Methodological quality assessment of paper-based systematic reviews published in oral health.

OBJECTIVES: This study aimed to conduct a methodological assessment of paper-based systematic reviews (SR) published in oral health using a validated checklist. A secondary objective was to explore temporal trends on methodological quality. MATERIAL AND METHODS: Two electronic databases (OVID Medline and OVID EMBASE) were searched for paper-based SR of interventions published in oral health from inception to October 2014. Manual searches of the reference lists of paper-based SR were also conducted. Methodological quality of included paper-based SR was assessed using an 11-item questionnaire, Assessment of Multiple Systematic Reviews (AMSTAR) checklist. Methodological quality was summarized using the median and inter-quartile range (IQR) of the AMSTAR score over different categories and time periods. RESULTS: A total of 643 paper-based SR were included. The overall median AMSTAR score was 4 (IQR 2-6). The highest median score (5) was found in the pain dentistry and periodontology fields, while the lowest median score (3) was found in implant dentistry, restorative dentistry, oral medicine, and prosthodontics. The number of paper-based SR per year and the median AMSTAR score increased over time (median score in 1990s was 2 (IQR 2-3), 2000s was 4 (IQR 2-5), and 2010 onwards was 5 (IQR 3-6)). CONCLUSION: Although the methodological quality of paper-based SR published in oral health has improved in the last few years, there is still scope for improving quality in most evaluated dental specialties. CLINICAL RELEVANCE: Large-scale assessment of methodological quality of dental SR highlights areas of methodological strengths and weaknesses that can be targeted in future publications to encourage better quality review methodology.

[Proteome analysis of undiluted vitreous humor in patients with branch retinal vein occlusion]. / Proteomanalyse unverdünnter Glaskörperflüssigkeit bei Patienten mit einem Venenastverschluss.

BACKGROUND: The pathophysiological mechanisms of macular edema secondary to branch retinal vein occlusion (BRVO) remain unclear. OBJECTIVES: To analyze the protein profile of human vitreous of patients with BRVO and to identify specific dysregulated proteins. MATERIALS AND METHODS: Undiluted vitreous humor samples from patients with treatment naïve BRVO and 15 controls with idiopathic floaters were analyzed in this clinical-experimental study using capillary electrophoresis coupled to a mass spectrometer (CE-MS) and tandem mass spectrometry (MS/MS). Quantitative analysis of the dysregulated proteins was performed with enzyme-linked immunosorbent assay (ELISA). Protein-protein interactions were depicted with the STRING database. RESULTS: A total of 84 proteins were found in the human vitreous samples of 15 patients with BRVO and 15 controls. In all, 14 proteins were significant when comparing the signal intensities of BRVO and control samples. Six significant dysregulated proteins with p < 0.001 were further verified with ELISA. Clusterin, complement factor C3, prostaglandin-H2 D­isomerase and vitronectin were significantly upregulated in the BRVO group and opticin was downregulated. The protein interactions analysis showed associations with inflammatory cascades, matrix changes, mechanisms of cell survival und death. CONCLUSIONS: The results of the study reveal that the proteomic composition of vitreous humor differed significantly between the patients with BRVO and the controls. Whether the identified proteins may serve as potential biomarkers for pathophysiology, diagnostics or therapy should be examine in further studies.

Topical negative pressure (TNP) for partial thickness burns.

BACKGROUND: A burn wound is a complex and evolving injury, with both local and systemic consequences. Treatment includes using variety of dressings, but newer strategies such as topical negative pressure therapy have been developed to try and promote the wound healing process and minimize burn wound progression to involve deeper tissue in the acute phase. Topical negative pressure uses a suction force to drain excess fluids. OBJECTIVES: To assess the effectiveness of TNP for those people with partial thickness burns. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (searched April 2007), the Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library Issue 2, 2007), Ovid MEDLINE (1950 to April Week 4 2007), Ovid EMBASE (1980 to Week 18 2007) and Ovid CINAHL (1982 to April Week 4 2007). SELECTION CRITERIA: All randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that evaluated the safety and effectiveness of TNP for partial thickness burns. DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. A narrative synthesis of results was undertaken as the absence of missing data, poor reporting, or both precluded the authors to undertake any formal statistical analysis. MAIN RESULTS: One RCT satisfied the inclusion criteria. The methodological quality of the trial was poor. AUTHORS' CONCLUSIONS: There is a paucity of high quality RCTs on TNP for partial thickness burn injury with insufficient sample size and adequate power to detect differences, if there are any, between TNP and conventional burn wound therapy dressings.

Lidocaine for pain relief in burn injured patients.

BACKGROUND: Pain is a major issue for patients suffering from many different types of wounds in particular those with burn injuries. Prompt, aggressive use of opioid analgesics such as morphine has been suggested as critical to avert the cycle of pain and anxiety, but side effects are encountered. It is proposed that newer agents such as lidocaine could be effective in reducing pain and alleviating the escalating opioid dosage requirements in patients with burn injury. OBJECTIVES: To assess the safety and effectiveness of intravenous lidocaine as a means of pain relief versus no therapy, placebo, other drugs or two or more of the above therapies in combination in patients exposed to burn injury. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2007), MEDLINE (1966 to March 2007), EMBASE (1980 to 2007), CINAHL (1982 to March 2007). SELECTION CRITERIA: Those trials that were considered were: randomised controlled trials (RCTs) and controlled clinical trials (CCTs), both published and unpublished studies, which assessed the efficacy of intravenous lidocaine varying doses as a single-agent therapy with no therapy, placebo, other analgesics such as opioids, lidocaine plus another drug, or two or more of the above therapies as a means of pain relief in patients exposed to burn injury. DATA COLLECTION AND ANALYSIS: The two review authors applied the entry criteria to identified studies. MAIN RESULTS: No clinically relevant RCTs or CCTs were identified through the above searches. AUTHORS' CONCLUSIONS: No information is available from the published RCTs or CCTs on clinically relevant primary outcome measures which can influence current burns care practice and management. Therefore, since current clinical evidence is subject to the inherent weaknesses of case series or reports, intravenous lidocaine must be considered a pharmacological agent under investigation in burns care whose effectiveness is yet to be determined in well-designed and conducted clinical trials.

Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy.

BACKGROUND: Children with hemiplegic cerebral palsy learn strategies to manage daily tasks (for example play) using one hand and often the affected limb is disregarded or not used. Constraint-induced movement therapy (CIMT) is emerging as a treatment approach for use with children with hemiplegic cerebral palsy. It aims to increase spontaneous use of the affected upper limb and thereby limit the effects of developmental disregard. CIMT is based on two fundamental principles: constraint of the non-affected limb and massed practice of therapeutic tasks with the affected limb. OBJECTIVES: The objective of this review was to evaluate the effectiveness of CIMT, modified CIMT or Forced Use in the treatment of the affected upper limb in children with hemiplegic cerebral palsy. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 3), MEDLINE (1966 to August Week 4 2006), CINAHL (1982 to July Week 3 2006), EMBASE (1980 to August 2006), PsychInfo (1985 to August Week 4 2006) and reference lists of all relevant articles. SELECTION CRITERIA: All randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing CIMT, modified CIMT and Forced Use with traditional services such as occupational therapy, physiotherapy or no treatment were selected. DATA COLLECTION AND ANALYSIS: Two review authors extracted the data independently using standardised forms. Each trial was assessed for internal validity with differences in ratings resolved by discussion. Data were extracted and entered into Review Manager 4.2 where appropriate. MAIN RESULTS: Three studies met the inclusion criteria. The results of one RCT showed a trend for positive treatment effect favouring CIMT using the Dissociated Movement subscale of the Quality of Upper Extremity Skills Test (QUEST). Other outcome measures, that were without reported psychometric properties, showed significant treatment effects. A CCT demonstrated a significant treatment effect favouring modified CIMT at two and six months using the Assisting Hand Assessment (AHA). Another trial with inaccurate reporting and ambiguous methodology, showed a significant treatment effect at 6 weeks on the self care component of the WeeFIM using a Forced Use protocol. All other measures showed no significant treatment effect. AUTHORS' CONCLUSIONS: This systematic review found a significant treatment effect using modified CIMT in a single trial. A positive trend favouring CIMT and Forced Use was also demonstrated. Given the limited evidence, the use of CIMT, modified CIMT and Forced Use should be considered experimental in children with hemiplegic cerebral palsy. Further research using adequately powered RCTs, rigorous methodology and valid and reliable outcome measures is essential to provide higher level support of the effectiveness of CIMT for children with hemiplegic cerebral palsy.

Scopolamine (hyoscine) for preventing and treating motion sickness.

BACKGROUND: Motion sickness - the discomfort experienced when perceived motion disturbs the organs of balance - may include symptoms such as nausea, vomiting, pallor, cold sweats, hypersalivation, hyperventilation and headaches. The control and prevention of these symptoms have included pharmacological, behavioural and complementary therapies. Although scopolamine (hyoscine) has been used in the treatment and prevention of motion sickness for decades, there have been no systematic reviews of its effectiveness. OBJECTIVES: To assess the effectiveness of scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination for motion sickness in persons (both adults and children) without known vestibular, visual or central nervous system pathology. SEARCH STRATEGY: The Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2007), MEDLINE (OVID, 1966 to May 2007), EMBASE (1974 to May 2007) CINAHL (OVID, 1982 to May 2007) and reference lists of retrieved studies were searched for relevant studies. No language restrictions were applied. The date of the last search was May 2007. SELECTION CRITERIA: All parallel-arm, randomised controlled trials (RCTs) focusing on scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination were included. Outcomes relating to the prevention of onset or treatment of clinically-defined motion sickness, task ability and psychological tests, changes in physiological parameters and adverse effects were considered. DATA COLLECTION AND ANALYSIS: Data from the studies were extracted independently by two authors using standardised forms. Study quality was assessed. Dichotomous data were expressed as odds ratio (OR) and a pooled OR was calculated using the random-effects model. MAIN RESULTS: Of 35 studies considered potentially relevant, 14 studies enrolling 1025 subjects met the entry criteria. Scopolamine was administered via transdermal patches, tablets or capsules, oral solutions or intravenously. Scopolamine was compared against placebo, calcium channel antagonists, antihistamine, methscopolamine or a combination of scopolamine and ephedrine. Studies were generally small in size and of varying quality. Scopolamine was more effective than placebo in the prevention of symptoms. Comparisons between scopolamine and other agents were few and suggested that scopolamine was superior (versus methscopolamine) or equivalent (versus antihistamines) as a preventative agent. Evidence comparing scopolamine to cinnarizine or combinations of scopolamine and ephedrine is equivocal or minimal. Although sample sizes were small, scopolamine was no more likely to induce drowsiness, blurring of vision or dizziness compared to other agents. Dry mouth was more likely with scopolamine than with methscopolamine or cinnarizine. No studies were available relating to the therapeutic effectiveness of scopolamine in the management of established symptoms of motion sickness. AUTHORS' CONCLUSIONS: The use of scopolamine versus placebo in preventing motion sickness has been shown to be effective. No conclusions can be made on the comparative effectiveness of scopolamine and other agents such as antihistamines and calcium channel antagonists. In addition, no randomised controlled trials were identified that examined the effectiveness of scopolamine in the treatment of established symptoms of motion sickness.

Recompression and adjunctive therapy for decompression illness.

BACKGROUND: Decompression illness (DCI) is due to bubble formation in the blood or tissues following the breathing of compressed gas. Clinically, DCI may range from a trivial illness to loss of consciousness, death or paralysis. Recompression is the universally accepted standard for the treatment of DCI. When recompression is delayed, a number of strategies have been suggested in order to improve the outcome. OBJECTIVES: To examine the effectiveness and safety of both recompression and adjunctive therapies in the treatment of DCI. SEARCH STRATEGY: We searched CENTRAL (The Cochrane Library 2005, Issue 2); MEDLINE (1966 to August 2005); CINAHL (1982 to August 2005); EMBASE (1980 to August 2005); the Database of Randomised Controlled Trials in Hyperbaric Medicine (August 2005), and hand-searched journals and texts. SELECTION CRITERIA: We included randomized controlled trials that compared the effect of any recompression schedule or adjunctive therapy with a standard recompression schedule. We applied no language restrictions. DATA COLLECTION AND ANALYSIS: Three authors extracted the data independently. We assessed each trial for internal validity and resolved differences by discussion. Data was entered into RevMan 4.2. MAIN RESULTS: Two randomized controlled trials satisfied the inclusion criteria. Pooling of data was not possible. In one study there was no evidence of improved effectiveness with the addition of a non-steroidal anti-inflammatory drug (tenoxicam) to routine recompression therapy (at six weeks: relative risk (RR) 1.04, 95% confidence interval (CI) 0.90 to 1.20, P = 0.58) but there was a reduction in the number of compressions required when tenoxicam was added (P = 0.01, 95% CI 0 to 1). In the other study, the odds of multiple recompressions was lower with a helium and oxygen (heliox) table compared to an oxygen treatment table (RR 0.56, 95% CI 0.31 to 1.00, P = 0.05). AUTHORS' CONCLUSIONS: Recompression therapy is standard for the treatment of DCI, but there is no randomized controlled trial evidence. Both the addition of an NSAID or the use of heliox may reduce the number of recompressions required, but neither improves the odds of recovery. The application of either of these strategies may be justified. The modest number of patients studied demands a cautious interpretation. Benefits may be largely economic and an economic analysis should be undertaken. There is a case for large randomized trials of high methodological rigour in order to define any benefit from the use of different breathing gases and pressure profiles during recompression therapy.

Female patients display poorer burn-specific quality of life 12 months after a burn injury.

INTRODUCTION: Although gender differences in morbidity and mortality have been measured in patients with moderate to severe burn injury, little attention has been directed at gender effects on health-related quality of life (HRQoL) following burn injury. The current study was therefore conducted to prospectively measure changes in HRQoL for males and females in a sample of burn patients. METHODS: A total of 114 adults who received treatment at a statewide burns service for a sustained burns injury participated in this study. Instruments measuring generic health status (Short Form 36 Medical Outcomes Survey version 2), burn-specific HRQoL (Burns Specific Health Scale-Brief), psychological distress (Kessler Psychological Distress Scale) and alcohol use (Alcohol Use Disorders Identification Tool) were prospectively measured at 3, 6 and 12 months post-burn. RESULTS: In the 12 months post-injury, female patients showed overall poorer physical (p=0.01) and mental health status (p<0.001), greater psychological distress (p<0.001), and greater difficulty with aspects of burn-specific HRQoL: body image (p<0.001), affect (p<0.001), interpersonal functioning (p=0.005), heat sensitivity (p=0.01) and treatment regime (p=0.01). While significant interaction effects suggested that female patients had more improvement in difficulties with treatment regime (p=0.007), female patients continued to report greater difficulty with multiple aspects of physical and psychosocial health status 12 months post-injury. CONCLUSION: Even though demographic variables, injury characteristics and burn care interventions were similar across genders, following burn injury female patients reported greater impairments in generic and burn-specific HRQoL along with psychological morbidity, when compared to male patients. Urgent clinical and research attention utilising an evidence-based research framework, which incorporates the use of larger sample sizes, the use of validated instruments to measure appropriate outcomes, and a commitment to monitoring long-term care, can only improve burn-care.

Methodological quality and reporting of systematic reviews in hand and wrist pathology.

The objective of this study was to assess methodological and reporting quality of systematic reviews in hand and wrist pathology. MEDLINE, EMBASE and Cochrane Library were searched from inception to November 2016 for relevant studies. Reporting quality was evaluated using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and methodological quality using a measurement tool to assess systematic reviews, the Assessment of Multiple Systematic Reviews (AMSTAR). Descriptive statistics and linear regression were used to identify features associated with improved methodological quality. A total of 91 studies were included in the analysis. Most reviews inadequately reported PRISMA items regarding study protocol, search strategy and bias and AMSTAR items regarding protocol, publication bias and funding. Systematic reviews published in a plastics journal, or which included more authors, were associated with higher AMSTAR scores. A large proportion of systematic reviews within hand and wrist pathology literature score poorly with validated methodological assessment tools, which may affect the reliability of their conclusions. LEVEL OF EVIDENCE: I.

Autologous cartilage implantation for full thickness articular cartilage defects of the knee.

BACKGROUND: Treatments for managing articular cartilage defects of the knee, including drilling and abrasion arthroplasty, are not always effective. When they are, long-term benefits may not be maintained and osteoarthritis may develop, resulting in the need for a total knee replacement. An alternative is the surgical implantation of healthy cartilage cells into damaged areas (autologous cartilage implantation). OBJECTIVES: To determine the effectiveness of autologous cartilage implantation (ACI) in people with full thickness articular cartilage defects of the knee. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (15 December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2005), MEDLINE (1966 to December 2005), CINAHL (1982 to December Week 2, 2004), EMBASE (1988 to 2005 Week 50), SPORTDiscus (1830 to January 2005) and the National Research Register Issue 3, 2005. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing ACI with any other type of treatment (including no treatment or placebo) for symptomatic cartilage defects of the medial or lateral femoral condyle, femoral trochlea or patella. DATA COLLECTION AND ANALYSIS: Two review authors selected studies for inclusion independently. We assessed study quality based on adequacy of the randomisation process, adequacy of the allocation concealment process, potential for selection bias after allocation and level of masking. Data was not pooled due to clinical and methodological heterogeneity in the studies. MAIN RESULTS: We included four randomised controlled trials (266 participants). One trial of ACI versus mosaicplasty reported statistically significant results for ACI at one year, but only in a post-hoc subgroup analysis of participants with medial condylar defects; 88% had excellent or good results with ACI versus 69% with mosaicplasty. A second trial of ACI versus mosaicplasty found no statistically significant difference in clinical outcomes at two years. There was no statistically significant difference in outcomes at two years in a trial comparing ACI with microfracture. In addition, one trial of matrix-guided ACI versus microfracture did not contain enough long-term results to reach definitive conclusions. AUTHORS' CONCLUSIONS: The use of ACI and other chondral resurfacing techniques is becoming increasingly widespread. However, there is at present no evidence of significant difference between ACI and other interventions. Additional good quality randomised controlled trials with long-term functional outcomes are required.

Early versus delayed enteral nutrition support for burn injuries.

BACKGROUND: A burn injury increases the body's metabolic demands, and therefore nutritional requirements. Provision of an adequate supply of nutrients is believed to lower the incidence of metabolic abnormalities, thus reducing septic morbidity, improving survival rates, and decreasing hospital length of stay. Enteral nutrition support is the best feeding method for patients who are unable to achieve an adequate oral intake to maintain gastrointestinal functioning, however, its timing (i.e. early versus late) needs to be established. OBJECTIVES: To assess the effectiveness and safety of early versus late enteral nutrition support in adults with burn injury. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 1, 2006), the Cochrane Injuries Group's Specialised Register, MEDLINE (1966 to May week 1, 2006), EMBASE (1980 to week 17, 2005) and CINAHL (1982 to May week 1, 2006). SELECTION CRITERIA: We included all randomised controlled trials comparing early enteral nutrition support (within 24 hours of injury) versus delayed enteral support (greater than 24 hours). DATA COLLECTION AND ANALYSIS: Two authors used standardised forms to independently extract the data. Each trial was assessed for internal validity with differences resolved by discussion. MAIN RESULTS: A total of three randomised controlled trials were eligible for inclusion in this review. Results of the studies indicate that evidence about the benefit of early enteral nutritional support on standardised clinical outcomes such as length of hospital stay and mortality, remains inconclusive. Similarly, the question of whether early enteral feeding influenced or decreased metabolic rate as documented in part by our included studies, remains uncertain. AUTHORS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the effectiveness of early versus late enteral nutrition support in adults with burn injury. The trials showed some promising results that would suggest early enteral nutrition support may blunt the hypermetabolic response to thermal injury, but this is insufficient to provide clear guidelines for practice. Further research incorporating larger sample sizes and rigorous methodology that utilises valid and reliable outcome measures, is essential.

Hyperbaric oxygen therapy for acute ischaemic stroke.

BACKGROUND: Most cases of stroke are caused by impairment of blood flow to the brain (ischaemia) which results in a reduction in oxygen available and subsequent cell death. It has been postulated that hyperbaric oxygen therapy (HBOT) may reduce the volume of brain that will die by greatly increasing the oxygen available, and it may further improve outcome by reducing brain swelling. Some centres are using HBOT routinely to treat stroke. OBJECTIVES: To assess the effectiveness and safety of adjunctive HBOT in the treatment of acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched 9 January 2004), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 3, 2004), MEDLINE (1966 to July 2004), EMBASE (1980 to July 2004), CINAHL (1982 to July 2004), and DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) (from inception to 2004). We handsearched journals and conference proceedings, searched reference lists of articles, and contacted researchers in an effort to identify additional published and unpublished studies. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of adjunctive HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors used standardised forms to extract the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data were extracted and entered into RevMan 4.2. MAIN RESULTS: Three randomised controlled trials (106 participants) satisfied the inclusion criteria. The methodological quality of the trials varied but was generally high. Data could be pooled for a limited number of clinically important outcomes. There were no significant differences in mortality rate at six months in those receiving HBOT compared to the control group (relative risk 0.61, 95% confidence interval (CI) 0.17 to 2.2, P value 0.45). Two of 15 scale measures of disability and functional indicated an improvement following HBOT, both at one year follow up: the mean Trouillas Disability Scale was lower with HBOT (mean difference (MD) 2.2 points reduction with HBOT, 95% CI 0.15 to 4.3, P value 0.04) and the mean Orgogozo Scale was higher (MD 27.9 points, 95% CI 4.0 to 51.8, P value 0.02). These improvements were not reflected in other trials or functional scales. AUTHORS' CONCLUSIONS: This systematic review has not found evidence to show that HBOT improves clinical outcomes when applied during the acute presentation of ischaemic stroke. While evidence from the three randomised controlled trials is insufficient to provide clear guidelines for practice, clinical benefit does not seem likely. Further research is required to better define the role of HBOT in this condition.

Systematic Review and Quality Appraisal of Economic Evaluation Publications in Dentistry.

Economic evaluation (EE) studies have been undertaken in dentistry since the late 20th century because economic data provide additional information to policy makers to develop guidelines and set future direction for oral health services. The objectives of this study were to assess the methodological quality of EEs in oral health. Electronic searching of Ovid MEDLINE, the Cochrane Library, and the NHS Economic Evaluation Database from 1975 to 2013 were undertaken to identify publications that include costs and outcomes in dentistry. Relevant reference lists were also searched for additional studies. Studies were retrieved and reviewed independently for inclusion by 3 authors. Furthermore, to appraise the EE methods, 1 author applied the Drummond 10-item (13-criteria) checklist tool to each study. Of the 114 publications identified, 79 studies were considered full EE and 35 partial. Twenty-eight studies (30%) were published between the years 2011 and 2013. Sixty-four (53%) studies focused on dental caries prevention or treatment. Median appraisal scores calculated for full and partial EE studies were 11 and 9 out of 13, respectively. Quality assessment scores showed that the quality of partial EE studies published after 2000 significantly improved (P = 0.02) compared to those published before 2000. Significant quality improvement was not found in full EE studies. Common methodological limitations were identified: absence of sensitivity analysis, discounting, and insufficient information on how costs and outcomes were measured and valued. EE studies in dentistry increased over the last 40 y in both quantity and quality, but a number of publications failed to satisfy some components of standard EE research methods, such as sensitivity analysis and discounting.

Autologous cartilage implantation for full thickness articular cartilage defects of the knee.

BACKGROUND: A variety of strategies have been employed for managing articular cartilage defects of the knee, including drilling and abrasion arthroplasty. These treatments are not always effective and when they are, the benefits may only be transitory. Unsuccessfully treated cartilage damage may progress to degenerative disease states and result in the need for a total knee replacement. In recent years the surgical implantation of healthy cartilage cells (autologous cartilage implantation [ACI] ) into damaged areas has been seen as an alternative option and is currently under investigation as a potential improvement over the current strategies for the management and treatment of articular cartilage defects. OBJECTIVES: To determine the effectiveness of ACI in patients with full thickness articular cartilage defects of the knee. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (May 2002), Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 to June Week 4 2001), CINAHL (1982 to July Week 2 2001), EMBASE (1980 to 2001 Week 27), SPORTDiscus (1949 to June 2001), Current Contents (1993 Week 26 to 2001 Week 30) and the National Research Register (Issue 2, May 2002). SELECTION CRITERIA: Randomised and quasi-randomised trials comparing ACI with any other type of treatment (including no treatment or placebo) for symptomatic cartilage defects of the medial or lateral femoral condyle, trochlea or patella. DATA COLLECTION AND ANALYSIS: Two independent reviewers applied the entry criteria to identified studies. MAIN RESULTS: No completed randomised controlled trials investigating this treatment were identified through the above searches. One possible trial has been placed in Studies Awaiting Assessment, awaiting translation of the full trial report. Ongoing trials currently underway will be incorporated in future updates of this review. REVIEWER'S CONCLUSIONS: No information is available from RCTs which can influence current practice. Therefore, since current evidence is subject to the inherent weaknesses of case series or reports, ACI must currently be considered as a technology under investigation whose effectiveness is yet to be determined in well designed and conducted clinical trials. The results of ongoing randomised clinical trials will help improve this situation.

Botulinum toxin A as an adjunct to treatment in the management of the upper limb in children with spastic cerebral palsy.

BACKGROUND: Cerebral palsy (CP) is a central nervous system deficit resulting from a non-progressive lesion in the developing brain. Although the brain lesions are static, the movement disorders that arise are not unchanging and are characterised by atypical muscle tone, posture and movement (Rang 1990). The spastic motor type is the most common form of CP and its conventional therapeutic management may include splinting/casting, passive stretching, facilitation of posture and movement, spasticity-reducing medication and surgery. More recently, health care professionals have begun to use botulinum toxin A (BtA) as an adjunct to interventions in an attempt to reduce muscle tone and spasticity to improve function OBJECTIVES: To assess the effectiveness of intramuscular BtA injections as an adjunct to managing the upper limb in children with spastic CP. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (1966 to March Week 3 2004), EMBASE (1980 to 2003 Week 16) and CINAHL (1982 to Week 3 March 2004). SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing intramuscular BtA injections into any muscle group of the upper limb with placebo, no treatment or other interventions. DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Two trials met the inclusion criteria, each having short-term follow up, a small number of subjects and using a single set of injections. The study by Corry 1997 compared BtA with an injection of normal saline and found promising results in elbow extension, elbow and wrist muscle tone. At three months, encouraging results for wrist muscle tone and grasp and release were noted. The trial reported median change, range of changes and the difference in these measures between groups. The study by Fehlings 2000 compared BtA with no intervention. When data were analysed no treatment effect was found for quality of upper limb function, passive range of motion, muscle tone, grip strength or self-care ability. REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the use of intramuscular injections of BtA as an adjunct to managing the upper limb in children with spastic cerebral palsy. Only one of the two identified RCTs reported some promising results in support of reduced muscle tone following BtA injections. Further research incorporating larger sample sizes, rigorous methodology, measurement of upper limb function and functional outcomes is essential.

Botulinum toxin A as an adjunct to treatment in the management of the upper limb in children with spastic cerebral palsy.

BACKGROUND: Cerebral palsy (CP) is a central nervous system deficit resulting from a non-progressive lesion in the developing brain. Although the brain lesions are static, the movement disorders that arise are not unchanging and are characterised by atypical muscle tone, posture and movement (Rang 1990). The spastic motor type is the most common form of CP and its conventional therapeutic management may include splinting/casting, passive stretching, facilitation of posture and movement, spasticity-reducing medication and surgery. More recently, health care professionals have begun to use botulinum toxin A (BtA) as an adjunct to interventions in an attempt to reduce muscle tone and spasticity to improve function OBJECTIVES: To assess the effectiveness of intramuscular BtA injections as an adjunct to managing the upper limb in children with spastic CP. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (1966 to March Week 3 2004), EMBASE (1980 to 2003 Week 16) and CINAHL (1982 to Week 3 March 2004). SELECTION CRITERIA: All randomised controlled trials (RCTs) comparing intramuscular BtA injections into any muscle group of the upper limb with placebo, no treatment or other interventions. DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Two trials met the inclusion criteria, each having short-term follow up, a small number of subjects and using a single set of injections. The study by Corry 1997 compared BtA with an injection of normal saline and found promising results in elbow extension, elbow and wrist muscle tone. At three months, encouraging results for wrist muscle tone and grasp and release were noted. The trial reported median change, range of changes and the difference in these measures between groups. The study by Fehlings 2000 compared BtA with no intervention. When data were analysed no treatment effect was found for quality of upper limb function, passive range of motion, muscle tone, grip strength or self-care ability. REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the use of intramuscular injections of BtA as an adjunct to managing the upper limb in children with spastic cerebral palsy. Only one of the two identified RCTs reported some promising results in support of reduced muscle tone following BtA injections. Further research incorporating larger sample sizes, rigorous methodology, measurement of upper limb function and functional outcomes is essential.

Percutaneous transluminal rotational atherectomy for coronary artery disease.

BACKGROUND: Percutaneous transluminal coronary rotational atherectomy (PTCRA) debulks atherosclerotic plaque from coronary arteries using an abrasive burr. On rotation, the burr selectively removes hard tissue. OBJECTIVES: To assess the effects of PTCRA for coronary artery disease in patients with non-complex and complex lesions (e.g., ostial, long, or diffuse lesions or those arising from in-stent restenosis) of the coronary arteries. SEARCH STRATEGY: We searched the Heart Group specialised register, the Cochrane Library to Issue 2, 2001, and MEDLINE, CINAHL, EMBASE and Current Contents to December 2002 and reviewed reference lists for relevant articles. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials of PTCRA compared with placebo, no treatment or another intervention and excluded cross-over trials. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two authors. We asked authors of trials to provide information when missing data was encountered. Statistical summaries used risk ratios (RR) and weighted mean differences. MAIN RESULTS: We included 9 trials enrolling 3,066 patients. There was no evidence of the effectiveness of PTCRA in non-complex lesions. In complex lesions, there were no statistically significant differences in restenosis rates at 6 months (relative risk 1.00; 95% confidence interval 0.83 to 1.20) and 1 year (relative risk 1.21; 95% confidence interval =0.95 to 1.55) in those receiving PTCRA with adjunctive PTCA (PTCRA/PTCA) compared to those receiving PTCA alone. Morphological characteristics distinguishing complex lesions have not been examined in parallel-arm randomised controlled trials. There is equivocal evidence of the effectiveness of PTCRA in in-stent restenosis. Compared to angioplasty alone, PTCRA/PTCA did not result in a statistically significant increase in the risk of major adverse cardiac events (myocardial infarction, emergency cardiac surgery or death) during the in-hospital period (relative risk 1.19; 95% confidence interval =0.78 to 1.83). Compared to angioplasty, PTCRA was associated with 9 times the risk of an angiographically-detectable vascular spasm (relative risk 9.23; 95% confidence interval 4.61 to 18.47), 4 times the risk of perforation (relative risk 3.87; 95% confidence interval 0.82 to 18.21) and about 2 times the risk of transient vessel occlusions (relative risk 2.28; 95% confidence interval 1.00, 5.19) while angiographic dissections (relative risk 0.49; 95% confidence interval 0.33 to 0.75) and stents used as a bailout procedure (relative risk 0.38; 95% confidence interval 0.22 to 0.65) were less common. REVIEWER'S CONCLUSIONS: When conventional PTCA is feasible, PTCRA appears to confer no additional benefits. There is limited published evidence and no long-term data to support the routine use of PTCRA in in-stent restenosis. In certain circumstances (e.g., patients ineligible for cardiac surgery, those with architecturally complex lesions, or those with lesions that fail PTCA), PTCRA may achieve satisfactory revascularisation in subsequent procedures.

Scopolamine for preventing and treating motion sickness.

BACKGROUND: Motion sickness - the discomfort experienced when perceived motion disturbs the organs of balance - may include symptoms such as nausea, vomiting, pallor, cold sweats, hypersalivation, hyperventilation and headaches. The control and prevention of these symptoms have included pharmacological, behavioural and complementary therapies. Although scopolamine has been used in the treatment and prevention of motion sickness for decades, there have been no systematic reviews of its effectiveness. OBJECTIVES: To assess the effectiveness of scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination for motion sickness in persons (both adults and children) without known vestibular, visual or central nervous system pathology. SEARCH STRATEGY: The Cochrane Ear, Nose and Throat Disorders Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2003), MEDLINE (OVID, 1966 to March Week 1 2004), EMBASE (1974 to 2004) CINAHL (Ovid, 1982 to March Week 1 2004) and reference lists of retrieved studies were searched for relevant studies. No language restrictions were applied. SELECTION CRITERIA: All parallel-arm, randomised controlled trials (RCTs) focusing on scopolamine versus no therapy, placebo, other drugs, behavioural and complementary therapy or two or more of the above therapies in combination were included. Outcomes relating to the prevention of onset or treatment of clinically-defined motion sickness, task ability and psychological tests, changes in physiological parameters and adverse effects were considered. DATA COLLECTION AND ANALYSIS: Data from the studies were extracted independently by two authors using standardised forms. Study quality was assessed. Dichotomous data were expressed as odds ratio (OR) and a pooled OR was calculated using the random effects model. MAIN RESULTS: Of 27 studies considered potentially relevant, 12 studies enrolling 901 subjects met the entry criteria. Scopolamine was administered via transdermal patches, tablets or capsules, oral solutions or intravenously. Scopolamine was compared against placebo, calcium channel antagonists, antihistamine, meth-scopolamine or a combination of scopolamine and ephedrine. Studies were generally small in size and of varying quality. Scopolamine was more effective than placebo in the prevention of symptoms. Comparisons between scopolamine and other agents were few and suggested that scopolamine was superior (versus meth-scopolamine) or equivalent (versus antihistamines) as a preventative agent. Evidence comparing scopolamine to cinnarizine or combinations of scopolamine and ephedrine is equivocal or minimal. Although sample sizes were small, scopolamine was no more likely to induce drowsiness, blurring of vision or dizziness compared to other agents. Dry mouth was more likely with scopolamine than with meth-scopolamine or cinnarizine. No studies were available relating to the therapeutic effectiveness of scopolamine in the management of established symptoms of motion sickness. REVIEWERS' CONCLUSIONS: The use of scopolamine versus placebo in preventing motion sickness has been shown to be effective. No conclusions can be made on the comparative effectiveness of scopolamine and other agents such as antihistamines and calcium channel antagonists. In addition, no randomised controlled trials were identified that examined the effectiveness of scopolamine in the treatment of established symptoms of motion sickness.

Hyperbaric oxygen therapy for thermal burns.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than 1 atmosphere in a pressure vessel. This technology has been used to treat a variety of disease states and has been described as helping patients who have sustained burns. OBJECTIVES: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of thermal burns. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (Ovid 1966 to November Week 2, 2003), CINAHL (Ovid 1982 to December Week 2 2003), EMBASE (Ovid 1980 to September 2003), DORCTHIM (Database of Randomised Controlled Trials in Hyperbaric Medicine) from inception to 2003, and reference lists of articles. SELECTION CRITERIA: We included all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: Two authors using standardised forms extracted the data independently. Each trial was assessed for internal validity with differences resolved by discussion. Data was extracted and entered into RevMan 4.2.3. MAIN RESULTS: Four randomised controlled trials were identified, of which two satisfied the inclusion criteria. The trials were of poor methodological quality. As a result, it was difficult to have confidence in the individual results and it would not have been appropriate to attempt to pool the data. One trial reported no difference in length of stay, mortality, or number of surgeries between the control and HBO-treated groups once these variables were adjusted for the patient's condition. The second trial reported mean healing times that were shorter in patients exposed to HBOT (mean: 19.7 days versus 43.8 days). REVIEWERS' CONCLUSIONS: This systematic review has not found sufficient evidence to support or refute the effectiveness of HBOT for the management of thermal burns. Evidence from the two randomised controlled trials is insufficient to provide clear guidelines for practice. Further research is needed to better define the role of HBOT in the treatment of thermal burns.

[Synthesis of certain derivatives of 3-(N'-substituted)acetamide hydantoin and predicted pharmacologic action]. / Syntezy niektórych pochodnych3-(N'-podstawionych)acetamidohydantoinyo spodziewanym dzialaniu farmakologicznym.

Synthesis of 5,5-disubstituted derivatives of 3-N'-(diethyl-, isopropyl- and diphenyl-)-acetamidhydantoin is described.