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2014 JAMA
A bipartisan agreement reached by Sen Bernie Sanders (I, Vt) and Sen John McCain (R, Ariz) would give authority to the acting Veterans Affairs (VA) chief to fire senior officials immediately and to allow veterans who have experienced long waits or who live 40 miles or more from a VA facility to seek care with private physicians at other facilities. The legislation would also create a task force charged with reviewing the VA’s scheduling needs (http://1.usa.gov/1oa1ero). Similar legislation passed the House in May. A bipartisan bill seeks to reform the Department of Veterans Affairs (VA) and expand veterans’ access to medical care beyond VA facilities. ©iStock.com/OlegAlbinsky The bill would authorize the VA to spend $500 million to hire new physicians and nurses to address growing demands, improve access to care for military sexual assault survivors, and provide in-state tuition for veterans at public colleges or universities and GI Bill tuition benefits to the spouses of troops who died in the line of duty. The proposed bill comes after reports of inappropriate scheduling and falsification of records to conceal the long wait times experienced by many veterans seeking medical appointments. Senators Sanders and McCain compromised on the legislation after unveiling separate measures within the same week (http://1.usa.gov/1kTk4Rp; http://1.usa.gov/SHEYGG).
Iranmanesh, Pouya; Frossard, Jean-Louis; Mugnier-Konrad, Béatrice; Morel, Philippe; Majno, Pietro; Nguyen-Tang, Thai; Berney, Thierry; Mentha, Gilles; Toso, Christian
2014 JAMA
doi: 10.1001/jama.2014.7587pmid: 25005650
ImportanceThe optimal management of treatment for patients at intermediate risk of a common duct stone (including increased liver function tests but bilirubin <4 mg/dL and no cholangitis) is a matter of debate. Many stones migrate spontaneously into the duodenum, making preoperative common duct investigations unnecessary. ObjectiveTo compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone. The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations, morbidity, and costs. Design, Setting, and ParticipantsInterventional, randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013, with a patient follow-up of 6 months. The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital, Geneva, Switzerland, for acute gallstone-related conditions with an intermediate risk of a common duct stone. Fifty patients were randomized to each group. InterventionsCholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group. Main Outcomes and MeasuresLength of initial hospital stay (primary end point), number of common duct investigations and morbidity and mortality within 6 months after initial admission, and quality of life at 1 and 6 months after discharge (EQ-5D-5L [EuroQol Group, 5-level] questionnaire). ResultsPatients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay (median, 5 days [interquartile range {IQR}, 1-8] vs median, 8 days [IQR, 6-12]; P < .001), with fewer common duct investigations (25 vs 71; P < .001), no significant difference in morbidity or quality of life. Conclusions and RelevanceAmong patients at intermediate risk of a common duct stone, initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity. If these findings are confirmed, initial cholecystectomy with intraoperative cholangiogram may be a preferred approach. Trial RegistrationClinicaltrials.gov Identifier: NCT01492790.
Regimbeau, Jean Marc; Fuks, David; Pautrat, Karine; Mauvais, Francois; Haccart, Vincent; Msika, Simon; Mathonnet, Muriel; Scotté, Michel; Paquet, Jean Christophe; Vons, Corinne; Sielezneff, Igor; Millat, Bertrand; Chiche, Laurence; Dupont, Hervé; Duhaut, Pierre; Cossé, Cyril; Diouf, Momar; Pocard, Marc
2014 JAMA
doi: 10.1001/jama.2014.7586pmid: 25005651
ImportanceNinety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment. ObjectiveTo determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy. Design, Setting, and PatientsA total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012. InterventionsAfter surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days. Main Outcomes and MeasuresThe proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit. ResultsAn imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, −8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, −5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V. Conclusions and RelevanceAmong patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections. Trial Registrationclinicaltrials.gov Identifier: NCT01015417
Koegelenberg, Coenraad F. N.; Noor, Firdows; Bateman, Eric D.; van Zyl-Smit, Richard N.; Bruning, Axel; O’Brien, John A.; Smith, Clifford; Abdool-Gaffar, Mohamed S.; Emanuel, Shaunagh; Esterhuizen, Tonya M.; Irusen, Elvis M.
2014 JAMA
doi: 10.1001/jama.2014.7195pmid: 25005652
ImportanceBehavioral approaches and pharmacotherapy are of proven benefit in assisting smokers to quit, but it is unclear whether combining nicotine replacement therapy (NRT) with varenicline to improve abstinence is effective and safe. ObjectiveTo evaluate the efficacy and safety of combining varenicline and a nicotine patch vs varenicline alone in smoking cessation. Design, Setting, and ParticipantsRandomized, blinded, placebo-controlled clinical trial with a 12-week treatment period and a further 12-week follow-up conducted in 7 centers in South Africa from April 2011 to October 2012. Four hundred forty-six generally healthy smokers were randomized (1:1); 435 were included in the efficacy and safety analyses. InterventionsNicotine or placebo patch treatment began 2 weeks before a target quit date (TQD) and continued for a further 12 weeks. Varenicline was begun 1 week prior to TQD, continued for a further 12 weeks, and tapered off during week 13. Main Outcomes and MeasuresTobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at TQD and at intervals thereafter up to 24 weeks. The primary end point was the 4-week exhaled carbon monoxide–confirmed continuous abstinence rate for weeks 9 through 12 of treatment, ie, the proportion of participants able to maintain complete abstinence from smoking for the last 4 weeks of treatment, as assessed using multiple imputation analysis. Secondary end points included point prevalence abstinence at 6 months, continuous abstinence rate from weeks 9 through 24, and adverse events. Multiple imputation also was used to address loss to follow-up. ResultsThe combination treatment was associated with a higher continuous abstinence rate at 12 weeks (55.4% vs 40.9%; odds ratio [OR], 1.85; 95% CI, 1.19-2.89; P = .007) and 24 weeks (49.0% vs 32.6%; OR, 1.98; 95% CI, 1.25-3.14; P = .004) and point prevalence abstinence rate at 6 months (65.1% vs 46.7%; OR, 2.13; 95% CI, 1.32-3.43; P = .002). In the combination treatment group, there was a numerically greater incidence of nausea, sleep disturbance, skin reactions, constipation, and depression, with only skin reactions reaching statistical significance (14.4% vs 7.8%; P = .03); the varenicline-alone group experienced more abnormal dreams and headaches. Conclusions and RelevanceVarenicline in combination with NRT was more effective than varenicline alone at achieving tobacco abstinence at 12 weeks (end of treatment) and at 6 months. Further studies are needed to assess long-term efficacy and safety. Trial Registrationclinicaltrials.gov Identifier: NCT01444131
Dvir, Danny; Webb, John G.; Bleiziffer, Sabine; Pasic, Miralem; Waksman, Ron; Kodali, Susheel; Barbanti, Marco; Latib, Azeem; Schaefer, Ulrich; Rodés-Cabau, Josep; Treede, Hendrik; Piazza, Nicolo; Hildick-Smith, David; Himbert, Dominique; Walther, Thomas; Hengstenberg, Christian; Nissen, Henrik; Bekeredjian, Raffi; Presbitero, Patrizia; Ferrari, Enrico; Segev, Amit; de Weger, Arend; Windecker, Stephan; Moat, Neil E.; Napodano, Massimo; Wilbring, Manuel; Cerillo, Alfredo G.; Brecker, Stephen; Tchetche, Didier; Lefèvre, Thierry; De Marco, Federico; Fiorina, Claudia; Petronio, Anna Sonia; Teles, Rui C.; Testa, Luca; Laborde, Jean-Claude; Leon, Martin B.; Kornowski, Ran
2014 JAMA
doi: 10.1001/jama.2014.7246pmid: 25005653
ImportanceOwing to a considerable shift toward bioprosthesis implantation rather than mechanical valves, it is expected that patients will increasingly present with degenerated bioprostheses in the next few years. Transcatheter aortic valve-in-valve implantation is a less invasive approach for patients with structural valve deterioration; however, a comprehensive evaluation of survival after the procedure has not yet been performed. ObjectiveTo determine the survival of patients after transcatheter valve-in-valve implantation inside failed surgical bioprosthetic valves. Design, Setting, and ParticipantsCorrelates for survival were evaluated using a multinational valve-in-valve registry that included 459 patients with degenerated bioprosthetic valves undergoing valve-in-valve implantation between 2007 and May 2013 in 55 centers (mean age, 77.6 [SD, 9.8] years; 56% men; median Society of Thoracic Surgeons mortality prediction score, 9.8% [interquartile range, 7.7%-16%]). Surgical valves were classified as small (≤21 mm; 29.7%), intermediate (>21 and <25 mm; 39.3%), and large (≥25 mm; 31%). Implanted devices included both balloon- and self-expandable valves. Main Outcomes and MeasuresSurvival, stroke, and New York Heart Association functional class. ResultsModes of bioprosthesis failure were stenosis (n = 181 [39.4%]), regurgitation (n = 139 [30.3%]), and combined (n = 139 [30.3%]). The stenosis group had a higher percentage of small valves (37% vs 20.9% and 26.6% in the regurgitation and combined groups, respectively; P = .005). Within 1 month following valve-in-valve implantation, 35 (7.6%) patients died, 8 (1.7%) had major stroke, and 313 (92.6%) of surviving patients had good functional status (New York Heart Association class I/II). The overall 1-year Kaplan-Meier survival rate was 83.2% (95% CI, 80.8%-84.7%; 62 death events; 228 survivors). Patients in the stenosis group had worse 1-year survival (76.6%; 95% CI, 68.9%-83.1%; 34 deaths; 86 survivors) in comparison with the regurgitation group (91.2%; 95% CI, 85.7%-96.7%; 10 deaths; 76 survivors) and the combined group (83.9%; 95% CI, 76.8%-91%; 18 deaths; 66 survivors) (P = .01). Similarly, patients with small valves had worse 1-year survival (74.8% [95% CI, 66.2%-83.4%]; 27 deaths; 57 survivors) vs with intermediate-sized valves (81.8%; 95% CI, 75.3%-88.3%; 26 deaths; 92 survivors) and with large valves (93.3%; 95% CI, 85.7%-96.7%; 7 deaths; 73 survivors) (P = .001). Factors associated with mortality within 1 year included having small surgical bioprosthesis (≤21 mm; hazard ratio, 2.04; 95% CI, 1.14-3.67; P = .02) and baseline stenosis (vs regurgitation; hazard ratio, 3.07; 95% CI, 1.33-7.08; P = .008). Conclusions and RelevanceIn this registry of patients who underwent transcatheter valve-in-valve implantation for degenerated bioprosthetic aortic valves, overall 1-year survival was 83.2%. Survival was lower among patients with small bioprostheses and those with predominant surgical valve stenosis.
Murad, Mohammad Hassan; Montori, Victor M.; Ioannidis, John P. A.; Jaeschke, Roman; Devereaux, P. J.; Prasad, Kameshwar; Neumann, Ignacio; Carrasco-Labra, Alonso; Agoritsas, Thomas; Hatala, Rose; Meade, Maureen O.; Wyer, Peter; Cook, Deborah J.; Guyatt, Gordon
2014 JAMA
doi: 10.1001/jama.2014.5559pmid: 25005654
Clinical decisions should be based on the totality of the best evidence and not the results of individual studies. When clinicians apply the results of a systematic review or meta-analysis to patient care, they should start by evaluating the credibility of the methods of the systematic review, ie, the extent to which these methods have likely protected against misleading results. Credibility depends on whether the review addressed a sensible clinical question; included an exhaustive literature search; demonstrated reproducibility of the selection and assessment of studies; and presented results in a useful manner. For reviews that are sufficiently credible, clinicians must decide on the degree of confidence in the estimates that the evidence warrants (quality of evidence). Confidence depends on the risk of bias in the body of evidence; the precision and consistency of the results; whether the results directly apply to the patient of interest; and the likelihood of reporting bias. Shared decision making requires understanding of the estimates of magnitude of beneficial and harmful effects, and confidence in those estimates.
Moore, Andrew; Wiffen, Philip; Kalso, Eija
2014 JAMA
doi: 10.1001/jama.2014.6336pmid: 25005656
Clinical QuestionAre antiepileptic drugs associated with reduced pain intensity in patients with neuropathic pain or fibromyalgia? Bottom LineIn treating diabetic neuropathy and postherpetic neuralgia compared with placebo, gabapentin and pregabalin are associated with a modest increase in the number of patients experiencing meaningful pain reduction. In treating fibromyalgia, compared with placebo, pregabalin alone is associated with a small increase in the number of patients experiencing meaningful pain reduction. There is insufficient evidence for other antiepileptics.