Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

AIM: To evaluate published trials examining oral post-operative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results.METHODS: Database searches (MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: “oral’’ or “enteral’’ and “postoperative care’’ or “post-surgical’’ and “proteins’’ or “milk proteins’’ or “dietary proteins’’ or “dietary supplements’’ or “nutritional supplements’’. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted.RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements (discrete from other nutritional components) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage.CONCLUSION: The optimal level of protein supplementation required to maximise recovery in gastrointestinal surgery patients is effectively unknown, and may warrant further study.     

Characteristics and publication discrepancies of foot & ankle surgery-related clinical trials

BackgroundTrial registration can provide more reliable study designs, however, the final publications are not exempt from bias. This study aimed to show the characteristics of foot & ankle surgery-related clinical trials registered in ClinicalTrials.gov (CTG) and analyze possible risk factors that can lead to discrepancies between the original trial registry and published results.MethodsFoot & ankle surgery-related randomized controlled studies registered in CTG with an anticipated completion date until 2018 were extracted. 157 trials were found eligible for final analysis and corresponding publications were investigated through literature databases. Discrepancies between trial registries and published results were analyzed.Results67.5% of trials were registered whether during the trial period or after completion. 46.5% were funded by industry. 54.8% of trials were reported to be completed. The results of 66 (42%) trials were published in a journal. There was a sample size discrepancy in 57.6%, follow-up time discrepancy in 28.8%, primary outcome discrepancy in 45.5%, and inclusion/exclusion criteria discrepancy in 89.4% of registries. Sample size, inclusion/exclusion criteria discrepancies were significantly more in trials funded by industry (p = 0.024, 0.001, 0.037, respectively). Industry-funded studies reported positive results more frequently (p = 0.011).ConclusionOnly 42% of all registered foot & ankle surgery-related studies had the chance to be published. The majority of studies presented discrepancies in sample size, outcome assessment method, follow-up time, or inclusion/exclusion criteria. Industry-funded studies showed a higher rate of discrepancies and were more inclined towards reporting positive results indicating a risk of bias in assessments.Level of clinical evidenceLevel 3.     

Driving improved burns care and patient outcomes through clinical registry data: A review of quality indicators in the Burns Registry of Australia and New Zealand

BackgroundIn 2009, the Burns Registry of Australia and New Zealand (BRANZ) published a set of clinical quality indicators (QIs) to monitor performance, improve quality of care, and inform and change policy. With several years of data collected since the initial development of the indicators for burns, the BRANZ QI Working Party reviewed the clinical QIs for relevance and meaning, and considered new QIs that had not been collected previously.MethodUsing published literature and expert opinion, the QI Working Party, consisting of multidisciplinary burn clinicians, reviewed the QIs for burn care to be included as routine data items in the BRANZ.ResultsIn July 2016, the list of clinical QIs in the BRANZ was updated to 23 QIs/data items, covering structure, process, and outcome measures. Four QIs were removed as they were not found to be useful, nine QIs/data items were revised, and eight new QIs/data items were added as they were considered to be clinically useful.ConclusionThis review outlines the changes made to the QIs collected by the BRANZ four years since their development and implementation. Ongoing refinement of the BRANZ QIs will ensure that high quality data is collected to drive improvements in clinical and patient outcomes.     

Transition from congress abstract to full publication for clinical trials presented at laser meetings

The present study aims to identify (1) what proportion of abstracts of clinical trials presented at The American Society for Laser Medicine and Surgery (ASLMS) annual meetings are published as full reports, (2) time to publication, and (3) factors that may predict the publication of research in peer-reviewed journals. Two investigators independently hand-searched all abstracts of the ASLMS meetings to identify all reports of clinical trials. Details of sample size, the country of origin, topic of research, type of presentation, type of laser, direction of outcome, and statistical significance were recorded for each abstract. To determine the full publication status of each study, The Cochrane Central Register of Controlled Trials, PubMed, and EMBASE was searched. A total of 198 abstracts were identified. Of these, 87 abstracts (44%) have been fully published. The average time from presentation at the meeting to full publication was 57 months (95% confidence interval = 52-61), and the estimated rate of abstracts published at 1, 2, and 4 years was 15, 30, and 38%, respectively. There is significant tendency for being fully published in high-power laser studies, with USA as country of origin, and orally presented. Our findings supports this opinion that conference abstracts can be an important source for systematic reviews and failure to identify trials presented in congresses might threaten the validity of systematic reviews.     

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

ObjectivesPatient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer.MethodsA systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research.ResultsIn total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data.ConclusionsWe found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.     

谷氨酰胺增强型肠内营养对危重病患者临床结局的影响:随机对照试验的系统评价

目的 系统评价谷氨酰胺(Gln)增强型肠内营养治疗对危重病患者预后及治疗费用的影响.方法 检索8个生物医学数据库(<中国生物医学文献数据库>、、<科学引文索引数据库>等)1976年以后的文献资料.鉴定随机对照试验(RCT),纳人研究的标准包括:(1)采用随机对照的临床研究,设立平行对照;(2)危重病患者,急性生理与慢性健康评估评分Ⅱ大于10分或烧伤面积大于30%TBSA者;(3)以肠内营养中是否添加Gln作为研究组与对照组的惟一差别;(4)临床结局指标包括患者死亡、院内感染、器官功能衰竭发生情况、住院日及费用.研究方法学质量按照Cochrane系统评价员手册及Jadad评分量表进行评定.用Rev Man 5.0软件进行Meta分析.结果 224篇相关文献中,共7项RCT符合全部纳入标准.死亡情况:共5项研究报告了545例患者中的死亡例数,研究间无异质性(P=0.46),合并相对危险度(RR)为0.94,95%置信区间(CI)为0.68～1.30,P=0.70.Gln组死亡风险与对照组比较,差异无统计学意义(P>0.05).院内感染:共3项研究报告了489例患者中的院内感染发生情况.研究间无异质性(P=0.08),采用固定效应模型,合并RR=0.72,95%CI为0.52～0.99,P=0.04.与对照组比较,Gln组院内感染率下降了28%.器官功能衰竭:共3项研究报告了460例患者中发生器官功能衰竭或MODS的情况,研究间无异质性(P=0.65),采用固定效应模型,合并RR=1.27,95%CI为0.70～2.30,P=0.43.Gln组与对照组比较,差异无统计学意义(P>0.05).住院时间:4项研究报告了患者入住重症监护病房(ICU)的时间,其中3项研究以中位数(四分位间距)形式表示结果,2组患者比较差异无统计学意义(P>0.05);另1项研究给出了2组患者入住ICU时间的x±s,差异亦无统计学意义(P>0.05).此外,有3项关于重症烧伤患者的研究给出了住院时间,研究间无异质性(P=0.08),采用固定效应模型,合并均数差值为-7.24,95%CI为-13.28～-1.19,P=0.02.与对照组比较,Gln组住院时间约缩短7.24 d.结论 Gln增强型肠内营养用于危重病患者,可以降低院内感染的发生率,有可能缩短重症烧伤患者住院时间,但病死率及经济学指标尚需进行更多大样本研究进一步验证.     

Methodological quality of randomised controlled trials in burns care. A systematic review

Objective

To evaluate the methodological quality of published randomised controlled trials (RCTs) in burn care treatment and management.

Methods

Using a predetermined search strategy we searched Ovid MEDLINE (1950 to January 2008) database to identify all English RCTs related to burn care. Full text studies identified were reviewed for key demographic and methodological characteristics. Methodological trial quality was assessed using the Jadad scale.

Results

A total of 257 studies involving 14,535 patients met the inclusion criteria. The median Jadad score was 2 (out of a best possible score of 5). Information was given in the introduction and discussion sections of most RCTs, although insufficient detail was provided on randomisation, allocation concealment, and blinding. The number of RCTs increased between 1950 and 2008 (Spearman's rho = 0.6129, P < 0.001), although the reporting quality did not improve over the same time period (P = 0.1896) and was better in RCTs with larger sample sizes (median Jadad score, 4 vs. 2 points, P < 0.0001). Methodological quality did not correlate with journal impact factor (P = 0.2371).

Conclusions

The reporting standards of RCTs are highly variable and less than optimal in most cases. The advent of evidence-based medicine heralds a new approach to burns care and systematic steps are needed to improve the quality of RCTs in this field. Identifying and reviewing the existing number of RCTs not only highlights the need for burn clinicians to conduct more trials, but may also encourage burn health clinicians to consider the importance of conducting trials that follow appropriate, evidence-based standards.     

Burn camps for burns survivors—Realising the benefits for early adjustment: A systematic review

ObjectivesChild and adolescent burn survivors benefit from skills to cope with the physical and mental challenges associated with their injuries. Burn camps can offer an opportunity to build these skills. In this study, we systematically review the best available evidence on burn camps in order to better assess their impact on burn survivors.MethodA systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A total of 815 articles on recreational therapeutic camps for burn survivors were retrieved from PubMed, PsycINFO, CINAHL and Scopus restricted to the English language and published before or by May 2018. Critical Appraisal Skills Programme (CASP) for Qualitative Studies Checklist and the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for non-randomized experimental studies were used to assess the methodological rigour of the quantitative studies.ResultsQuantitative data did not support any long-lasting impacts on psychosocial wellbeing. Qualitative data showed children, parents and staff all perceived benefits from camp attendance, including companionship and belonging.ConclusionFurther research is required to understand the lack on congruence between qualitative and quantitative data. Qualitative data suggests burn camps are beneficial for children with burn injuries.     

从循证医学角度分析《中华烧伤杂志》2000-2004年发表的临床试验论文

目的了解我国烧伤专业临床试验研究的现状，进一步提高论文的学术水平。方法按照循证医学（EBM）的标准，对《中华烧伤杂志）2000--2004年刊登的临床试验论文进行回顾性检索及综合分析，以评价其质量。结果临床试验论文共计89篇，其中随机对照试验（RCT）43篇占48．3％，临床对照试验（CCT）46篇占51．7％，RCT论文呈逐年增多趋势，而CCT论文波动较大。采用盲法试验的论文5篇，占5．6％；有明确纳入、排除标准的论文53篇，占59．6％；64篇论文未提供分组的基线资料比较情况，占71．9％；10篇论文在统计分析时仅给出了P值，未说明采取何种统计学方法，占11．2％；仅有2篇论文提及随访、失访情况，占2．2％，但未详细报道结果；10篇论文对不良反应进行了报道，占11．2％；对混杂干扰因素进行分析说明的论文有5篇，占5．6％；无一篇论文对样本含量的估计以及随机化方法进行说明。结论我国烧伤领域部分论文在科研设计、伦理学思考方面尚存在不足，有待进一步改进和提高。     

Enrollment and reporting practices in pediatric general surgical randomized clinical trials: A systematic review and observational analysis

Background

Pediatric surgical randomized clinical trials (RCTs) are labor-intensive and costly. This systematic review investigated patient accrual and estimates of study duration in RCTs by interrogating enrollment and registration practices.

Site of catheter insertion in burn patients and infection: A systematic review

The aim of the study was to conduct a systematic review to identify and appraise the evidence on possible association of the site of venous catheter insertion in burn patients and an increased occurrence of catheter-related infection. Searches were performed in MEDLINE, LILACS, CINAHL, EMBASE, Web of Science and The Cochrane Library. Nine studies were selected for the review; four of them mentioned, directly or indirectly, an association between catheter-related infection and the insertion of the catheter either in the burn wound or in surrounding area, and five studies investigated the occurrence of infection related to both the catheter and the anatomical sites of catheter insertion. Higher infection rates occurred when the catheters were inserted directly in the burn wound or near the wound (level of evidence IV) or in the femoral vein (level of evidence IV). No significant differences in infection occurrence rates were observed between central catheters and peripherally inserted central catheter (level of evidence IV). Further investigations for techniques and types of coverage of venous catheter insertion dressings are important for preventing infection in burn patients. Also, new technologies for venous access must be evaluated.     

Fibroblast growth factor in the treatment of burns: A systematic review

IntroductionA burn is a trauma that breaks the skin barrier, causing local and systemic responses. Treatment is complex, multiprofessional and expensive. In addition to surgical treatment, topical dressings can be used to keep the wound moist, reduce the risk of infection and stimulate healing. Clinical studies show that topical use of fibroblast growth factors may accelerate healing. An assessment of the quality of the available evidence and its strength of recommendation is necessary.ObjectiveThis study aimed to evaluate the effectiveness and safety of topical use of fibroblast growth factor, compared to other topical treatments or placebo, in the healing of burns, to determine the strength of recommendation.MethodBased on a defined search strategy, randomized and quasi-randomized clinical trials, available in electronic databases, were gathered. These compare the topical use of FGF versus other topical or non-treatment. The primary outcome was healing and as adverse effects: pain, infection and mortality. The systematic review protocol was registered on the PROSPERO platform (CRD42018089556), developed in accordance with the “Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015” and within the “SWiM guideline 2019”. GRADEpro was used for the critical analysis of the methodology of the studies.ResultsFour clinical trials were found, in which FGF reduced the healing time and improved the appearance of the scar. Two trials were determined to be of low strength, while two others have a moderate recommendation strength.ConclusionThis review gathered available evidence, between low and moderate recommendation strength for the use of FGF as a topical dressing. Further rigorous trials are needed to improve the strength of recommendation for topical use of FGF for burns.     

Chemical burn to the skin: A systematic review of first aid impacts on clinical outcomes

Chemical burns can cause deep injury and subsequently significant scarring to the skin. The mechanism and pathophysiology of chemical burns is distinct to thermal burns, and recommended first aid approaches are consequently different. Twenty minutes of cool running water is an effective first aid measure to improve outcomes after thermal burn. For chemical burns to the skin, the recommendations are immediate water lavage for 60 min, removal of contaminated clothing if not stuck to the skin and then covering the wound with a sterile dressing. This review assesses the peer-reviewed literature to find the evidence behind the efficacy of cutaneous chemical burn first aid on short term outcomes such as length of hospital stay, depth of burn and longer-term outcomes such as scarring; in particular, the effect of immediate or early water lavage, and the effect of the duration of water lavage. Ocular chemical burns were not included in this review. The review suggests some evidence to support that the early application of cool water irrigation may reduce length of hospital stay and the extent of scarring. Community education should emphasize that water irrigation is recommended and that the earlier this happens, the better.