Lauren A. Beaupre

Liberal or Restrictive Transfusion in High-Risk Patients after Hip Surgery

BACKGROUND The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture. METHODS We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up. RESULTS A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, -3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, -0.9%; 99% CI, -3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, -1.9 to 4.0). The rates of other complications were similar in the two groups. CONCLUSIONS A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.).

The Effect of Time to Definitive Treatment on the Rate of Nonunion and Infection in Open Fractures

Objectives To determine the association between time to definitive surgical management and the rates of nonunion and infection in open fractures resulting from blunt trauma. To determine the association of other clinical determinants with these same adverse events. Design Retrospective review of a consecutive series of open long bone fractures. Setting Referral trauma center with transport times often extending beyond eight hours from the time of injury. Patients A total of 227 skeletally mature patients with 241 open long bone fractures were treated between January 1996 and December 1998; 215 fractures were available for review at a minimum of twelve months postinjury. Intervention Medical charts of all patients were reviewed using a standardized data collection form. All available records and radiograph reports were inspected. All cases were followed to clinical and radiographic union of the fracture or until a definitive procedure for nonunion or deep infection was carried out. Main Outcome Measures Occurrence of deep infections or nonunions after fracture treatment. Results The mean time to definitive treatment was eight hours and twenty-five minutes (range 1 hour 35 minutes to 30 hours 40 minutes). Forty patients went on to nonunion, and twenty developed a deep infection. In the final multivariate regression model, time was not a significant factor in predicting either nonunion or infection (p > 0.05). The strongest determinants for nonunion were found to be presence of infection and grade of injury (p < 0.05). The strongest predictors for the development of a deep infection were fracture grade and a lower extremity fracture (p < 0.05). Conclusions The risk of developing an adverse outcome was not increased by aggressive debridement/lavage and definitive fixation up to thirteen hours from the time of injury when early prophylactic antibiotic administration and open fracture first aid were instituted.

Best practices for elderly hip fracture patients. A systematic overview of the evidence.

OBJECTIVES: To determine evidence-based best practices for elderly hip fracture patients from the time of hospital admission to 6 months postfracture. DATA SOURCES: MEDLINE, Cochrane Library, CINAHL, Embase, PEDro, Ageline, NARIC, and CIRRIE databases were searched for potentially eligible articles published between 1985 and 2004. REVIEW METHODS: Two independent reviewers determined studies appropriate for inclusion using standardized selection criteria, extracted data, evaluated internal validity, and then rated studies according to levels of evidence. Only Level 1 or 2 evidence was included in our summary of clinical recommendations. RESULTS: Spinal anesthesia, pressure-relieving mattresses, perioperative antibiotics, and deep vein thromboses prophylaxes had consistent evidence of benefit. Routine preoperative traction was not associated with any benefits and should be abandoned. Types of surgical management, postoperative wound drainage, and even “multidisciplinary” care, lacked sufficient evidence to determine either benefit or harm. There was little evidence to either determine best subacute rehabilitation practices or to direct ongoing medical issues (e.g., nutrition). Studies conducted during the subacute recovery period were heterogeneous in terms of treatment settings, interventions, and outcomes studied and had no clear evidence for best treatment practices. CONCLUSIONS: The evidence for perioperative practices is relatively robust and evidence-based perioperative treatment guidelines can be easily established. Conversely, more evidence is required to better guide the care of elderly patients with hip fracture during the subacute recovery period and convalescence.

The influence of early weight-bearing compared with non-weight-bearing after surgical repair of the Achilles tendon.

BACKGROUND The optimal rehabilitation protocol after surgical repair of an Achilles tendon rupture has not been well defined. The objective of this randomized study was to compare the effect of early weight-bearing with that of non-weight-bearing on early postoperative recovery following repair of an acutely ruptured Achilles tendon. METHODS Between October 2003 and May 2006, 110 patients with a surgically repaired Achilles tendon rupture were enrolled from one of two major trauma-care tertiary hospitals. All patients were non-weight-bearing for the first two weeks postoperatively. At the two-week postoperative visit, patients were randomized to either weight-bearing or non-weight-bearing for an additional four weeks. Compliance was measured with a pressure sensor in the fixed-hinge ankle-foot orthosis given to each patient. Follow-up assessments were performed at six weeks, three months, and six months postoperatively. The primary outcome was health-related quality of life assessed with use of the RAND 36-Item Health Survey (RAND-36). Secondary outcomes were activity level, calf strength, ankle range of motion, return to sports and work, and complications. RESULTS Ninety-eight patients (89%) completed the six-month follow-up. At six weeks, the weight-bearing group had significantly better scores than the non-weight-bearing group in the RAND-36 domains of physical functioning, social functioning, role-emotional, and vitality scores (p < 0.05). Patients in the weight-bearing group also reported fewer limitations of daily activities at six weeks postoperatively (p < 0.001). At six months, no significant differences between the groups were seen in any outcome, although both groups had poor endurance of the calf musculature. No rerupture occurred in either group. CONCLUSIONS Early weight-bearing after surgical repair of an acute Achilles tendon rupture improves health-related quality of life in the early postoperative period and has no detrimental effect on recovery.

Comparative effectiveness of pain management interventions for hip fracture: a systematic review.

BACKGROUND Pain management is integral to the management of hip fracture. PURPOSE To review the benefits and harms of pharmacologic and nonpharmacologic interventions for managing pain after hip fracture. DATA SOURCES 25 electronic databases (January 1990 to December 2010), gray literature, trial registries, and reference lists, with no language restrictions. STUDY SELECTION Multiple reviewers independently and in duplicate screened 9357 citations to identify randomized, controlled trials (RCTs); nonrandomized, controlled trials (non-RCTs); and cohort studies of pain management techniques in older adults after acute hip fracture. DATA EXTRACTION Independent, duplicate data extraction and quality assessment were conducted, with discrepancies resolved by consensus or a third reviewer. Data extracted included study characteristics, inclusion and exclusion criteria, participant characteristics, interventions, and outcomes. DATA SYNTHESIS 83 unique studies (64 RCTs, 5 non-RCTs, and 14 cohort studies) were included that addressed nerve blockade (n = 32), spinal anesthesia (n = 30), systemic analgesia (n = 3), traction (n = 11), multimodal pain management (n = 2), neurostimulation (n = 2), rehabilitation (n = 1), and complementary and alternative medicine (n = 2). Overall, moderate evidence suggests that nerve blockades are effective for relieving acute pain and reducing delirium. Low-level evidence suggests that preoperative traction does not reduce acute pain. Evidence was insufficient on the benefits and harms of most interventions, including spinal anesthesia, systemic analgesia, multimodal pain management, acupressure, relaxation therapy, transcutaneous electrical neurostimulation, and physical therapy regimens, in managing acute pain. LIMITATIONS No studies evaluated outcomes of chronic pain or exclusively examined participants from nursing homes or with cognitive impairment. Systemic analgesics (narcotics, nonsteroidal anti-inflammatory drugs) were understudied during the search period. CONCLUSION Nerve blockade seems to be effective in reducing acute pain after hip fracture. Sparse data preclude firm conclusions about the relative benefits or harms of many other pain management interventions for patients with hip fracture. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial

BACKGROUND Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy. METHODS In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032. FINDINGS Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4-4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95-1·25]; p=0·21). INTERPRETATION Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20-25% or cause of death. FUNDING National Heart, Lung, and Blood Institute.

Functional Outcome and Health-Related Quality of Life after Surgical Repair of Full-Thickness Rotator Cuff Tear Using a Mini-Open Technique:

Background Rotator cuff tear, a common shoulder injury, can lead to shoulder pain and functional loss. Hypothesis Surgical repair of full-thickness rotator cuff tears using the mini-open surgical technique will improve shoulder function and health-related quality of life. Study Design Cohort study. Level of evidence, 2. Methods Patients with a full-thickness rotator cuff tear who underwent a mini-open repair were evaluated for (1) active shoulder range of motion preoperatively, and 6 months and 12 months postoperatively and (2) health-related quality of life preoperatively, 6 months postoperatively, and annually up to 5 years postoperatively. Satisfaction with the repair and return to work status were ascertained 1 year postoperatively. A subgroup analysis of tear size and patient age was also undertaken. Results Of the subjects, 61 (73%) were men, and the average age was 53.2 (±9.9) years. According to repeated-measures analysis of variance, shoulder range of motion (flexion and external rotation) improved significantly from before surgery to 1 year after surgery (P < .001). The mean American Shoulder and Elbow Surgeons scores improved from 53.3 (±20.6) preoperatively to 90.6 (±11.7) 1 year postoperatively (P < .001). The mean Western Ontario Rotator Cuff scores also improved from 43.2 (±20.2) preoperatively to 87.2 (±14.3) 1 year postoperatively (P < .001). No differences were seen in either the American Shoulder and Elbow Surgeons scores or Western Ontario Rotator Cuff scores between the 1-year examination and the last follow-up assessment undertaken at a median of 5 years postoperatively (P > .05). Ninety-six percent of patients were satisfied or very satisfied with the results of their repair; 78% of patients who were working before surgery returned to work without modification by 1 year postoperatively. For the most part, patient age and size of tear did not influence postoperative range of motion or health-related quality of life. Conclusion Mini-open rotator cuff repair led to improved shoulder function and health-related quality of life up to 5 years postoperatively.

Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial.

BACKGROUND The impact of posterior cruciate ligament-substituting and posterior cruciate ligament-retaining devices on the range of motion of the knee following primary total knee arthroplasty is unclear. The primary objective of our study was to compare the range of motion of the knee over the first two postoperative years between subjects who had received the ligament-substituting design and those who had received the ligament-retaining design. Secondarily, pain, function, and health-related quality of life were compared between the two groups. METHODS We undertook a prospective randomized study of 100 patients with noninflammatory osteoarthritis who were undergoing primary total knee arthroplasty. Patients were randomized at the time of surgery to receive one of the two study prosthesis designs. They were evaluated preoperatively, at the time of hospital discharge, at three months postoperatively, and at up to two years postoperatively by a physical therapist who was blinded to the group allocation. Active knee flexion and extension, measured with a goniometer, were the primary outcome measures. Self-reported pain, function, and health-related quality of life were measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the RAND 36-Item Health Survey (RAND-36). Complications and revision rates were determined through hospital record review and at each patient evaluation. RESULTS Eighty percent (seventy-eight) of the ninety-eight available patients returned for the final assessment. At two years postoperatively, the mean difference between the groups with regard to knee flexion was 0.03 degrees (95% confidence interval, -5.9 degrees to 6.0 degrees ) and the mean difference in knee extension was 1.0 degrees (95% confidence interval, -0.36 degrees to 2.4 degrees ). Ninety-one (93%) of the ninety-eight available patients completed questionnaires at the time of the final assessment. The two treatment groups had similar pain, function, and quality-of-life scores and complication rates. One subject in the cruciate-retaining group required revision, secondary to a deep joint infection, and one subject in the cruciate-substituting group required manipulation to address poor knee flexion. CONCLUSIONS Overall, the two treatment groups had a similar range of motion of the knee over the initial two-year postoperative time period. A satisfactory range of motion was achieved by three months postoperatively and was maintained at the final assessment.

Lack of association between mortality and timing of surgical fixation in elderly patients with hip fracture: results of a retrospective population-based cohort study.

Background:Conventional wisdom suggests high-quality care for most patients with hip fractures is surgical fixation within 24 hours to reduce mortality and complications, although there is little evidence to support this standard. Objectives:We sought to determine the relationship between timing of hip fracture surgery and early mortality. Design and Subjects:This was a retrospective population-based cohort study of 3981 patients with hip fractures >60 years of age that were admitted to hospitals in one Canadian health region from 1994–2000. Methods:We collected sociodemographic, prefracture comorbidity, and postoperative complication data. Timing of surgery was classified as within 24 hours (“early surgery,” the referent group for all analyses), 24–48 hours, and beyond 48 hours. Main outcome was in-hospital mortality. We used multivariable logistic regression methods, including adjustments with propensity scores and a validated hip fracture-specific mortality index, to determine the independent association between early versus later surgery and mortality. Results:Median age of patients was 82 years, 71% were women, and 26% had >4 prefracture comorbidities. Unadjusted in-hospital mortality was 6%; it was 5% for those who had surgery within 24 hours or from 24 to 48 hours, 10% for surgery beyond 48 hours, and 21% for patients that did not have surgery. Compared with those who had surgery within 24 hours, there was no independent association between timing of surgery and in-hospital mortality (24–48 hours, adjusted odds ratio 0.89, 95% confidence interval 0.62–1.30, P = 0.55; beyond 48 hours 1.30, 95% confidence interval 0.86–2.00], P = 0.21). Conclusions:The timing of surgical fixation of hip fracture was not associated with early mortality in carefully adjusted analyses, and the use of “surgery within 24 hours” as a measure of high quality care may be inappropriate.

Osteoporosis Case Manager for Patients With Hip Fractures: Results of a Cost-effectiveness Analysis Conducted Alongside a Randomized Trial

BACKGROUND In a randomized trial of patients with hip fractures, we previously demonstrated that a hospital-based case manager could increase rates of appropriate osteoporosis treatment to 51% compared with 22% for usual care (P < .001). Alongside that trial, we conducted an economic analysis. METHODS Patients with hip fractures were randomized to usual care (n = 110) or a case manager (n = 110) and followed up for 1 year. Time-motion studies were used to determine intervention costs. From a third-party health care payer perspective and over the patients remaining lifetime, a Markov decision-analytic model was constructed to determine cost-effectiveness of the intervention compared with usual care. Costs and benefits were discounted at 3% and expressed in 2006 Canadian dollars. RESULTS The intervention cost CaD