Randomized Controlled Trial of Bixalomer Versus Sevelamer Hydrochloride in Hemodialysis Patients With Hyperphosphatemia

Hyperphosphatemia is a prognostic factor for morbidity and mortality in chronic kidney disease. Bixalomer is a nonabsorbable polymer that decreases serum phosphate levels by binding phosphate in the gastrointestinal tract. This study compared the efficacy and safety of bixalomer versus sevelamer hydrochloride for controlling hyperphosphatemia in hemodialysis patients. This was a multicenter, randomized open‐label, non‐inferiority study. The primary endpoint was serum phosphate on completion of treatment. Administration of bixalomer was started at 1.5 g/day and adjusted to a maximum of 7.5 g/day depending on the serum phosphate level. Sevelamer hydrochloride was started at 3.0 or 6.0 g/day and adjusted to a maximum of 9.0 g/day. Treatment was continued for 12 weeks. Fifty‐five patients were randomized to each treatment group. After 12 weeks, the baseline adjusted mean serum phosphate level was 5.87 mg/dL in the bixalomer group and 5.55 mg/dL in the sevelamer group, with a difference of 0.31 mg/dL and 95% confidence interval (CI) of [?0.13 to 0.76]. The upper limit of the 95%CI for the difference of the mean serum phosphate level between the two groups was <1.0 mg/dL, which was the non‐inferiority margin in this study. Thus, non‐inferiority of bixalomer to sevelamer was confirmed. The incidence of adverse events was lower in the bixalomer group, and bixalomer did not promote acidosis. Bixalomer achieved a similar reduction of serum phosphate to sevelamer, while causing fewer adverse reactions. Consequently, the usefulness of bixalomer for treating hyperphosphatemia was confirmed.     

Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool

BackgroundPrimary care providers manage most patients with chronic pain. Pain is a complex problem, particularly in underserved populations. A technology-enabled, point-of-care decision support tool may improve pain management outcomes.MethodsWe created an electronic health record (EHR)-based decision support tool, the Pain Management Support System–Primary Care (PMSS-PC), and studied the tool-plus-education in 6 Federally Qualified Health Center practices using a randomized, wait-list controlled design. The PMSS-PC generated “best practice alerts,” gave clinicians access to a pain assessment template, psychological distress and substance use measures, guidelines for drug and non-drug therapies, and facilitated referrals. Practices were randomly assigned to early vs delayed (after 6 months) implementation of the intervention, including technical support and 6 webinars. The primary outcome was change in worst pain intensity scores after 6 months, assessed on the Brief Pain Inventory-Short Form. Changes in outcomes were compared between the practices using linear multilevel modeling. The EHR provided clinician data on PMSS-PC utilization.ResultsThe 256 patients in the early implementation practices had significantly improved worst pain (standardized effect size [ES] = −.32) compared with the 272 patients in the delayed implementation practices (ES = −.11). There was very low clinician uptake of the intervention in both conditions.ConclusionsEarly implementation of the PMSS-PC improved worst pain, but this effect cannot be attributed to clinician use of the tool. Further PMSS-PC development is not indicated, but practice-level interventions can improve pain, and studies are needed to identify the determinants of change.     

Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial

BACKGROUND

Low organ donation rates remain a major barrier to organ transplantation.

OBJECTIVE

We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider.

DESIGN

This was a randomized controlled trial between February 2013 and May 2014.

SETTING

The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio.

PATIENTS

The study included 915 patients over 15.5 years of age who had not previously consented to organ donation.

INTERVENTIONS

Just prior to their clinical encounter, intervention patients (n?=?456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n?=?459) visited their provider per usual routine.

MAIN MEASURES

The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter.

KEY RESULTS

Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10–2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1–20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61–1.25).

LIMITATION

How the observed increases in organ donation consent might translate into a greater organ supply is unclear.

CONCLUSION

Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01697137

     

Electronic Risk Alerts to Improve Primary Care Management of Chest Pain: A Randomized,Controlled Trial

BACKGROUND  

The primary care evaluation of chest pain represents a significant diagnostic challenge.     

Oral Food Intake Versus Fasting on Postoperative Pancreatic Fistula After Distal Pancreatectomy: A Multi-Institutional Randomized Controlled Trial

The usefulness of enteral nutrition via a nasointestinal tube for patients who develop postoperative pancreatic fistula (POPF) after miscellaneous pancreatectomy procedures has been reported. However, no clear evidence regarding whether oral intake is beneficial or harmful during management of POPF after distal pancreatectomy (DP) is currently available.To investigate the effects of oral food intake on the healing process of POPF after DP.Multi-institutional randomized controlled trial in Nagoya University Hospital and 4 affiliated hospitals.Patients who developed POPF were randomly assigned to the dietary intake (DI) group (n = 15) or the fasted group (no dietary intake [NDI] group) (n = 15). The primary endpoint was the length of drain placement.No significant differences were found in the length of drain placement between the DI and NDI groups (12 [6–58] and 12 [7–112] days, respectively; P = 0.786). POPF progressed to a clinically relevant status (grade B/C) in 5 patients in the DI group and 4 patients in the NDI group (P = 0.690). POPF-related intra-abdominal hemorrhage was found in 1 patient in the NDI group but in no patients in the DI group (P = 0.309). There were no significant differences in POPF-related intra-abdominal hemorrhage, the incidence of other complications, or the length of the postoperative hospital stay between the 2 groups.Food intake did not aggravate POPF and did not prolong drain placement or hospital stay after DP. There may be no need to avoid oral DI in patients with POPF.     

A Randomized Clinical Trial of Alcohol Care Management Delivered in Department of Veterans Affairs Primary Care Clinics Versus Specialty Addiction Treatment

BACKGROUNDAlcohol use disorder is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments, few individuals with an alcohol use disorder are actively engaged in treatment. Available evidence suggests that primary care may play a crucial role in the identification of patients with an alcohol use disorder, delivery of interventions, and the success of treatment.OBJECTIVEThe principal aims of this study were to test the effectiveness of a primary care-based Alcohol Care Management (ACM) program for alcohol use disorder and treatment engagement in veterans.DESIGNThe design of the study was a 26-week single-blind randomized clinical trial. The study was conducted in the primary care practices at three VA medical centers. Participants were randomly assigned to treatment in ACM or standard treatment in a specialty outpatient addiction treatment program.PARTICIPANTSOne hundred and sixty-three alcohol-dependent veterans were randomized.INTERVENTIONACM focused on the use of pharmacotherapy and psychosocial support. ACM was delivered in-person or by telephone within the primary care clinic.CONCLUSIONSResults demonstrate that treatment for an alcohol use disorder can be delivered effectively within primary care, leading to greater rates of engagement in treatment and greater reductions in heavy drinking.KEY WORDS: addiction, primary care, treatment, randomized clinical trial     

Plate Versus Intramedullary Fixation Care of Displaced Midshaft Clavicular Fractures: A Meta-Analysis of Prospective Randomized Controlled Trials

In recent decades, there has been a growing trend to the operative treatment of displaced midshaft clavicular fractures. Open reduction and internal plate fixation, and intramedullary nailing fixation are 2 of the widely used techniques for operative treatment, but the optimal fixation method for these types of fractures remains a topic of debate. The objective of this study was to determine the effectiveness of plate fixation versus intramedullary nailing fixation for displaced midshaft clavicle fractures by comparing their clinical results.Literature searches of the Pubmed, EMBASE, and Web of Science were performed from 1966 to April, 2015. Only randomized controlled clinical trials comparing plate and intramedullary nailing treatment for displaced midshaft clavicle fractures were included. Literature was screened, data were extracted, and methodological quality of the eligible trials was assessed by 2 independent reviewers accordingly.Seven randomized controlled trials involving 421 patients were included. Compared to intramedullary nailing fixation, plate fixation had a relatively longer mean surgical time and a trend towards a faster functional improvement during the first 6 months after surgery; apart from this, the pooled results revealed no significant differences in functional scores after 6 months postoperatively, complication rate and patients’ satisfaction between plate fixation and intramedullary fixation.Our results demonstrated that these 2 methods were comparable and safe in the treatment of displaced midshaft clavicle fractures. We advocate both techniques for the treatment of displaced midshaft clavicle fractures, and the superior surgical technique was those that the surgeon was originally trained to perform.     

Virtual Reality Training Versus Blended Learning of Laparoscopic Cholecystectomy: A Randomized Controlled Trial With Laparoscopic Novices

This study compared virtual reality (VR) training with low cost-blended learning (BL) in a structured training program.Training of laparoscopic skills outside the operating room is mandatory to reduce operative times and risks.Laparoscopy-naïve medical students were randomized in 2 groups stratified for sex. The BL group (n = 42) used E-learning for laparoscopic cholecystectomy (LC) and practiced basic skills with box trainers. The VR group (n = 42) trained basic skills and LC on the LAP Mentor II (Simbionix, Cleveland, OH). Each group trained 3 × 4 hours followed by a knowledge test concerning LC. Blinded raters assessed the operative performance of cadaveric porcine LC using the Objective Structured Assessment of Technical Skills (OSATS). The LC was discontinued when it was not completed within 80 min. Students evaluated their training modality with questionnaires.The VR group completed the LC significantly faster and more often within 80 min than BL (45% v 21%, P = .02). The BL group scored higher than the VR group in the knowledge test (13.3 ± 1.3 vs 11.0 ± 1.7, P < 0.001). Both groups showed equal operative performance of LC in the OSATS score (49.4 ± 10.5 vs 49.7 ± 12.0, P = 0.90). Students generally liked training and felt well prepared for assisting in laparoscopic surgery. The efficiency of the training was judged higher by the VR group than by the BL group.VR and BL can both be applied for training the basics of LC. Multimodality training programs should be developed that combine the advantages of both approaches.