Unintended consequences of policy change to watchful waiting for asymptomatic inguinal hernias

Introduction

In 2009 the Department of Health instructed McKinsey & Company to provide advice on how commissioners might achieve world class National Health Service productivity. Asymptomatic inguinal hernia repair was identified as a potentially cosmetic procedure, with limited clinical benefit. The Birmingham and Solihull primary care trust cluster introduced a policy of watchful waiting for asymptomatic inguinal hernia, which was implemented across the health economy in December 2010. This retrospective cohort study aimed to examine the effect of a change in clinical commissioning policy concerning elective surgical repair of asymptomatic inguinal hernias.

Methods

A total of 1,032 patients undergoing inguinal hernia repair in the 16 months after the policy change were compared with 978 patients in the 16 months before. The main outcome measure was relative proportion of emergency repair in groups before and after the policy change. Multivariate binary logistic regression was used to adjust the main outcome for age, sex and hernia type.

Results

The period after the policy change was associated with 59% higher odds of emergency repair (3.6% vs 5.5%, adjusted odds ratio [OR]: 1.59, 95% confidence interval [CI]: 1.03–2.47). In turn, emergency repair was associated with higher odds of adverse events (4.7% vs 18.5%, adjusted OR: 3.68, 95% CI: 2.04–6.63) and mortality (0.1% vs 5.4%, p<0.001, Fisher’s exact test).

Conclusions

Introduction of a watchful waiting policy for asymptomatic inguinal hernias was associated with a significant increase in need for emergency repair, which was in turn associated with an increased risk of adverse events. Current policies may be placing patients at risk.     

Longitudinal quality of life data: a comparison of continuous and ordinal approaches

Purpose

In cancer clinical trials, health-related quality of life (HRQoL) is a major outcome measure. It is generally assessed at specified time intervals by filling out a questionnaire with ordered response categories. Despite recent advances in the statistical methodology for handling ordinal longitudinal outcome data, most users keep treating HRQoL scales as continuous rather than ordinal variables regardless of the number of categories. The purpose of this study was to compare the results of analyzing HRQoL longitudinal data under both approaches, continuous and ordinal.

Methods

The EORTC QLQ-C30 scores of two EORTC randomized brain cancer clinical trials (26951 and 26981) were analyzed using the two approaches. In the 26951 trial, a total of 368 patients were randomly assigned to receive either radiotherapy (RT) or the same RT plus procarbazine, CCNU, and vincristine. In the 26981 trial, 573 patients were randomly allocated to RT or RT plus temozolomide. Comparison of the two treatment arms was done using methods for longitudinal quantitative and longitudinal ordinal data. Both statistical methods were adapted to account for missing data and compared in terms of statistical significance of the results (p values) but also with respect to data interpretation.

Results

Three scales, i.e., appetite loss, insomnia, and drowsiness, presenting four response categories ("Not at all", "A little", "Quite a bite", and "Very much") were analyzed in each trial. Both statistical methods (continuous and ordinal) showed statistically significant differences between the two treatments, not only globally but also at the same assessment time points. The magnitude of the p values, however, varied at some time points and was less pronounced in the ordinal approach.

Conclusions

The analysis of the two clinical trials showed that treating the HRQoL scales by a quantitative or an ordinal method did not make much difference as far as statistical significance was concerned. The interpretation of results, however, was easier under the ordinal approach. Treatment effects may be more meaningful when expressed in terms of odds ratios than as mean values, particularly when the number categories is small.     

急性心肌梗死后CD34+干细胞自体动员的意义

目的:已有理论提出急性心肌梗死后骨髓和外周血中的CD34 干细胞具有自身动员的潜能,观察这一潜能的变化特征及其对心肌梗死组织再生能力的影响。方法:实验于2004-09/2005-02在阜外心血管病医院完成。①实验动物:雄性SD大鼠40只,随机数字表法分为心肌梗死组、假手术组,20只/组。②实验方法:心肌梗死组大鼠采用冠状动脉结扎法建立心肌梗死模型。心电图ST段抬高或有室性心律出现,前壁心肌呈苍白色为造模成功。假手术组仅作开胸手术,前降支不予结扎。③实验评估:于心肌梗死后3,7,14,28d,流式细胞仪检测骨髓和外周血中CD34 干细胞的含量。用免疫组化方法检测梗死心肌组织中的Ki67细胞和毛细血管数量。结果:①外周血及骨髓CD34 干细胞含量的变化:心肌梗死组外周血中的CD34 干细胞数量于造模后3d开始上升,7d后明显高于假手术组(P<0.01),至14,28d时逐渐回落至假手术组水平(P>0.05)。心肌梗死组骨髓中的CD34 干细胞数量于造模后各时间点始终无明显变化(P>0.05)。②组织学评定:心肌梗死组梗死区Ki67细胞和毛细血管数量于造模后3d开始增多,7d时明显多于非梗死区(P<0.05);至14,28d梗死区Ki67细胞数量明显少于造模后7d(P<0.05),毛细血管数量的减少不明显(P>0.05)。免疫组化染色显示少数Ki67细胞分化为血管内皮细胞,未见向心肌细胞分化。③相关性分析:梗死区Ki67细胞、毛细血管数量于造模后7d与外周血中CD34 干细胞数量呈显著正相关(r=0.913,P=0.021;r=0.887,P=0.035)。结论:机体CD34 干细胞的自体动员、增殖反应的潜能随急性心肌梗死时间的延长而逐渐减弱,自体动员的干细胞功能尚不足以达到修复梗死心肌组织的效果。     

Evaluation of atypical human immunodeficiency virus immunoblot reactivity in blood donors

Blood donors reactive by enzyme-linked immunosorbent assay for antibody to the human immunodeficiency virus (HIV) who showed atypical patterns of viral core protein reactivity on Western blot were monitored for several months. Characterization of their antibodies was performed by 1) use of recombinant HIV proteins; 2) determination of cross-reactivity to HTLV-I, HTLV-II, and HTLV-IV: 3) assessment of immune status; and 4) identification of potentially interfering autoantibodies. Nineteen of 20 donors maintained the same HIV antibody reactivity throughout the follow-up period; the other donor became fully antibody-positive. Eighteen of 20 donors' sera showed clear reactivity with HIV recombinant core proteins. Ten of 19 donor samples demonstrated cross-reactivity to HTLV-IV; 3 of these 10 also cross-reacted with HTLV-I. The immune status of all donors was normal, although the medical histories and HLA antibody screens suggested possible autoimmune reactivity in 9 of 18 donors. During follow-up interviews, three donors reported possible risk factors for HIV infection that had not been acknowledged at the time of blood donation. We conclude that exclusion of donors with these atypical serologic test results is warranted while further studies to determine significance are being conducted.     

The administration of folic acid to institutionalized epileptic adults with phenytoin-induced gingival hyperplasia. A double-blind, randomized, placebo-controlled, parallel study.

Twenty severely retarded institutionalized epileptic adults with phenytoin-induced gingival hyperplasia were divided into two groups and received a daily 3 mg capsule of either folic acid or lactose for 16 weeks in a randomized, double-blind, parallel study. Serum folate and phenytoin levels were recorded at baseline and on completion of the study. Twelve areas of the gingiva on each patient were graded at 4-week intervals for 16 weeks with respect to the three indexes: hyperplasia, gingival health, and plaque index. There were no significant differences between treatment groups for any of the three indexes over time. The poststudy serum folate levels were three times baseline levels for the active drug group (p less than 0.001) but unchanged in the placebo group. Phenytoin blood levels that began within the therapeutic window (10 to 20 micrograms/ml) tended to remain within the therapeutic window for both groups, with no reported seizure activity. A single daily oral 3 mg capsule of folic acid did not show efficacy as the sole therapeutic agent in the reduction of phenytoin-induced gingival hyperplasia.     

耐一线药物及注射药物对耐多药结核病治疗效果的影响

背景和目的:最近的研究结果表明,对其他一线药物和注射类药物(如卡那霉素、卷曲霉素)等耐药是影响耐多药结核病(MDR-TB)患者治疗效果的独立危险因素.本研究旨在明确耐其他一线药物和注射类药物对韩国不合并人免疫缺陷病毒(HIV)感染的MDR-TB患者临床疗效的影响.方法:采用回顾性队列研究分析1996年1月至2005年12月首尔国家大学附属医院治疗的211例MDR-TB患者治疗效果,排除7例丢失和7例迁出,对197例患者进行了最终分析.