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Randomized Controlled Trials (randomized + controlled_trials)
Selected AbstractsEfficacy of enamel matrix derivatives (Emdogain®) in treatment of replanted teeth , a systematic review based on animal studiesDENTAL TRAUMATOLOGY, Issue 5 2008Annette Wiegand A review of the published literature [search term: (Emdogain OR enamel matrix derivative OR enamel matrix protein] AND [avulsion OR replantation OR autotransplantation)] was conducted by two independent investigators according to defined selection criteria. For data extraction of the identified animal studies, the following histomorphometric findings were considered: (i) healed PDL, (ii) surface resorption, (iii) inflammatory resorption and (iv) replacement resorption. The heterogenity of data collection and the small amount of identified publications did not allow for statistical analysis. Four controlled trials (CT) conducted in animals, but no randomized controlled trials (RCT) or clinical controlled trials (CCT) could be received from the systematic search. From the selected studies, two CT gave evidence of EMD treatment to be effective in inducing healing of replanted teeth, while one CT found no differences between EMD treated teeth and controls. Finally, one CT compared EMD and sodium fluoride application, but revealed no differences between the treatments. The data of controlled trials available are limited and conflicting. No firm conclusion regarding the efficacy of EMD application on healing of replanted or autotransplanted permanent teeth can be drawn because of lack of RCT and CCT. [source] Long-acting insulin analogues vs.DIABETES OBESITY & METABOLISM, Issue 4 2009NPH human insulin in type 1 diabetes. Aim:, Basal insulin in type 1 diabetes can be provided using either NPH (Neutral Protamine Hagedorn) human insulin or long-acting insulin analogues, which are supposed to warrant a better metabolic control with reduced hypoglycaemic risk. Aim of this meta-analysis is the assessment of differences with respect to HbA1c (Glycated hemoglobin), incidence of hypoglycaemia, and weight gain, between NPH human insulin and each long-acting analogue. Methods:, Of 285 randomized controlled trials with a duration > 12 weeks comparing long-acting insulin analogues (detemir or glargine) with NPH insulin in type 1 diabetic patients identified through Medline search and searches on www.clinicaltrials.gov, 20 met eligibility criteria (enrolling 3693 and 2485 in the long-acting analogues and NPH group respectively). Data on HbA1c and body mass index at endpoint, and incidence of any, nocturnal and severe hypoglycaemia, were extracted and meta-analysed. Results:, Long-acting analogues had a small, but significant effect on HbA1c [-0.07 (,0.13; ,0.01)%; p = 0.026], in comparison with NPH human insulin. When analysing the effect of long-acting analogues on body weight, detemir was associated with a significantly smaller weight gain than human insulin [by 0.26 (0.06;0.47) kg/m2; p = 0.012]. Long-acting analogues were associated with a reduced risk for nocturnal and severe hypoglycaemia [OR (Odd Ratio, 95% Confidence Intervals) 0.69 (0.55; 0.86), and OR 0.73 (0.60; 0.89) respectively; all p < 0.01]. Conclusions:, The switch from NPH to long-acting analogues as basal insulin replacement in type 1 diabetic patients had a small effect on HbA1c, and also reduced the risk of nocturnal and severe hypoglycaemia. [source] Treatment of isolated systolic hypertension in diabetes mellitus type 2DIABETES OBESITY & METABOLISM, Issue 4 2006Ingrid Os Age-related arterial stiffness is more pronounced in diabetics compared to non-diabetics, which could explain the prevalence of isolated systolic hypertension (ISH, systolic blood pressure ,140 mmHg and diastolic blood pressure <90 mmHg) being approximately twice that of the general population without diabetes. Large-scale interventional outcome trials have also shown that diabetics usually have higher pulse pressure and higher systolic blood pressure than non-diabetics. Advanced glycation end-product formation has been implicated in vascular and cardiac complications of diabetes including loss of arterial elasticity, suggesting possibilities for new therapeutic options. With increasing age, there is a shift to from diastolic to systolic blood pressure and pulse pressure as predictors of cardiovascular disease. This may affect drug treatment as different antihypertensive drugs may have differential effects on arterial stiffness that can be dissociated from their effects on blood pressure. While thiazide diuretics are associated with little or no change in arterial stiffness despite a robust antihypertensive effect, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and calcium-channel blockers have been shown to reduce arterial stiffness. However, combination therapy is nearly always necessary to obtain adequate blood pressure control in diabetics. There are no randomized controlled trials looking specifically at treatment of ISH in diabetics. Recommendations regarding treatment of ISH in diabetes mellitus type 2 are based on extrapolation from studies in non-diabetics, post-hoc analyses and prespecified subgroup analysis in large-scale studies, and metaanalysis. These analyses have clearly demonstrated that blood pressure lowering in ISH confers improved prognosis and reduced cardiovascular and renal outcomes in both diabetics and non-diabetics. [source] The value of debridement and Vacuum-Assisted Closure (V.A.C.) Therapy in diabetic foot ulcersDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue S1 2008Magnus Eneroth Abstract Background Treatment of diabetic foot ulcers includes a number of different regimes such as glycaemic control, re-vascularization, surgical, local wound treatment, offloading and other non-surgical treatments. Although considered the standard of care, the scientific evidence behind the various debridements used is scarce. This presentation will focus on debridement and V.A.C. Therapy, two treatments widely used in patients with diabetes and foot ulcers. Methods A review of existing literature on these treatments in diabetic foot ulcers, with focus on description of the various types of debridements used, the principles behind negative pressure wound therapy (NPWT) using the V.A.C. Therapy system and level of evidence. Results Five randomized controlled trials (RCT) of debridement were identified; three assessed the effectiveness of a hydrogel as a debridement method, one evaluated surgical debridement and one evaluated larval therapy. Pooling the three hydrogel RCTs suggested that hydrogels are significantly more effective than gauze or standard care in healing diabetic foot ulcers. Surgical debridement and larval therapy showed no significant benefit. Other debridement methods such as enzyme preparations or polysaccharide beads have not been evaluated in RCTs of people with diabetes. More than 300 articles have been published on negative pressure wound therapy, including several small RCTs and a larger multi-centre RCT of diabetic foot ulcers. Negative pressure wound therapy seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care. Conclusions Although debridement of the ulcer is considered a prerequisite for healing of diabetic foot ulcers, the grade of evidence is quite low. This may be due to a lack of studies rather than lack of effect. Negative pressure wound therapy seems to be safe and effective in the treatment of some diabetic foot ulcers, although there is still only one well-performed trial that evaluates the effect. Copyright © 2008 John Wiley & Sons, Ltd. [source] Effectiveness of screening and monitoring tests for diabetic retinopathy , a systematic reviewDIABETIC MEDICINE, Issue 7 2000A. Hutchinson SUMMARY Aims To determine which screening and monitoring tests for diabetic retinopathy are most effective and under what circumstances. Methods A systematic review of the English language literature, published from 1983 to April 1999. Results Available studies are generally limited in their ability to answer the important questions on the effectiveness of tests for early detection of diabetic retinopathy. No randomized controlled trials were identified although primary studies exist for two screening tests: ophthalmoscopy, either direct or indirect, and retinal photography, using either mydriasis or non-mydriasis. Retinal photography under mydriasis appears to be the most effective test, with the majority reporting levels of sensitivity in excess of 80%. However effectiveness is compromised when photographs are ungradable. Ophthalmoscopy can also reach acceptable standards of sensitivity and specificity. Conclusion Based on an assessment of available cohort studies, the most effective strategy for testing is the use of mydriatic retinal photography with the additional use of ophthalmoscopy for cases where photographs are ungradable. This does not exclude the use of ophthalmoscopy alone for opportunistic case finding but there is evidence of considerable variation in effectiveness of this test. [source] Mental Health First Aid: an international programme for early interventionEARLY INTERVENTION IN PSYCHIATRY, Issue 1 2008Betty A. Kitchener Abtract Aim: To describe the development of the Mental Health First Aid (MHFA) programme in Australia, its roll-out in other countries and evaluation studies which have been carried out. Methods: A description of the programme's development and evaluation, its cultural adaptations and its dissemination in seven countries. Results: The programme was developed in Australia in 2001. By the end of 2007, there were 600 instructors and 55 000 people trained as mental health first aiders. A number of evaluations have been carried out, including two randomized controlled trials that showed changes in knowledge, attitudes and first aid behaviours. Special adaptations of the course have been rolled out for Aboriginal and Torres Strait Islander peoples and some non-English speaking immigrant groups. The course has spread to seven other countries with varying degrees of penetration. In all countries, the programme has been initially supported by government funding. Independent evaluations have been carried out in Scotland and Ireland. Conclusions: The concept of first aid by the public for physical health crises is familiar in many countries. This has made it relatively easy to extend this approach to early intervention by members of the public for mental disorders and crises. Through MHFA training, the whole of a community can assist formal mental health services in early intervention for mental disorders. [source] Outcome of long-term heroin-assisted treatment offered to chronic, treatment-resistant heroin addicts in the NetherlandsADDICTION, Issue 2 2010Peter Blanken ABSTRACT Aims To describe 4-year treatment retention and treatment response among chronic, treatment-resistant heroin-dependent patients offered long-term heroin-assisted treatment (HAT) in the Netherlands. Design Observational cohort study. Setting and intervention Out-patient treatment in specialized heroin treatment centres in six cities in the Netherlands, with methadone plus injectable or inhalable heroin offered 7 days per week, three times per day. Prescription of methadone plus heroin was supplemented with individually tailored psychosocial and medical support. Participants Heroin-dependent patients who had responded positively to HAT in two randomized controlled trials and were eligible for long-term heroin-assisted treatment (n = 149). Measurements Primary outcome measures were treatment retention after 4 years and treatment response on a dichotomous, multi-domain response index, comprising physical, mental and social health and illicit substance use. Findings Four-year retention was 55.7% [95% confidence interval (CI): 47.6,63.8%]. Treatment Response was significantly better for patients continuing 4 years of HAT compared to patients who discontinued treatment: 90.4% versus 21.2% [difference 69.2%; odds ratio (OR) = 48.4, 95% CI: 17.6,159.1]. Continued HAT treatment was also associated with an increasing proportion of patients without health problems and who had stopped illicit drug and excessive alcohol use: from 12% after the first year to 25% after 4 years of HAT. Conclusions Long-term HAT is an effective treatment for chronic heroin addicts who have failed to benefit from methadone maintenance treatment. Four years of HAT is associated with stable physical, mental and social health and with absence of illicit heroin use and substantial reductions in cocaine use. HAT should be continued as long as there is no compelling reason to stop treatment. [source] EFNS guidelines on pharmacological treatment of neuropathic painEUROPEAN JOURNAL OF NEUROLOGY, Issue 11 2006N. Attal Neuropathic pain treatment remains unsatisfactory despite a substantial increase in the number of trials. This EFNS Task Force aimed at evaluating the existing evidence about the pharmacological treatment of neuropathic pain. Studies were identified using first the Cochrane Database then Medline. Trials were classified according to the aetiological condition. All class I and II controlled trials (according to EFNS classification of evidence) were assessed, but lower-class studies were considered in conditions that had no top level studies. Only treatments feasible in an outpatient setting were evaluated. Effects on pain symptoms/signs, quality of life and comorbidities were particularly searched for. Most of the randomized controlled trials included patients with postherpetic neuralgia (PHN) and painful polyneuropathies (PPN) mainly caused by diabetes. These trials provide level A evidence for the efficacy of tricyclic antidepressants, gabapentin, pregabalin and opioids, with a large number of class I trials, followed by topical lidocaine (in PHN) and the newer antidepressants venlafaxine and duloxetine (in PPN). A small number of controlled trials were performed in central pain, trigeminal neuralgia, other peripheral neuropathic pain states and multiple-aetiology neuropathic pains. The main peripheral pain conditions respond similarly well to tricyclic antidepressants, gabapentin, and pregabalin, but some conditions, such as HIV-associated polyneuropathy, are more refractory. There are too few studies on central pain, combination therapy, and head-to-head comparison. For future trials, we recommend to assess quality of life and pain symptoms or signs with standardized tools. [source] Forum on: the role of recombinant factor VIII in children with severe haemophilia AHAEMOPHILIA, Issue 2 2009M. FRANCHINI Summary., The development of recombinant FVIII (rFVIII) products, fuelled by the need for improved safety of treatment arising from the dramatic widespread blood-borne virus transmission in the 1970,1980s revolutionized the care of children with haemophilia A over the last two decades. The larger availability of perceived safer replacement therapy associated with the introduction of rFVIII products reassured the haemophilia community and there was a strong push in some Western countries to treat haemophilic children only with rFVIII. Moreover, this significantly contributed in the 1990s to the diffusion outside Northern Europe of prophylactic regimens implemented at an early age to prevent bleeding and the resultant joint damage (i.e. primary prophylaxis), together with the possibility of home treatment. These changes led to a substantial improvement of the quality of life of haemophilic children and of their families. The general agreement that primary prophylaxis represents the first-choice treatment for haemophilic children has been recently supported by two randomized controlled trials carried out with rFVIII products, providing evidence on the efficacy of early prophylaxis over on-demand treatment in preserving joint health in haemophilic children. However, the intensity and optimal modalities of implementation of prophylaxis in children, in particular with respect to the issue of the venous access, are still debated. A number of studies also supports the role of secondary prophylaxis in children, frequently used in countries in which primary prophylaxis was introduced more recently. With viral safety now less than an issue and with the more widespread use of prophylaxis able to prevent arthropathy, the most challenging complication of replacement therapy for children with haemophilia remains the risk of inhibitor development. Despite conflicting data, there is no evidence that the type of FVIII concentrate significantly influences the complex multifactorial process leading to anti-FVIII alloantibodies, whereas other treatment-related factors are likely to increase (early intensive treatments due to surgery or severe bleeds) or reduce (prophylaxis) the risk. Although the optimal regimen is still uncertain, eradication of anti-FVIII antibodies by immune tolerance induction (ITI), usually with the same product administered at inhibitor detection, should be the first-choice treatment for all patients with recent onset inhibitors. This issue applies particularly to children, as most patients undergo ITI at an early age, when inhibitors usually appear. The availability of a stable and long-lasting venous access represents a leading problem also in this setting. These and other topics concerning rFVIII treatment of haemophilic children were discussed in a meeting held in Rome on 27 February 2008 and are summarized in this report. [source] Open versus laparoscopic resection for liver tumoursHPB, Issue 6 2009Thomas Van Gulik Abstract Background:, The issue under debate is whether laparoscopic liver resections for malignant tumours produce outcomes which are comparable with conventional, open liver resections. Methods:, Literature review on liver resection and laparoscopy. Results:, There are no randomized controlled trials (RCTs) published that provide any evidence for the benefits of laparoscopic liver resections for liver tumours. In case,control series reporting short-term outcomes, laparoscopic liver resection has been shown to have the advantage of a reduced length of hospital stay. There are as yet, however, no adequate long-term survival studies demonstrating that laparoscopic liver resection is oncologically equivalent to open resection. Discussion:, The challenge for the near future is to test the oncological integrity of laparoscopic liver resection in controlled trials in the same way that we have learned from the RCTs carried out in laparoscopic resection for colorectal cancer. It is likely that laparoscopic liver resection will then have to compete with fast-track, open liver resection. Already, concerns have been raised regarding the learning curve required to master the techniques of laparoscopic liver resection. [source] Preoperative biliary drainage before resection for cholangiocarcinoma (Pro)HPB, Issue 2 2008Y. NIMURA Abstract Three types of preoperative biliary drainage (BD): percutaneous transhepatic (PTBD), endoscopic (EBD), and endoscopic nasobiliary (ENBD) can be indicated before resection of cholangiocarcinoma. However, three randomized controlled trials (RCTs) have revealed that preoperative PTBD does not improve perioperative results. Other RCTs have revealed that preoperative EBD for malignant obstructive jaundice has no demonstrable benefit and after EBD for hilar cholangiocarcinoma there are highly developed infectious complications. Most patients with distal cholangiocarcinoma undergo pancreatoduodenectomy (PD) without preoperative BD. However, no RCTs have been performed to clarify the safety of major hepatectomy without preoperative BD for cholestatic patients with hilar cholangiocarcinoma. Furthermore, preoperative intrahepatic segmental cholangitis is a prognostic factor in the outcome of major hepatectomy for biliary cancer. Preoperative BD has another purpose in the preoperative management of patients with hilar cholangiocarcinoma. Selective cholangiography via ENBD and/or PTBD catheters provides precise information about the complicated segmental anatomy of the intrahepatic bile ducts and extent of cancer along the separated segmental bile ducts, which contributes toward designing a type of resective procedure. RCTs in biliary cancer patients undergoing major hepatectomy have revealed that bile replacement during external biliary drainage and perioperative synbiotic treatment can prevent postoperative infectious complications. Although preoperative EBD increases the risk of cholangitis, major hepatectomy combined with preoperative biliary drainage, preferably PTBD and/or ENBD, followed by portal vein embolization has been established as a safer management strategy for perihilar cholangiocarcinoma. [source] Treatment of osteopenia and osteoporosis in anorexia nervosa: A systematic review of the literatureINTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 3 2009Philip S. Mehler MD Abstract Objective: To systematically review the evidence supporting treatment of osteopenia and osteoporosis in patients with anorexia nervosa (AN). Data sources: We identified controlled clinical studies of interventions for low bone mass in AN via searches of MEDLINE; the Cochrane Library; EMBASE; PsycINFO; and cumulative index to nursing and allied health literature. Outcomes of interest were changes in bone mineral density and fracture incidence. Results: Six randomized controlled trials (RCTs) and two cohort trials examined five classes of medical therapy on bone mineral density outcomes. One RCT of bisphosphonates showed no benefit and a second flawed RCT showed some benefit; one RCT showed a benefit of insulin-like growth factor-I; none of the five trials evaluating estrogen therapy showed benefit. Discussion: Although patients with AN are often losing bone mass when they should be optimizing bone growth, there is no good evidence to guide medicinal interventions. Therefore, early detection and weight restoration are of utmost importance whereas ongoing trials define effective therapies. © 2008 by Wiley Periodicals, Inc. Int J Eat Disord 2009 [source] Optimal timing and dosing of platelet transfusionsISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010N. M. Heddle Background, Over the past 20 years there have been more than 20 randomized controlled trials (RCTs) that have investigated various aspects of platelet transfusion therapy in haematology/oncology patients. These studies have focused on the best platelet product, the importance of ABO compatibility, pathogen inactivation of platelets, platelet triggers and the optimal platelet dose. Aims, This article summarizes current evidence to support the timing and dosing of platelet transfusions and to explore some ideas of where clinical research in this area may be heading. Materials and Methods, The articles reviewed in this presentation were identified through a search of PubMed using the term, platelet transfusion and setting limits to identify clinical studies, human studies and manuscripts in English. Results and Discussion, Three RCTs have informed practices around platelet transfusion trigger with the largest study by Rebulla et al., being the primary study that has changed practices worldwide, with a move towards a lower prophylactic platelet transfusion trigger of 10 × 109/l. Two groups (Germany and Oxford, UK) are currently investigating whether we can push the boundaries of prophylactic platelet transfusions even further by eliminating this form of therapy. Preliminary results from these studies have been published but we will await the final results to determine whether this research will indeed change practice. Over the past year there has also been two major studies (one by the BEST Collaborative, and the second by the US Transfusion Medicine/Hemostasis Network), that provide new information to guide platelet dosing. The Study by the BEST Collaborative (SToP) compared low dose platelets to standard dose platelets with WHO bleeding greater than or equal to Grade 2 as the primary outcome. The US study (PLADO) compared three doses (low, medium and high) and measured the same outcome (WHO bleeding , Grade 2). Conclusions, Although all of these studies further our knowledge to prescribe platelet transfusions, they also raise some interesting questions about the clinical relevance of the outcomes that we are currently using for these studies. The trend over the past decade has been to use bleeding as the primary outcome; however, bleeding is a complex composite outcome (Grades 2, 3 and 4) comprised of some surrogate components (Grades 2 and 3). It is also an outcome that may be difficult to measure and grade in a consistent and reliable manner. The clinical relevance of this outcome is also complex and may vary depending on the perspective from which it is viewed. [source] Controversy concerning platelet doseISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2007N. M. Heddle The highest level of support for evidence based decisions is the randomized controlled trial (RCT); however, RCT results are only useful if the study has strong internal and external validity. There have been a number of clinical trials that have addressed the issue of the optimal platelet dose; however, none of these studies have provided definitive data on the optimal platelet dose due to a variety of methodological issues associated with the study designs. Currently two randomized controlled trials have been implemented to address the issue of optimal platelet dose. The results of these trials will not be available until 2007,2008. The BEST (Biomedical Excellence for Safer Transfusion) Collaborative has initiated a platelet dose study comparing the frequency of WHO bleeding Grade 2 with low and standard dose platelets. The Transfusion Medicine/ Haemostasis Clinical Trials Network (CTN) is also performing a platelet dose study comparing three treatment strategies (high, standard and low dose platelets). There were numerous methodological issues that had to be considered when designing these two studies. More recently some European investigators have questioned the need for prophylactic platelet transfusions and several studies are currently underway to investigate the efficacy of changing this practice. [source] Psychosocial treatments for people with co-occurring severe mental illness and substance misuse: systematic reviewJOURNAL OF ADVANCED NURSING, Issue 2 2009Michelle Cleary Abstract Title.,Psychosocial treatments for people with co-occurring severe mental illness and substance misuse: systematic review. Aim., This study is a report of a systematic review to assess current evidence for the efficacy of psychosocial interventions for reducing substance use, as well as improving mental state and encouraging treatment retention, among people with dual diagnosis. Background., Substance misuse by people with a severe mental illness is common and of concern because of its many adverse consequences and lack of evidence for effective psychosocial interventions. Data sources., Several electronic databases were searched to identify studies published between January 1990 and February 2008. Additional searches were conducted by means of reference lists and contact with authors. Review methods., Results from studies using meta-analysis, randomized and non-randomized trials assessing any psychosocial intervention for people with a severe mental illness and substance misuse were included. Results., Fifty-four studies were included: one systematic review with meta-analysis, 30 randomized controlled trials and 23 non-experimental studies. Although some inconsistencies were apparent, results showed that motivational interviewing had the most quality evidence for reducing substance use over the short term and, when combined with cognitive behavioural therapy, improvements in mental state were also apparent. Cognitive behavioural therapy alone showed little consistent support. Support was found for long-term integrated residential programmes; however, the evidence is of lesser quality. Contingency management shows promise, but there were few studies assessing this intervention. Conclusion., These results indicate the importance of motivational interviewing in psychiatric settings for the reduction of substance use, at least in the short term. Further quality research should target particular diagnoses and substance use, as some interventions may work better for some subgroups. [source] Qualitative systematic review: An example from primary prevention in adult mental healthJOURNAL OF COMMUNITY & APPLIED SOCIAL PSYCHOLOGY, Issue 3 2001Mark A. Papworth Abstract This paper describes a useful variant of the ,systematic review', a recent development in review ,science', using primary prevention in adult mental health as an illustration. Seventeen programme evaluations were identified as a result of rigorous search and inclusion criteria. The methodology of each study was then evaluated in terms of eight threats to validity, as outlined by Ellis et al. (1996). Additionally, the merits of the programmes were evaluated according to the type of study and it's outcomes. Most projects reported significant findings (N,=,13), but the sample included only seven randomized controlled trials. Whilst the research status of the field appears to have improved significantly over the last two decades, because of the methodological threats, the extent of any clear economic and clinical benefits resulting from the approach have yet to be established. Copyright © 2001 John Wiley & Sons, Ltd. [source] Exercise parameters in the treatment of clinical depression: a systematic review of randomized controlled trialsJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 3 2010Luke G. Perraton BPT MPT Abstract Rationale, aims and objectives, Previous systematic reviews have concluded that exercise programmes are effective in the management of clinical depression. The aim of this review was to analyse the parameters of exercise programmes reported in the primary research, in order to provide clinicians with evidence-based recommendations for exercise prescription for clinical depression. Methods, A systematic review of randomized controlled trials was undertaken. Only trials that reported exercise to be effective in treating depression were included and our review was limited to adults. Appropriate databases and reference lists were searched using established keywords. Data relating to the type, intensity, frequency, duration, mode of exercise and mode of application of exercise was extracted and collated. Results, A total of 14 randomized controlled trials were included in this review and from these trials 20 intervention arms were analysed. The majority of trials used an aerobic exercise intervention and were supervised. The most common exercise parameters were 60,80% of maximum heart rate for 30 minutes three times per week for an overall duration of 8 weeks. There is an equal volume of evidence supporting group as opposed to individually completed exercise programmes and no trends were identified which would support one mode of exercise over another. Conclusions, Currently the primary research on this topic supports the use of aerobic exercise which is supervised in some capacity. The current evidence base supports a prescription of three 30-minute sessions per week of aerobic exercise at 60,80% of maximum heart rate for at least 8 weeks. [source] Patient Problems, Advanced Practice Nurse (APN) Interventions, Time and Contacts Among Five Patient GroupsJOURNAL OF NURSING SCHOLARSHIP, Issue 1 2003Dorothy Brooten Purpose: To describe patient problems and APN interventions in each of five clinical trials and to establish links among patient problems, APN interventions, APN time and number of contacts, patient outcomes, and health care costs. Design and Methods: Analysis of 333 interaction logs created by APNs during five randomized controlled trials: (a) very low birthweight infants (n=39); (b) women with unplanned cesarean birth (n=61), (c) high-risk pregnancy (n=44), and (d) hysterectomy (n=53); and (e) elders with cardiac medical and surgical diagnoses (n=139). Logs containing recordings of all APN interactions with participants, APN time and type of patient contact were content analyzed with the smallest phrase or sentence representing a "unit." These units were then classified using the Omaha Classification System to determine patient problems and APN interventions. Groups were compared concerning total amount of APN time, number of contacts per patient, and mean length of time per APN contact. All studies were conducted in the United States. Findings: Groups with greater mean APN time and contacts per patient had greater improvements in patients' outcomes and greater health care cost savings. Of the 150,131 APN interventions, surveillance was the predominant APN function in all five patient groups. Health teaching, guidance, and counseling was the second most frequent category of APN intervention in four of the five groups. In all five groups, treatments and procedures accounted for < 1% of total APN interventions. Distribution of patient problems (N=150,131) differed across groups reflecting the health care problems common to the group. Conclusions: Dose of APN time and contacts makes a difference in improving patient outcomes and reducing health care costs. Skills needed by APNs in providing transitional care include well-developed skills in assessing, teaching, counseling, communicating, collaborating, knowing health behaviors, negotiating systems, and having condition-specific knowledge about different patient problems. [source] School Disrepair and Substance Use Among Regular and Alternative High School StudentsJOURNAL OF SCHOOL HEALTH, Issue 8 2010Rachel A. Grana MPH BACKGROUND: The physical environment influences adolescent health behavior and personal development. This article examines the relationship between level of school disrepair and substance use among students attending regular high school (RHS) and alternative high school (AHS). METHODS: Data were collected from students (N = 7058) participating in 2 randomized controlled trials of a school-based substance abuse prevention program implemented across the United States. Students provided substance use and demographic information on a self-reported survey. Data for the physical disrepair of schools were collected from individual rater observations of each school environment. We hypothesized that school disrepair would be positively associated with substance use controlling for individual characteristics and a socioeconomic status proxy. Multilevel mixed modeling was used to test the hypothesized association and accounted for students nested within schools. RESULTS: Findings indicated that students attending AHS with greater school disrepair were more likely to report the use of marijuana and other illicit drugs (ie, cocaine, heroin). Students attending RHS with greater school disrepair were less likely to report smoking cigarettes. CONCLUSIONS: Differences in findings between RHS and AHS students are discussed, and implications for substance use prevention programming are offered. Students attending AHS with greater school disrepair may require more substance abuse prevention programming, particularly to prevent illicit substance use. [source] Homocysteine and cardiovascular disease: A review of current recommendations for screening and treatmentJOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS, Issue 3 2005KarenL. Purpose To review the literature for, and provide advanced practice nurses (APNs) with, current recommendations for screening and treatment of hyperhomocysteinemia. Data sources Medscape literature search of selected research studies and related journal articles. Conclusions While data from most epidemiologic studies support the argument that hyperhomocysteinemia is an independent risk factor for cardiovascular disease, the debate continues as to when screening and treating patients is appropriate. The consensus is that more randomized controlled trials are needed to further study the benefits of routine screening and the efficacy of treating hyperhomocysteinemia. Implications for practice Until the results of ongoing clinical trials are available, APNs should follow the American Heart Association guidelines for screening for elevated levels of homocysteine and continue to promote a well-balanced diet that includes foods rich in folic acid as part of health promotion through primary prevention. [source] Evidence-based review of lasers, light sources and photodynamic therapy in the treatment of acne vulgarisJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 3 2008M Hædersdal Abstract Background, There is a considerable need for effective and safe treatment for acne vulgaris. Objective, In a systematic review with an evidence-based approach to assess the effects of optical treatments for acne vulgaris. Methods, Original publications of controlled clinical trials were identified through searches in PubMed and the Cochrane Library. Results, A total of 16 randomized controlled trials (RCT) and 3 controlled trials (CT) were identified, involving a total of 587 patients. Interventions included photodynamic therapy (PDT; 5 RCTs), infrared lasers (4 RCTs), broad-spectrum light sources (3 RCTs, 1 CT), pulsed dye lasers (PDL; 2 RCTs, 1 CT), intense pulsed light (IPL; 1 RCTs, 2 CTs), and potassium titanyl phosphate laser (1 RCT). The randomization method was mentioned in 6 of 16 RCTs, and one trial described adequate allocation concealment. Most trials were intraindividual trials (12 of 19), which applied blinded response evaluations (12 of 19) and assessed a short-term efficacy up to 12 weeks after treatment (17 of 19). Based on the present best available evidence, we conclude that optical treatments possess the potential to improve inflammatory acne on a short-term basis with the most consistent outcomes for PDT [up to 68% improvement, aminolevulinic acid (ALA), methyl-aminolevulinic acid (MAL) and red light]. IPL-assisted PDT seems to be superior to IPL alone. Only two trials compare optical vs. conventional treatments, and further studies are needed. Side-effects from optical treatments included pain, erythema, oedema, crusting, hyperpigmentation, pustular eruptions and were more intense for treatments combined with ALA or MAL. Conclusion, Evidence from controlled clinical trials indicates a short-term efficacy from optical treatments for acne vulgaris with the most consistent outcomes for PDT. We recommend that patients are preoperatively informed of the existing evidence, which indicates that optical treatments today are not included among first line treatments. [source] ORIGINAL ARTICLE: Subsegmental pulmonary embolism diagnosed by computed tomography: incidence and clinical implications.JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 8 2010A systematic review, meta-analysis of the management outcome studies Summary.,Background:,Multiple-detectors computed tomographic pulmonary angiography (CTPA) has a higher sensitivity for pulmonary embolism (PE) within the subsegmental pulmonary arteries as compared with single-detector CTPA. Multiple-detectors CTPA might increase the rate of subsegmental PE diagnosis. The clinical significance of subsegmental PE is unknown. We sought to summarize the proportion of subsegmental PE diagnosed with single- and multiple-detectors CTPA and assess the safety of diagnostic strategies based on single- or multiple-detectors CTPA to exclude PE. Patients and methods:,A systematic literature search strategy was conducted using MEDLINE, EMBASE and the Cochrane Register of Controlled Trials. We selected 22 articles (20 prospective cohort studies and two randomized controlled trials) that included patients with suspected PE who underwent a CTPA and reported the rate of subsegmental PE. Two reviewers independently extracted data onto standardized forms. Results:,The rate of subsegmental PE diagnosis was 4.7% [95% confidence interval (CI): 2.5,7.6] and 9.4 (95% CI: 5.5,14.2) in patients that underwent a single- and multiple-detectors CTPA, respectively. The 3-month thromboembolic risks in patients with suspected PE and who were left untreated based on a diagnostic algorithm including a negative CTPA was 0.9% (95% CI: 0.4,1.4) and 1.1% (95% CI: 0.7,1.4) for single- and multiple-detectors CTPA, respectively. Conclusion:,Multiple-detectors CTPA seems to increase the proportion of patients diagnosed with subsegmental PE without lowering the 3-month risk of thromboembolism suggesting that subsegmental PE may not be clinically relevant. [source] Influence of risk factors on endoscopic and clinical ulcers in patients taking rofecoxib or ibuprofen in two randomized controlled trialsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2001C. J. Hawkey Background: Highly selective inhibitors of the inducible cyclooxygenase-2 enzyme (coxibs) have been associated with less gastrotoxicity than nonselective NSAIDs in clinical studies. Aim: To evaluate the influence of risk factors for NSAID-induced gastrotoxicity on endoscopic and clinical ulcers in patients taking rofecoxib or ibuprofen. Methods: We analysed pooled data from two identical double-blind, randomized, 12-week endoscopy studies which compared the gastroduodenal toxicity of placebo (n=371), rofecoxib 25 mg (n=390), rofecoxib 50 mg (n=379), and ibuprofen 2400 mg daily (n=376) in patients with osteoarthritis. The potential risk factors evaluated were: age (< 65, , 65 years), sex, race (white, nonwhite), Helicobacter pylori status, presence of gastroduodenal erosions at baseline, a history of upper gastrointestinal disease, prior NSAID use within 30 days of study entry, and smoking. We also evaluated these factors for possible association with the development of clinically-evident gastrointestinal perforations, ulcers or bleeds over 12 weeks. Results: Across all treatment groups, the likelihood of detecting endoscopic ulcers, or of clinical presentation with a bleed, over 12 weeks was increased approximately 4,5-fold in patients with previous upper gastrointestinal disease (relative risk [95% confidence interval] of 4.2 [2.5, 7.1] for endoscopic ulcers; 3.8 [1.4, 10.6] for bleeds), or those with gastroduodenal erosions at baseline endoscopy (relative risk of 4.4 [2.6, 7.5] for endoscopic ulcers; 5.0 [1.9, 13.5] for bleeds). H. pylori infection did not increase the risk of endoscopic ulcers or bleeds (relative risk of 1.1 [0.8, 1.6] for endoscopic ulcers; 0.3 [0.1, 0.9] for bleeds). The risk factor sub-group effects were constant across all treatment groups, and the significantly higher incidence of ulcers with ibuprofen as compared to rofecoxib and placebo was maintained in all risk factor subgroups. Conclusions: Gastroduodenal erosions at baseline and a clinical history of upper gastrointestinal disease, but not H. pylori colonization, increased the risk for endoscopically-detected ulcers and clinical bleeds. Rofecoxib did not magnify the risk in any of the patient subgroups studied. [source] Evidence for benefit of transversus abdominis training alone or in combination with pelvic floor muscle training to treat female urinary incontinence: A systematic review,,NEUROUROLOGY AND URODYNAMICS, Issue 5 2009Kari Bø Abstract Aims Pelvic floor muscle training (PFMT) has Level A evidence to treat female urinary incontinence (UI). Recently, indirect training of the pelvic floor muscles (PFM) via the transversus abdominis muscle (TrA) has been suggested as a new method to treat UI. The aim of this article is to discuss whether there is evidence for a synergistic co-contraction between TrA and PFM in women with UI, whether TrA contraction is as effective, or more effective than PFMT in treating UI and whether there is evidence to recommend TrA training as an intervention strategy. Methods A computerized search on PubMed, and hand searching in proceedings from the meetings of the World Confederation of Physical Therapy (1993,2007), International Continence Society and International Urogynecology Association (1990,2007) were performed. Results While a co-contraction of the TrA normally occurs with PFM contraction, there is evidence that a co-contraction of the PFM with TrA contraction can be lost or altered in women with UI. No randomized controlled trials (RCTs) were found comparing TrA training with untreated controls or sham. Two RCTs have shown no additional effect of adding TrA training to PFMT in the treatment of UI. Conclusions To date there is insufficient evidence for the use of TrA training instead of or in addition to PFMT for women with UI. Neurourol. Urodyn. 28:368,373, 2009. © 2009 Wiley-Liss, Inc. [source] Radiofrequency Neurotomy for Low Back Pain: Evidence-Based Procedural GuidelinesPAIN MEDICINE, Issue 2 2005W. Michael Hooten MD ABSTRACT Objective., This review was undertaken to outline the procedural limitations of the randomized controlled trials (RCTs) of radiofrequency (RF) neurotomy for low back pain. Second, the literature related to patient selection, diagnostic testing, and the technique of performing lumbar spine, RF neurotomy will be critically reviewed and analyzed. Based on these analyses, diagnostic and procedural guidelines will be proposed. Design., A Medline and EMBASE search identified three RCTs and two systematic reviews of RF neurotomy for low back pain. A similar search identified pertinent literature related to the method of patient selection for a diagnostic block, the medial branch and L5 dorsal ramus comparative block, and the anatomical and technical parameters of lumbar spine RF neurotomy. Results., Substantial procedural shortcomings were identified in all three RCTs. In the systematic reviews, these procedural limitations were not accounted for by the quality assessment of study design which resulted in an inaccurate estimate of clinical effectiveness. Analysis using likelihood ratios showed that screening criteria could increase the probability of zygapophysial joint pain before performing diagnostic blocks. Similar analysis showed that comparative medial branch blocks, rather than single blocks, must be used before RF neurotomy. Anatomical studies demonstrated that the shorter distal compared with the circumferential radius of the RF lesion necessitates placement of the electrode parallel to the course of the nerve along the base of the superior articular process. Conclusions., The evidence-based procedural guidelines provide consistent criteria for multisite studies that could enroll a sufficiently large homogenous study cohort. [source] Evidence For and Against the Use of Opioid Analgesics for Chronic Nonmalignant Low Back Pain: A ReviewPAIN MEDICINE, Issue 3 2002J. D. Bartleson MD Abstract Introduction., Opioid analgesics are very effective for treating pain, but their chronic use in nonmalignant conditions is controversial. Low back pain is a common condition, and chronic low back pain (CLBP) is the most frequent regional pain syndrome in the United States. This article reviews the evidence for and against the use of chronic opioid analgesic therapy (COAT) for patients with CLBP unrelated to cancer. Methods., A literature review was conducted looking for reports of oral or transdermal opioid analgesic therapy for CLBP. Results., There are very few randomized controlled trials of COAT for CLBP. The scant evidence that is available suggests that over the short-term, COAT is helpful with patients with CLBP. In the published reports, most of which are brief in duration, COAT is associated with moderate side effects but a low risk of abuse or drug addiction. COAT was not associated with adverse long-term sequelae. Longer-acting opioid analgesics may be preferable to shorter-acting agents. Patient selection and close follow-up are critical to good outcomes. Conclusions., There is a place for the use of chronic oral or transdermal opioid analgesics in the treatment of some patients with CLBP. [source] Are peripheral and neuraxial blocks with ultrasound guidance more effective and safe in children?PEDIATRIC ANESTHESIA, Issue 2 2009KASIA RUBIN MD Summary Background and aims:, The efficacy and safety of ultrasound guided (USG) pediatric peripheral nerve and neuraxial blocks in children have not been evaluated. In this review, we have looked at the success rate, efficacy and complications with USG peripheral nerve blocks and compared with nerve stimulation or anatomical landmark based techniques in children. Methods:, All suitable studies in MEDLINE, EMBASE Drugs and Cochrane Evidence Based Medicine Reviews: Cochrane Database of Systemic Reviews databases were identified. In addition, citation review and hand search of recent pediatric anesthesia and surgical journals were done. All three authors read all selected articles independently and a consensus was achieved. All randomized controlled trials (RCTs) comparing USG peripheral and neuraxial blocks with other techniques in children were included. Results:, Ultrasound guidance has been demonstrated to improve block characteristics in children including shorter block performance time, higher success rates, shorter onset time, longer block duration, less volume of local anesthetic agents and visibility of neuraxial structures. Conclusion:, Clinical studies in children suggest that US guidance has some advantages over more traditional nerve stimulation,based techniques for regional block. However, the advantage of US guidance on safety over traditional has not been adequately demonstrated in children except ilio-inguinal blocks. [source] Case for and against specificity of depression in Alzheimer's diseasePSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 4 2010Christian Even MD Aims:, The aims of this study were to assess the epidemiological, phenomenological, and pathophysiological evidence that suggests the specificity of depression associated with Alzheimer's disease (AD). Methods:, We reviewed the English-language literature. Results:, Depression occurs significantly more often in patients with AD than in the general elderly population. While development of depression in response to the disability and emotional stress of AD may be a contributory factor in some patients, several studies showed that depression was not, or was only seldom, related to self-awareness of AD and these studies could not explain the high prevalence figures. To overcome the overlapping phenomenology of the two diseases, specific diagnostic criteria have been developed for depression in this context. Mixed findings have come from neuropathological and neuroimaging studies, with some evidence linking the underlying neural substrate of AD and depression, suggesting an overlapping cause of primary depression and depression comorbid with AD. Few randomized controlled trials for depression associated with AD have been conducted, with rather poor results for the use of antidepressants. Conclusions:, Currently, depression associated with AD is not considered a separate disorder by regulatory authorities and is unlikely to be considered as such in the near future. Several obstacles remain to support such a specific position, including the heterogenous nature of depression in general and within AD itself, the lack of a distinct set of symptoms, and limited treatment. [source] Exercise and quality of life during and after treatment for breast cancer: results of two randomized controlled trialsPSYCHO-ONCOLOGY, Issue 4 2009Lisa A. Cadmus Abstract Objective: To determine the effect of exercise on quality of life in (a) a randomized controlled trial of exercise among recently diagnosed breast cancer survivors undergoing adjuvant therapy and (b) a similar trial among post-treatment survivors. Methods: Fifty newly diagnosed breast cancer survivors were recruited through a hospital-based tumor registry and randomized to a 6-month, home-based exercise program (n=25) or a usual care group (n=25). In a separate trial, 75 post-treatment survivors were randomized to a 6-month, supervised exercise intervention (n=37) or to usual care (n=38). Participants in both studies completed measures of happiness, depressive symptoms, anxiety, stress, self-esteem, and quality of life at baseline and 6 months. Results: Forty-five participants completed the trial for newly diagnosed survivors and 67 completed the trial for post-treatment survivors. Good adherence was observed in both studies. Baseline quality of life was similar for both studies on most measures. Exercise was not associated with quality of life benefits in the full sample of either study; however exercise was associated with improved social functioning among post-treatment survivors who reported low social functioning at baseline (p<0.05). Conclusions: Exercise did not affect quality of life in either recently diagnosed or post-treatment breast cancer survivors; however this may be due in part to relatively high baseline functioning among participants in both studies. Strategies for future research include limiting enrollment to survivors who report reduced quality of life on screening questionnaires and targeting survivor subgroups known to be at particular risk for quality of life impairment. Copyright © 2009 John Wiley & Sons, Ltd. [source] Creatine supplementation for patients with COPD receiving pulmonary rehabilitation: A systematic review and meta-analysisRESPIROLOGY, Issue 5 2010Fahad AL-GHIMLAS ABSTRACT Background and objective: Creatine improves muscle strength in exercising healthy individuals, and in patients with neuromuscular disease and heart failure. The aim of this study was to assess whether creatine supplementation improves pulmonary rehabilitation (PR) outcomes in patients with COPD. Methods: A systematic review and meta-analysis was performed of randomized controlled trials published between January 1966 and February 2009 that evaluated the effect of creatine compared with placebo on exercise capacity, muscle strength and health-related quality of life (HR-QoL) in patients undergoing PR for COPD. The pooled estimates were expressed as mean differences (MD) or standardized mean differences (SMD). Results: Four randomized controlled trials that included 151 patients were identified. There was no effect of creatine supplementation on exercise capacity (SMD ,0.01, 95% CI: ,0.42 to 0.22, n = 151). Creatine supplementation did not improve lower extremity muscle strength (SMD 0.03, 95% CI: ,0.55 to 0.61, n = 140) or upper limb muscular strength (SMD 0.02, 95% CI: ,0.33 to 0.38, n = 128) compared with placebo. Two studies (n = 48) assessed quality of life using the St. George's Respiratory Disease Questionnaire. There were no differences in HR-QoL according to domain or total scores. Overall, creatine appeared to be safe and was well tolerated. Quality assessment of the studies showed important limitations. Conclusions: Creatine supplementation does not improve exercise capacity, muscle strength or HR-QoL in patients with COPD receiving PR. However, important limitations were identified in the quality of the available evidence, suggesting that further research is required in this area. [source] | ||||||||||||||||||||||||||||