Biomechanical evaluation of predictive parameters of progression in adolescent isthmic spondylolisthesis: a computer modeling and simulation study

Background

Pelvic incidence, sacral slope and slip percentage have been shown to be important predicting factors for assessing the risk of progression of low- and high-grade spondylolisthesis. Biomechanical factors, which affect the stress distribution and the mechanisms involved in the vertebral slippage, may also influence the risk of progression, but they are still not well known. The objective was to biomechanically evaluate how geometric sacral parameters influence shear and normal stress at the lumbosacral junction in spondylolisthesis.

Methods

A finite element model of a low-grade L5-S1 spondylolisthesis was constructed, including the morphology of the spine, pelvis and rib cage based on measurements from biplanar radiographs of a patient. Variations provided on this model aimed to study the effects on low grade spondylolisthesis as well as reproduce high grade spondylolisthesis. Normal and shear stresses at the lumbosacral junction were analyzed under various pelvic incidences, sacral slopes and slip percentages. Their influence on progression risk was statistically analyzed using a one-way analysis of variance.

Results

Stresses were mainly concentrated on the growth plate of S1, on the intervertebral disc of L5-S1, and ahead the sacral dome for low grade spondylolisthesis. For high grade spondylolisthesis, more important compression and shear stresses were seen in the anterior part of the growth plate and disc as compared to the lateral and posterior areas. Stress magnitudes over this area increased with slip percentage, sacral slope and pelvic incidence. Strong correlations were found between pelvic incidence and the resulting compression and shear stresses in the growth plate and intervertebral disc at the L5-S1 junction.

Conclusions

Progression of the slippage is mostly affected by a movement and an increase of stresses at the lumbosacral junction in accordance with spino-pelvic parameters. The statistical results provide evidence that pelvic incidence is a predictive parameter to determine progression in isthmic spondylolisthesis.     

Effect of l-Carnosine as adjunctive therapy in the management of children with autism spectrum disorder: a randomized controlled study

l-Carnosine is an amino acid that acts as an anti-oxidant, anti-toxic and neuroprotective agent. There is a paucity of data about the effectiveness of l-Carnosine in the management of autism spectrum disorder (ASD) in children. This study aimed at investigating the effectiveness of l-Carnosine as adjunctive therapy in the management of ASD. This was a randomized controlled trial. Children aged 3–6 years with a diagnosis of mild to moderate ASD were assigned to standard care arm (occupational and speech therapy) and intervention care arm (l-Carnosine, 10–15 mg/kg in 2 divided doses) plus standard care treatment. The children were assessed at the baseline and the end of 2 months for the scores of Childhood Autism Rating Scale, Second Edition—Standard Version (CARS2-ST), Autism Treatment Evaluation Checklist (ATEC), BEARS sleep screening tool and 6-item Gastrointestinal Severity Index (6-GSI). Of the sixty-seven children enrolled, sixty-three children had completed the study. No statistically significant difference (p > 0.05) was observed for any of the outcome measures assessed. Supplementation of l-Carnosine did not improve the total score of CARS2-ST, ATEC, BEARS sleep screening tool and 6-GSI scores of children with ASD. Further investigations are needed with more objective assessments to critically validate the effectiveness of l-Carnosine on ASD children for more decisive results.

     

Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Osteoarthritis (OA) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OH)D levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO) study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA. Methods/design: Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria) with both symptomatic knee OA and vitamin D deficiency (serum [25-(OH)D] level of >12.5 nmol/liter and <60 nmol/liter). Participants will be randomly allocated to vitamin D supplementation (50,000 IU compounded vitamin D3 capsule monthly) or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI) and Western Ontario and McMaster Universities Index of OA (WOMAC) knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized. DISCUSSION: The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA. Trial Registration: ClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials Registry: ACTRN12610000495022.     

Impact of community pharmacy diabetes monitoring and education programme on diabetes management: a randomized controlled study

Diabet. Med. 29, e326-e333 (2012) ABSTRACT: Aims To evaluate the impact of a pharmacist-led patient education and diabetes monitoring programme on HbA(1c) and other cardiovascular risk factors in the community setting. Methods Patients with Type?2 diabetes (n?=?46) attending two community pharmacies in Hertfordshire, UK were randomized to one of two groups. Patients in the intervention group (n?=?23) received a programme of education about diabetes, its treatment and associated cardiovascular risk factors. These patients were seen for monitoring/counselling by a community pharmacist on six occasions over a 12-month period. Measures included HbA(1c) , BMI, blood pressure, blood glucose and lipid profile. Patients in the control group (n?=?23) underwent these measurements at baseline and at 12?months only, without specific counselling or education over and above usual care. Results HbA(1c) fell from 66?mmol/mol (8.2%) to 49?mmol/mol (6.6%) (P?相似文献   

Supervised exercise with or without laser-guided feedback for people with non-specific chronic low back pain. A randomized controlled clinical trial

BackgroundAmong the most effective therapeutic interventions in non-specific chronic low back pain (NSCLBP), clinical practice guidelines highlight exercise therapy and patient education; However, regarding the combined intervention of exercise and Pain Neuroscience Education (PNE), there is no consensus on the most effective form of exercise.ObjetiveTo find out what changes occurred after the application of two exercise modalities [Supervised Exercise (SE) and Laser-Guided Exercise (LGE)] and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia and lumbar proprioception in subjects with NSCLBP.MethodsSingle-blind randomized clinical controlled trial. 60 subjects with NSCLBP. Both groups performed a a total of 16 therapeutic exercise sessions and 8 Pain Neuroscience Education sessions. With the Laser-Guided Exercise Therapy group performing laser-guided exercises.ResultsA significant decrease was observed for pain intensity for both groups between baseline and post-intervention and the 3 month follow-up (p < 0.001). There was a significant between-group difference between baseline and post-intervention scores in terms of pain intensity and kinesiophobia in favour of the LGE group.ConclusionSupervised exercise with or without laser feedback, when combined with PNE, reduces pain intensity, disability, pain catastrophizing, kinesiophobia and improves proprioception and PPTs in patients with NSCLBP. At a 3-month follow-up, the combination of LGE plus PNE is most effective for reducing pain intensity.     

Active management of labor: a cost analysis of a randomized controlled trial

Objective To compare the costs of a protocol of active management of labor with those of traditional labor management. Design Cost analysis of a randomized controlled trial. Methods From August 1992 to April 1996, we randomly allocated 405 women whose infants were delivered at the University of New Mexico Health Sciences Center, Albuquerque, to an active management of labor protocol that had substantially reduced the duration of labor or a control protocol. We calculated the average cost for each delivery, using both actual costs and charges. Results The average cost for women assigned to the active management protocol was $2,480.79 compared with an average cost of $2,528.61 for women in the control group (P = 0.55). For women whose infant was delivered by cesarean section, the average cost was $4,771.54 for active management of labor and $4,468.89 for the control protocol (P = 0.16). Spontaneous vaginal deliveries cost an average of $27.00 more for actively managed patients compared with the cost for the control protocol. Conclusions The reduced duration of labor by active management did not translate into significant cost savings. Overall, an average cost saving of only $47.91, or 2%, was achieved for labors that were actively managed. This reduction in cost was due to a decrease in the rate of cesarean sections in women whose labor was actively managed and not to a decreased duration of labor.Many obstetricians are concerned about the increase in the rate of cesarean sections in the United States. In 1970, the overall incidence of cesarean section was 5%.¹ By 1983, the rate had increased to 21%; it peaked at 24.7% in 1988^2,3 and remains greater than 20% of all deliveries.⁴ Lowering the rate of cesarean delivery decreases maternal risk for associated morbidity and should, therefore, significantly decrease the costs of delivery.The active management of labor, first introduced by O''Driscoll et al in the 1960s at the National Maternity Hospital in Dublin, Ireland,⁵ is a group of interventions initially devised to ensure short labors in nulliparous women. In addition, active management of labor was noted to be associated with a lower cesarean section rate,^6,7 which was thought to be due to a decrease in the number of cesarean deliveries performed for dystocia. Three randomized studies have been done to evaluate the efficacy of active management of labor.^8,9,10 These studies have demonstrated significant decreases in the duration of labor and the incidence of infectious morbidity, as well as a trend toward lower cesarean section rates.Rogers et al¹⁰ reported their experience with a protocol of active management of labor at the University of New Mexico Health Sciences Center, Albuquerque. A randomized trial, carried out between August 1992 and April 1996, compared two protocols, one using an active management of labor and the other a standard management of labor. No significant differences between the patient populations, neonatal outcomes, the incidence of uterine hyperstimulation, the use of epidural analgesia, infectious morbidity, or cesarean delivery rates were observed. A significant reduction in the duration of labor and a trend toward fewer cesarean deliveries were observed in the group whose labor was actively managed. In the present study, we undertook to evaluate the differences in cost of the two protocols. We hypothesized that the reduction in the duration of labor for women whose labor was actively managed would translate to significant cost savings. This is a cost-minimization analysis of a prospective trial of a protocol of active management of labor.     

Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial

Background

Preventive guidelines on cardiovascular risk management recommend lifestyle changes. Support for lifestyle changes may be a useful task for practice nurses, but the effect of such interventions in primary prevention is not clear. We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk.

Methods

We performed a cluster randomized controlled trial in 25 practices that included 615 patients. The intervention consisted of nurse-led cardiovascular risk management, including risk assessment, risk communication, a decision aid and adapted motivational interviewing. The control group received a minimal nurse-led intervention. The self-reported outcome measures at one year were smoking, alcohol use, diet and physical activity. Nurses assessed 10-year cardiovascular mortality risk after one year.

Results

There were no significant differences between the intervention groups. The effect of the intervention on the consumption of vegetables and physical activity was small, and some differences were only significant for subgroups. The effects of the intervention on the intake of fat, fruit and alcohol and smoking were not significant. We found no effect between the groups for cardiovascular 10-year risk.

Interpretation

Nurse-led risk communication, use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk, despite significant within-group differences.It is not clear if programs for lifestyle change are effective in the primary prevention of cardiovascular diseases. Some studies have shown lifestyle improvements with cardiovascular rehabilitation programs,^1–3 and studies in primary prevention have suggested small, but potentially important, reductions in the risk of cardiovascular disease. However, these studies have had limitations and have recommended further research.^4,5 According to national and international guidelines for cardiovascular risk management, measures to prevent cardiovascular disease, such as patient education and support for lifestyle change, can be delegated to practice nurses in primary care.^6–8 However, we do not know whether the delivery of primary prevention programs by practice nurses is effective. We also do no know the effect of nurse-led prevention, including shared decision-making and risk communication, on cardiovascular risk.Because an unhealthy lifestyle plays an important role in the development of cardiovascular disease,^9,10 preventive guidelines on cardiovascular disease and diabetes recommend education and counselling about smoking, diet, physical exercise and alcohol consumption for patients with moderately and highly increased risk.^6,11 These patients are usually monitored in primary care practices. The adherence to lifestyle advice ranges from 20% to 90%,^12–15 and improving adherence requires effective interventions, comprising cognitive, behavioural and affective components (strategies to influence adherence to lifestyle advice via feelings and emotions or social relationships and social supports).¹⁶ Shared treatment decisions are highly preferred. Informed and shared decision-making requires that all information about the cardiovascular risk and the pros and cons of the risk-reduction options be shared with the patient, and that the patients’ individual values, personal resources and capacity for self-determination be respected.^17–19 In our cardiovascular risk reduction study,²⁰ we developed an innovative implementation strategy that included a central role for practice nurses. Key elements of our intervention included risk assessment, risk communication, use of a decision aid and adapted motivational interviewing (Box 1).^19,21,22

Box 1.?Key features of the nurse-led intervention

• Risk assessment (intervention and control): The absolute 10-year mortality risk from cardiovascular diseases was assessed with use of a risk table from the Dutch guidelines (for patients without diabetes) or the UK Prospective Diabetes Study risk engine (for patients with diabetes).^6,23 Nurses in the control group continued to provide usual care after this step.
• Risk communication (intervention only): Nurses informed the patients of their absolute 10-year cardiovascular mortality risk using a risk communication tool developed for this study.^24–37
• Decision support (intervention only): Nurses provied support to the patients using an updated decision aid.²⁸ This tool facilitated the nurses’ interaction with the patients to arrive at informed, value-based choices for risk reduction. The tool provided information about the options and their associated relevant outcomes.
• Adapted motivational interviewing (intervention only): Nurses discussed the options for risk reduction. The patient’s personal values were elicited using adapted motivational interviewing.

In the present study, we investigated whether a nurse-led intervention in primary care had a positive effect on lifestyle and 10-year cardiovascular risk. We hypothesized that involving patients in decision-making would increase adherence to lifestyle changes and decrease the absolute risk of 10-year cardiovascular mortality.     

Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial

Objective To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain.Design Economic evaluation alongside a pragmatic randomised controlled trial.Setting Secondary care.Participants 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002.Main outcome measures Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY.Results At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be £7830 (SD £5202) in the surgery group and £4526 (SD £4155) in the intensive rehabilitation arm, a significant difference of £3304 (95% confidence interval £2317 to £4291). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (–0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be £48 588 per QALY gained (–£279 883 to £372 406).Conclusion Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change—for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.     

Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality and remain one of the most frequent surgical complications. Approximately 14% to 30% of all patients undergoing elective open abdominal surgery are affected and methods to reduce surgical site infection rates warrant further investigation and evaluation in randomized controlled trials. METHODS: To investigate whether the application of a circular plastic wound protector reduces the rate of surgical site infections in general and visceral surgical patients that undergo midline or transverse laparotomy by 50%. BaFO is a randomized, controlled, patient-blinded and observer-blinded multicenter clinical trial with two parallel surgical groups. The primary outcome measure will be the rate of surgical site infections within 45 days postoperative assessed according to the definition of the Center for Disease Control. Statistical analysis of the primary endpoint will be based on the intention-to-treat population. The global level of significance is set at 5% (2 sided) and sample size (n = 258 per group) is determined to assure a power of 80% with a planned interim analysis for the primary endpoint after the inclusion of 340 patients. DISCUSSION: The BaFO trial will explore if the rate of surgical site infections can be reduced by a single, simple, inexpensive intervention in patients undergoing open elective abdominal surgery. Its pragmatic design guarantees high external validity and clinical relevance. Trial registration http://www.clinicaltrials.gov NCT01181206. Date of registration: 11 August 2010; date of first patient randomized: 8 September 2010.     

Effect of a single acupuncture treatment on surgical wound healing in dogs: a randomized,single blinded,controlled pilot study

Background  

The aim of the study was to investigate the effect of acupuncture on wound healing after soft tissue or orthopaedic surgery in dogs.     

Effect of iron supplementation on fatigue in nonanemic menstruating women with low ferritin: a randomized controlled trial

Background:

The true benefit of iron supplementation for nonanemic menstruating women with fatigue is unknown. We studied the effect of oral iron therapy on fatigue and quality of life, as well as on hemoglobin, ferritin and soluble transferrin receptor levels, in nonanemic iron-deficient women with unexplained fatigue.

Methods:

We performed a multicentre, parallel, randomized controlled, closed-label, observer-blinded trial. We recruited from the practices of 44 primary care physicians in France from March to July 2006. We randomly assigned 198 women aged 18–53 years who complained of fatigue and who had a ferritin level of less than 50 ug/L and hemoglobin greater than 12.0 g/dL to receive either oral ferrous sulfate (80 mg of elemental iron daily; n = 102) or placebo (n = 96) for 12 weeks. The primary outcome was fatigue as measured on the Current and Past Psychological Scale. Biological markers were measured at 6 and 12 weeks.

Results:

The mean score on the Current and Past Psychological Scale for fatigue decreased by 47.7% in the iron group and by 28.8% in the placebo group (difference –18.9%, 95% CI −34.5 to −3.2; p = 0.02), but there were no significant effects on quality of life (p = 0.2), depression (p = 0.97) or anxiety (p = 0.5). Compared with placebo, iron supplementation increased hemoglobin (0.32 g/dL; p = 0.002) and ferritin (11.4 μg/L; p < 0.001) and decreased soluble transferrin receptor (−0.54 mg/L; p < 0.001) at 12 weeks.

Interpretation:

Iron supplementation should be considered for women with unexplained fatigue who have ferritin levels below 50 μg/L. We suggest assessing the efficiency using blood markers after six weeks of treatment. Trial registration no. EudraCT 2006–000478–56.The prevalence of fatigue ranges from 14% to 27% among patients in primary care.¹ In addition, 1%–2% of visits to general practices are because of fatigue, and women are three times more likely than men to mention fatigue.¹ Unexplained fatigue can be caused by iron deficiency.² Verdon and coauthors found an improvement in fatigue following iron supplementation in nonanemic women with unexplained fatigue.³ However, the hemoglobin levels of these patients were not available, which may have contributed to the ongoing debate about the appropriateness of reference limits defining anemia in women.^4,5 Thus, the effectiveness of iron supplementation in nonanemic menstruating women with major fatigue without an obvious clinical cause is unknown.⁶ Our main objective was to test the hypothesis that oral iron therapy for a short period may improve fatigue, hemoglobin, iron stores and quality of life in menstruating nonanemic women whose ferritin levels are below 50 μg/L. Our secondary objective was to evaluate whether this effect is dependent on the initial levels of hemoglobin, ferritin or transferrin saturation.     

Clinical evaluation of sizofiran combined with irradiation in patients with cervical cancer. A randomized controlled study; a five-year survival rate

Following a previous report we ascertained the effectiveness of sizofiran (Schizophyllan:SPG) to prolong the survival and time to recurrence of the patients with Stage II or III cervical cancer, as evaluated in a 5-year randomized controlled study conducted in 19 institutions in Japan. Of the overall patients with Stage II or III cancer, time to recurrence and survival rate in the group on SPG were significantly longer than in the control group. In the Stage II patients, there was significant difference in time to recurrence, and survival of SPG group tended to be longer than that of the control group. However, in the Stage III patients, there was no significant difference in either time to recurrence or survival rate.     

Cross-training effect of chronic whole-body vibration exercise: a randomized controlled study

Abstract

Purpose: To determine whether unilateral leg whole-body vibration (WBV) strength training induces strength gain in the untrained contralateral leg muscle. The secondary aim was to determine the potential role of spinal neurological mechanisms regarding the effect of WBV exercise on contralateral strength training.

Materials and Methods: Forty-two young adult healthy volunteers were randomized into two groups: WBV exercise and Sham control. An isometric semi-squat exercise during WBV was applied regularly through 20 sessions. WBV training was applied to the right leg in the WBV group and the left leg was isolated from vibration. Sham WBV was applied to the right leg of participants in the Control group. Pre- and post-training isokinetic torque and reflex latency of both quadricepses were evaluated.

Results: The increase in the strength of right (vibrated) knee extensors was 9.4?±?10.7% in the WBV group (p?=?.001) and was 1.2?±?6.6% in the Control group (p?=?.724). The left (non-vibrated) extensorsvibrated) knee extensors w4?±?8.4% in the WBV group (p?=?.038), whereas it decreased by 1.4?±?7.0% in the Control (p?=?.294). The strength gains were significant between the two groups. WBV induced the reflex response of the quadriceps muscle in the vibrated ipsilateral leg and also in the non-vibrated contralateral leg, though with a definite delay. The WBV-induced muscle reflex (WBV-IMR) latency was 22.5?±?7.7?ms for the vibrated leg and 39.3?±?14.6?ms for the non-vibrated leg.

Conclusions: Chronic WBV training has an effect of the cross-transfer of strength to contralateral homologous muscles. The WBV-induced muscular reflex may have a role in the mechanism of cross-transfer strength.     

A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD): study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders. METHODS: This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control).Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice.orControl group: Standard GP care, with referral to secondary care as required, but no access to ICCD.Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (<=7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients. DISCUSSION: Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.Trial registration[ClinicalTrials.gov: Identifier NCT00945204].