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Cerebellum (London, England) Jun 2012We aimed to perform a comprehensive systematic review of the existing ataxia scales. We described the disorders for which the instruments have been validated and used,... (Meta-Analysis)
Meta-Analysis Review
We aimed to perform a comprehensive systematic review of the existing ataxia scales. We described the disorders for which the instruments have been validated and used, the time spent in its application, its validated psychometric properties, and their use in studies of natural history and clinical trials. A search from 1997 onwards was performed in the MEDLINE, LILACS, and Cochrane databases. The web sites ClinicalTrials.gov and Orpha.net were also used to identify the endpoints used in ongoing randomized clinical trials. We identified and described the semiquantitative ataxia scales (ICARS, SARA, MICARS, BARS); semiquantitative ataxia and non-ataxia scales (UMSARS, FARS, NESSCA); a semiquantitative non-ataxia scale (INAS); quantitative ataxia scales (CATSYS 2000, AFCS, CCFS and CCFSw, and SCAFI); and the self-performed ataxia scale (FAIS). SARA and ICARS were the best studied and validated so far, and their reliability sustain their use. Ataxia and non-ataxia scores will probably provide a better view of the overall disability in long-term trials and studies of natural history. Up to now, no clear advantage has been disclosed for any of them; however, we recommend the use of specific measurements of gait since gait ataxia is the first significant manifestation in the majority of ataxia disorders and comment on the best scales to be used in specific ataxia forms. Quantitative ataxia scales will be needed to speed up evidence from phase II clinical trials, from trials focused on the early phase of diseases, and for secondary endpoints in phase III trials. Finally, it is worth remembering that estimation of the actual minimal clinically relevant difference is still lacking; this, together with changes in quality of life, will probably be the main endpoints to measure in future therapeutic studies.
Topics: Cerebellar Ataxia; Clinical Trials as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Friedreich Ataxia; Humans; Multiple System Atrophy; Randomized Controlled Trials as Topic; Reproducibility of Results; Spinocerebellar Ataxias
PubMed: 21964941
DOI: 10.1007/s12311-011-0316-8 -
European Journal of Obstetrics,... Feb 2020To measure the potential for outcome switching and selective reporting, in trials of luteal phase progestogen in assisted reproduction.
The strength of evidence supporting luteal phase progestogen after assisted reproduction: A systematic review with reference to trial registration and pre-specified endpoints.
OBJECTIVE
To measure the potential for outcome switching and selective reporting, in trials of luteal phase progestogen in assisted reproduction.
STUDY DESIGN
Trials identified through Medline and Embase in August 2017 using the MeSH term "assisted reproductive technology, luteal phase support" and associated text words. Randomised controlled trials (RCTs) comparing progestogen of any type, dose, and route of administration, with placebo or no treatment as luteal phase support in subfertile women undergoing in vitro fertilization (IVF) or intrauterine insemination (IUI). Eight trials after IVF and eleven after IUI, involving 1040 and 2764 participants respectively, were included.
RESULTS
None of the eight trials of progestogen therapy after IVF had been registered. Only 5/11 trials of progestogen after IUI had been registered, and only two of these prospectively. One of these had a registered primary outcome of "pregnancy sac plus heartbeat", but reported "pregnancy sac alone"; we judged this as an altered primary outcome. Three other trial had a registered primary outcome of "clinical pregnancy undefined" and reported "intra or extra-uterine pregnancy with a heartbeat"; we judged this alteration as minimal. That trial was negative. Overall, 26 different outcomes had been reported by the various trials. The three outcomes reported most often were pregnancy undefined (9/19), miscarriage (11/19) and clinical pregnancy (9/19). This suggests considerable potential for selective outcome reporting or outcome switching.
CONCLUSION
Apart from one negative trial, none of the evidence on luteal phase progestogen after assisted reproduction comes from prospectively registered trials: a slender reed indeed.
Topics: Female; Fertilization in Vitro; Humans; Luteal Phase; Non-Randomized Controlled Trials as Topic; Pregnancy; Pregnancy Rate; Progestins; Randomized Controlled Trials as Topic; Reproductive Techniques, Assisted; Treatment Outcome
PubMed: 31911377
DOI: 10.1016/j.ejogrb.2019.12.002 -
Journal of Neurology Aug 2012Delirium is a common complication in acute stroke yet there is uncertainty regarding how best to screen for and diagnose delirium after stroke. We sought to establish... (Review)
Review
Delirium is a common complication in acute stroke yet there is uncertainty regarding how best to screen for and diagnose delirium after stroke. We sought to establish how delirium after stroke is identified, its incidence rates and factors predicting its development. We conducted a systematic review of studies investigating delirium in acute stroke. We searched The Cochrane Collaboration, MEDLINE, EMBASE, CINHAL, PsychINFO, Web of Science, British Nursing Index, PEDro and OT Seeker in October 2010. A total of 3,127 citations were screened, full text of 60 titles and abstracts were read, of which 20 studies published between 1984 and 2010 were included in this review. The methods most commonly used to identify delirium were generic assessment tools such as the Delirium Rating Scale (n = 5) or the Confusion Assessment Method (n = 2) or both (n = 2). The incidence of delirium in acute stroke ranged from 2.3-66%, with our meta-analysis random effects approach placing the rate at 26% (95% CI 19-33%). Of the 11 studies reporting risk factors for delirium, increased age, aphasia, neglect or dysphagia, visual disturbance and elevated cortisol levels were associated with the development of delirium in at least one study. The outcomes associated with the condition are increased morbidity and mortality. Delirium is found in around 26% of stroke patients. Difference in diagnostic and screening procedures could explain the wide variation in frequency of delirium. There are a number of factors that may predict the development of the condition.
Topics: Clinical Trials as Topic; Delirium; Humans; Incidence; Predictive Value of Tests; Stroke
PubMed: 22234842
DOI: 10.1007/s00415-011-6383-4 -
Cancer Causes & Control : CCC Jun 2011Physically active individuals have lower rates of many cancers and improved cancer outcomes. Controlled exercise trials measuring putative biomarkers of cancer risk are... (Review)
Review
BACKGROUND
Physically active individuals have lower rates of many cancers and improved cancer outcomes. Controlled exercise trials measuring putative biomarkers of cancer risk are being conducted to further understand the role of exercise in cancer etiology and progression. We aimed to systematically review the effect of exercise on various biomarkers.
METHODS
A comprehensive search strategy identified 353 publications from January 1980 to August 2010. We included those clinical trials of exercise measuring biomarkers following minimum 4-week intervention among cancer survivors or people with one or more cancer risk factors. Two reviewers abstracted data and assessed quality independently. Effect sizes and 95% confidence intervals were estimated.
RESULTS
Four primary prevention and five tertiary prevention trials were included. Exercise had a small to moderate effect on improving concentrations of several blood biomarkers implicated in breast and colon cancer pathways including insulin, leptin, estrogens, and apoptosis regulation. In breast cancer survivors, exercise had a small to moderate effect on improving some biomarkers associated with prognosis including various insulin-like growth factor axis proteins, insulin, and inflammation; and a large effect on enhancing immune function.
CONCLUSION
Data are few, but there is some evidence to support the role of exercise in modulating various cancer pathways.
Topics: Algorithms; Clinical Trials as Topic; Exercise; Exercise Therapy; Humans; Motor Activity; Neoplasms; Survivors; Treatment Outcome
PubMed: 21461921
DOI: 10.1007/s10552-011-9761-4 -
The Cochrane Database of Systematic... 2003Therapeutic Touch (TT) as a treatment modality has increased in popularity over the past two decades. Its efficacy in relation to the healing of wounds has been... (Review)
Review
BACKGROUND
Therapeutic Touch (TT) as a treatment modality has increased in popularity over the past two decades. Its efficacy in relation to the healing of wounds has been expounded in anecdotal publications. To date however there has been no systematic review.
OBJECTIVES
To identify and review all relevant data to determine the effectiveness of TT in the promotion of wound healing.
SEARCH STRATEGY
The Cochrane Wounds Group Specialised Trials Register and the Cochrane Central Register of Controlled Trials were searched in May 2003. The Cochrane Complementary Medicine field database was searched in September 2002. In addition the Sigma Theta Tau International Registry of Nursing Research (1983 to 2002) was also searched in September 2002. Furthermore searches of MEDLINE (1966 to 2003) were conducted in 1997 and May 2003, CINAHL (1982 to 2002) in September 2002 and dissertation abstracts in September 2002.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials, which compared the effect of TT with a placebo, another treatment, or no treatment control were considered. Studies which used TT as a stand-alone treatment, or as an adjunct to other therapies, were eligible.
DATA COLLECTION AND ANALYSIS
One reviewer (DO) determined the eligibility for inclusion of all trials. Both reviewers conducted data extraction and evaluation of each trial's quality independently. Each trial was analysed based on predetermined criteria and a narrative of each trial's main conclusions was produced.
MAIN RESULTS
Four trials in people with experimental wounds were eligible for inclusion. The effect of TT on wound healing in these studies was variable. Two of the studies (n = 44 & 24) demonstrated a significant effect of TT. However the results of the two other trials favoured the control group (n = 15 & 38), one of these trials demonstrated a significant effect in favour of the control group.
REVIEWER'S CONCLUSIONS
There is insufficient evidence that TT promotes healing of acute wounds.
Topics: Biopsy; Humans; Randomized Controlled Trials as Topic; Therapeutic Touch; Wound Healing
PubMed: 14583953
DOI: 10.1002/14651858.CD002766 -
Cartilage Jan 2021The management of complex cartilage pathology in young, otherwise healthy patients can be difficult.
Wide Variation in Methodology in Level I and II Studies on Cartilage Repair: A Systematic Review of Available Clinical Trials Comparing Patient Demographics, Treatment Means, and Outcomes Reporting.
BACKGROUND
The management of complex cartilage pathology in young, otherwise healthy patients can be difficult.
PURPOSE
To determine the nature of the design, endpoints chosen, and rate at which the endpoints were met in published studies and ongoing clinical trials that investigate cartilage repair and restoration procedures.
STUDY DESIGN
Systematic review.
METHODS
A systematic review of the publicly available level I/II literature and of the publicly listed clinical trials regarding cartilage repair and restoration procedures for the knee was conducted adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
Seventeen published studies and 52 clinical trials were included. Within the 17 published studies, the most common procedure studied was microfracture (MFX) + augmentation ( = 5; 29.4%) and the most common comparison/control group was MFX ( = 10; 58.8%). In total, 13 different cartilage procedure groups were evaluated. For published studies, the most common patient-reported outcome (PRO) measures assessed is the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale-Pain (VAS) ( = 10 studies, 58.8% each, respectively). Overall, there are 10 different PROs used among the included studies. Ten studies demonstrate superiority, 5 demonstrate noninferiority, and 2 demonstrate inferiority to the comparison or control groups. For the clinical trials included, the most common procedure studied is MFX + augmentation ( = 16; 30.8%). The most common PRO assessed is KOOS ( = 36 trials; 69.2%), and overall there are 24 different PROs used among the included studies.
CONCLUSIONS
Recently published studies and clinical trials evaluate a variety of cartilage repair and restoration strategies for the knee, most commonly MFX + augmentation, at various time points of outcome evaluation, with KOOS and VAS scores being used most commonly. MFX remains the most common comparison group for these therapeutic investigations. Most studies demonstrate superiority versus comparison or control groups. Understanding the nature of published and ongoing clinical trials will be helpful in the investigation of emerging technologies required to navigate the regulatory process while studying a relatively narrow population of patients.
Topics: Adolescent; Adult; Arthroplasty, Subchondral; Cartilage; Clinical Trials as Topic; Demography; Female; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Research Design; Research Subjects; Treatment Outcome; Young Adult
PubMed: 30378453
DOI: 10.1177/1947603518809398 -
The Cochrane Database of Systematic... Jul 2013Ultrasonography is regarded as the tool of choice for early diagnostic investigations in patients with suspected blunt abdominal trauma. Although its sensitivity is too... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Ultrasonography is regarded as the tool of choice for early diagnostic investigations in patients with suspected blunt abdominal trauma. Although its sensitivity is too low for definite exclusion of abdominal organ injury, proponents of ultrasound argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of computed tomography scans and cut costs.
OBJECTIVES
To assess the effects of trauma algorithms that include ultrasound examinations in patients with suspected blunt abdominal trauma.
SEARCH METHODS
We searched the Cochrane Injuries Group's Specialised Register, CENTRAL (The Cochrane Library), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EBSCO), publishers' databases, controlled trials registers and the Internet. Bibliographies of identified articles and conference abstracts were searched for further elligible studies. Trial authors were contacted for further information and individual patient data. The searches were updated in February 2013.
STUDIES
randomised controlled trials (RCTs) and quasi-randomised trials (qRCTs).
PARTICIPANTS
patients with blunt torso, abdominal or multiple trauma undergoing diagnostic investigations for abdominal organ injury.
INTERVENTIONS
diagnostic algorithms comprising emergency ultrasonography (US).
CONTROLS
diagnostic algorithms without ultrasound examinations (for example, primary computed tomography [CT] or diagnostic peritoneal lavage [DPL]).
OUTCOME MEASURES
mortality, use of CT and DPL, cost-effectiveness, laparotomy and negative laparotomy rates, delayed diagnoses, and quality of life.
DATA COLLECTION AND ANALYSIS
Two authors independently selected trials for inclusion, assessed methodological quality and extracted data. Where possible, data were pooled and relative risks (RRs), risk differences (RDs) and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed- or random-effects modelling, as appropriate.
MAIN RESULTS
We identified four studies meeting our inclusion criteria. Overall, trials were of moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. We pooled mortality data from three trials involving 1254 patients; relative risk in favour of the US arm was 1.00 (95% CI 0.50 to 2.00). US-based pathways significantly reduced the number of CT scans (random-effects RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result is unclear. Given the low sensitivity of ultrasound, the reduction in CT scans may either translate to a number needed to treat or number needed to harm of two.
AUTHORS' CONCLUSIONS
There is currently insufficient evidence from RCTs to justify promotion of ultrasound-based clinical pathways in diagnosing patients with suspected blunt abdominal trauma.
Topics: Abdominal Injuries; Algorithms; Emergencies; Humans; Randomized Controlled Trials as Topic; Ultrasonography; Wounds, Nonpenetrating
PubMed: 23904141
DOI: 10.1002/14651858.CD004446.pub3 -
Contemporary Clinical Trials Sep 2016Adrenal tumors are quite rare in infancy and childhood with the exception of neuroblastoma. In fact, adrenocortical tumors (ACT) account for only 0.2% of all malignant... (Review)
Review
Adrenal tumors are quite rare in infancy and childhood with the exception of neuroblastoma. In fact, adrenocortical tumors (ACT) account for only 0.2% of all malignant cancers in children and adolescents. According to a multicenter registry investigation, the median interval between first endocrine symptoms and the diagnosis of ACT is 5months, and death is seen in 38% of patients, who suffer from tumor progression following the diagnosis in about 2½years. The prognosis of pediatric ACC is poor with a 5-year event-free survival of 54%. To face this dreadful scenario, a few decades ago the International Pediatric Adrenocortical Tumor Registry (IPACTR) was established. Moreover, Children's Oncology Group (COG) and National Cancer Institute (NCI) have approved several clinical trials designed to investigate new treatment options in pediatric ACT. In this systematic review, we summarize the diagnostic histopathologic criteria, bio-markers, and clinical trials of this challenging diagnosis. Eleven pediatric ACT trials were reviewed in our investigation. Two out of 11 studies were conducted in Brazil showing apparently an increased rate of germline mutation-related pediatric ACT. A heterogeneous methodology was evident with four non-randomized clinical trials, three prospective cohort studies, and four retrospective case-control studies limiting higher statistical approach. Tumor histology remains the backbone to diagnose ACT creating a common investigative platform and potentially supporting studies aiming to increase international collaborative research, which is crucial for this challenging disease.
Topics: Adrenal Cortex Neoplasms; Adrenocortical Carcinoma; Biomarkers, Tumor; Child; Clinical Trials as Topic; Humans; Neoplasm Staging; Prognosis; Research Design; Survival Rate
PubMed: 27424218
DOI: 10.1016/j.cct.2016.07.011 -
Clinical and Experimental Dermatology Jul 2017Human scabies (infestation with the mite Sarcoptes scabiei var hominis) causes a significant disease burden worldwide, yet there are no agreed diagnostic guidelines. We... (Review)
Review
Human scabies (infestation with the mite Sarcoptes scabiei var hominis) causes a significant disease burden worldwide, yet there are no agreed diagnostic guidelines. We aimed to determine whether a consistent approach to diagnosing scabies has been used for published scabies therapeutic trials. The data sources used were the MEDLINE, Embase and Cochrane databases, from 1946 to 29 August 2013. Eligible studies were trials of therapeutic interventions against scabies in human subjects, published in English, enrolling patients with scabies, and using various therapeutic interventions. Language was a limitation of this study as some relevant trials published in languages other than English may have been excluded. Each study was reviewed by two independent authors, who assessed the clinical examination and testing approaches used for scabies diagnosis in the included studies. We found that of 71 included trials, 40 (56%) specified which clinical findings were used for diagnosis, which were predominantly rash, rash distribution, pruritus and mite burrows. Parasitological testing was used in 63% of trials (n = 45) and was used more frequently in clinic-based than in field studies. Nearly one-quarter of trials (24%, n = 17) did not define the diagnostic method used. Overall, the diagnostic approaches were poorly described, prohibiting accurate comparison of existing studies. This review further supports the need for consensus diagnostic guidelines for scabies.
Topics: Clinical Trials as Topic; Diagnosis, Differential; Humans; Scabies
PubMed: 28556185
DOI: 10.1111/ced.13152 -
Expert Opinion on Drug Metabolism &... Feb 2014Ivabradine is a new heart-rate-lowering drug; the aim of this review was to analyze its role in heart failure (HF). (Review)
Review
INTRODUCTION
Ivabradine is a new heart-rate-lowering drug; the aim of this review was to analyze its role in heart failure (HF).
AREAS COVERED
This systematic review on the role of ivabradine in HF is based on material searched and obtained through Pubmed and Medline up to September 2013.
EXPERT OPINION
Heart rate (HR) is a risk factor in patients with HF, and its reduction is considered an important goal of therapy. The BEAUTIFUL trial demonstrated the benefits of ivabradine on prognosis (only on ischemic endpoints) in patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) and HR ≥ 60 bpm. In the SHIFT trial, which enrolled patients with LVSD, HF and HR ≥ 70 bpm, ivabradine administration (on top of guideline-based therapy, including β-blockers [BB]) was associated with a reduction of cardiovascular death and hospitalizations for HF, but BB were underutilized. Further studies are needed to test the efficacy of ivabradine in CAD patients with high HR and to shed light on the comparison between ivabradine and a more aggressive therapy with higher doses of BB in HF patients.
Topics: Animals; Benzazepines; Clinical Trials as Topic; Heart Failure; Heart Rate; Humans; Ivabradine; Treatment Outcome
PubMed: 24377458
DOI: 10.1517/17425255.2014.876005