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Health Technology Assessment... Jul 2016Skin cancer is one of the most common cancers in the UK. The main risk factor is exposure to ultraviolet radiation from sunlight or the use of sunbeds. Patients with... (Review)
Review
BACKGROUND
Skin cancer is one of the most common cancers in the UK. The main risk factor is exposure to ultraviolet radiation from sunlight or the use of sunbeds. Patients with suspicious skin lesions are first examined with a dermoscope. After examination, those with non-cancerous lesions are discharged, but lesions that are still considered clinically suspicious are surgically removed. VivaScope(®) is a non-invasive technology designed to be used in conjunction with dermoscopy to provide a more accurate diagnosis, leading to fewer biopsies of benign lesions or to provide more accurate presurgical margins reducing the risk of cancer recurrence.
OBJECTIVES
To evaluate the clinical effectiveness and cost-effectiveness of VivaScope(®) 1500 (Caliber Imaging and Diagnostics, Rochester, NY, USA; Lucid Inc., Rochester, NY, USA; or Lucid Inc., MAVIG GmbH, Munich, Germany) and VivaScope(®) 3000 (Caliber Imaging and Diagnostics, Rochester, NY, USA) in the diagnosis of equivocal skin lesions, and VivaScope 3000 in lesion margin delineation prior to surgical excision of lesions.
DATA SOURCES
Databases (MEDLINE, EMBASE and The Cochrane Library) were searched on 14 October 2014, reference lists of included papers were assessed and clinical experts were contacted for additional information on published and unpublished studies.
METHODS
A systematic review was carried out to identify randomised controlled trials (RCTs) or observational studies evaluating dermoscopy plus VivaScope, or VivaScope alone, with histopathology as the reference test. A probabilistic de novo economic model was developed to synthesise the available data on costs and clinical outcomes from the UK NHS perspective. All costs were expressed as 2014 prices.
RESULTS
Sixteen studies were included in the review, but they were too heterogeneous to be combined in a meta-analysis. One of two diagnostic studies that were deemed most representative of UK clinical practice reported that dermoscopy plus VivaScope 1500 was significantly more sensitive than dermoscopy alone in the diagnosis of melanoma (97.8% vs. 94.6%; p = 0.043) and significantly more specific than dermoscopy alone in the diagnosis of non-melanoma (92.4% vs. 26.74%; p < 0.000001). The results of another study suggest 100% [95% confidence interval (CI) 86.16% to 100%] sensitivity for dermoscopy plus VivaScope 1500 versus 100% (95% CI 91.51% to 100%) for dermoscopy alone. Specificity varied from 51.77% to 80.2% depending on the analysis set used. In terms of margin delineation with VivaScope, one study found that 17 out of 29 patients with visible lentigo maligna (LM) had subclinical disease of > 5 mm beyond the dermoscopically identified margin. Using 'optimistic' diagnostic data, the economic model resulted in an incremental cost-effectiveness ratio (ICER) of £8877 per quality-adjusted life-year (QALY) (£9362 per QALY), while the 'less favourable' diagnostic data resulted in an ICER of £19,095 per QALY (£25,453 per QALY) in the diagnosis of suspected melanomas. VivaScope was also shown to be a dominant strategy when used for the diagnostic assessment of suspected basal cell carcinoma (BCC). Regarding margin delineation of LM, mapping with VivaScope was cost-effective, with an ICER of £10,241 per QALY (£11,651 per QALY). However, when VivaScope was used for diagnosis as well as mapping of LM, then the intervention cost was reduced and VivaScope became a dominant strategy.
LIMITATIONS
There is an absence of UK data in the included studies and, therefore, generalisability of the results to the UK population is unclear.
CONCLUSIONS
The use of VivaScope appears to be a cost-effective strategy in the diagnostic assessment of equivocal melanomas and BCCs, and in margin delineation of LM prior to surgical treatment.
FUTURE WORK
High-quality RCTs are required in a UK population to assess the diagnostic accuracy of VivaScope in people with equivocal lesions.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42014014433.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Carcinoma, Basal Cell; Cost-Benefit Analysis; Dermoscopy; Germany; Humans; Melanoma; Microscopy, Confocal; Models, Econometric; Observational Studies as Topic; Randomized Controlled Trials as Topic; Sensitivity and Specificity; Skin Diseases; Skin Neoplasms; Technology Assessment, Biomedical
PubMed: 27483991
DOI: 10.3310/hta20580 -
Trials Jun 2016There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with... (Review)
Review
BACKGROUND
There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus.
METHODS
Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded.
RESULTS
Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used.
CONCLUSIONS
Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments.
PROSPERO REGISTRATION
The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.
Topics: Adult; Clinical Trials as Topic; Humans; Research Design; Tinnitus; Treatment Outcome
PubMed: 27250987
DOI: 10.1186/s13063-016-1399-9 -
The Journal of Rheumatology Dec 2015To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies. (Review)
Review
OBJECTIVE
To identify the instruments used to assess polymyalgia rheumatica (PMR) in published studies.
METHODS
A systematic literature review of clinical trials and longitudinal observational studies related to PMR, published from 1970 to 2014, was carried out. All outcome and assessment instruments were extracted and categorized according to core areas and domains, as defined by the OMERACT (Outcome Measures in Rheumatology) Filter 2.0.
RESULTS
Thirty-five articles (3221 patients) were included: 12 randomized controlled trials (RCT); 3 nonrandomized trials; and 20 observational studies. More than 20 domains were identified, measured by 29 different instruments. The most frequently used measures were pain, morning stiffness, patient global assessment and physician global assessment, erythrocyte sedimentation rate, and C-reactive protein. The definition of outcomes varied considerably between studies.
CONCLUSION
The outcome measures and instruments used in PMR are numerous and diversely defined. The establishment of a core set of validated and standardized outcome measurements is needed.
Topics: Activities of Daily Living; Antirheumatic Agents; Blood Sedimentation; C-Reactive Protein; Consensus Development Conferences as Topic; Controlled Clinical Trials as Topic; Female; Humans; Immunosuppressive Agents; Male; Observational Studies as Topic; Outcome Assessment, Health Care; Pain Measurement; Polymyalgia Rheumatica; Practice Guidelines as Topic; Quality of Life; Randomized Controlled Trials as Topic; Risk Assessment; Severity of Illness Index
PubMed: 26568600
DOI: 10.3899/jrheum.150515 -
Journal of Addictive Diseases 2022Auriculotherapy has been used to reduce withdrawal symptoms during drug detoxication. The purpose of this study was to review the results of the randomized controlled...
Auriculotherapy has been used to reduce withdrawal symptoms during drug detoxication. The purpose of this study was to review the results of the randomized controlled trials (RCTs) that examined the impact of auriculotherapy on addiction. This study aimed to find an effective protocol involving auricular acupuncture points, intervention duration and frequency, and stimulating methods. We searched PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Medline for articles published between January 1, 1994, and March 31, 2021. The keywords used were auricular, acupuncture, addiction, substance misuse, smoking, randomized controlled trial, clinical trial, and human. Each RCT was evaluated for quality applying the risk of bias tool by the Cochrane group. Effect size (Hedges's g) was calculated using the mean values and standard deviation of the experimental and control groups. The risk for bias of these studies was moderate to high and only four studies (11.1%) earned scores of 6, indicating the lowest risk of bias and highest quality RCT. Out of 36 studies, 23 (64%) reported that auriculotherapy was effective for treating addiction such as opioids, cocaine, alcohol, heroin, nicotine, and gambling. The most commonly used combination of acupuncture points (four of 36 studies) was shenmen, sympathetic, liver, lung, and kidney, which are called NADA protocol. The following most frequently used combination of acupressure points (four out of 36 studies) was shenmen, subcortex, heart, lung, and liver. Acupressure could be considered to be used for the treatment of addiction.
Topics: Auriculotherapy; Behavior, Addictive; Humans; Randomized Controlled Trials as Topic; Smoking; Substance Withdrawal Syndrome; Treatment Outcome
PubMed: 35179436
DOI: 10.1080/10550887.2021.2016011 -
World Neurosurgery Jul 2018The PulseRider is an innovative stent-like device designed for the treatment of intracranial bifurcation aneurysms. The aim of this study was to assess the current... (Review)
Review
BACKGROUND
The PulseRider is an innovative stent-like device designed for the treatment of intracranial bifurcation aneurysms. The aim of this study was to assess the current evidence on safety and effectiveness of the PulseRider.
METHODS
A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: PubMed, Ovid MEDLINE, and Scopus. The search strategy consisted of "pulserider," "bifurcation aneurysm," and "endovascular" in both AND and OR combinations. Studies included were original research articles in peer-reviewed journals. The manuscripts were thoroughly examined for study design, outcomes, and results.
RESULTS
Three studies were identified describing use of the PulseRider device in the treatment of 63 patients with 63 bifurcation aneurysms. We identified 2 multicenter case series and 1 single-arm clinical trial. The majority of aneurysms treated were located at the basilar tip (37, 58.7%). All devices were successfully deployed, and there were 5 intraoperative complications (7.9%), including 2 intraoperative aneurysm ruptures, 1 vessel dissection, and 2 thrombus formations. Immediate complete aneurysm occlusion was achieved in 61.9% (39/63) of cases and at the 6-month imaging follow-up, 66.7% (42/63) achieved complete aneurysm occlusion. One recanalization was reported in 1 of the multicenter case series within the 6-month follow-up.
CONCLUSIONS
The PulseRider is safe and probably effective for the treatment of intracranial bifurcation aneurysms, sometimes not amenable for stent-assisted coiling. However, current evidence is limited to a small sample and short follow-up. In addition, the device has not been compared with other treatment modalities.
Topics: Clinical Trials as Topic; Endovascular Procedures; Humans; Intracranial Aneurysm; Self Expandable Metallic Stents; Treatment Outcome
PubMed: 29698797
DOI: 10.1016/j.wneu.2018.04.102 -
Epidemiologic Reviews Jan 2017Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients... (Review)
Review
Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.
Topics: Activities of Daily Living; Clinical Trials as Topic; Health Status; Humans; Neoplasms; Patient Reported Outcome Measures; Quality of Life; Symptom Assessment
PubMed: 28453627
DOI: 10.1093/epirev/mxx008 -
Clinical and Experimental Allergy :... Mar 2022To determine whether treatment effectiveness can be established for a range of vocal cord dysfunction (VCD) interventions in adolescents and adults. (Review)
Review
OBJECTIVE
To determine whether treatment effectiveness can be established for a range of vocal cord dysfunction (VCD) interventions in adolescents and adults.
DESIGN
A systematic review of the literature and risk of bias appraisal was completed using the Joanna Briggs Institute Critical Appraisal Tools. Data were qualitatively synthesized in the broad intervention groups of glottic airway and respiratory retraining, pharmacological therapies, airway device therapies and psychological therapies.
DATA SOURCES
Nine electronic databases, two clinical trial registries and the grey literature were searched from inception to September 2021 for articles on VCD interventions or equivalent terms.
ELIGIBILITY CRITERIA
Studies were included if they were randomized controlled trials, non-randomized controlled trials, quasi-experimental pre- and post-test studies and within-subject repeated measure designs, participants were 13 years or older, VCD was diagnosed using laryngoscopy or CT larynx, VCD intervention was provided and outcome measures reported on VCD symptoms.
RESULTS
The search yielded no randomized controlled trials. There were 17 quasi-experimental studies that met the eligibility criteria, and these studies reported on glottic airway and respiratory retraining, botulinum toxin injections, inspiratory muscle strength training and amitriptyline; all were associated with VCD symptom reduction. In addition, 2 within-subject repeated measure studies reported inspiratory muscle strength training and respiratory retraining to be effective in reducing symptoms in participants with exertional VCD. The included studies were reported in full-text publications (11) and conference proceedings (8). There was a high risk of bias and low quality of evidence across all intervention areas.
CONCLUSION
Glottic airway and respiratory retraining, botulinum toxin injections, low-dose amitriptyline and inspiratory muscle strength training devices have been associated with symptom reduction in adults and adolescents with vocal cord dysfunction. Limited objective data exist to support the effectiveness of these interventions, and robust controlled trials are needed in this area. Systematic Review Registration: CRD42018092274 (PROSPERO).
Topics: Adolescent; Adult; Humans; Randomized Controlled Trials as Topic; Treatment Outcome; Vocal Cord Dysfunction
PubMed: 34699093
DOI: 10.1111/cea.14036 -
Trials Oct 2018A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target...
BACKGROUND
A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the randomised groups and then estimate the corresponding sample size. The sample size is chosen to provide reassurance that the trial will have high statistical power to detect the target difference at the planned statistical significance level. Alternative approaches are also available, though most still require specification of a target difference. The sample size has many implications for the conduct of the study, as well as incurring scientific and ethical aspects. Despite the critical role of the target difference for the primary outcome in the design of a randomised controlled trial (RCT), the manner in which it is determined has received little attention. This article reports the development of the DELTA guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for a RCT.
METHODS
The DELTA (Difference ELicitation in TriAls) project has five components comprising systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2), a Delphi study (stage 3), a 2-day consensus meeting bringing together researchers, funders and patient representatives (stage 4), and the preparation and dissemination of a guidance document (stage 5).
RESULTS
The project started in April 2016. The literature search identified 28 articles of methodological developments relevant to a method for specifying a target difference. A Delphi study involving 69 participants, along with a 2-day consensus meeting were conducted. In addition, further engagement sessions were held at two international conferences. The main guidance text was finalised on April 18, 2018, after revision informed by feedback gathered from stages 2 and 3 and from funder representatives.
DISCUSSION
The DELTA Delphi study identified a number of areas (such as practical recommendations and examples, greater coverage of different trial designs and statistical approaches) of particular interest amongst stakeholders which new guidance was desired to meet. New relevant references were identified by the review. Such findings influenced the scope, drafting and revision of the guidance. While not all suggestions could be accommodated, it is hoped that the process has led to a more useful and practical document.
Topics: Clinical Trial Protocols as Topic; Consensus; Data Interpretation, Statistical; Delphi Technique; Humans; Numbers Needed To Treat; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 30305155
DOI: 10.1186/s13063-018-2887-x -
American Journal of Rhinology & Allergy Sep 2021Odontogenic sinusitis affects a significant proportion of patients with paranasal sinus infections. Nevertheless, no shared diagnostic criteria for this condition have...
BACKGROUND
Odontogenic sinusitis affects a significant proportion of patients with paranasal sinus infections. Nevertheless, no shared diagnostic criteria for this condition have yet been implemented and published studies differ in their definition of the disease.
OBJECTIVE
The present systematic review of the literature was undertaken to characterize and analyze the different diagnostic criteria currently employed for odontogenic sinusitis.
METHODS
Systematic searches for studies published between 2009 and 2019 were performed in Medline, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases. Search criteria were designed to identify all studies focusing, even partially, on odontogenic sinusitis. Human original studies except single case reports published in the English, French, German, Spanish, or Italian language were included. We removed duplicate abstracts and conducted full-text reads, data extraction, and quality assessment procedures (using the Oxford Centre for Evidence-based Medicine levels of evidence and National Heart Lung and Blood Institute Study Quality Assessment Tools). We reviewed articles for diagnostic criteria, both in terms of definition and etiology identification.
RESULTS
Among 1,000 unique citations, 63 studies were deemed eligible. Most articles (n = 45) were retrospective case series; a single randomized clinical trial was available. Only 49 studies reported diagnostic criteria, yet relied marginally on published guidelines (n = 10 articles) for identifying sinusitis, often choosing instead to develop their own clinical (n = 15 articles), endoscopic (n = 12 articles), and/or radiologic (n = 30 articles) criteria. For odontogenic focus identification, 14 papers required a multidisciplinary evaluation, 11 papers required a time relationship between dental procedures and sinusitis, 24 papers required oroscopy and/or dental evaluation, and 53 papers required computed tomography.
CONCLUSIONS
Current diagnostic criteria for odontogenic sinusitis are extremely heterogeneous. Establishing shared diagnostic criteria aimed at defining both sinusitis and related odontogenic foci would spur collaboration between investigators and support more comprehensive outcomes evaluations together with a better understanding of treatment options.
Topics: Endoscopy; Humans; Maxillary Sinusitis; Paranasal Sinuses; Randomized Controlled Trials as Topic; Retrospective Studies; Sinusitis; Tomography, X-Ray Computed
PubMed: 33236664
DOI: 10.1177/1945892420976766 -
Journal of Lower Genital Tract Disease Jul 2018To systematically evaluate the literature regarding vulvodynia treatment outcome measures. (Review)
Review
OBJECTIVES OF THE STUDY
To systematically evaluate the literature regarding vulvodynia treatment outcome measures.
METHODS
A systematic literature search on OVID, PubMed, and PsycINFO databases was conducted from inception until May 2016. Studies were included/excluded based on prespecified criteria. Reported outcome measures were organized into 6 core outcome domains recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT): pain; physical functioning, emotional functioning, participant ratings of global improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition.
RESULTS
Of the 206 articles identified for full-text screening, 33 met our criteria. One study adhered to all IMMPACT recommendations. The number of outcomes measured per study ranged from 1 to greater than 20. Patient-reported pain outcomes were found in the majority (27/33; 82%) of studies. Pain severity with intercourse was reported by 24 (73%) of 33 studies-9 different scales were used to measure this outcome. Clinician-reported outcomes were present in 14 (42%) of 33 studies. Methods of measuring vestibular sensitivity by "cotton swab" test were different in 8 of 10 studies. Other domains reported included; physical function (8/33 studies; 24%), sexual function (23/33 studies; 70%), and emotional function (13/33 studies; 39%). Symptoms and adverse events were reported by 15 (45%) of 33 studies. One study formally reported participant disposition using all the information recommended by CONSORT.
CONCLUSIONS
Comparison of clinical trial results in vulvodynia is not possible because of a lack of standard treatment outcome measures. Vulvodynia researchers should apply the IMMPACT criteria to guide the development of a minimum core set of standard outcome measures that measure holistic health.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Clinical Trials as Topic; Female; Humans; Middle Aged; Treatment Outcome; Vulvodynia; Young Adult
PubMed: 29933290
DOI: 10.1097/LGT.0000000000000406