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1.
2.

Background

There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs) of cancer treatments.

Methods

A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted.

Results

Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work.

Conclusion

There is not a strong evidence-base for interventions that increase cancer patient participation in randomised trials. Further research is required to evaluate the effectiveness of strategies to increase participation in cancer treatment trials.  相似文献   

3.
This paper discusses some of the problems involved in drawing conclusions across studies about the efficacy of biofeedback. It focuses on biofeedback for the treatment of hypertension, but the same difficulties arise when considering the effect of biofeedback in other disorders. Large multicenter studies using the same inclusion and exclusion criteria, biofeedback protocol, and methodology are badly needed if biofeedback practitioners are ever going to demonstrate the real effectiveness of biofeedback.  相似文献   

4.
Tripterygium wilfordii is a Chinese herb with immunosuppressive effects and an established history of use in the treatment of rheumatoid arthritis (RA). We have carried out a systematic review of randomised clinical trials (RCTs) which assess the effectiveness of T. wilfordii in this indication. We included only randomised and controlled studies which tested the effectiveness of T. wilfordii monopreparations in the treatment of RA. Studies in any language were included. A search of five electronic databases from inception to February 2005 identified 18 articles which could potentially meet our inclusion criteria. Only 16 of these could be retrieved from the scientific literature and after reading these in full, only two unique RCTs meeting our inclusion criteria were identified. Both indicated that T. wilfordii has beneficial effects on the symptoms of RA. However, the literature indicates that T. wilfordii is associated with serious adverse events which make the risk-benefit analysis for this herb unfavourable. Therefore, we cannot recommend its use.  相似文献   

5.
ABSTRACT

The aim of this systematic review was to evaluate quantitative studies of companion animals and human loneliness. Five electronic databases (PubMed, Medline, Web of Science, Academic Search Premier, Psychlnfo) were searched for articles on companion animals (including animal-assisted therapies [AAT]) and human loneliness. Searches were not limited to a particular language or timeframe. Three randomized controlled studies (RCTs), one controlled study, one prospective cohort study, two longitudinal, and 14 cross-sectional studies satisfied all inclusion criteria and were each evaluated independently by both authors according to standardized criteria, with disagreements resolved by discussion. All except one study was underpowered. The methodological quality of the three RCTs was low, as measured on the Jadad scale. Eleven studies reported positive findings, of which five related to service dogs. While none of the positive studies provided convincing evidence that companion animals help to alleviate loneliness, there was promising evidence that AAT may do this (although effects may be due to aspects of the therapy rather than the animal). As further cross-sectional studies are unlikely to improve understanding of the role of companion animals on human loneliness, we suggest that there is a need for rigorous and adequately powered RCTs.  相似文献   

6.
BackgroundThe number of robotic assisted radical cystectomy (RARC) procedures is increasing despite the lack of Level I evidence showing any advantages over open radical cystectomy (ORC). However, several systematic reviews with meta-analyses including non-randomised studies, suggest an overall benefit for RARC compared to ORC. We performed a systematic review with meta-analysis of randomised controlled trials (RCTs) to evaluate the perioperative morbidity and efficacy of RARC compared to ORC in patients with bladder cancer.MethodsLiterature searches of Medline/Pubmed, Embase, Web of Science and clinicaltrials.gov databases up to 10th March 2016 were performed. The inclusion criteria for eligible studies were RCTs which compared perioperative outcomes of ORC and RARC for bladder cancer. Primary objective was perioperative and histopathological outcomes of RARC versus ORC while the secondary objective was quality of life assessment (QoL), oncological outcomes and cost analysis.ResultsFour RCTs (from 5 articles) met the inclusion criteria, with a total of 239 patients all with extracorporeal urinary diversion. Patient demographics and clinical characteristics of RARC and ORC patients were evenly matched. There was no significant difference between groups in perioperative morbidity, length of stay, positive surgical margin, lymph node yield and positive lymph node status. RARC group had significantly lower estimated blood loss (p<0.001) and wound complications (p = 0.03) but required significantly longer operating time (p<0.001). QoL was not measured uniformly across trials and cost analysis was reported in one RCTs. A test for heterogeneity did highlight differences across operating time of trials suggesting that surgeon experience may influence outcomes.ConclusionsThis study does not provide evidence to support a benefit for RARC compared to ORC. These results may not have inference for RARC with intracorporeal urinary diversion. Well-designed trials with appropriate endpoints conducted by equally experienced ORC and RARC surgeons will be needed to address this.  相似文献   

7.

Objective

To critically assess the current evidence from randomized clinical trials (RCTs) for or against the effectiveness or efficacy of Rhodiola rosea.

Data sources

Systematic literature searches were performed in six electronic databases: AMED (1985-July 2009), CINAHL (1982-July 2009), The Cochrane Library (search in July 2009), EMBASE (1974-July 2009), MEDLINE (1950-July 2009) and Web of Science (searched in July 2009). No language restrictions were imposed. Reference lists of all retrieved articles were searched, and experts and manufacturers were contacted for unpublished RCT.

Review methods

RCTs testing the efficacy or effectiveness of mono-preparations of R. rosea as sole treatment administered orally against a control intervention in any human individual suffering from any condition or healthy human volunteers were included. Studies were selected, data extracted, and quality assessed by two independent reviewers.

Results

Eleven RCTs met the inclusion criteria; all were placebo-controlled. Six trials investigated the effects of R. rosea on physical performance, four on mental performance, and two in patients diagnosed with mental health condition. The methodological quality of most trials was moderate or good. Only few mild adverse events were reported.

Conclusion

R. rosea may have beneficial effects on physical performance, mental performance, and certain mental health conditions. There is, however, a lack of independent replications of the single different studies. Five of the 10 RCTs reached more than three points on the Jadad score (i.e., good quality). More research seems warranted.  相似文献   

8.
9.
doi:10.1111/j.1741‐2358.2009.00299.x
A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review Background: It has been stated that mandibular overdentures are more satisfactory than conventional dentures, but problems relating to the use of retrospective ratings, lack of control group and sequential provision of treatment may compromise the findings. Objective: To establish a comparison between treatment with conventional complete dentures and implant‐retained overdentures in elderly patients by conducting a literature review. Materials and methods: A search of English language peer‐review literature was completed using Medline up to 2008 focusing on evidence‐based research. Randomised clinical trials (RCTs) and longitudinal prospective studies were favoured in the review, using a general hierarchical classification. Articles that did not focus exclusively on the comparison of patient satisfaction between complete dentures and overdentures were excluded from further evaluation. The last search was conducted in February 2008. Key terms included quality of life, patient satisfaction, edentulism, complete denture and overdenture. Results: Among the 90 articles found in the initial search, 27 met the inclusion criteria. This included 18 RCTs and eight prospective and one cohort study. Most of the articles stated superiority of the mandibular implant‐retained overdenture therapy over the conventional complete denture regarding patient satisfaction and quality of life. Conclusion: Even with implant treatment presenting higher patient satisfaction and improvement of quality of life, it was not possible to establish a direct comparison between the studies due to differences in adopted methodologies.  相似文献   

10.
Peripheral nerve injury (PNI) is a serious public health problem that is linked with motor, sensory and autonomic deficits. Given the fact that this type of disorder leads to a decreased quality of life in most patients and adherence of available drugs is limited and have adverse effects, we investigated the efficacy of natural products in a PNI model. The search terms plants, medicinal, nerve regeneration, nerve crush, sciatic nerve as well as MeSH terms or free-text words were used to retrieve English language articles in PubMed, Scopus, Web of Science and LILACS published until July 2015. After sciatic nerve crush, natural products have improved significantly motor performance, sensory function and electrical conductance measured over weeks. Among the pharmacological targets suggested by the action of natural products, there were citations on the activation of the antiapoptotic signaling pathway, modulation in the expression of pro-inflammatory cytokines and neurotrophic factors. The systematic review provides scientific evidence that natural products are pharmacologically effective in the treatment of PNI such as sciatic nerve crush.  相似文献   

11.
The purpose of this systematic review was to evaluate the efficacy and safety of plyometric training for improving motor performance in young children; to determine if this type of training could be used to improve the strength, running speed, agility, and jumping ability of children with low motor competence; and to examine the extent and quality of the current research literature. Primary research articles were selected if they (a) described the outcomes of a plyometric exercise intervention; (b) included measures of strength, balance, running speed, jumping ability, or agility; (c) included prepubertal children 5-14 years of age; and (d) used a randomized control trial or quasiexperimental design. Seven articles met the inclusion criteria for the final review. The 7 studies were judged to be of low quality (values of 4-6). Plyometric training had a large effect on improving the ability to run and jump. Preliminary evidence suggests plyometric training also had a large effect on increasing kicking distance, balance, and agility. The current evidence suggests that a twice a week program for 8-10 weeks beginning at 50-60 jumps a session and increasing exercise load weekly results in the largest changes in running and jumping performance. An alternative program for children who do not have the capability or tolerance for a twice a week program would be a low-intensity program for a longer duration. The research suggests that plyometric training is safe for children when parents provide consent, children agree to participate, and safety guidelines are built into the intervention.  相似文献   

12.

Background

Chronic heart failure (CHF) is a global public health problem. Therefore, novel and effective drugs that show few side-effects are needed. Early literature studies indicated that Huangqi injection is one of the most commonly used traditional Chinese patent medicines for CHF in China. As a large number of clinical studies has been carried out and published, it is essential to evaluate the effectiveness and safety of Huangqi injection. Therefore, we carried out this systematic review under the support of the framework of the Joint Sino-Italian Laboratory (JoSIL).

Objectives

To evaluate the efficacy and safety of Huangqi injection for CHF according to the available scientific knowledge.

Methods

An extensive search including PubMed, EMBASE, CBM, the Cochrane Library and Chinese literature databases was performed up to July 2008. Clinical trials regarding Huangqi injection for the treatment of CHF were searched for, irrespective of languages. The quality of each trial was assessed according to the Cochrane Reviewers'' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration and STATA 9.2 were used for data analysis.

Results

After selection of 1,205 articles, 62 RCTs and quasi-RCTs conducted in China and published in Chinese journals were included in the review. The methodological quality of the trials was low. In most trials inclusion and exclusion criteria were not specified. Furthermore, only one study evaluated the outcomes for drug efficacy after an adequate period of time. For these reasons and because of the different baseline characteristics we did not conduct a meta-analysis.

Conclusions

Although available studies are not adequate to draw a conclusion on the efficacy and safety of Huangqi injection (a traditional Chinese patent medicine), we hope that our work could provide useful experience on further studies on Huangqi injections. The overall level of TCM clinical research needs to be improved so that the efficacy of TCM can be evaluated by the international community and possibly some TCM can enter into the international market.  相似文献   

13.
The scientific and medical community remains skeptical regarding the efficacy of nutrition for osteoarthritis despite their broad acceptation by patients. In this context, this paper systematically reviews human clinical trials evaluating the effects of nutritional compounds on osteoarthritis. We searched the Medline, Embase, and Biosis databases from their inception to September 2005 using the terms random, double-blind method, trial, study, placebo, and osteoarthritis. We selected all peer-reviewed articles reporting the results of randomised human clinical trials (RCTs) in osteoarthritis that investigated the effects of oral interventions based on natural molecules. Studies on glucosamine and chondroitin sulfate were excluded. The quality of the RCTs was assessed with an osteoarthritic-specific standardised set of 12 criteria and a validated instrument. A best-evidence synthesis was used to categorise the scientific evidence behind each nutritional compound as good, moderate, or limited. A summary of the most relevant in vitro and animal studies is used to shed light on the potential mechanisms of action. Inclusion criteria were met by 53 RCTs out of the 2,026 identified studies. Good evidence was found for avocado soybean unsaponifiables. Moderate evidence was found for methylsulfonylmethane and SKI306X, a cocktail of plant extracts. Limited evidence was found for the Chinese plant extract Duhuo Jisheng Wan, cetyl myristoleate, lipids from green-lipped mussels, and plant extracts from Harpagophytum procumbens. Overall, scientific evidence exists for some specific nutritional interventions to provide symptom relief to osteoarthritic patients. It remains to be investigated whether nutritional compounds can have structure-modifying effects.  相似文献   

14.
Objective To evaluate the effectiveness of multivitamins and mineral supplements in reducing infections in an elderly population.Design Systematic review and meta-analysis of randomised controlled trials.Data sources Medline and other databases. Reference lists of identified articles were inspected for further relevant articles.Selection of studies Trials were included if they evaluated the effect of multivitamins and mineral supplements on infections in an elderly population.Review methods Studies were assessed for the methodological quality by using the Jadad instrument. If the data required for the analyses were not available from the published articles we requested them from the original study authors. Meta-analysis was undertaken on three outcomes: the mean difference in number of days spent with infection, the odds ratio of at least one infection in the study period, and the incidence rate ratio for the difference in infection rates. Data on adverse events were also extracted.Results Eight trials met our inclusion criteria. Owing to inconsistency in the outcomes reported, only a proportion of the trials could be included in each meta-analysis. Multivitamins and mineral supplements were found to reduce the mean annual number of days spent with infection (three studies) by 17.5 (95% confidence interval 11 to 24, P < 0.001). The odds ratio for at least one infection in the study period (three studies) was 1.10 (0.81 to 1.50, P = 0.53). The infection rate ratio (four studies) was 0.89 (0.78 to 1.03, P = 0.11). Reporting of adverse events was poor.Conclusion The evidence for routine use of multivitamin and mineral supplements to reduce infections in elderly people is weak and conflicting. Study results are heterogeneous, and this is partially confounded by outcome measure.  相似文献   

15.
鞘内注射两性霉素 B 治疗隐球菌脑膜炎的 META 分析   总被引:2,自引:0,他引:2  
目的 评价鞘内注射两性霉素B用于隐球菌脑膜炎患者治疗的有效性和安全性.方法 采用循证医学系统评价方法,检索Cochran图书馆注册临床对照试验数据库2012年第1期,PubMed、Ovid、Springer、外文生物医学期刊全文数据库,中国生物医学文献数据库、中文生物医学期刊文献数据库、中国知网、万方数据库、维普中文期刊数据库、中华医学会数字期刊数据库.文献检索时间从建库至2012年2月,纳入探讨鞘内注射两性霉素B治疗隐球菌脑膜炎的临床对照试验,并逐个进行质量评价和资料提取,运用RevMan 5.1.6软件进行统计分析.结果 共检出89篇文献,最终纳入6篇,涉及临床对照试验6项,纳入患者175例.Meta分析提示:鞘内注射给药组较对照组有效率高[OR =4.59,95%CI (2.19,9.64),P<0.0001].可使脑膜刺激征持续时间平均缩短8.56 d(95%CI-11.74~-5.38,P<0.000 01),但相应不良反应较多.结论 鞘内注射两性霉素B治疗隐球菌脑膜炎可以提高疗效,但较多的不良反应限制了其广泛应用,能否作为首选治疗手段有待于更大样本的高质量临床对照研究证实.  相似文献   

16.
Background: The combination of Cisplatin plus Etoposide (EP) is currently the standard treatment for small cell lung cancer (SCLC). However, a large number of alternative treatments (monotherapies and combinations) have been studied in randomized controlled trials (RCTs) to identify more effective treatments. Aim of the present study was to assess the relative effectiveness and tolerability of these treatments. Methods: PubMed, EMBASE and Cochrane Central Register of Controlled Trials were systematically searched to identify all RCTs that compared treatments for SCLC. Then, effectiveness of the treatments relative to the combination of Cisplatin plus Etoposide, reference treatment) was estimated by performing a network of treatments analysis. The analysis evaluated two efficacy outcomes (complete response – CR and objective response rate – ORR) and two tolerability outcomes (neutropenia and febrile neutropenia). All RCTs that provided data for calculating the odds ratios (OR) for the selected outcomes were considered. The network analysis involved direct and indirect analyses. Results: We identified 71 articles eligible for inclusion, involving 91 different treatments. In total, 16,026 patients were included in the analysis. In the direct analysis the combination of Cisplatin plus Cyclophosphamide plus Etoposide plus Epirubicin showed better response than EP for the ORR outcome, but with worse tolerability (presence of neutropenia). The indirect analysis revealed that the combination of Cisplatin plus Doxorubicin plus Etoposide (plus Vincrisitine) showed better response that EP for the ORR outcome. Conclusions: No therapy shows better response for the two efficacy outcomes (CR and ORR); though, Cisplatin plus Doxorubicin plus Etoposide plus Vincrisitine might be a promising therapy for SCLC. The results should be interpreted with caution because the network was dominated by indirect comparisons. Large scale head-to-head RCTs are needed to confirm the present findings.  相似文献   

17.
Dietary n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) reduce adipogenesis and lipogenesis in adult rodents, but it is not clear whether an increased n-3 LCPUFA supply during the perinatal period influences body fat mass in the offspring. This systematic review aimed to evaluate the existing evidence from animal studies, which have addressed this question. Medline was searched for relevant articles. Studies were included if they involved maternal n-3 PUFA or LCPUFA supplementation and measured fat mass in the offspring. The design and quality of each study was assessed. Only four animal studies met our inclusion criteria. Three studies reported a lower fat mass in offspring of n-3 LCPUFA supplemented dams, however only one of these studies confined the intervention to the perinatal period. The dose of n-3 PUFA, the nature of the control treatment, the approaches used and outcomes assessed differed between studies. This review highlights the paucity of robust animal data as to the effect of increased n-3 LCPUFA exposure during the perinatal period alone, on body fat mass in the offspring and calls for further studies.  相似文献   

18.

Objective

The goal of this study was to determine how the choice of the primary endpoint influenced sample size estimates in randomised controlled trials (RCTs) of treatments for primary Sjögren’s syndrome (pSS).

Methods

We reviewed all studies evaluating biotechnological therapies in pSS to identify their inclusion criteria and primary endpoints. Then, in a large cohort (ASSESS), we determined the proportion of patients who would be included in RCTs using various inclusion criteria sets. Finally, we used the population of a large randomised therapeutic trial in pSS (TEARS) to assess the impact of various primary objectives and endpoints on estimated sample sizes. These analyses were performed only for the endpoints indicating greater efficacy of rituximab compared to the placebo.

Results

We identified 18 studies. The most common inclusion criteria were short disease duration; systemic involvement; high mean visual analogue scale (VAS) scores for dryness, pain, and fatigue; and biological evidence of activity. In the ASSESS cohort, 35 percent of patients had recent-onset disease (lower than 4 years), 68 percent systemic manifestations, 68 percent high scores on two of three VASs, and 52 percent biological evidence of activity. The primary endpoints associated with the smallest sample sizes (nlower than 200) were a VAS dryness score improvement higher to 20 mm by week 24 or variable improvements (10, 20, or 30 mm) in fatigue VAS by week 6 or 16. For patients with systemic manifestations, the ESSDAI change may be the most logical endpoint, as it reflects all domains of disease activity. However, the ESSDAI did not improve significantly with rituximab therapy in the TEARS study. Ultrasound score improvement produced the smallest sample size estimate in the TEARS study.

Conclusion

This study provides valuable information for designing future RCTs on the basis of previously published studies. Previous RCTs used inclusion criteria that selected a small part of the entire pSS population. The endpoint was usually based on VASs assessing patient complaints. In contrast to VAS dryness cut-offs, VAS fatigue cut-offs did not affect estimated sample sizes. SGUS improvement produced the smallest estimated sample size. Further studies are required to validate standardised SGUS modalities and assessment criteria. Thus, researchers should strive to develop a composite primary endpoint and to determine its best cut-off and assessment time point.  相似文献   

19.
The purpose of this review was to build upon a recent review by Weigelt et al. which examined visual search strategies and face identification between individuals with autism spectrum disorders (ASD) and typically developing peers. Seven databases, CINAHL Plus, EMBASE, ERIC, Medline, Proquest, PsychInfo and PubMed were used to locate published scientific studies matching our inclusion criteria. A total of 28 articles not included in Weigelt et al. met criteria for inclusion into this systematic review. Of these 28 studies, 16 were available and met criteria at the time of the previous review, but were mistakenly excluded; and twelve were recently published. Weigelt et al. found quantitative, but not qualitative, differences in face identification in individuals with ASD. In contrast, the current systematic review found both qualitative and quantitative differences in face identification between individuals with and without ASD. There is a large inconsistency in findings across the eye tracking and neurobiological studies reviewed. Recommendations for future research in face recognition in ASD were discussed.  相似文献   

20.

Background

Rapid muscle fatigue during functional electrical stimulation (FES)-evoked muscle contractions in individuals with spinal cord injury (SCI) is a significant limitation to attaining health benefits of FES-exercise. Delaying the onset of muscle fatigue is often cited as an important goal linked to FES clinical efficacy. Although the basic concept of fatigue-resistance has a long history, recent advances in biomedical engineering, physiotherapy and clinical exercise science have achieved improved clinical benefits, especially for reducing muscle fatigue during FES-exercise. This review evaluated the methodological quality of strategies underlying muscle fatigue-resistance that have been used to optimize FES therapeutic approaches. The review also sought to synthesize the effectiveness of these strategies for persons with SCI in order to establish their functional impacts and clinical relevance.

Methods

Published scientific literature pertaining to the reduction of FES-induced muscle fatigue was identified through searches of the following databases: Science Direct, Medline, IEEE Xplore, SpringerLink, PubMed and Nature, from the earliest returned record until June 2015. Titles and abstracts were screened to obtain 35 studies that met the inclusion criteria for this systematic review.

Results

Following the evaluation of methodological quality (mean (SD), 50 (6) %) of the reviewed studies using the Downs and Black scale, the largest treatment effects reported to reduce muscle fatigue mainly investigated isometric contractions of limited functional and clinical relevance (n = 28). Some investigations (n = 13) lacked randomisation, while others were characterised by small sample sizes with low statistical power. Nevertheless, the clinical significance of emerging trends to improve fatigue-resistance during FES included (i) optimizing electrode positioning, (ii) fine-tuning of stimulation patterns and other FES parameters, (iii) adjustments to the mode and frequency of exercise training, and (iv) biofeedback-assisted FES-exercise to promote selective recruitment of fatigue-resistant motor units.

Conclusion

Although the need for further in-depth clinical trials (especially RCTs) was clearly warranted to establish external validity of outcomes, current evidence was sufficient to support the validity of certain techniques for rapid fatigue-reduction in order to promote FES therapy as an integral part of SCI rehabilitation. It is anticipated that this information will be valuable to clinicians and other allied health professionals administering FES as a treatment option in rehabilitation and aid the development of effective rehabilitation interventions.  相似文献   

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