A clinical trial of estrogen-replacement therapy after ischemic stroke.

BACKGROUND: Observational studies have suggested that estrogen-replacement therapy may reduce a woman's risk of stroke and death. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of estrogen therapy (1 mg of estradiol-17beta per day) in 664 postmenopausal women (mean age, 71 years) who had recently had an ischemic stroke or transient ischemic attack. Women were recruited from 21 hospitals in the United States and were followed for the occurrence of stroke or death. RESULTS: During a mean follow-up period of 2.8 years, there were 99 strokes or deaths among the women in the estradiol group, and 93 among those in the placebo group (relative risk in the estradiol group, 1.1; 95 percent confidence interval, 0.8 to 1.4). Estrogen therapy did not reduce the risk of death alone (relative risk, 1.2; 95 percent confidence interval, 0.8 to 1.8) or the risk of nonfatal stroke (relative risk, 1.0; 95 percent confidence interval, 0.7 to 1.4). The women who were randomly assigned to receive estrogen therapy had a higher risk of fatal stroke (relative risk, 2.9; 95 percent confidence interval, 0.9 to 9.0), and their nonfatal strokes were associated with slightly worse neurologic and functional deficits. CONCLUSIONS: Estradiol does not reduce mortality orthe recurrence of stroke in postmenopausal women with cerebrovascular disease. This therapy should not be prescribed for the secondary prevention of cerebrovascular disease.     

Risk communication methods in hip fracture prevention: a randomised trial in primary care

Background

Treatment acceptance by patients is influenced by the way treatment effects are presented. Presentation of benefits using relative risk increases treatment acceptance compared to the use of absolute risk. It is not known whether this effect is modified by prior presentation of a patient''s individualised risk estimate or how presentation of treatment harms by relative or absolute risk affects acceptance.

Aim

To compare acceptance of a hypothetical treatment to prevent hip fracture after presentation of the treatment''s benefit in relative or absolute terms in the context of a personal fracture risk estimate, and to reassess acceptance following subsequent presentation of harm in relative orabsolute terms.

Design and setting

Randomised controlled trial of patients recruited from 10 GPs'' lists in Christchurch, New Zealand.

Method

Women aged ≥50 years were invited to participate. Participants were given a personal 10-year hip fracture risk estimate and randomised to receive information on a hypothetical treatment''s benefit and harm in relative orabsolute terms.

Results

Of the 1140 women invited to participate 393 (34%) took part. Treatment acceptance was greater following presentation of benefit using absolute terms than relative terms after adjustment forage, education, previous osteoporosis diagnosis, and self-reported risk (OR 1.73, 95% confidence interval [CI] = 1.10 to 2.73, P = 0.018). Presentation of the treatment''s harmful effect in relative terms led to a greater proportion of participants declining treatment than did presentation in absolute terms (OR 4.89, 95% CI = 2.3 to 11.0, P<0.001).

Conclusion

Presentation of treatment benefit and harm using absolute risk estimates led to greater treatment acceptance than presentation of the same information in relative terms.     

Membranoproliferative glomerulonephritis. A prospective clinical trial of platelet-inhibitor therapy

Forty patients with Type I membranoproliferative glomerulonephritis were treated for one year with dipyridamole, 225 mg per day, and aspirin, 975 mg per day, in a prospective, randomized, double-blind, placebo-controlled study. At the base line, the half-life of 51Cr-labeled platelets was reduced in 12 of 17 patients. The platelet half-life became longer and renal function stabilized in the treated group, as compared with the placebo group, suggesting a relation between platelet consumption and the glomerulopathy. The glomerular filtration rate, determined by iothalamate clearance, was better maintained in the treated group (average decrease, 1.3 ml per minute per 1.73 m2 of body-surface area per 12 months) than in the placebo group (average decrease, 19.6). Fewer patients in the treated group than in the placebo group had progression to end-stage renal disease (3 of 21 after 62 months as compared with 9 of 19 after 33 months). The data suggest that dipyridamole and aspirin slowed the deterioration of renal function and the development of end-stage renal disease.     

Limitations of student-driven formative assessment in a clinical clerkship. A randomised controlled trial

Background  

Teachers strive to motivate their students to be self-directed learners. One of the methods used is to provide online formative assessment material. The concept of formative assessment and use of these processes is heavily promoted, despite limited evidence as to their efficacy.     

Efficacy of homoeopathic treatment for diabetic distal symmetric polyneuropathy: A multicentric randomised double-blind placebo-controlled clinical trial.

BackgroundIn course of diabetes, some 20–90% of individuals eventually develop diabetic neuropathy. Looking at the disease burden research studies in Homoeopathy were conducted and have shown positive results. These studies were not robust enough to prove the efficacy of individualized homoeopathy.ObjectiveTo assess efficacy of individualized homoeopathic medicines in management of DDSP.MethodsA multi-centric double-blind, placebo controlled, randomised clinical trial was conducted by the Central Council for Research in Homoeopathy at six centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention. Primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months.ResultsData of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M.ConclusionFurther studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.     

A cluster randomised trial to evaluate a nutrition training programme.

BACKGROUND: The need for training to equip primary care staff with the knowledge and skills to provide dietary advice to the public has been acknowledged. Little is known about the effectiveness of such training at improving the dietary counselling skills of multidisciplinary practice teams. AIM: To evaluate the effectiveness of a nutrition training programme, delivered to primary care teams by a dietitian. DESIGN OF STUDY: A paired-cluster randomised trial. SETTING: Twelve general practices in Sunderland, in the United Kingdom. METHOD: A nutrition training programme, aimed at improving the quality of dietary consultations, was developed and delivered to six primary care teams by a dietitian. Main outcome measures were patients' recall of seven key consulting behaviours. Data were collected from patients in intervention and control practices, pre- and post-intervention. Change in knowledge and attitude of practitioners was also measured. RESULTS: All 12 practices completed the trial. Data were collected from 251 patients pre-intervention and 228 patients post-intervention. Of the seven consulting behaviours targeted in the training, only the proportion of consultations where written information (diet sheets) was provided to patients was significantly higher (13% higher, 95% confidence interval [CI = 4 to 21, P = 0.004) in the intervention practices post-training. Some evidence of improved practitioner knowledge and attitude was detected. CONCLUSION: This evaluation of a nutrition training intervention detected only a limited impact on the behaviour, knowledge, and attitudes of primary care practitioners in dietary consultations.     

髋部骨折内固定术失败后行人工髋关节置换术的临床分析

目的 探讨髋部骨折内固定治疗失败的原因,并分析行人工髋关节置换术的临床疗效。方法 回顾性研究。纳入2011年3月—2018年7月哈尔滨医科大学附属第一医院收治的股骨颈及股骨粗隆间骨折内固定失败患者45例,其中男16例、女29例,年龄35~80岁,平均47.5岁;股骨颈骨折33例,股骨粗隆间骨折12例。股骨颈骨折依据Garden分型标准,Ⅱ型6例、Ⅲ型20例、Ⅳ型7例;股骨粗隆间骨折依据改良Evan分型标准,Ⅲ型1例、Ⅳ型4例、Ⅴ型7例。45例患者中,采用全髋关节置换术35例,人工股骨头置换术10例。观察患者手术时间、术中出血量、骨折愈合时间及术后并发症发生情况;末次随访时采用Harris评分评定髋关节功能及疗效,并与术前Harris评分进行对比分析;同时分析内固定失败原因。结果 所有患者均顺利完成手术,术中假体周围骨折1例,给予钢丝捆扎固定。手术时间50～150 min,平均72 min。术中失血量150～600 mL,平均260 mL。术后下肢深静脉血栓形成5例、浅表感染4例,予相应处理后治愈,肢体不等长(超过2 cm)2例,未给予特殊处理。45例患者均获随访,随访时间5～30个月,平均10.5个月。随访期间无感染、假体周围骨折、关节脱位、假体松动等并发症发生。假体周围骨折于术后3个月愈合。末次随访时Harris评分82～94(88±6)分,明显高于术前的32～36(34±2)分,差异有统计学意义(t=49.258, P＜0.01)。采用Harris评分评定疗效,优16例、良24例、可4例、差1例,优良率88.9%(40/45)。初次手术失败原因:内固定手术技术原因27例,其中螺钉置入位置或长度不理想12例、内固定物选择不当8例、骨折复位不良10例;股骨颈骨折手术时间＞伤后72 h 18例,其中＞1周9例;术后负重时间过早(＜12周)15例;术后再次跌倒或碰撞伤6例;原因不明7例。结论 导致髋部骨折内固定失败的原因包括医源性因素与患者源性因素。对于髋部骨折内固定术失败的患者,依据患者年龄及全身状况,采用全髋关节置换术或人工股骨头置换术治疗临床效果良好。     

The effects of physical therapy on cerebral palsy. A controlled trial in infants with spastic diplegia

Legislatively mandated programs for early intervention on behalf of handicapped infants often stipulate the inclusion of physical therapy as a major component of treatment for cerebral palsy. To evaluate the effects of physical therapy, we randomly assigned 48 infants (12 to 19 months of age) with mild to severe spastic diplegia to receive either 12 months of physical therapy (Group A) or 6 months of physical therapy preceded by 6 months of infant stimulation (Group B). The infant-stimulation program included motor, sensory, language, and cognitive activities of increasing complexity. Masked outcome assessment was performed after both 6 and 12 months of therapy to evaluate motor quotient, motor ability, and mental quotient. After six months, the infants in Group A had a lower mean motor quotient than those in Group B (49.1 vs. 58.1, P = 0.02) and were less likely to walk (12 vs. 35 percent, P = 0.07). These differences persisted after 12 months of therapy (47.9 vs. 63.3, P less than 0.01, and 36 vs. 73 percent, P = 0.01, respectively). We noted no significant differences between the groups in the incidence of contractures or the need for bracing or orthopedic surgery. Group A also had a lower mean mental quotient than Group B after six months of therapy (65.6 vs. 75.5, P = 0.05). The routine use of physical therapy in infants with spastic diplegia offered no short-term advantage over infant stimulation. Because of the limited scope of the trial, our conclusions favoring infant stimulation are preliminary. The results suggest that further study of the effects of both physical therapy and infant stimulation is indicated.     

Primary care patients with mental health problems: outcome of a randomised clinical trial.

BACKGROUND: The prevalence of patients with mental health problems in general practice is high, and at least one-third of these problems last for 6 months or longer. Patients with these problems take up more time during a consultation and attend more frequently. AIM: This study investigated the effectiveness of problem-solving treatment for primary care patients with mental health problems. The hypothesis was that patients receiving problem-solving treatment from a nurse would have fewer symptoms after 3 months, or a lower attendance rate, compared with patients receiving the usual care from the GP. DESIGN OF THE STUDY: Randomised clinical trial. SETTING: Twelve general practices in Amsterdam and 12 nurses from a mental healthcare institution. METHOD: A sample of patients aged >or=18 years were screened for mental health problems with the general health questionnaire (GHQ-12) in the waiting room of the general practices, and were randomised. Patients receiving the problem-solving treatment were required to complete four to six treatment sessions, while patients in the control group were treated as usual by the GP. RESULTS: No significant difference was found between the groups in terms of improved psychopathology or a decrease in attendance rate. Post-hoc analyses showed a sub-group of patients with more severe pathology who may benefit from problem-solving treatment. CONCLUSION: The main results show that problem-solving treatment provided by a nurse adds little to the usual care from the GP for frequent attenders with mental health problems. Post-hoc analyses show that there may be a sub-group of more severely depressed patients who could benefit from problem-solving treatment.     

动力髋螺钉内固定与髋关节置换治疗高龄股骨粗隆间骨折疗效比较

目的探讨动力髋螺钉内固定(DHS)及人工髋关节置换术治疗高龄股骨粗隆间骨折的临床疗效。方法本组230例,发病原因146例跌倒伤,69例车祸伤。骨折按Evans分型:Ⅲ型99例,Ⅳ型131例。分别采用DHS、髋关节置换两种手术方法治疗,分析临床疗效。结果术后随访5~24个月,平均13.6个月,所有患者患髋功能恢复良好,局部疼痛明显缓解或消失,患肢负重行走无需扶拐。两组在引流量、术后下地时间等方面有显著性差异。采用髋关节功能Harris评分系统评定,两种手术方法之间有显著性差异。结论 DHS与人工髋关节置换均为治疗高龄股骨粗隆间骨折的有效方式,人工髋关节置换更有理论上的优势,但各有优缺点,综合考虑选择合适的治疗方案才能取得满意的疗效。     

Chronic fatigue in general practice: is counselling as good as cognitive behaviour therapy? A UK randomised trial.

BACKGROUND: Fatigue is a common symptom for which patients consult their doctors in primary care. With usual medical management the majority of patients report that their symptoms persist and become chronic. There is little evidence for the effectiveness of any fatigue management in primary care. AIM: To compare the effectiveness of cognitive behaviour therapy (CBT) with counselling for patients with chronic fatigue and to describe satisfaction with care. DESIGN OF STUDY: Randomised trial with parallel group design. SETTING: Ten general practices located in London and the South Thames region of the United Kingdom recruited patients to the trial between 1996 and 1998. Patients came from a wide range of socioeconomic backgrounds and lived in urban, suburban, and rural areas. METHOD: Data were collected before randomisation, after treatment, and six months later. Patients were offered six sessions of up to one hour each of either CBT or counselling. Outcomes include: self-report of fatigue symptoms six months later, anxiety and depression, symptom attributions, social adjustment and patients' satisfaction with care. RESULTS: One hundred and sixty patients with chronic fatigue entered the trial, 45 (28%) met research criteria for chronic fatigue syndrome; 129 completed follow-up. All patients met Chalder et al's standard criteria for fatigue. Mean fatigue scores were 23 on entry (at baseline) and 15 at six months' follow-up. Sixty-one (47%) patients no longer met standard criteria for fatigue after six months. There was no significant difference in effect between the two therapies on fatigue (1.04 [95% CI = -1.7 to 3.7]), anxiety and depression or social adjustment outcomes for all patients and for the subgroup with chronic fatigue syndrome. Use of antidepressants and consultations with the doctor decreased after therapy but there were no differences between groups. CONCLUSION: Counselling and CBT were equivalent in effect for patients with chronic fatigue in primary care. The choice between therapies can therefore depend on other considerations, such as cost and accessibility.     

髋部骨质疏松性骨折患者骨质疏松药物治疗现状调查

背景：髋部骨质疏松是其骨折的主要原因。 目的：调查50岁以上骨质疏松髋部骨折患者骨质疏松相关评估和药物治疗现状。 方法：通过电子病历回顾及电话随访的方式,对于2009-07/2010-12在北京积水潭医院住院的50岁及以上、骨质疏松髋部骨折患者进行调查。完成有效调查484例,调查内容包括骨密度检查、骨质疏松相关药物的应用现状以及患者对骨质疏松的知晓率。 结果与结论：患者中骨折前曾进行过骨密度检查的患者仅为13例(2.7%),曾经用过骨质疏松相关药物的46例(9.5%),骨折住院期间为93例(19.2%)和219例(45.2%),随访期间分别为14例(2.9%),96例(19.8%)。随访期仅骨质疏松相关药物应用率显著高于住院前(P=0.000)。患者或其家人对其患有骨质疏松症知晓率仅为45.9%,主要获取途径来自于医务人员占54%。提示大多数骨质疏松髋部骨折患者在发生骨折前和康复期没有接受骨质疏松相关检查,骨质疏松的知晓率低,治疗率更低。     

A brief compassion focused therapy intervention can help self-critical parents and their children: A randomised controlled trial

Background

Parents can be highly self-critical of their own parenting, which can negatively impact parenting style and child outcomes.

Aims

The aim of this randomised controlled trial (RCT) was to examine the efficacy of a brief 2-hour Compassion Focused Therapy intervention (CFT) for parents to determine if it can reduce self-criticism, improve parenting and improve child social, emotional and behavioural outcomes.

Materials & Methods

In total, 102 parents (87 mothers) were randomised to either a CFT intervention (n = 48) or waitlist control group (n = 54). Participants were measured at pre-, 2-week post-intervention and the CFT group again at 3-month follow-up.

Results

At 2-week post-intervention parents in the CFT group compared to waitlist control had significantly reduced levels of self-criticism, significant reductions in child emotional and peer problems, but no changes in parental style. At 3-month follow-up, these outcomes improved, with self-criticism further decreasing, parental hostility and verbosity decreasing, as well as a range of childhood improvements.

Conclusion

The results from this first RCT evaluation of a brief 2-hour CFT intervention for parents show promise for not only improving how parents relate to themselves with self-criticism and self-reassurance, but also for improving parenting styles and child outcomes.     

MRI signal intensity of anterior cruciate ligament graft after transtibial versus anteromedial portal technique (TRANSIG): A randomised controlled clinical trial

BackgroundTwo primary surgical femoral drilling techniques are used to reconstruct the anterior cruciate ligament (ACL): the transtibial (TT) technique and the anteromedial portal (AMP) technique. Currently there is no consensus on which surgical technique elicits the best clinical and functional outcomes. MRI-derived measures of the signal intensity (SI) of the ACL graft have been described as an independent predictor of graft properties. The purpose of this study was to assess MRI-derived SI measurements of the ACL graft one year after ACL reconstruction, in order to compare graft maturation of both AMP and TT ACL reconstruction techniques.MethodsThis randomised controlled trial included 33 patients admitted for primary unilateral ACL reconstruction. Primary outcome was MRI Signal intensity ratio (SIR) of the ACL graft one year after ACL reconstruction. Differences in MRI SIR were assessed on two MRI sequencies: sagittal Proton Density Turbo Spin Echo weighted images (PDTSE) and 3D T2 Gradient Echo (T2*) weighted images. Analysis of interobserver and intraobserver variability was conducted for the SIR measurements.ResultsNo difference in signal intensity of the graft was found between the TT and AMP techniques one year after ACL reconstruction (PDTSE p = 0.665, T2* p = 0.957). Both interobserver and intraobserver variability showed strong agreement (ICC 0.64–0.94).ConclusionNo differences in signal intensity of the graft on MRI were seen between the femoral drilling techniques one year after ACL reconstruction, suggesting similar graft maturation at that time. Follow-up studies are needed to determine whether graft intensity changes in the long term.Level of evidenceTherapeutic study with level of evidence I.     

A poisson process model for hip fracture risk

The primary method for assessing fracture risk in osteoporosis relies primarily on measurement of bone mass. Estimation of fracture risk is most often evaluated using logistic or proportional hazards models. Notwithstanding the success of these models, there is still much uncertainty as to who will or will not suffer a fracture. This has led to a search for other components besides mass that affect bone strength. The purpose of this paper is to introduce a new mechanistic stochastic model that characterizes the risk of hip fracture in an individual. A Poisson process is used to model the occurrence of falls, which are assumed to occur at a rate, λ. The load induced by a fall is assumed to be a random variable that has a Weibull probability distribution. The combination of falls together with loads leads to a compound Poisson process. By retaining only those occurrences of the compound Poisson process that result in a hip fracture, a thinned Poisson process is defined that itself is a Poisson process. The fall rate is modeled as an affine function of age, and hip strength is modeled as a power law function of bone mineral density (BMD). The risk of hip fracture can then be computed as a function of age and BMD. By extending the analysis to a Bayesian framework, the conditional densities of BMD given a prior fracture and no prior fracture can be computed and shown to be consistent with clinical observations. In addition, the conditional probabilities of fracture given a prior fracture and no prior fracture can also be computed, and also demonstrate results similar to clinical data. The model elucidates the fact that the hip fracture process is inherently random and improvements in hip strength estimation over and above that provided by BMD operate in a highly “noisy” environment and may therefore have little ability to impact clinical practice.