Clinical trials and clinical practice: do doctors use the same criteria to judge outcome?

Aims The results of clinical trials often seem to have little influence on the practice of individual doctors. This could be because trial information is presented in the style of a scientific experiment which cannot often be clearly related to the context of everyday patient care. We tested the hypothesis that such framing effects would cause doctors to assess the clinical significance of treatment outcomes differently when presented as clinical trial results rather than as individual patient data.
Methods Fourteen rheumatologists independently reviewed the same 50 sets of data obtained from patients with rheumatoid arthritis. The data consisted of 10 commonly used clinical and laboratory variables measured before and after a period of treatment. The same data were presented in two formats on two separate occasions. The patient data format was a collection of typed sheets attributing each set of results to an individual patient. The clinical trial format was a professionally printed and bound booklet in which each set of results was laid out as summary results of a small uncontrolled clinical trial. Doctors judged the degree of improvement or deterioration and its clinical importance for each data set for both formats. These changes were converted into units of 'Clinical Importance'.
Results Although some statistically significant differences emerged in the individual doctors' judgements between the formats none of these was of a clinically important size. The median of the mean trial—patient difference between the formats for all 14 doctors was 0.035 units of clinical importance [ 95% CI −0.244 to 0.074].
Conclusions This evidence does not support the hypothesis that framing effects are a major cause of the failure of clinical trials to influence clinical practice.     

CT引导下腹腔神经丛阻滞术治疗上腹部癌痛的临床应用研究

目的研究腹腔神经丛阻滞术治疗腹部顽固性癌痛的方法及疗效。方法30例各类上腹部恶性肿瘤患者，均有顽固性上腹疼痛，在CT引导下进行膈脚前及腹膜后肿大淋巴结内乙醇阻滞治疗。结果手术成功率100％，CT显示乙醇在腹主动脉周围及淋巴结内弥散良好，术后即刻至2周，总有效率达100％，随访至半年总有效率71．4％。结论CT引导下腹腔神经丛阻滞术，定位准确，疼痛缓解率高，并发症少，值得临床推广应用。     

新生儿窒息新诊断标准在临床实践中的认识和体会

本文重点叙述应用中国医师协会新生儿分会近年颁布的《新生儿诊断和和分度标准建议》在临床实践中的认识和体会,本院近两年出生的2408例活产婴中,低Apgar评分儿共112例,仅17例确诊窒息,95例经脐动脉血气和相关检查证实为其他情况和疾病。大幅度减少了窒息的误诊。并列举了3例典型病例。文末作了简要讨论。     

Sutures in abdominal surgery: biomechanical study and clinical application

The aim of this study is to improve treatment results and SSI prevention by differential usage of the contemporary suture materials and choice of proper suturing technique. To simulate suturing process and compared two suturing techniques, two FE models were developed. Finite-element analysis (FEA) was based on experimental data of contemporary commercial sutures and soft tissue properties. We applied obtained results for abdominal wall closure in rats and compared non-absorbable suture (capron) with absorbable suture (PDS Plus) for chosen technique. Cross-sections were examined by lighting electron microscope. Afterwards, the results of patients’ treatment are also presented. It was shown that running sew was more appropriate for aponeurosis suturing compared to interrupted sew. The optimal parameters of suturing techniques were computed. Single-row running sew by PDS Plus was proved to hold wound edges for 90 days with less inflammatory response compared to other suture in the result of histological analysis. Application of contemporary synthetic absorbable suture materials with antibacterial coating for laparotomic wounds closure and anastomosis decreases local inflammatory reaction and provides the successful tissue regeneration. Application of advanced SSI prophylactics algorithm was shown to decrease risk of post-operative suppurative complications from 14.2 to 1.6 %.     

全球领导人共识营养不良诊断标准在临床实践中的实施方法与应用

营养不良是全球性的问题。随着疾病谱的改变,人们关注到除摄入不足、吸收障碍外,疾病相关的营养不良的重要性。2018年达成的全球领导人共识营养不良诊断标准(GLIM),旨在对成年病人进行营养不良评定及严重程度分级,及早营养支持治疗可以降低30 d全因死亡率、入重症监护室概率及再住院率以及远期并发症。鉴于各系统疾病的差异,在实施GLIM标准第一步时营养风险筛查并无统一筛查工具,各筛查工具及评估方法的适用性不同,且在GLIM标准下不同组合的临床效用也不同。该综述旨在探讨GLIM标准下各筛查工具及评定方法在诊断营养不良的适用情况以及GLIM标准在临床实践中的有效性,为临床诊断营养不良提供便捷。     

Clinical trial: evaluation of a clinical decision-support model for upper abdominal complaints in primary-care practice

Background: Gastro-oesophageal reflux disease (GERD) and dyspepsia affect 25-40% of the general population. In the absence of alarm symptoms, the current recommended policy in young dyspeptic patients is a 'test and treat' strategy for Helicobacter pylori; in GERD patients, a therapeutic trial with proton pump inhibitors is the treatment of choice. AIM: To create a short and simple clinical algorithm, for the diagnosis and treatment of patients with upper gastrointestinal complaints. METHODS: The clinical usefulness and cost-effectiveness of the new algorithm were evaluated in a controlled clinical trial, held in primary-care clinics in Israel. Clinical and economical treatment outcomes were evaluated after 1, 3 and 6 months comparing doctors who used the algorithm (cases) vs. those who did not (controls). RESULTS: 78 cases and 54 controls completed the 6 months of follow up. The improvement in symptom severity and quality of life was greater in the cases than in the controls (P < 0.05). General practitioner clinics visits (P = 0.04), gastroenterology clinics visits (P = 0.02) and medication costs (P = 0.004) were all significantly reduced among cases. Controls underwent also more imaging tests (computerized tomography, ultrasound and X-ray) and endoscopies. The average cost for 6 months' treatment and follow-up was $US 199 for cases compared with an average of $US 336 in the control group. CONCLUSION: The use of a clinical decision-support tool can facilitate and promote the implementation of management guidelines by general practitioners. The short algorithm presented in the study was found to be useful and easy to apply in clinical practice. Its effectiveness can be further increased by implementing it in computerized medical systems.     

脑梗死中药临床试验的纳入标准与疗效评估中的若干思考

根据脑梗死的病理和临床分型,作者提出脑梗死中药临床试验的纳入标准和疗效评价方法应当与中药的治疗定位相适应。起病时间、梗死类型和病情程度应当在纳入时作分层处理,并在统计时注意分析上述因素与疗效的关系。疗效指标的选择和测量时间依据脑梗死类型不同而异,腔隙性脑梗死的中药疗效评价应当有专门的试验设计,以增强疗效评价的客观性。建议制定临床试验设计指南,进一步规范脑梗死的中药临床试验。     

Relationship between background cancer pain,breakthrough pain,and analgesic treatment: a preliminary study for a better interpretation of epidemiological and clinical studies

Abstract

Background:

The different operational definitions of breakthrough cancer pain (BTcP) has generated unclear epidemiological data.     

Relevance of exclusion criteria in antidepressant clinical trials: a replication study

INTRODUCTION: Patients in clinical randomized controlled trials (RCTs) of antidepressants are different from those typically treated in clinical practice, which may affect the generalizability of data from RCTs. We attempted to replicate the work of Zimmerman and colleagues (Zimmerman M, Mattia JI, Posternak MA. Are subjects in phamacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry. 2002;159:469-473), demonstrating that most patients seeking clinical treatment of depression would not qualify for an RCT based on common exclusion criteria. METHODS: Eight hundred seventeen patients presenting to an outpatient private practice were evaluated by retrospective chart review. The 11 exclusion criteria outlined in the previous study were applied to a sample of 348 depressed adults to determine the percentage that would have qualified for an RCT. RESULTS: We have closely replicated the study of Zimmerman et al, finding that 91% of our sample would not qualify for an RCT based on presence of any of the 11 exclusion criteria. Prevalence of 7 criteria applied were found significantly different in our population when compared with the study of Zimmerman et al, yet exclusion rates came within 0.2%. When only the 5 most common criteria were applied, exclusion rates remained high. CONCLUSIONS: Some exclusion criteria are essential for ethical or diagnostic purposes or to reduce heterogeneity; others are somewhat arbitrary, widening the gap between research and clinical practice. Ninety-one percent of patients presenting for treatment of depression would not qualify for RCTs if the 11 exclusion criteria identified were applied; if a standard severity cutoff score and 4 criteria considered relevant to safety or diagnostic validity were used, nearly 75% would not qualify. Use of antidepressants in a typical clinical population is an extrapolation from research data.     

Available evidence and outcome of off-label use of rituximab in clinical practice

Purpose

To analyze the therapeutic indications for off-label use of rituximab, the available evidence for its use, the outcomes, and the cost.

Methods

This was a retrospective analysis of patients treated with rituximab for off-label indications from January 2007 to December 2009 in two tertiary hospitals. Information on patient characteristics, medical conditions, and therapeutic responses was collected from medical records. Available evidence for the efficacy of rituximab in each condition was reviewed, and the cost of treatment was calculated.

Results

A total of 101 cases of off-label rituximab use were analyzed. The median age of the patients involved was 53 [interquartile range (IQR) 37.5–68.0] years; 55.4 % were women. The indications for prescribing rituximab were primarily hematological diseases (46 %), systemic connective tissue disorders (27 %), and kidney diseases (20 %). Available evidence supporting rituximab treatment for these indications mainly came from individual cohort studies (53.5 % of cases) and case series (25.7 %). The short-term outcome (median 3 months, IQR 2–4 months) was a complete response in 38 % of cases and partial response in 32.6 %. The highest short-term responses were observed for systemic lupus erythematosus and membranous glomerulonephritis, and the lowest was for neuromyelitis optica, idiopathic thrombocytopenic purpura, and miscellaneous indications. Some response was maintained in long-term follow-up (median 23 months IQR 12–30 months) in 69.2 % of patients showing a short-term response. Median cost per patient was € 5,187.5 (IQR € 5,187.5–7,781.3).

Conclusions

In our study, off-label rituximab was mainly used for the treatment of hematological, kidney, and systemic connective tissue disorders, and the response among our patient cohort was variable depending on the specific disease. The level of evidence supporting the use of rituximab for these indications was low and the cost was very high. We conclude that more clinical trials on the off-label use of rituximab are needed, although these may be difficult to conduct in some rare diseases. Data from observational studies may provide useful information to assist prescribing in clinical practice.