Longer Time Off Research Articles

Dynamics and durability of HIV-1 neutralization are determined by viral replication

Human immunodeficiency virus type 1 (HIV-1)-neutralizing antibodies (nAbs) that prevent infection are the main goal of HIV vaccine discovery. But as no nAb-eliciting vaccines are yet available, only data from HIV-1 neutralizers—persons with HIV-1 who naturally develop broad and potent nAbs—can inform about the dynamics and durability of nAb responses in humans, knowledge which is crucial for the design of future HIV-1 vaccine regimens. To address this, we assessed HIV-1-neutralizing immunoglobulin G (IgG) from 2,354 persons with HIV-1 on or off antiretroviral therapy (ART). Infection with non-clade B viruses, CD4+ T cell counts <200 µl−1, being off ART and a longer time off ART were independent predictors of a more potent and broad neutralization. In longitudinal analyses, we found nAb half-lives of 9.3 and 16.9 years in individuals with no- or low-level viremia, respectively, and 4.0 years in persons who newly initiated ART. Finally, in a potent HIV-1 neutralizer, we identified lower fractions of serum nAbs and of nAb-encoding memory B cells after ART initiation, suggesting that a decreasing neutralizing serum activity after antigen withdrawal is due to lower levels of nAbs. These results collectively show that HIV-1-neutralizing responses can persist for several years, even at low antigen levels, suggesting that an HIV-1 vaccine may elicit a durable nAb response.

Does Fitzpatrick Score Predict Flap Loss? Microsurgical Breast Reconstruction Outcomes of Varying Skin Color.

This is a retrospective study conducted on patients who underwent any type of autologous flap breast reconstruction performed by the two senior authors at an academic center between January 2010 and December 2021. The sole primary outcome variable was flap loss. Patient skin tone was assessed using the Fitzpatrick scale on clinical photographs of patients. A total of 1115 pateints underwent autologous flap breast reconstruction, of which only 56 met both exclusion and inclusion criteria with 58 individual breasts being included in the final study population. The most common race of subjects was White (n = 33; 56.9%) while the most common Fitzpatrick score skin tone was type II (n = 22; 37.9%). The Cochran-Armitage test of trend showed a statistically significant linear trend, P = 0.006, with darker Fitzpatrick score skin tones associated with a higher proportion of flap loss in patients who had vascular compromise. A logistic regression showed that none of the predictor variables were significant. Patients with darker Fitzpatrick skin tones were associated with flap loss after vascular compromise. To prevent flap loss in patients who have darker Fitzpatrick score skin tones, more aggressive flap monitoring should be taken into consideration in the immediate postoperative setting.

The Characteristics of Accepted Work-related Injuries and Diseases Claims in the Australian Coal Mining Industry

BackgroundCoal mining is a hazardous industry. The purpose of the study is to identify the nature of occupational injuries and diseases among coal miners and to determine the factors that affect the rate of injury and duration of time loss from work. MethodsA retrospective cohort study was conducted using accepted workers' compensation claims data of 30,390 Australian coal miners between July 2003 and June 2017. ResultsMusculoskeletal and fracture conditions accounted for approximately 60% of claims in all occupational groups. Cox regression analysis showed that older age and female gender were significant predictors of longer time off work. Injury types and occupations were associated with work time loss: mental health conditions, and machine operators and drivers had significantly longer durations of time off work. ConclusionFuture research can further address how these factors led to longer time off work so that coal industry regulators, employers, and healthcare providers can target interventions more effectively to these at-risk workers.

The Association Between Statin Use and Outcomes in Patients Initiating Androgen Deprivation Therapy

BackgroundStudies have conflicting results regarding the association between statin use and biochemical recurrence for prostate cancer (PCa). A limited number of studies examining statins in advanced stages report positive results, with a few specifically examining statins and androgen deprivation therapy (ADT). ObjectiveTo perform a post hoc secondary analysis of a randomised controlled trial (RCT) of men initiating ADT to examine the association between statin use and outcomes. Design, setting, and participantsPatients with prostate-specific antigen (PSA) >3 ng/ml >1 yr following primary/salvage radiotherapy were enrolled in an RCT of intermittent androgen deprivation (IAD) versus continuous ADT (NCT00003653). Baseline and on-study statin use was modelled as a time-dependent covariate. Outcome measurements and statistical analysisThe primary endpoint was overall survival. Models were adjusted for age, time from radiotherapy to ADT, baseline PSA, and prior ADT. Results and limitationsOf 1364 patients, statin users (585; 43%) were younger (72.7 vs 73.8 yr, p = 0.001) and less likely to have PSA >15 ng/ml (20% vs 25%, p = 0.04). After a median follow-up of 6.9 yr, statin use was associated with reduced overall (hazard ratio [HR]: 0.64; 95% confidence interval [CI] 0.53–0.78, p < 0.001) and PCa-specific (HR: 0.65, 95% CI 0.48–0.87, p = 0.004) mortality. Statin users had 13% longer time to castration resistance, but this did not reach statistical significance (p = 0.15). As an exploratory endpoint, in the IAD arm, statin users had longer time off treatment (median: 0.85 vs 0.64 yr, p = 0.06). Limitations include potential for residual confounding between statin users and nonusers, and confounding by indication. ConclusionsIn men treated with ADT following primary or salvage radiotherapy, statin use was associated with improved overall and PCa-specific survival. In patients treated with IAD, statin use was associated with a trend towards longer time off treatment. A prospective trial of statins in men commencing ADT is warranted. Patient summaryWe found a favourable association between statin use and survival outcomes in patients initiating androgen deprivation therapy.

Impact of Patient-Surgeon Relationship on Patient’s Return to Work

Upper-limb injuries and musculoskeletal disorders represent a major economic burden for both patients and society, largely due to limitations in returning to work. We hypothesized that a positive patient-surgeon relationship may facilitate patients' recovery and lead to a faster return to work. This longitudinal observational study comprised 219 patients, from 8 French hand trauma centers, who were 18 to 55 years of age and were on sick leave from work because of an injury or musculoskeletal disorder of the upper limb. In addition to instruments measuring patients' functional scores and quality of life, the quality of the patient-surgeon relationship was assessed at enrollment using a specific questionnaire (Q-PASREL [Quality of PAtient-Surgeon RELationship]). Six months after enrollment, the return-to-work status was assessed. Logistic and Cox regression models were developed to identify predictors of return to work (yes/no) and the time off from work in days. Overall, 74% of the patients who returned to work within 6 months after enrollment had a high or medium-high Q-PASREL score, whereas 64% of the patients who were still on sick leave had a low or medium-low Q-PASREL score. The odds of patients with a low or medium-low Q-PASREL score returning to work were, respectively, 95% and 71% lower than the odds of patients with a high score doing so, with a percent difference of 56% (95% confidence interval [CI] = 40% to 71%) for low versus high (odds ratio [OR] = 0.05 [95% CI = 0.02 to 0.13]) and 25% (95% CI = 6% to 44%) for medium-low versus high (OR = 0.29 [95% CI = 0.11 to 0.76]). All Q-PASREL items and scores were significantly associated with return to work. Patients with a lower Q-PASREL score and more severe disability were less likely to return to work within 6 months and had a longer time off from work. Efforts to improve the quality of patient-surgeon relationships may minimize the duration of sick leaves and accelerate patient recovery. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

MYOCARDIAL DAMAGEq

Background: Intermittent antegrade warm blood cardioplegia is routinely usedas a mean of myocardial protection since its introduction. There is a considerable debate onthe longest time off cardioplegia interval during aortic cross clamping. Objective: To see thefrequency and extent of myocardial damage in patients undergoing CABG receiving intermittentantegrade warm blood Cardioplegia at LTOC (longest time off cardioplegia) 11-15 minutes(Group I) and 16-20 minutes (Group II). Patients and Methods: A randomized prospectivestudy involving 94 patients was arranged to see the safe periods of intermittency. There weretwo groups of patients having LTOC of 11-15 minutes (Group I) and 16-20 minutes (GroupII). 20 minutes was the upper limit. The duration of study was from 1-09-2013 to 10-02-2014.Data was analyzed using SPSS Version 16. Independent sample t-test and chi-square wereapplied to see the significance. Results: Mean age was 54.1±9.36 years. There were moremales as compared to females. More than 50% of the patients had Hypertension and Diabetes.There was no urgent surgery. Triple vessel disease (TVD) was present in 48.9% patients and40.4% had Double vessel disease (DVD). Average blood flow during CPB was 2.4±0.14 (L/min.m-2). Average body temperatures were 31.7±2.30C. Cardioplegia temperature was 36-370C.According to Left Ventricular Function Classification, 43.6% of the patients were of LV grade IIand 10.6% of LV grade III. There was no significant increase in the levels of CK-MB in two groups.77.8% patient in Group I and 66.7% in Group II gained spontaneous rhythm (p-value 0.16). IABPwas inserted in 5.4% patients in group I and 5.6% in group II (p-value 0.97). There was no failureto wean off from bypass and no peri-operative mortality. The levels of inotropes viz dopamineand epinephrine on weaning were also almost the same. Perioperative MI occurred only in 7patients (ruled out by biochemical evidence). Conclusions: A reasonable margin of safetyexists with intermittent antegrade warm blood cardioplegia in these two groups. So the LTOC(longest time off cardioplegia) up to 20 minutes is unlikely to lead to adverse clinical outcomesand is clinically acceptable.

Factors Associated With Noncompliance With Long-term Follow-up Care Among Pediatric Cancer Survivors.

Most childhood cancer survivors do not receive risk-based care through a survivorship program, but factors associated with dropping out of care are unclear. This study aimed to identify characteristics of pediatric cancer survivors who do not return to a cancer center survivorship program for recommended care after at least 1 visit compared with those who continue to attend. Patient characteristics (demographics, school functioning, psychiatric history) and treatment characteristics (diagnosis, treatment) were abstracted from medical records for all eligible patients. Unadjusted and multivariable logistic regression analyses examined the associations among patient and treatment characteristics and nonattendance. The charts of 400 eligible patients (children below 18, n=123; adults, n=277) were reviewed. Of these, 60.3% of patients had not been seen in clinic within 1 year of their last recommended follow-up appointment. Adult-aged survivors were less likely to return to clinic than child-aged survivors (P<0.001). For child survivors, longer time off treatment was associated with noncompliance with follow-up. For adult survivors, current age, nonwhite race, and longer time off treatment were associated with noncompliance. Additional methods to identify survivors at risk for noncompliance with follow-up and interventions for at-risk survivors are needed to improve survivorship care.

Treatment of glenohumeral instability in rugby players.

Rugby is a high-impact collision sport, with impact forces. Shoulder injuries are common and result in the longest time off sport for any joint injury in rugby. The most common injuries are to the glenohumeral joint with varying degrees of instability. The degree of instability can guide management. The three main types of instability presentations are: (1) frank dislocation, (2) subluxations and (3) subclinical instability with pain and clicking. Understanding the exact mechanism of injury can guide diagnosis with classical patterns of structural injuries. The standard clinical examination in a large, muscular athlete may be normal, so specific tests and techniques are needed to unearth signs of pathology. Taking these factors into consideration, along with the imaging, allows a treatment strategy. However, patient and sport factors need to be also considered, particularly the time of the season and stage of sporting career. Surgery to repair the structural damage should include all lesions found. In chronic, recurrent dislocations with major structural lesions, reconstruction procedures such as the Latarjet procedure yields better outcomes. Rehabilitation should be safe, goal-driven and athlete-specific. Return to sport is dependent on a number of factors, driven by the healing process, sport requirements and extrinsic pressures.Level of evidence V.

MP73-04 THE ASSOCIATION BETWEEN STATIN USE AND OUTCOMES IN PATIENTS INITIATING ANDROGEN DEPRIVATION THERAPY

Abstract Background Studies have conflicting results regarding the association between statin use and biochemical recurrence for prostate cancer (PCa). A limited number of studies examining statins in advanced stages report positive results, with a few specifically examining statins and androgen deprivation therapy (ADT). Objective To perform a post hoc secondary analysis of a randomised controlled trial (RCT) of men initiating ADT to examine the association between statin use and outcomes. Design, setting, and participants Patients with prostate-specific antigen (PSA) >3 ng/ml >1 yr following primary/salvage radiotherapy were enrolled in an RCT of intermittent androgen deprivation (IAD) versus continuous ADT (NCT00003653). Baseline and on-study statin use was modelled as a time-dependent covariate. Outcome measurements and statistical analysis The primary endpoint was overall survival. Models were adjusted for age, time from radiotherapy to ADT, baseline PSA, and prior ADT. Results and limitations Of 1364 patients, statin users (585; 43%) were younger (72.7 vs 73.8 yr, p = 0.001) and less likely to have PSA >15 ng/ml (20% vs 25%, p = 0.04). After a median follow-up of 6.9 yr, statin use was associated with reduced overall (hazard ratio [HR]: 0.64; 95% confidence interval [CI] 0.53–0.78, p Conclusions In men treated with ADT following primary or salvage radiotherapy, statin use was associated with improved overall and PCa-specific survival. In patients treated with IAD, statin use was associated with a trend towards longer time off treatment. A prospective trial of statins in men commencing ADT is warranted. Patient summary We found a favourable association between statin use and survival outcomes in patients initiating androgen deprivation therapy.

Controversies relating to the management of acromioclavicular joint dislocations

The aim of this review is to address controversies in the management of dislocations of the acromioclavicular joint. Current evidence suggests that operative rather than non-operative treatment of Rockwood grade III dislocations results in better cosmetic and radiological results, similar functional outcomes and longer time off work. Early surgery results in better functional and radiological outcomes with a reduced risk of infection and loss of reduction compared with delayed surgery. Surgical options include acromioclavicular fixation, coracoclavicular fixation and coracoclavicular ligament reconstruction. Although non-controlled studies report promising results for arthroscopic coracoclavicular fixation, there are no comparative studies with open techniques to draw conclusions about the best surgical approach. Non-rigid coracoclavicular fixation with tendon graft or synthetic materials, or rigid acromioclavicular fixation with a hook plate, is preferable to fixation with coracoclavicular screws owing to significant risks of loosening and breakage. The evidence, although limited, also suggests that anatomical ligament reconstruction with autograft or certain synthetic grafts may have better outcomes than non-anatomical transfer of the coracoacromial ligament. It has been suggested that this is due to better restoration horizontal and vertical stability of the joint. Despite the large number of recently published studies, there remains a lack of high-quality evidence, making it difficult to draw firm conclusions regarding these controversial issues.

Factors that contribute to post-treatment follow-up care for survivors of childhood cancer

As children complete cancer treatment and enter survivorship, follow-up care is critical to monitor for and treat relapses, secondary malignancies, and late effects of treatment. Relative contributions of cancer and treatment variables and sociodemographic factors in engagement with follow-up care are not fully understood. This study aimed to identify risk factors for inadequate follow-up care. The sample included a cohort of 173 children (birth-18 years) diagnosed with cancer in 2004 and treated at a children's hospital. Sociodemographics (gender, patient current age, ethnic minority status, distance from hospital, type of insurance), cancer and treatment variables (patient age at diagnosis, type of cancer, treatment modality, time off treatment, relapse, on clinical trial protocol), and follow-up care through 2009 were gathered via the hospital tumor registry and medical charts. In simultaneous linear regression analysis (full model: F(12, 160) = 3.49, R2 = 0.21, p = 0.001), having a liquid tumor (p < 0.05), presence of relapse (p = 0.009), and shorter distance from hospital (p = 0.006) predicted total number of follow-up visits between completion of treatment and 5 years post-diagnosis. In simultaneous logistic regression analysis (full model: χ2 (12, N = 173) = 53.27, p < 0.001), being male (p = 0.077), having a brain tumor (p = 0.055), longer time off treatment (p = 0.004), and greater distance from hospital (p = 0.003) decreased the likelihood of completing a follow-up or survivorship visit between completion of treatment and 5 years post-diagnosis. In simultaneous linear regression analysis (full model: F(12, 160) = 4.52, R2 = 0.25, p = 0.001), non-White race (p = 0.001) and having public insurance (p = 0.002) predicted total number of no shows between completion of treatment and 5 years post-diagnosis. These results extend knowledge of health disparities in pediatric cancer follow-up care suggesting that cancer and treatment-related variables (type of cancer, relapse, number of treatment modalities) and sociodemographic factors (distance from treatment center, non-White race, public insurance) are important predictors of engagement in follow-up care. Survivors at risk for poor engagement may benefit from targeted interventions designed to increase likelihood of follow-up care.

Incidence and management of shoulder injuries in premier league professional football players

Shoulder injuries in football are less common than lower limb injuries, but are often more serious than many other injuries and result in a longer time off play. No study...

Commentary on Vangeli et al. (2011): Towards an improved understanding of smoking relapse predictors – recipe for success?

Commentary on Vangeli <i>et al</i>. (2011): Towards an improved understanding of smoking relapse predictors – recipe for success?

Operative versus nonoperative treatment of acute undisplaced and minimally displaced scaphoid waist fractures—A systematic review

Introduction Undisplaced and minimally displaced scaphoid waist fractures can be managed either operatively (percutaneous or ORIF) or non-operatively with both methods obtaining high rates of fracture union and subsequent return of function. The aim of this systematic review is to identify and evaluate the best available evidence to determine whether they should be managed operatively or non-operatively. Materials and methods A Medline and journal hand search was performed with strict eligibility criteria to obtain the highest quality evidence from meta-analyses, randomised controlled trials (RCT) and comparative studies. Included studies were critically appraised using levels of evidence and RCTs were further appraised using a scoring tool. Results The search found 112 studies, of which 12 met the eligibility criteria for inclusion. Three level 1 RCTs, three level 2 RCTs, two meta-analyses, one economic analysis, and three retrospective studies were critically appraised. The evidence suggests that percutaneous fixation may result in faster union rates by approximately 5 weeks and an earlier return to sport and work by approximately 7 weeks over cast treatment. This difference is not seen when comparing ORIF with cast treatment. Although cast treatment results in a higher non-union rate than ORIF, this needs to be balanced with the 30% minor complication rate. Manual workers require significantly longer time off work than non-manual workers regardless of the method of treatment, although they did return to work sooner after ORIF than after cast treatment. Conclusion The majority of these injuries can be treated in a cast with good results. Operative treatment should be reserved for patients unable to work in a cast and considered for most manual workers and high-level athletes.

Payments to injured professional jockeys in British horse racing (1996–2006)

Objective:To determine the direct and indirect cost of injuries in professional jockeys as a result of race riding.Design:Cohort study.Setting:Professional horse racing.Participants:Professional jockeys in the UK registered with the Jockey Club.Main...

Locally advanced prostate cancer—biochemical results from a prospective phase II study of intermittent androgen suppression for men with evidence of prostate‐specific antigen recurrence after radiotherapy

Biochemical results from a prospective Phase II trial of intermittent androgen suppression for recurrent prostate cancer after radiotherapy were analyzed for correlations to the onset of hormone-refractory disease. Patients with histologically confirmed adenocarcinoma of the prostate and a rising serum prostate-specific antigen (PSA) level after external beam irradiation of the prostate were treated intermittently with a 36-week course of cyproterone acetate and leuprolide acetate. Then, patients were stratified according to their serum PSA range at the start of each cycle and were followed with further biochemical testing until disease progression was evident. The mean PSA reduction was 95.2% irrespective of stratification group. A baseline serum PSA level <10 microg/L and a serum PSA nadir <or=0.2 microg/L were associated with the longest time off treatment. The overall mean nadir PSA value in the progression group at 1.40 +/- 0.19 microg/L was 2.6-fold greater than the value of 0.55 +/- 0.88 microg/L in the no-progression group (P = .0002). Recovery of serum testosterone to a level of >or=7.5 nmol/L was observed in 75%, 50%, 40%, and 30% of men in Cycles 1 to 4, respectively, and was sufficient to normalize the level of hemoglobin in each cycle, which dropped by an average of 10.8 g/L during treatment (P < .0001). The length of the off-treatment interval during cyclic androgen withdrawal therapy was related inversely to baseline and nadir levels of serum PSA. Nadir PSA was a powerful predictor of early progression to androgen independence.

Comparison of direct and indirect costs of internal fixation and cast treatment in acute scaphoid fractures: A randomized trial involving 52 patients

Background The most cost-effective treatment of scaphoid fractures has not yet been determined.Methods In a prospective trial, 52 employed or selfemployed patients with scaphoid fractures were randomized to closed (cast) or surgical treatment.Results There were 3 complications in the surgical group and 1 in the cast group. Median time off work was numerically but not statistically significantly greater after cast than after surgery (74/39 days). Manual workers (manuals) had a longer time away from work than non-manual employees/individuals who were selfemployed (non-manuals; median 84 days and 16 days, respectively; p < 0.001) and they had a longer time off work after cast than after surgery (median 100 days and 61 days; p = 0.03). Hospital costs were lower after cast than after surgery (p < 0.001). Work disability costs were numerically but not statistically significantly higher after cast than after surgery, and similarly, the total costs were lower after cast than after surgery. Work disability costs and total costs were higher in manuals than in non-manuals (p < 0.001). Non-manuals had lower total costs after cast than after surgery (p = 0.05).Interpretation There was a longer period of absence from work after cast than after surgery in manuals, but not in non-manuals. In non-manuals, total costs were lower after cast than after surgery. Socioeconomic classification had a greater influence on cost than mode of treatment.

A study of factors influencing return to work after wrist or ankle fractures

Factors associated with time to return to work are poorly understood for occupational injuries, other than those to the back. Anonymized data on claims for work-related wrist or ankle fracture between 1/1/1998 and 12/31/2002 were identified in administrative data held by the Workers Compensation Board in Alberta, Canada. Bivariate and Cox regression analyses were used to identify factors associated with return to work. Increased duration of temporary disability (TD) was associated with older age, female gender, work in construction and construction trade services, smaller company size, higher industry claim rates, a fall/jump from a height, ankle fracture, and greater medical aid costs in the 30 days following injury (used as a proxy for severity). Factors associated with longer time off work were largely consistent with those reported following back injury. Median time to return to work was longer following ankle than wrist fracture. Although Workers' Compensation Board (WCB) administrative data provided information that could be used to identify factors affecting return to work, better information on injury severity would considerably enhance their research potential.

Ein einfaches Bewertungssystem zur Einschätzung von Handverletzungen hinsichtlich der resultierenden Arbeitsunfähigkeit

Hintergrund: Bei Handverletzungen besteht ein Interesse, möglichst frühzeitig anhand des Verletzungsmusters die voraussichtliche Dauer der Arbeitsunfähigkeit einzuschätzen. Existierende Bewertungsschemata wie z. B. der HISS-Score (Hand Injury Severity Scoring System) sind komplex und aufwändig zu bestimmen. Material und Methoden: Basierend auf bei Handverletzungen auftretenden Verletzungsmustern bzw. der beteiligten Strukturen wurde ein einfach zu bestimmendes Bewertungssystem entwickelt. Anhand dieses Schemas wurden 180 Arbeitsunfälle (1997 - 2002), bei denen isoliert eine Hand betroffen war, prospektiv analysiert. Das mittlere Alter der Verletzten betrug 37,9 (18 - 65) Jahre, der Frauenanteil 11 %. Ergebnisse: Die häufigste Verletzungslokalisation waren mit 55 % der Fälle die Langfinger, von denen wiederum der Zeigefinger am häufigsten betroffen war. Die längste Dauer der Arbeitsunfähigkeit wurde durch revaskularisationspflichtige Schäden und Weichteildefekte verursacht. Die Korrelation zwischen dem neu entwickelten Bewertungsschema und der Dauer der AU (p < 0,0001, r = 0,46) war stärker als die Korrelation zwischen HISS-Wert und Dauer der AU (p < 0,0001, r = 0,37). Weiterhin ergab sich eine signifikante Korrelation zwischen dem Bewertungsschema und der Dauer des stationären Aufenthaltes (p < 0,0001). Schlussfolgerung: Durch den Score kann schnell und auf einfache Weise eine grobe Einschätzung der voraussichtlichen Dauer der Arbeitsunfähigkeit erfolgen.

Endoscopic balloon dilation compared with sphincterotomy for extraction of bile duct stones

Endoscopic retrograde cholangiopancreatography is commonly performed to remove bile duct stones. The aim of this study was to determine short-term outcomes of endoscopic balloon dilation of the sphincter of Oddi compared with sphincterotomy for stone extraction. A randomized, controlled multicenter study of 117 patients assigned to dilation and 120 to sphincterotomy was performed in a spectrum of clinical and academic practices. Characteristics of the patients, procedures, and endoscopists were similar except that dilation patients were younger. Procedures were successful in 97.4% and 92.5% of the dilation and sphincterotomy patients, respectively. Overall morbidity occurred in 17.9% and 3.3% ( P < .001; difference, 14.6; 95% confidence interval, 7-22.3) and severe morbidity, including 2 deaths, in 6.8% and 0%( P < .004; difference, 6.8; 95% confidence interval, 2.3-11.4) for dilation and sphincterotomy, respectively. Complications for dilation and sphincterotomy, respectively, included: pancreatitis, 15.4% and .8% ( P < .001; difference, 14.6; 95% confidence interval, 7.8-21.3); cystic duct fistula, 1.7% and 0%; cholangitis, .9% and .8%; perforation, 0% and .8%; and cholecystitis, 0% and .8%. There were 2 deaths (1.7%) due to pancreatitis following dilation and none with sphincterotomy. The study was terminated at the first interim analysis. Dilation patients required significantly more invasive procedures, longer hospital stays, and longer time off from normal activities. In a broad spectrum of patients and practices, endoscopic balloon dilation compared with sphincterotomy for biliary stone extraction is associated with increased short-term morbidity rates and death due to pancreatitis. Balloon dilation of the sphincter of Oddi for stone extraction should be avoided in routine practice.