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The International Journal of... 2009A systematic review and meta-analysis of studies that specifically compared immediate to conventional loading of single implant crowns was conducted and the overall... (Comparative Study)
Comparative Study Meta-Analysis Review
PURPOSE
A systematic review and meta-analysis of studies that specifically compared immediate to conventional loading of single implant crowns was conducted and the overall treatment effect was estimated.
MATERIALS AND METHODS
MEDLINE, the Cochrane Controlled Trials Register, and bibliographies of relevant primary and review articles were searched. Randomized and nonrandomized controlled studies that compared immediate with conventional loading of single implant crowns were selected according to strict criteria. From the 105 articles screened, five studies with 248 implants were analyzed. The meta-analysis was prepared in accordance with the Quality of Reporting of Meta-analyses (QUOROM) statement. Descriptive and outcome data were extracted using specially designed data extraction forms. The data were entered into MIX software for meta-analysis using a fixed effects model, relative risk, and 95% confidence interval (CI).
RESULTS
Immediate loading of single implant crowns was associated with a significantly higher risk of implant failure (relative risk: 5.07, 95% CI: 2.00 to 12.84, P < .001). Pooling of randomized controlled trials showed similar results, although the difference was not statistically significant. Immediate nonocclusal loading was also associated with worse outcomes when compared to conventional loading (relative risk: 4.76, 95% CI: 1.74 to 13.02, P = .002).
CONCLUSIONS
This systematic review and meta-analysis shows that better outcomes are currently achieved using conventional loading of single implants with crowns, as opposed to immediately loaded ones, which are at a higher risk of failure. Further adequately powered clinical trials are needed. Caution with immediate loading of implants with crowns as a standard of care for single tooth replacement is recommended.
Topics: Controlled Clinical Trials as Topic; Crowns; Dental Abutments; Dental Implantation, Endosseous; Dental Implants, Single-Tooth; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Humans; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
PubMed: 19639076
DOI: No ID Found -
Gut Jan 2018Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted... (Review)
Review
OBJECTIVE
Although several pharmacological agents have emerged as potential adjunctive therapies to a gluten-free diet for coeliac disease, there is currently no widely accepted measure of disease activity used in clinical trials. We conducted a systematic review of coeliac disease activity indices to evaluate their operating properties and potential as outcome measures in registration trials.
DESIGN
MEDLINE, EMBASE and the Cochrane central library were searched from 1966 to 2015 for eligible studies in adult and/or paediatric patients with coeliac disease that included coeliac disease activity markers in their outcome measures. The operating characteristics of histological indices, patient-reported outcomes (PROs) and endoscopic indices were evaluated for content and construct validity, reliability, responsiveness and feasibility using guidelines proposed by the US Food and Drug Administration (FDA).
RESULTS
Of 19 123 citations, 286 studies were eligible, including 24 randomised-controlled trials. Three of five PROs identified met most key evaluative criteria but only the Celiac Disease Symptom Diary (CDSD) and the Celiac Disease Patient-Reported Outcome (CeD PRO) have been approved by the FDA. All histological and endoscopic scores identified lacked content validity. Quantitative morphometric histological analysis had better reliability and responsiveness compared with qualitative scales. Endoscopic indices were infrequently used, and only one index demonstrated responsiveness to effective therapy.
CONCLUSIONS
Current best evidence suggests that the CDSD and the CeD PRO are appropriate for use in the definition of primary end points in coeliac disease registration trials. Morphometric histology should be included as a key secondary or co-primary end point. Further work is needed to optimise end point configuration to inform efficient drug development.
Topics: Biomarkers; Celiac Disease; Clinical Trials as Topic; Endoscopy, Gastrointestinal; Humans; Outcome Assessment, Health Care; Reproducibility of Results; Severity of Illness Index
PubMed: 27799282
DOI: 10.1136/gutjnl-2016-312762 -
Journal of Orofacial Pain 2009To describe evidence for a relationship between diagnoses and findings of clinical examination and diagnoses and findings of magnetic resonance imaging (MRI) examination... (Comparative Study)
Comparative Study Review
Relationship between clinical and magnetic resonance imaging diagnoses and findings in degenerative and inflammatory temporomandibular joint diseases: a systematic literature review.
AIM
To describe evidence for a relationship between diagnoses and findings of clinical examination and diagnoses and findings of magnetic resonance imaging (MRI) examination for degenerative and inflammatory temporomandibular joint diseases.
METHODS
PubMed and the Cochrane Library were searched using specific indexing terms and reference lists were hand-searched. Included publications satisfied pre-established criteria. Primary studies were interpreted using a modification of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool.
RESULTS
The literature search yielded 219 titles and abstracts. Eighty-two studies were selected and read in full-text. After data extraction and interpretation with the QUADAS tool, 23 studies remained. There was a vast heterogeneity in study design, clinical examination methods, and diagnostic criteria. No clear evidence was found for a relationship between clinical and MRI diagnoses and findings. Several studies reported a relationship between clinical pain and internal derangements diagnosed with MRI, but the calculated odds ratio (OR) for this relationship was generally low (1.54-2.04). ORs for the relationship between pain and disc displacement without reduction (4.82) or between crepitation and disc displacement without reduction (3.71) were higher.
CONCLUSION
This review reveals a need for studies with improved quality in reporting of samples, examination techniques, findings, and definitions and rationales for cutoffs, categories, and diagnoses. We recommend that standardized protocols such as the Research Diagnostic Criteria for temporomandibular disorders (RDC/TMD) and the Standards for Reporting of Diagnostic Accuracy (STARD) statement be implemented in future studies.
Topics: Arthritis; Clinical Trials as Topic; Facial Pain; Humans; Joint Dislocations; Magnetic Resonance Imaging; Odds Ratio; Osteoarthritis; Physical Examination; Quality Assurance, Health Care; Reference Standards; Sound; Temporomandibular Joint Disorders
PubMed: 19492537
DOI: No ID Found -
Acta Anaesthesiologica Scandinavica Jan 2011The evidence underpinning oesophageal Doppler monitoring (ODM)-guided fluid administration in colorectal surgery has not been critically appraised despite quantitative... (Meta-Analysis)
Meta-Analysis Review
The evidence underpinning oesophageal Doppler monitoring (ODM)-guided fluid administration in colorectal surgery has not been critically appraised despite quantitative meta-analyses. A qualitative systematic review of the methodology and findings of all published randomised-controlled trials (RCTs) exploring ODM-guided fluid administration in major abdominal surgery was conducted. Four, well-designed single-centre trials inclusive of 393 patients in total have primarily demonstrated that ODM-guided intraoperative fluid administration decreases hospital length of stay (LOS) and complications by optimising intraoperative cardiac parameters. One subsequently published RCT shows that ODM-guided fluid administration predisposes to a greater LOS and significantly increased complications. However, all the trials have been hampered by imprecise definitions with heterogeneity in patient selection, intraoperative fluid administration strategies and methods of outcome assessment. ODM-guided fluid administration has only been investigated in the setting of laparoscopic colonic surgery and within an optimised perioperative care protocol in one trial, where it was not shown to be beneficial. Nevertheless, it was recommended for use in this context before the trial was even published. ODM-guided fluid administration has not been compared with intraoperative fluid restriction. Current evidence regarding the use of Doppler-guided fluid administration is limited by heterogeneity in the trial design, and the initial clinical benefits observed may be largely offset by recent advances in surgical techniques and perioperative care.
Topics: Clinical Trials as Topic; Colon; Esophagus; Fluid Therapy; Humans; Intraoperative Care; Intraoperative Period; Perioperative Care; Postoperative Care; Randomized Controlled Trials as Topic; Rectum; Research Design; Treatment Outcome; Ultrasonography, Doppler; Vasoconstrictor Agents
PubMed: 21126237
DOI: 10.1111/j.1399-6576.2010.02308.x -
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 -
Drug treatment of scrub typhus: a systematic review and meta-analysis of controlled clinical trials.Transactions of the Royal Society of... Aug 2017Scrub typhus, a potentially fatal infection caused by the pathogen Orientia tsutsugamushi, has a wide geographical distribution. This systematic review analyses the... (Meta-Analysis)
Meta-Analysis Review
Scrub typhus, a potentially fatal infection caused by the pathogen Orientia tsutsugamushi, has a wide geographical distribution. This systematic review analyses the evidence from prospective controlled clinical studies for the efficacy of antibiotics in the treatment of scrub typhus. PubMed, Embase, Scopus, Cochrane Library, CINAHL and clinical trial registries in China, India and Sri Lanka were searched for controlled prospective clinical trials (randomized, quasi-randomized or non-randomized) enrolling patients with confirmed scrub typhus for treatment with antibiotics. The PROSPERO registration number for this review is CRD42017071374. Eleven studies (from Southeast Asia and China) that enrolled 957 patients into 28 study groups met the inclusion criteria. Doxycycline was the most frequent comparator with other antibiotics. Chloramphenicol, tetracycline and azithromycin (limited evidence for roxithromycin, telithromycin, levofloxacin and rifampicin) had equal efficacy to doxycycline in achieving clinical cure. The cure rates in all studies varied from 64 to 100%. Of the antibiotics frequently used in current practice, azithromycin had the best evidence compared with doxycycline for equal efficacy in clinical cure (three trials, 280 participants, moderate quality evidence) with fewer gastrointestinal adverse events. The preferred choice of antibiotics for each patient depends on the adverse effect profile, personal circumstances (e.g., age, pregnancy), cost and local prescription guidelines.
Topics: Anti-Bacterial Agents; Controlled Clinical Trials as Topic; Humans; Prospective Studies; Scrub Typhus; Treatment Outcome
PubMed: 29253266
DOI: 10.1093/trstmh/trx066 -
JAMA Dermatology Nov 2018Up to 51% of patients with psoriasis report the use of complementary and alternative medicine (CAM) in their treatment regimen, although it is unclear which CAM... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Up to 51% of patients with psoriasis report the use of complementary and alternative medicine (CAM) in their treatment regimen, although it is unclear which CAM therapies are effective for treatment of psoriasis.
OBJECTIVE
This review compiles the evidence on the efficacy of the most studied CAM modalities for treatment of patients with plaque psoriasis and discusses those therapies with the most robust available evidence.
EVIDENCE REVIEW
PubMed, Embase, and ClinicalTrials.gov searches (1950-2017) were used to identify all documented CAM psoriasis interventions in the literature. The criteria were further refined to focus on those treatments identified in the first step that had the highest level of evidence for plaque psoriasis with more than 1 randomized clinical trial supporting their use. This excluded therapies lacking randomized clinical trial (RCT) data or showing consistent inefficacy.
FINDINGS
Primary CAM therapy searches identified 457 articles, of which 107 articles were retrieved for closer examination. Of those articles, 54 were excluded because the CAM therapy did not have more than 1 RCT on the subject or showed consistent lack of efficacy. An additional 7 articles were found using references of the included studies, resulting in a total of 44 RCTs (17 double-blind, 13 single-blind, and 14 nonblind), 10 uncontrolled trials, 2 open-label nonrandomized controlled trials, 1 prospective controlled trial, and 3 meta-analyses. Compared with placebo, application of topical indigo naturalis, studied in 5 RCTs with 215 participants, showed significant improvements in the treatment of psoriasis. Treatment with curcumin, examined in 3 RCTs (with a total of 118 participants), 1 nonrandomized controlled study, and 1 uncontrolled study, conferred statistically and clinically significant improvements in psoriasis plaques. Fish oil treatment was evaluated in 20 studies (12 RCTs, 1 open-label nonrandomized controlled trial, and 7 uncontrolled studies); most of the RCTs showed no significant improvement in psoriasis, whereas most of the uncontrolled studies showed benefit when fish oil was used daily. Meditation and guided imagery therapies were studied in 3 single-blind RCTs (with a total of 112 patients) and showed modest efficacy in treatment of psoriasis. One meta-analysis of 13 RCTs examined the association of acupuncture with improvement in psoriasis and showed significant improvement with acupuncture compared with placebo.
CONCLUSIONS AND RELEVANCE
The CAM therapies with the most robust evidence of efficacy for treatment of psoriasis are indigo naturalis, curcumin, dietary modification, fish oil, meditation, and acupuncture. This review will aid practitioners in advising patients seeking unconventional approaches for treatment of psoriasis.
Topics: Clinical Trials as Topic; Complementary Therapies; Humans; Psoriasis; Treatment Outcome
PubMed: 30193251
DOI: 10.1001/jamadermatol.2018.2972 -
Chinese Journal of Integrative Medicine Mar 2013Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This... (Meta-Analysis)
Meta-Analysis Review
Syndrome pattern (SP) is a core concept of Chinese medicine (CM) and is used to diagnose and treat patients based on an overall analysis of symptoms and signs. This study aimed to systematically review randomized controlled trials (RCTs) using the SP concept and to demonstrate how the SP concept could be applied to the study design of parallel RCTs, considering a gold standard of clinical research. After conducting a brief systematic review by way of a PubMed search, we analyzed how the SP concept was applied to the design of RCT in a CM herbal medicine trial. We then formulated possible research questions, applied the SP concept to answer the research questions, and suggested possible RCT designs to be used for conducting future trials. Fourteen RCTs were included in our systematic review, and three key points of the SP concept were formulated for the design of parallel RCTs: the time point of SP diagnosis between before and after randomization; the relationship between the international classification of diseases (ICD) and SP for the inclusion of target population; and the proper diagnostic method of SP. In this study, we formulated three possible research questions and then suggested perspectives for five possible RCT models arrived at using SP concepts. Future trials applying SP concept to RCTs should overcome the shortcomings of past SP trials, moving CM forward from experience-based to evidence-based medicine.
Topics: Humans; Randomized Controlled Trials as Topic; Research Design; Syndrome; Treatment Outcome
PubMed: 23212576
DOI: 10.1007/s11655-012-1256-y -
Clinical Rehabilitation Oct 2012To assess the effectiveness of surface neuromuscular electrical stimulation in the treatment of knee osteoarthritis. (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To assess the effectiveness of surface neuromuscular electrical stimulation in the treatment of knee osteoarthritis.
DESIGN
Systematic review and meta-analysis of randomized controlled and controlled clinical trials
METHODS
Studies were identified from databases (MEDLINE, EMBASE, CINAHL, Sports Discus, PEDro and the Cochrane Library) searched to January 2011 using a battery of keywords. Two reviewers selected studies meeting inclusion criteria. The methodological quality of the included studies was assessed using the Thomas Test and the strength of the evidence was then graded using the Agency for Health Care Policy and Research guidelines. Data were pooled and meta-analyses were performed.
RESULTS
Nine randomized controlled trials and one controlled clinical trial, studying a total of 409 participants (n = 395 for randomized controlled trials, and n = 14 for controlled trial) with a diagnosis of osteoarthritis were included. Inconsistent evidence (level D) was found that neuromuscular electrical stimulation has a significant impact on measures of pain, function and quadriceps femoris muscle strength in knee osteoarthritis.
CONCLUSION
The role of neuromuscular electrical stimulation in the treatment of knee osteoarthritis is ambiguous. Therefore, future work is needed in this field to clearly establish the role of neuromuscular electrical stimulation in this population.
Topics: Controlled Clinical Trials as Topic; Electric Stimulation Therapy; Female; Humans; Male; Muscle Strength; Osteoarthritis, Knee; Pain Measurement; Patient Satisfaction; Quadriceps Muscle; Randomized Controlled Trials as Topic; Range of Motion, Articular; Severity of Illness Index; Treatment Outcome; United States
PubMed: 22324059
DOI: 10.1177/0269215511431902 -
American Journal of Kidney Diseases :... Sep 2013The use of rasburicase has been evaluated extensively in children, but not in adults. We review the current literature to evaluate its effect on adults. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The use of rasburicase has been evaluated extensively in children, but not in adults. We review the current literature to evaluate its effect on adults.
STUDY DESIGN
Systematic review and meta-analysis.
SETTING & POPULATION
Adults receiving rasburicase for tumor lysis syndrome (TLS).
SELECTION CRITERIA FOR STUDIES
Electronic databases, regulatory documents, and websites were searched up to August 7, 2012. Reference lists of published articles were examined for additional relevant references. Any controlled trial or observational studies (controlled before and after) were included. Studies considering children only or mixing data for children and adults were excluded.
INTERVENTION
Rasburicase for TLS.
OUTCOMES
The primary outcome was TLS development. Secondary outcomes included percentage of patients improving, total adverse events, acute kidney failure, deaths, and serum uric acid and creatinine levels.
RESULTS
21 studies (24 publications) reported data for 1,261 adult patients, 768 receiving rasburicase for either the treatment or prophylaxis of TLS; these comprised 4 controlled trials and 17 observational studies. No statistically significant differences in clinical TLS development were observed in the controlled trials between the rasburicase and control groups. For the observational studies, 7.4% of patients developed clinical TLS after rasburicase (95% CI, 1.7%-16.7%), 93.4% of patients achieved normalized serum uric acid levels after rasburicase treatment (95% CI, 91.7%-94.6%), 4.4% developed acute kidney injury (95% CI, 3.0%-6.0%), and 2.6% died (95% CI, 0.95%-5.0%). The mean reduction in serum uric acid levels ranged from 5.3-12.8 mg/dL, and for serum creatinine levels, from 0.10-2.1 mg/dL.
LIMITATIONS
Controlled trials differed in outcomes reported; meta-analysis was not performed.
CONCLUSIONS
Rasburicase is effective in reducing serum uric acid levels in adults with TLS but at a significant cost, and evidence currently is lacking in adults to report whether rasburicase use improves clinical outcomes compared with other alternatives. Until new evidence is available, use of rasburicase may be limited to adult patients with a high risk of TLS.
Topics: Adult; Antineoplastic Agents; Clinical Trials as Topic; Humans; Recombinant Proteins; Treatment Outcome; Tumor Lysis Syndrome; Urate Oxidase
PubMed: 23684124
DOI: 10.1053/j.ajkd.2013.02.378