials, moderate certainty evidence). It is uncertain whether discharge planning reduces readmission rates for patients admitted to hospital following a fall (RR 1.36, 95% CI 0.46 to 4.01, 2 trials, very low certainty evidence). For elderly patients with a medical condition, there was little or no difference between groups for mortality (RR 0.99, 95% CI 0.79 to 1.24, moderate certainty). There was also little evidence regarding mortality for participants recovering from surgery or who had a mix of medical and surgical conditions. Discharge planning may lead to increased satisfaction for patients and healthcare professionals (low certainty evidence, six trials). It is uncertain whether there is any difference in the cost of care when discharge planning is implemented with patients who have a medical condition (very low certainty evidence, five trials).
AUTHORS' CONCLUSIONS
A discharge plan tailored to the individual patient probably brings about a small reduction in hospital length of stay and reduces the risk of readmission to hospital at three months follow-up for older people with a medical condition. Discharge planning may lead to increased satisfaction with healthcare for patients and professionals. There is little evidence that discharge planning reduces costs to the health service.
Topics: Aftercare; Controlled Clinical Trials as Topic; Health Care Costs; Humans; Intention to Treat Analysis; Length of Stay; Outcome Assessment, Health Care; Patient Discharge; Patient Readmission; Randomized Controlled Trials as Topic
PubMed: 26816297
DOI: 10.1002/14651858.CD000313.pub5 -
Journal of Surgical Oncology Feb 2018The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use. (Review)
Review
BACKGROUND
The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use.
OBJECTIVE
To evaluate published and ongoing clinical trials seeking to better define role of CRS/HIPEC in the treatment of peritoneal surface malignancies.
METHODS
Systematic review by PubMed search was performed using terms "Clinical trial," "intraperitoneal chemotherapy," and "HIPEC." ClinicalTrials.gov and EudraCT registries were searched for active clinical trials. Eligibility included CRS/HIPEC trials investigating adult patient populations from published clinical reports and/or trials currently accruing or at completion.
RESULTS
Thirteen published trials and 57 active clinical trials were included for review.
CONCLUSIONS
Published and ongoing U.S. and international clinical trials for CRS and HIPEC are defining important parameters that include improving patient selection, strategic sequences of treatment, cytoreductive strategies, chemotherapeutics, optimal hyperthermic temperature and timing, and toxicity profiles. Main barriers or limitations to trial development remain patient enrollment, trial design, and oncologic community collaboration. Overall progress is positive with increasing number of clinical trials throughout the world. Collaboration between surgeons and the wider oncologic community will be crucial to validate this important treatment strategy.
Topics: Chemotherapy, Cancer, Regional Perfusion; Clinical Trials as Topic; Cytoreduction Surgical Procedures; Humans; Hyperthermia, Induced; Meta-Analysis as Topic; Peritoneal Neoplasms; Prognosis; Survival Rate
PubMed: 29120491
DOI: 10.1002/jso.24813 -
Mycoses Aug 2021Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise... (Review)
Review
BACKGROUND
Onychomycosis is the most common nail disease seen in clinical practice. Inclusion of diverse groups in onychomycosis clinical trials subjects is necessary to generalise efficacy data.
OBJECTIVES
We aimed to systematically review race and ethnicity reporting and representation, as well as, treatment outcomes in onychomycosis clinical trials.
METHODS
A PubMed search for onychomycosis clinical trials was performed in August 2020. Primary clinical trial data were included and post hoc analyses were excluded. Categorical variables were compared using chi-squared and Fisher's exact tests. Statistical significance was set at p < .05. Photos in articles were categorised by Fitzpatrick skin type.
RESULTS
Only 32/182 (17.5%) trials reported on race and/or ethnicity and only one trial compared treatment efficacy in different subgroups. Darker skin colours were infrequently depicted in articles. Topical treatment, location with ≥1 US-based site, industry funding type and publication date after 2000 were significantly associated with reporting of racial/ethnic data (p < .05 for all comparisons).
LIMITATIONS
Demographics on excluded subjects and methods of recruitment were not available. Assigning Fitzpatrick skin type is inherently subjective.
CONCLUSIONS
This study highlights a need for consistent reporting of races and ethnicities of onychomycosis clinical trial participants with subgroup analyses of treatment efficacies.
Topics: Administration, Topical; Antifungal Agents; Clinical Trials as Topic; Foot Dermatoses; Humans; Onychomycosis; Treatment Outcome
PubMed: 33655595
DOI: 10.1111/myc.13262