Lack Of Difference In Outcome Research Articles

Lack of differences in outcomes between 3 immunosuppression protocols in the first year after pediatric liver transplantation: A multicenter study.

Advances in immunosuppression have extended patient and graft survival rates after solid organ transplantation; however, this is not free of side effects. Balancing safety and efficacy is of paramount importance, particularly in the pediatric setting. Current literature comparing different protocols is scarce, and decisions are mostly guided by physician preference. We aimed to compare 3 different protocols from 4 different centers to identify differences in outcomes after 1 year of follow-up. A retrospective analysis of the databases of the participating centers was performed. Consecutive patients aged <18 years with a first liver-only transplant and no other underlying congenital or acquired immunodeficiency were included. Patients were classified according to the immunosuppression protocol as follows: group A (prednisone + tacrolimus + basiliximab), group B (prednisone + tacrolimus + basiliximab + antithymocyte globulin), and group C (prednisone + tacrolimus). Differences in survival, frequency of rejection, infections, and other complications were analyzed in the entire group (n = 97) and the group with biliary atresia (n = 48). After 1 year of follow-up, no differences in patient or graft survival were observed when comparing either the entire group (n = 97) or patients with biliary atresia only (n = 48). The frequencies of rejection and episodes of infection were similar. Renal function showed no differences either before or after transplantation or between the groups. Immunosuppression protocols used in this study appeared to be equally safe and effective. This could offer the opportunity to tailor them to the patient's individual characteristics without compromising the outcome.

Outcomes after intervention for enteral nutrition in patients with amyotrophic lateral sclerosisin multidisciplinary clinics.

Patients with amyotrophic lateral sclerosis (ALS) are susceptible to malnutrition, with appropriate management of nutritional interventions an active area of investigation. We sought to determine the impact of gastrostomy tube placement in ALS patients, exploring the correlation between forced vital capacity (FVC), malnutrition, and perioperative complications. A retrospective review was performed of clinically diagnosed ALS patients treated at two multidisciplinary clinics (University of Kansas, University of Nebraska) from January 2009 to September 2020 who were referred for gastrostomy. Data collected included demographics, disease characteristics, and key gastrostomy related dates/outcomes. Two hundred thirty-nine patients were included with a median age of 65 years and median of 589 days from symptom onset to gastrostomy (interquartile range, 404-943). The population was predominantly Non-Hispanic White with bulbar-onset ALS. 30-day mortality was 4% and 30-day morbidity was 13%. Weight loss, body mass index, and predicted FVC at placement showed no increased 30-day morbidity or mortality association. Bulbar-onset ALS patients exhibited higher overall mortality postplacement than limb onset (odds ratio: 1.85, 95% confidence interval: 1.03-3.33). There was a 5% incidence of symptoms suggestive of refeeding syndrome. Rates of major/minor complications and 30-day mortality related to gastrostomy placement in our population were similar compared with prior studies in ALS. The lack of difference in outcomes based on FVC at procedure may suggest this is not predictive of outcome, or perhaps, high-quality perioperative respiratory management. Alternative reasons may account for the increased morbidity and mortality of gastrostomy placement in the ALS population.

Randomized Controlled Trial Comparing Early Mobilization vs Six Weeks of Immobilization in a Walking Cast Following Total Ankle Replacement

Rehabilitation for patients after total ankle replacement traditionally involves weeks of immobilization in a plaster cast followed by progressive mobilization. In a small randomized trial, we compared teh outcomes of patients who received a 3-component cementless, unconstrained, mobile-bearing prosthesis and were initially immobilised in a plaster cast for 6 weeks to thoese who received the same prosthesis but were allowed to mobilise early. Gait, clinical, patient-reported, and radiologic outcomes were measured. The study included 20 patients, 10 in the plaster cast group and 10 in the early mobilization group, and the demographics of the groups did not differ significantly. All patients were followed-up for 24 months. There were no significant differences between the 2 groups 2 years after surgery in ankle dorsiflexion, spatiotemporal gait characteristics, American Orthopaedic Foot and Ankle Society ankle-hindfoot scores, Timed Up and Go Test times, WOMAC (pain, stiffness, function) scores, SF-36 (quality-of-life) scores, or patient satisfaction (pain relief, daily-living, recreational activities, and overall) (all p > .05). Bone mineral density decrease of the medial malleolus and increase at middle tibia, calculated with DEXA scans, was significantly better in early mobilization than plaster cast group at one and 2 years postoperatively, but this was also the case preoperatively. The lack of differences in outcomes suggests that early ankle mobilization may be a safe and reliable method to enhance recovery following ankle arthroplasty with a 3-component cementless, unconstrained, mobile-bearing prosthesis. Compared to traditional plaster casting, patients who are engaged in early mobilization after arthroplasty may enjoy similar functional, mobility, quality-of-life, pain relief, activity level, and satisfaction outcomes.

The impact of responsible fatherhood programs on parenting, psychological well-being, and financial outcomes: A randomized controlled trial.

The objective of this study was to examine differences in parenting, psychological well-being, and economic outcomes between fathers receiving two different programs offered by Fathers & Families Support Center for economically disadvantaged fathers: (a) Family Formation (FF), a 6-week/240-h program focused on economic stability/mobility, responsible fatherhood, and healthy relationships, with case management and legal services; (b) Economic Stability (ES), a 4-week/80-h program focused only on economic stability with limited case management and legal services. A randomized controlled trial (RCT) was used to compare fathers in FF (n=350) vs. ES (n=342). Surveys were administered at enrollment and 3- and 12-months postintervention. Linear and generalized linear mixed models were used to assess changes in program outcomes over time and across study groups. Four hundred and eighty-two fathers responded to either follow-up survey (251 FF, 231 ES). Nearly all (98%) were non-white (93% Black, 5% other/mixed race) and were on average 34years old. Approximately 46% attended ≥75% of program sessions (FF 48% vs. ES 44%). Both FF and ES groups experienced improvements in parenting, psychological well-being, and financial outcomes after the programs, but changes in outcomes over time did not differ significantly by program. The lack of difference in outcomes between fathers in FF and ES groups could be due to a similar core focus on employment-related curriculum for both groups. Gaining financial stability could have contributed to positive improvements in other fatherhood domains. Implications for future research and practice are discussed herein.

500. A Real-World Cohort Study of Bamlanivimab Versus Bamlanivimab-Etesevimab for Non-severe COVID-19

BackgroundAnti-spike monoclonal antibodies (mAb) including Bamlanivimab (BAM) and Bamlanivimab-Etesevimab (BAM/E) have shown reduced hospitalization rates for non-severe coronavirus disease 2019 (COVID-19) in clinical trials. Recent studies provided real-world hospitalization rates for BAM. But, similar data on those who received BAM/E are lacking. In spring 2021, Michigan experienced a surge of COVID-19 with more cases per capita than any other state. We sought to quantify the impact of BAM monotherapy versus BAM/E combination on hospitalization and mortality among a real-world high-risk cohort of outpatients with COVID-19.MethodsThis retrospective cohort study evaluated outpatients ≥18 years with laboratory-confirmed mild/moderate COVID-19 who received mAb in a Detroit health system based on emergency use authorization criteria. Inclusion began on December 3rd 2020 with BAM monotherapy, changed to BAM/E combination on March 27, 2021, and included patients until April 19th 2021 (Figure 1). Demographics, comorbidities, and clinical characteristics were compared between patients who received BAM verses BAM/E using Chi-square and Mann-Whitney U test. Primary outcome was 30-day COVID-19 related hospitalization. Secondary outcomes were 30-day mortality and length of stay (LOS). Inclusion began on December 3rd 2020 with BAM monotherapy, changed to BAM/E combination on March 27, 2021, and included patients until April 19th 2021. In spring 2021, Michigan experienced a surge of COVID-19 with more cases per capita than any other state resulting in a large sample of real-world patients for analysis.Results643 patients received mAb (294 in BAM group and 349 in BAM/E group). Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar (Table 1). BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p< 0.001). COVID-19 related 30-day hospitalization rates did not differ between groups (7.8 vs 7.2%, p=0.751). LOS and 30-day mortality (1% vs 0.3%, p=0.238) were also similar (Table 2). Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p<0.001). COVID-19 related 30-day hospitalization rates did not differ between groups. Length of stay and 30-day mortality were also similar.ConclusionRates of hospitalization in our study were higher than in clinical trials of mAB and may reflect differences in study populations (Table 3). Compared to other real-world studies, our cohort of young, obese, and Black patients, had similar hospitalization rates of 7.5%. The lack of difference in outcomes noted among the mAB formulations in our study may be related to longer time from symptom onset to infusion in the BAM/E combination group. Our patients were older with higher rates of obesity and other comorbidities than those in clinical trials (shown in orange). Compared to other real-world studies (in blue), our cohort of younger, more obese Black patients had similar hospitalization rates of 7.5%.Disclosures All Authors: No reported disclosures

A cluster-randomized trial comparing two SWITCH implementation support strategies for school wellness intervention effectiveness

BackgroundThe School Wellness Integration Targeting Child Health (SWITCH) intervention has demonstrated feasibility as an implementation approach to help schools facilitate changes in students’ physical activity (PA), sedentary screen time (SST), and dietary intake (DI). This study evaluated the comparative effectiveness of enhanced (individualized) implementation and standard (group-based) implementation. MethodsTwenty-two Iowa elementary schools participated, with each receiving standardized training (wellness conference and webinars). Schools were matched within region and randomized to receive either individualized or group implementation support. The PA, SST, and DI outcomes of 1097 students were assessed at pre- and post-intervention periods using the Youth Activity Profile. Linear mixed models evaluated differential change in outcomes by condition, for comparative effectiveness, and by gender. ResultsBoth implementation conditions led to significant improvements in PA and SST over time (p < 0.01), but DI did not improve commensurately (p value range: 0.02‒0.05). There were no differential changes between the group and individualized conditions for PA (p = 0.51), SST (p = 0.19), or DI (p = 0.73). There were no differential effects by gender (i.e., non-significant condition-by-gender interactions) for PA (pfor interaction = 0.86), SST (pfor interaction = 0.46), or DI (pfor interaction = 0.15). Effect sizes for both conditions equated to approximately 6 min more PA per day and approximately 3 min less sedentary time. ConclusionThe observed lack of difference in outcomes suggests that group implementation of SWITCH is equally effective as individualized implementation for building capacity in school wellness programming. Similarly, the lack of interaction by gender suggests that SWITCH can be beneficial for both boys and girls. Additional research is needed to understand the school-level factors that influence implementation (and outcomes) of SWITCH.

Retrospective multicentric study comparing durations of surgery and anesthesia and likelihoods of short- and long-term complications between cats positioned in sternal or dorsal recumbency for perineal urethrostomy.

To compare the durations of surgery and anesthesia and the likelihoods of short- and long-term postoperative complications between cats positioned in sternal recumbency versus dorsal recumbency for perineal urethrostomy (PU). 247 client-owned cats that underwent PU between January 2004 and December 2015 at 6 veterinary teaching hospitals and 1 private veterinary referral hospital. Medical records were reviewed, and signalment, presenting complaints, previous history of urethral obstruction or PU, diet fed, medications administered, indication for PU, durations of surgery and anesthesia for PU, suture type and size, suture pattern for skin closure, and short- and long-term postoperative complications were recorded. Univariable and multivariable analyses were performed to identify differences in durations of surgery and anesthesia and the likelihoods of short- and long-term complications between cats positioned in sternal recumbency and those positioned in dorsal recumbency. Patient position was not associated with durations of surgery and anesthesia for PU, even if a concurrent cystotomy was necessary or the patient required repositioning from sternal to dorsal recumbency. Likewise, patient position was not associated with the likelihood of short- and long-term complications. The observed lack of differences in outcomes between sternal and dorsal recumbency suggested that logistic considerations and personal preference can continue to guide veterinarians when positioning cats for PU.

Effect of the Timing of Antiretroviral Treatment Initiation on Outcomes in Children Living With Human Immunodeficiency Virus Admitted With Severe Acute Malnutrition.

Delays in early infant diagnosis and antiretroviral treatment (ART) initiation in developing countries frequently result in malnutrition at initial presentation with associated higher mortality and delayed immune recovery. The optimal timing of ART initiation is yet to be established. Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled. Patients were randomized to initiate ART within 14 days from admission (early arm) or delay ART initiation until nutritional recovery and >14 days after admission (delayed arm). All patients received a standardized treatment and feeding protocol and were followed to 48 weeks. The mean age of the patients at baseline was 23.3 months (standard deviation [SD], 27.9; range, 1.6-129 months). The mean time from admission to ART initiation was 5.6 days (SD, 4.4) in the early arm and 23 days (SD, 5.8) in the delayed arm (P < .001). There was no significant difference in mortality (P = .62), virologic response (P = .53), and anthropometric response (P = .57) between the 2 groups at 48 weeks. However, the rates of change in CD4, viral load, weight for age z score, and height for age z score occurred earlier and favored the delayed arm at early time points but were not significant at 24 and 48 months. Despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.In this randomised controlled study of ART initiation in children admitted with HIV and severe acute malnutrition (SAM), despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM. PACTR 21609001751384.

Abstract TP388: Does Management of Anemia After Acute Ischemic Stroke Improve Outcomes?

Introduction: Anemia is associated with increased morbidity and mortality in patients with acute ischemic stroke (AIS). However, it is unclear if management of anemia after stroke can improve outcomes. Objective: To assess the impact of anemia, and its treatment, on AIS patient outcomes. Methods: Adult AIS patients admitted to a rural academic medical center for primary stroke between 1/1/2012 - 12/31/2016 were included. Patient medical records were reviewed for relevant health information. Results: A sample of 753 patients treated for AIS was evaluated. Moderate or severe anemia (hemoglobin &lt; 11 g/dL for both sexes) was associated with increased mortality at 6 months (57.6% [45.0-68.3], 80.3% [72.9-85.9], 86.9% [83.6-89.5] for moderate/severe, mild and no anemia, respectively; p&lt; 0.0001). This difference in survival was still seen after adjustments for other covariables, such as age, renal insufficiency, atrial fibrillation, heart failure and diabetes mellitus, in multivariate analysis. Following AIS, only 41% (90/219) of patients with anemia had documented management of anemia. We did not detect a difference in long term survival or stroke recurrence for managed vs. unmanaged patients. However, the anemia management most often occurred in the months following stroke, while anemia had the largest impact on outcome in the initial weeks after stroke. Conclusions: This study confirmed the poor prognosis seen with moderate and severe anemia after AIS. The lack of difference in outcome for managed vs. unmanaged patients may reflect the fact that the adverse effect of anemia was greatest in the first days to weeks after stroke while management was undertaken later. Thus, more aggressive treatment of anemia in patients at risk for stroke may be beneficial. In conclusion, more investigation into the relationship between anemia treatment and stroke mortality is warranted, such as a prospective study looking at management of anemia in patients with stroke risk factors.

Small randomized clinical trial shows lack of difference in outcomes when comparing surgically guided and conventional protocol implant placement

Small randomized clinical trial shows lack of difference in outcomes when comparing surgically guided and conventional protocol implant placement

One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study)

The purpose of this study was to assess the safety and efficacy of the Misago stent (Terumo Corp, Tokyo, Japan) in occlusive and stenotic superficial femoral artery (SFA) disease. The safety and efficacy of the Misago SFA stent were evaluated prospectively in this initial collaboration trial between Japan and the United States. Because this trial enrolled patients mainly from Japan and the United States and because there is a question as to whether a race difference exists in SFA stent performance, the race difference on outcome was also analyzed. In addition, results were compared with a prior SFA stent trial. The Misago stent was implanted in 261 subjects with TransAtlantic Inter-Society Consensus (TASC) type A and type B SFA lesions (201 subjects in the United States, 50 in Japan, 9 in Taiwan, 1 in South Korea). The mean age of the patients was 69.3 ± 10.0 years, and the mean lesion length was 83.8 ± 41.3 mm. The overall 12-month primary patency rate and clinically driven target lesion revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) and outcomes between U.S. and Asian patients were similar, including primary patency (82.9% vs 83.0%; P = .889), clinically driven target lesion revascularization (13.4% vs 11.7%; P = .829), stent fracture rate (1.3% vs 0.0%; P = 1.000), and stent thrombosis rate (0.5% vs 0.0%; P = 1.000). OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials.

Rehabilitation for distal radial fractures in adults.

Rehabilitation for distal radial fractures in adults.

Insulin therapy in hyperglycemic children with severe acute asthma

Objectives: The aim of this study was to assess the effect of intravenous (IV) insulin administration in children with severe acute asthma (SAA) and hyperglycemia on IV salbutamol consumption and length of stay (LOS) in a pediatric intensive care unit (PICU). Methods: Retrospective, descriptive study of the clinical course before and after implementation of an insulin protocol for the treatment of hyperglycemia (i.e. blood glucose >8 mmol/L or 144 mg/dL, respectively) in the PICU of a tertiary care university hospital. Admissions between 1994 and 2010 were reviewed. The insulin protocol was introduced in 2006. Results: A total of 131 pediatric patients with SAA complicated by hyperglycemia requiring IV salbutamol were included. Severity of illness before and after implementation of the insulin protocol did not significantly differ. The insulin-treated patient group had significantly higher maximum blood glucose levels and higher cumulative IV salbutamol dose than the non-treated group. There were no differences between these groups in the duration of IV salbutamol administration and LOS. Conclusions: In view of the lack of difference in outcomes and considering that the insulin protocol is labor-intensive, the question is whether this protocol is efficacious for the treatment of pediatric SAA associated with hyperglycemia.

Screening and brief interventions for hazardous and harmful alcohol use among hospital outpatients in South Africa: results from a randomized controlled trial

BackgroundHigh prevalence rates of hazardous and harmful alcohol use have been found in a hospital outpatient setting in South Africa. Hospital settings are a particularly valuable point of contact for the delivery of brief interventions because of the large access to patient populations each year. With this in mind, the primary purpose of this randomized controlled trial is to provide screening for alcohol misuse and to test the effectiveness of brief interventions in reducing alcohol intake among hospital outpatients in South Africa.MethodsThe study design for this effectiveness study is a randomized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous or harmful drinkers in a hospital setting. Outpatients were screened for alcohol problems, and those identified as hazardous or harmful drinkers were randomized into an experimental or control group. The experimental group received one brief counselling session on alcohol risk reduction, while the control group received a health education leaflet.ResultsOf the 1419 screened for alcohol misuse who agreed to participate in the trial 392 (27.6%) screened positive for hazardous or harmful use on the Alcohol Use Disorder Identification Test (AUDIT) (score 7/8-19) and 51 (3.6%) had an AUDIT score of 20 or more. Among the 282 (72%) hospital outpatients who also attended the 12-month follow-up session, the time effects on the AUDIT scores were significant [F (1,195 = 7.72), P < 0.01] but the intervention effect on the AUDIT score was statistically not significant [F (1,194 = 0.06), P < 0.804].ConclusionGiven the lack of difference in outcome between control and intervention group, alcohol screening and the provision of an alcohol health education leaflet may in itself cause reduction in drinking.Trial registrationPACTR201110000319392

Screening and efficacy of radical prostatectomy

Screening and efficacy of radical prostatectomy

Heavy Episodic Drinking in Early Adulthood and Outcomes in Midlife

This study assessed to what extent drinking patterns of young adults persist into midlife and whether frequent heavy episodic drinking as a young adult is associated with educational attainment, labor market, and health outcomes at midlife. Using the National Longitudinal Survey of Youth 1979, we grouped individuals into three baseline drinking categories using data on the number of occasions they consumed six or more drinks on one occasion from the 1982-1984 surveys. Categories were frequent heavy episodic drinker, occasional heavy episodic drinker, and other drinker/abstainer. We used propensity score matching to compare baseline drinking groups on midlife alcohol consumption, educational attainment, and labor market and health outcomes. Frequent heavy episodic drinkers substantially reduced alcohol consumption between baseline and follow-up 25 years later. However, they were much more likely to abuse alcohol and be alcohol dependent in 1994 and be heavy episodic drinkers at the 25-year follow-up compared with the other drinking groups. After matching, there was little indication that being in a higher consumption baseline alcohol group was adversely associated with years of schooling completed by middle age, the probability of being employed, earnings conditional on being employed in midlife, and health problems in midlife. Results on the probability of surviving to follow-up were mixed. Frequent heavy episodic drinking at ages 17-25 years was associated with higher rates of alcohol dependence and abuse at a 10-year follow-up and alcohol consumption 25 years following baseline but not with other study outcomes at midlife. Lack of differences in outcomes at midlife may be because of decreased heavy episodic drinking among the heaviest baseline drinkers.

Screening and Brief Intervention for Risky Alcohol Consumption in the Workplace: Results of a 1-Year Randomized Controlled Study

To assess the effectiveness of brief alcohol intervention on hazardous and harmful drinking in the 12-month period after a voluntary alcohol screening. At a large transport company, employees presenting to the occupational health services for a routine health and lifestyle check-up were offered to undertake an alcohol screening by means of self-report (the Alcohol Use Disorders Identification Test-AUDIT) and a biomarker (carbohydrate-deficient transferrin in serum-CDT). Those screening positive for the AUDIT and/or CDT were randomized to a brief or comprehensive intervention group or to a control group. An identical follow-up session was performed 12 months later. Of 990 employees (68% men) that volunteered for the alcohol screening, 194 (20%) tested positive for the AUDIT and/or CDT. Among the 158 (81%) subjects who also attended the follow-up session, the frequency of positive screening results at baseline/follow-up were 51%/23% for the AUDIT (P < 0.0001) and 58%/34% (P < 0.0001) for CDT. However, there were no significant differences between the brief and comprehensive intervention groups or between the intervention groups and the control group. The results suggested that alcohol screening and brief intervention performed in connection with routine health and lifestyle examinations in the workplace may be effective in reducing alcohol consumption. Given the lack of difference in outcome between the intervention groups and the control group, alcohol screening may in itself cause reduction in drinking. In addition, at least some of the positive effect may be explained by regression towards the mean.

CaRESS at 4 Years:Will Cumulative Data Support Changes in Policy?

This is what we have been waiting for...those of us who believe that carotid artery stenting (CAS) and carotid endarterectomy (CEA) are equivalent methods of treating carotid bifurcation disease based on personal and institutional experiences have anticipated reporting of longer-term data from larger prospective trials to substantiate our evolving biases. CaRESS (Carotid Revascularization Using Endarterectomy or Stenting Systems) was designed to focus on ‘‘non-high-risk’’ individuals who are routinely encountered in daily practice and to provide comparative CAS and CEA outcomes unique to this patient subset. The current CaRESS results add to a short list of prospective trials with midand longterm (2–4 years) data. The overall 4-year results of the CaRESS trial are most impressive. Equipoise is seen between CAS and CEA procedures in terms of individual [stroke, death, myocardial infarction (MI)] and composite endpoints. While the development of recurrent stenosis and the need for repeat angiography and/or carotid reintervention were more frequent after CAS than CEA, the proportions of patients affected by these events were small (5%–15%) and were not associated with increased adverse events. The relatively low incidence of necessary secondary intervention after CAS (6% at 4 years) can be contrasted with reintervention/ failure rates after percutaneous coronary interventions (30% at 2 years), infrainguinal endovascular procedures (20%–40% at 2 years), or endovascular repair of abdominal aortic aneurysm (20% at 5 years). In addition to early procedural safety, CaRESS data show CAS (like CEA) to be a durable treatment technique as well. The lack of outcome differences seen between various CaRESS patient subsets is of lesser importance in this article. The overall cohort size was relatively small (n5397), and post-hoc analyses are potentially underpowered to reveal true endpoint differences between smaller subsets of patients separated by gender, extremes of age, presenting symptom status, stenosis severity, or combinations of the latter two [CMS (Centers for Medicare and Medicaid Services) risk stratification]. Such information may be reliably extracted only from larger trials or carefully performed meta-analyses. The ‘‘bottom line’’ is that CAS does not appear inferior to CEA in any specific CaRESS patient subgroup. Where do we go from here? By including a majority of ‘‘non-high-risk’’ patients, CaRESS demonstrated no appreciable differences in stroke, death, MI, or composite endpoints between CAS and CEA patients with highor non-high-risk factors. As most large prospective trials have focused on high-risk patients, CMS reimbursement (based on demonstrated procedural safety) has accordingly been ex-

The effectiveness of brief alcohol interventions in primary care settings: A systematic review

Numerous studies have reported that brief interventions delivered in primary care are effective in reducing excessive drinking. However, much of this work has been criticised for being clinically unrepresentative. This review aimed to assess the effectiveness of brief interventions in primary care and determine if outcomes differ between efficacy and effectiveness trials. A pre-specified search strategy was used to search all relevant electronic databases up to 2006. We also hand-searched the reference lists of key articles and reviews. We included randomised controlled trials (RCT) involving patients in primary care who were not seeking alcohol treatment and who received brief intervention. Two authors independently abstracted data and assessed trial quality. Random effects meta-analyses, subgroup and sensitivity analyses and meta-regression were conducted. The primary meta-analysis included 22 RCT and evaluated outcomes in over 5800 patients. At 1 year follow up, patients receiving brief intervention had a significant reduction in alcohol consumption compared with controls [mean difference: -38 g week(-1), 95%CI (confidence interval): -54 to -23], although there was substantial heterogeneity between trials (I(2) = 57%). Subgroup analysis confirmed the benefit of brief intervention in men but not in women. Extended intervention was associated with a non-significantly increased reduction in alcohol consumption compared with brief intervention. There was no significant difference in effect sizes for efficacy and effectiveness trials. Brief interventions can reduce alcohol consumption in men, with benefit at a year after intervention, but they are unproven in women for whom there is insufficient research data. Longer counselling has little additional effect over brief intervention. The lack of differences in outcomes between efficacy and effectiveness trials suggests that the current literature is relevant to routine primary care.

Pulsology Reloaded

The Losartan Intervention For Endpoint reduction in hypertension (LIFE) Study,1 the Second Australian National Blood Pressure Trial (ANBP2),2 and the Anglo-Scandinavian Cardiovascular Outcome Trials3 have shown that different antihypertensive treatments may have different impacts on the rate of events in hypertension while achieving comparable brachial blood pressure (BP) reduction. Thus, although brachial BP estimation by classic Riva–Rocci cuff sphygmomanometer and the Korotkoff auscultatory technique have provided almost all of our knowledge on epidemiology, prognosis, and treatment of hypertension,4,5 recent trials1–3 are revealing intrinsic limitations of the conventional approach, because the real goal of treatment in hypertension is the reduction in the number and the rate of untoward events. More recently, the Conduit Artery Function Evaluation (CAFE) Study6 described higher central BP as a key factor explaining the greater number and rate of events with atenolol than with amlodipine plus perindopril. Central pressure waveform and BP values can be estimated by applanation tonometry, a method supported by solid theoretical principles and modeling studies in experimental settings.7 Analysis of the systolic portion of the carotid pressure waveform allows for obtaining indices of the arterial viscous-elastic properties that correlate with end-organ damage and clinical outcomes in hypertension.8 Therefore, the indices of arterial waveform reflection and mechanics and central BP assessed by applanation tonometry have the potential to add significant information for risk stratification beyond and above brachial BP. In fact, the conclusions of the CAFE Study were well received.9 In addition, applanation tonometry has also been associated with 2D-guided M-mode vascular ultrasonography to assess simultaneously the viscous-elastic properties of the carotid artery, the intima–media thickness, and quantification of atherosclerosis.8 Assessment of cardiovascular target organ damage is curial for a global risk assessment …