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BACKGROUND: Women seeking nonhormonal interventions for vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM) may seek out complementary and alternative medicine or therapies (CAMs). PURPOSE: To summarize published evidence of CAMs for GSM. DATA SOURCES: Ovid MEDLINE, EMBASE, and CINAHL from inception through 11 December 2023. STUDY SELECTION: Randomized controlled trials (RCTs) 8 weeks or more in duration that evaluated the effectiveness or harms of CAMs for postmenopausal women with GSM and reported 1 or more outcomes of interest, with sample sizes of 20 or more participants randomly assigned per group. DATA EXTRACTION: Data were abstracted by 1 reviewer and verified by a second. DATA SYNTHESIS: An evidence map approach was used to organize and describe trials. Studies were organized by type of intervention, with narrative summaries for population, study characteristics, interventions, and outcomes. Fifty-seven trials were identified that investigated 39 unique interventions. Studies were typically small (n < 200), and most were done in Iran (k = 24) or other parts of Asia (k = 9). Few trials evaluated similar combinations of populations, interventions, comparators, or outcomes. Most studies (k = 44) examined natural products (that is, herbal or botanical supplements and vitamins), whereas fewer reported on mind and body practices (k = 6) or educational programs (k = 7). Most studies reported 1 or 2 GSM symptoms, mainly sexual (k = 44) or vulvovaginal (k = 30). Tools used to measure outcomes varied widely. Most trials reported on adverse events (k = 33). LIMITATIONS: Only English-language studies were used. Effect estimates, risk of bias, and certainty of evidence were not assessed. CONCLUSION: There is a large and heterogeneous literature of CAM interventions for GSM. Trials were small, and few were done in North America. Standardized population, intervention, comparator, and outcomes reporting in future RCTs are needed. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684).

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BACKGROUND: Postmenopausal women commonly experience vulvovaginal, urinary, and sexual symptoms associated with genitourinary syndrome of menopause (GSM). PURPOSE: To evaluate effectiveness and harms of vaginal estrogen, nonestrogen hormone therapies, and vaginal moisturizers for treatment of GSM symptoms. DATA SOURCES: Medline, Embase, and CINAHL through 11 December 2023. STUDY SELECTION: Randomized controlled trials (RCTs) of at least 8 weeks' duration enrolling postmenopausal women with at least 1 GSM symptom and reporting effectiveness or harms of hormonal interventions or vaginal moisturizers. DATA EXTRACTION: Risk of bias and data extraction were performed by one reviewer and verified by a second reviewer. Certainty of evidence (COE) was assessed by one reviewer and verified by consensus. DATA SYNTHESIS: From 11 993 citations, 46 RCTs evaluating vaginal estrogen (k = 22), nonestrogen hormones (k = 16), vaginal moisturizers (k = 4), or multiple interventions (k = 4) were identified. Variation in populations, interventions, comparators, and outcomes precluded meta-analysis. Compared with placebo or no treatment, vaginal estrogen may improve vulvovaginal dryness, dyspareunia, most bothersome symptom, and treatment satisfaction. Compared with placebo, vaginal dehydroepiandrosterone (DHEA) may improve dryness, dyspareunia, and distress, bother, or interference from genitourinary symptoms; oral ospemifene may improve dryness, dyspareunia, and treatment satisfaction; and vaginal moisturizers may improve dryness (all low COE). Vaginal testosterone, systemic DHEA, vaginal oxytocin, and oral raloxifene or bazedoxifene may provide no benefit (low COE) or had uncertain effects (very low COE). Although studies did not report frequent serious harms, reporting was limited by short-duration studies that were insufficiently powered to evaluate infrequent serious harms. LIMITATIONS: Most studies were 12 weeks or less in duration and used heterogeneous GSM diagnostic criteria and outcome measures. Few studies enrolled women with a history of cancer. CONCLUSION: Vaginal estrogen, vaginal DHEA, oral ospemifene, and vaginal moisturizers may improve some GSM symptoms in the short term. Few long-term data exist on efficacy, comparative effectiveness, tolerability, and safety of GSM treatments. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42023400684).

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OBJECTIVES: The US Agency for Healthcare Research and Quality, through the Evidence-based Practice Center (EPC) Program, aims to provide health system decision makers with the highest-quality evidence to inform clinical decisions. However, limitations in the literature may lead to inconclusive findings in EPC systematic reviews (SRs). The EPC Program conducted pilot projects to understand the feasibility, benefits, and challenges of utilizing health system data to augment SR findings to support confidence in healthcare decision-making based on real-world experiences. STUDY DESIGN AND SETTING: Three contractors (each an EPC located at a different health system) selected a recently completed SR conducted by their center and identified an evidence gap that electronic health record (EHR) data might address. All pilot project topics addressed clinical questions as opposed to care delivery, care organization, or care disparities topics that are common in EPC reports. Topic areas addressed by each EPC included infantile epilepsy, migraine, and hip fracture. EPCs also tracked additional resources needed to conduct supplemental analyses. The workgroup met monthly in 2022-2023 to discuss challenges and lessons learned from the pilot projects. RESULTS: Two supplemental data analyses filled an evidence gap identified in the SRs (raised certainty of evidence, improved applicability) and the third filled a health system knowledge gap. Project challenges fell under three themes: regulatory and logistical issues, data collection and analysis, and interpretation and presentation of findings. Limited ability to capture key clinical variables given inconsistent or missing data within the EHR was a major limitation. The workgroup found that conducting supplemental data analysis alongside an SR was feasible but adds considerable time and resources to the review process (estimated total hours to complete pilot projects ranged from 283 to 595 across EPCs), and that the increased effort and resources added limited incremental value. CONCLUSION: Supplementing existing SRs with analyses of EHR data is resource intensive and requires specialized skillsets throughout the process. While using EHR data for research has immense potential to generate real-world evidence and fill knowledge gaps, these data may not yet be ready for routine use alongside SRs.

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BACKGROUND: Among adults with cancer, malnutrition is associated with decreased treatment completion, more treatment harms and use of health care, and worse short-term survival. To inform the National Institutes of Health Pathways to Prevention workshop, "Nutrition as Prevention for Improved Cancer Health Outcomes," this systematic review examined the evidence for the effectiveness of providing nutrition interventions before or during cancer therapy to improve outcomes of cancer treatment. METHODS: We identified randomized controlled trials enrolling at least 50 participants published from 2000 through July 2022. We provide a detailed evidence map for included studies and grouped studies by broad intervention and cancer types. We conducted risk of bias (RoB) and qualitative descriptions of outcomes for intervention and cancer types with a larger volume of literature. RESULTS: From 9798 unique references, 206 randomized controlled trials from 219 publications met the inclusion criteria. Studies primarily focused on nonvitamin or mineral dietary supplements, nutrition support, and route or timing of inpatient nutrition interventions for gastrointestinal or head and neck cancers. Most studies evaluated changes in body weight or composition, adverse events from cancer treatment, length of hospital stay, or quality of life. Few studies were conducted within the United States. Among intervention and cancer types with a high volume of literature (n = 114), 49% (n = 56) were assessed as high RoB. Higher-quality studies (low or medium RoB) reported mixed results on the effect of nutrition interventions across cancer and treatment-related outcomes. CONCLUSIONS: Methodological limitations of nutrition intervention studies surrounding cancer treatment impair translation of findings into clinical practice or guidelines.

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OBJECTIVES: The purpose of this study was to determine whether baseline self-efficacy, fear of pain with movement (kinesiophobia), or change in either were associated with clinically important improvement in disability among older adults with chronic low back pain after 12 weeks of chiropractic spinal manipulation (CSM) and exercise. METHODS: This secondary analysis used randomized trial data from community-dwelling adults aged 65 years or older with chronic spinal disability who received non-pharmacological treatment of CSM and exercise. Those with ≥30% reduction in the Oswestry Disability Index (ODI) after 12 weeks of treatment were considered responders to care. Psychosocial measures included the Pain Self-Efficacy Questionnaire (PSEQ) and the Tampa Scale of Kinesiophobia (TSK). Logistic regression-assessed associations were between psychosocial, demographic, and low back predictors and 30% ODI improvement. RESULTS: There were 176 community-dwelling older adults included in this analysis. Mean age was 71 years, 59.7% were women; 176 (96.7%) had complete data. Baseline disability (ODI = 26.1 ± 9.3) and back pain (5.0 ± 1.9, 0-10 scale) were moderate. Baseline PSEQ reflected higher self-efficacy (47.7 ± 7.8, 0-60 scale) with minimal kinesiophobia (TSK 34.3 ± 5.2, 17-68 scale). Seventy-two (40.9%) achieved 30% reduction in ODI (mean -5.4 ± 7.9) after 12 weeks of treatment. Mean self-efficacy improvement was clinically important (2.5 ± 6.5 points); kinesiophobia (-2.7 ± 4.4 points) and LBP (-1.6 points) also improved. Baseline PSEQ and percent improvement in PSEQ and TSK were associated with response to treatment in univariate regression analyses but not in multiple regression models that included low back predictors. LBP duration >4 years negatively impacted recovery. CONCLUSIONS: Among this sample of older adults who received chiropractic manipulation and exercise, baseline self-efficacy and improvements in self-efficacy and kinesiophobia were individually associated with clinically important reductions in disability post-intervention, although not in adjusted models when LBP duration was included.

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BACKGROUND: Effects of drug treatment of clinical Alzheimer-type dementia (CATD) are uncertain. PURPOSE: To summarize evidence on the effects of prescription drugs and supplements for CATD treatment. DATA SOURCES: Electronic bibliographic databases (inception to November 2019), ClinicalTrials.gov (to November 2019), and systematic review bibliographies. STUDY SELECTION: English-language trials of prescription drug and supplement treatment in older adults with CATD that report cognition, function, global measures, behavioral and psychological symptoms of dementia (BPSD), or harms. Minimum treatment was 24 weeks (≥2 weeks for selected BPSD). DATA EXTRACTION: Studies with low or medium risk of bias (ROB) were analyzed. Two reviewers rated ROB. One reviewer extracted data; another verified extraction accuracy. DATA SYNTHESIS: Fifty-five studies reporting non-BPSD outcomes (most ≤26 weeks) and 12 reporting BPSD (most ≤12 weeks) were analyzed. Across CATD severity, mostly low-strength evidence suggested that, compared with placebo, cholinesterase inhibitors produced small average improvements in cognition (median standardized mean difference [SMD], 0.30 [range, 0.24 to 0.52]), no difference to small improvement in function (median SMD, 0.19 [range, -0.10 to 0.22]), no difference in the likelihood of at least moderate improvement in global clinical impression (median absolute risk difference, 4% [range, 2% to 4%]), and increased withdrawals due to adverse events. In adults with moderate to severe CATD receiving cholinesterase inhibitors, low- to insufficient-strength evidence suggested that, compared with placebo, add-on memantine inconsistently improved cognition and improved global clinical impression but not function. Evidence was mostly insufficient about prescription drugs for BPSD and about supplements for all outcomes. LIMITATION: Most drugs had few trials without high ROB, especially for supplements, active drug comparisons, BPSD, and longer trials. CONCLUSION: Cholinesterase inhibitors and memantine slightly reduced short-term cognitive decline, and cholinesterase inhibitors slightly reduced reported functional decline, but differences versus placebo were of uncertain clinical importance. Evidence was mostly insufficient on drug treatment of BPSD and on supplements for all outcomes. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42018117897).

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OBJECTIVE: The purpose of this cross-sectional study was to compare functional limitations and comorbidity prevalence between older adult users and nonusers of chiropractic and osteopathic (DC/DO) manipulation to inform provider training. METHODS: We conducted a secondary analysis of the 2012 National Health Interview Survey data. Adults age 65 or older who responded to the survey were included. Descriptive statistics are reported for adults who used DC/DO manipulation (vs nonusers) regarding function, comorbidities, musculoskeletal complaints, and medical services. Weighted percentages were derived using SAS and compared with χ2 tests. RESULTS: The DC/DO users were more often female, overweight or obese, and of white race than nonusers. More DC/DO users reported arthritis (55.3% vs 47.0%, <0.01) or asthma (15.0% vs 10.0%, P < .01) than nonusers; hypertension (61.9% vs 55.5%, P = .02) and diabetes (20.3% vs 15.7%, P = .02) were more prevalent in nonusers; and other comorbidities were comparable. The DC/DO users reported more joint pain/stiffness (55.7% vs 44.8%), chronic pain (19.8% vs 14.2%), low back pain (27.8% vs 18.4%), low back with leg pain (18.8% vs 10.6%), and neck pain (24.2% vs 13.1%) than nonusers (all P < .01). Functional limitations affected two-thirds overall, but DC/DO users reported more difficulties stooping and bending; other limitations were comparable. One in 9 reported activities of daily living or instrumental activities of daily living limitations; nonusers were more affected. Surgery was more common among DC/DO users (26.1% vs 19.3%, <0.01); emergency room visits were comparable. CONCLUSION: Differences existed between older adult manipulation users and nonusers, especially surgical utilization, musculoskeletal complaints, and comorbidities; functional differences were modest. Our findings highlight areas for provider training and awareness regarding comorbidity burden and management needs in older patients who may simultaneously use manipulation and medical care for musculoskeletal complaints.

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Background: Optimal long-term osteoporosis drug treatment (ODT) is uncertain. Purpose: To summarize the effects of long-term ODT and ODT discontinuation and holidays. Data Sources: Electronic bibliographic databases (January 1995 to October 2018) and systematic review bibliographies. Study Selection: 48 studies that enrolled men or postmenopausal women aged 50 years or older who were being investigated or treated for fracture prevention, compared long-term ODT (>3 years) versus control or ODT continuation versus discontinuation, reported incident fractures (for trials) or harms (for trials and observational studies), and had low or medium risk of bias (ROB). Data Extraction: Two reviewers independently rated ROB and strength of evidence (SOE). One extracted data; another verified accuracy. Data Synthesis: Thirty-five trials (9 unique studies) and 13 observational studies (11 unique studies) had low or medium ROB. In women with osteoporosis, 4 years of alendronate reduced clinical fractures (hazard ratio [HR], 0.64 [95% CI, 0.50 to 0.82]) and radiographic vertebral fractures (both moderate SOE), whereas 4 years of raloxifene reduced vertebral but not nonvertebral fractures. In women with osteopenia or osteoporosis, 6 years of zoledronic acid reduced clinical fractures (HR, 0.73 [CI, 0.60 to 0.90]), including nonvertebral fractures (high SOE) and clinical vertebral fractures (moderate SOE). Long-term bisphosphonates increased risk for 2 rare harms: atypical femoral fractures (low SOE) and osteonecrosis of the jaw (mostly low SOE). In women with unspecified osteoporosis status, 5 to 7 years of hormone therapy reduced clinical fractures (high SOE), including hip fractures (moderate SOE), but increased serious harms. After 3 to 5 years of treatment, bisphosphonate continuation versus discontinuation reduced radiographic vertebral fractures (zoledronic acid; low SOE) and clinical vertebral fractures (alendronate; moderate SOE) but not nonvertebral fractures (low SOE). Limitation: No trials studied men, clinical fracture data were sparse, methods for estimating harms were heterogeneous, and no trials compared sequential treatments or different durations of drug holidays. Conclusion: Long-term alendronate and zoledronic acid therapies reduce fracture risk in women with osteoporosis. Long-term bisphosphonate treatment may increase risk for rare adverse events, and continuing treatment beyond 3 to 5 years may reduce risk for vertebral fractures. Long-term hormone therapy reduces hip fracture risks but has serious harms. Primary Funding Source: National Institutes of Health and Agency for Healthcare Research and Quality. (PROSPERO: CRD42018087006).

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OBJECTIVE: The purpose of this study is to determine whether the 2013 implementation of ACGME minimum case requirements was associated with increased documented case volume of closed manipulation of forearm and wrist fractures (CMFWF) for graduating orthopedic surgery residents. DESIGN: We reviewed ACGME case log data for CMFWF among graduating orthopedic surgery residents from 2007 to 2016. Annual national mean, and median number of CMFWF performed by residents in the 10th, 30th, 50th, and 90th case volume percentile were evaluated. Preminimum (2007-2010) data was compared to postminimum (2013-2016) values to assess the impact of ACGME minimum requirements on resident case volume. SETTING: Review of publically available ACMGE Orthopedic Surgery Residency Program case log data. PARTICIPANTS: ACGME case log data for orthopedic surgery residents graduating between 2007 and 2016. RESULTS: National mean number of CMFWF increased significantly pre- to postminimum requirement (30.0 ± 2.84 to 45.0 ± 3.36, p < 0.001). Between 2010 and 2016 there was a 1100%, 300%, 83%, and 9% increase in the median number of CMFWF within the 10th, 30th, 50th, and 90th percentiles, respectively. CONCLUSIONS: ACGME's 2013 case minimum requirement corresponded to an increase in case counts for CMFWF; the greatest increase occurred in residents below the 50th percentile of case volume. Implementation of case minimum requirements may allow for more accurate depiction of resident experience and program strengths with regards to procedural exposure. However, the current case log system measures only case quantity, which may inaccurately depict mastery of given procedures. Future work should focus not only on improving case counts in underperforming residents and training sites, but also on refining metrics that ensure accurate assessment of resident skill for essential orthopedic procedures prior to graduation.

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OBJECTIVES: The goals of this study were to identify self-reported differences in function, comorbidities, and medical service utilization among adults who reported using chiropractic and/or osteopathic manipulation in the 2012 National Health Interview Survey, and to compare these between older and younger adults. METHODS: We conducted a descriptive study of adults aged 18 or older who were included in the 2012 National Health Interview Survey and the Alternative Medicine Questionnaire. We included those who reported using chiropractic and/or osteopathic manipulation in the past 12 months. Responses were analyzed using SAS software. Weighted estimates were reported as percentages of chiropractic/osteopathic users overall and by age group (<65 years vs ≥65 years). RESULTS: Among the 8.5% of US adults who reported receiving manipulation, 97.6% saw chiropractors. Most adults were under age 65 (83.7%), female (56.6%), and white (85.1%). Except for sitting tolerance, functional limitations were significantly higher among older manipulation users compared with younger manipulation users (all P < .001). Older (vs younger) chiropractic/osteopathic users more often reported functional limitations (65.7% vs 37.2%), had difficulty walking without equipment (14.7% vs 2.8%), found it very difficult or were unable to walk one-quarter mile (15.7% vs 3.8%) or climb 10 steps (11.4% vs 2.5%), and needed help with instrumental activities of daily living (6.9% vs 2.0%). Comorbidities differed by age: cardiovascular events/conditions, cancer, diabetes, and arthritis were more common among older adults, and headaches, neck pain, and depression were more frequent in younger adults. Similar proportions of older and younger adults had emergency room visits (23.0% vs 21.7%); older adults reported more surgeries (26.1% vs 15.4%). CONCLUSIONS: Notable differences exist in functional limitations and comorbidities between older and younger chiropractic and osteopathic manipulation users. This information could inform clinical practice, education, and policy.

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BACKGROUND: Multilevel posterior spine fusion is associated with significant intraoperative blood loss. Tranexamic acid is an antifibrinolytic agent that reduces intraoperative blood loss. The goal of this study was to compare the percent of total blood volume lost during posterior spinal fusion (PSF) with or without tranexamic acid in patients with adolescent idiopathic scoliosis (AIS). METHODS: Thirty-six AIS patients underwent PSF in 2011-2014; the last half (n=18) received intraoperative tranexamic acid. We retrieved relevant demographic, hematologic, intraoperative and outcomes information from medical records. The primary outcome was the percent of total blood volume lost, calculated from estimates of intraoperative blood loss (numerator) and estimated total blood volume per patient (denominator, via Nadler's equations). Unadjusted outcomes were compared using standard statistical tests. RESULTS: Tranexamic acid and no-tranexamic acid groups were similar (all p>0.05) in mean age (16.1 vs. 15.2 years), sex (89% vs. 83% female), body mass index (22.2 vs. 20.2 kg/m2), preoperative hemoglobin (13.9 vs. 13.9 g/dl), mean spinal levels fused (10.5 vs. 9.6), osteotomies (1.6 vs. 0.9) and operative duration (6.1 hours, both). The percent of total blood volume lost (TBVL) was significantly lower in the tranexamic acid-treated vs. no-tranexamic acid group (median 8.23% vs. 14.30%, p = 0.032); percent TBVL per level fused was significantly lower with tranexamic acid than without it (1.1% vs. 1.8%, p=0.048). Estimated blood loss (milliliters) was similar across groups. CONCLUSIONS: Tranexamic acid significantly reduced the percentage of total blood volume lost versus no tranexamic acid in AIS patients who underwent PSF using a standardized blood loss measure.Level of Evidence: 3. Institutional Review Board status: This medical record chart review (minimal risk) study was approved by the University of Minnesota Institutional Review Board.

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BACKGROUND: No systematic review has examined the collective randomized and nonrandomized evidence for fecal incontinence treatment effectiveness across the range of surgical treatments. OBJECTIVE: The purpose of this study was to assess the efficacy, comparative effectiveness, and harms of surgical treatments for fecal incontinence in adults. DATA SOURCES: Ovid MEDLINE, EMBASE, Physiotherapy Evidence Database, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine, and the Cochrane Central Register of Controlled Trials, as well as hand searches of systematic reviews, were used as data sources. STUDY SELECTION: Two investigators screened abstracts for eligibility (surgical treatment of fecal incontinence in adults, published 1980-2015, randomized controlled trial or observational study with comparator; case series were included for adverse effects). Full-text articles were reviewed for patient-reported outcomes. We extracted data, assessed study risk of bias, and evaluated strength of evidence for each treatment-outcome combination. INTERVENTIONS: Surgical treatments for fecal incontinence were included interventions. MAIN OUTCOME MEASURES: Fecal incontinence episodes/severity, quality of life, urgency, and pain were measured. RESULTS: Twenty-two studies met inclusion criteria (13 randomized trials and 9 observational trials); 53 case series were included for harms. Most patients were middle-aged women with mixed FI etiologies. Intervention and outcome heterogeneity precluded meta-analysis. Evidence was insufficient for all of the surgical comparisons. Few studies examined the same comparisons; no studies were high quality. Functional improvements varied; some authors excluded those patients with complications or lost to follow-up from analyses. Complications ranged from minor to major (infection, bowel obstruction, perforation, and fistula) and were most frequent after the artificial bowel sphincter (22%-100%). Major surgical complications often required reoperation; few required permanent colostomy. LIMITATIONS: Most evidence is intermediate term, with small patient samples and substantial methodologic limitations. CONCLUSIONS: Evidence was insufficient to support clinical or policy decisions for any surgical treatments for fecal incontinence in adults. More invasive surgical procedures had substantial complications. The lack of compliance with study reporting standards is a modifiable impediment in the field. Future studies should focus on longer-term outcomes and attempt to identify subgroups of adults who might benefit from specific procedures.

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Clinical studies frequently lack the ability to reliably answer their research questions because of inadequate sample sizes. Underpowered studies are subject to multiple sources of bias, may not represent the larger population, and are regularly unable to detect differences between treatment groups. Most importantly, an underpowered study can lead to incorrect conclusions. Big data can be used to address many of these concerns, enabling researchers to answer questions with increased certainty and less likelihood of bias. Big datasets, such as The National Hip Fracture Database in the United Kingdom and the Swedish Hip Arthroplasty Registry, collect valuable clinical information that can be used by researchers to guide patient care and inform policy makers, chief executives, commissioners, and clinical staff. The range of research questions that can be examined is directly related to the quality and complexity of the data, which is positively associated with the cost of the data. However, technological advancements have unlocked new possibilities for efficient data capture and widespread opportunities to merge massive datasets, particularly in the setting of national registries and administrative data.

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BACKGROUND: The incidence of inpatient pulmonary embolism in patients who have elective primary hip and knee arthroplasty in the United States is unknown. Prior studies have included patients with cancer, trauma, or revisions. The goal of this study was to determine the incidence and risks of inpatient pulmonary embolism after elective arthroplasty by type of procedure. METHODS: We used the 1998 to 2009 Healthcare Cost and Utilization Project Nationwide Inpatient Sample for this retrospective cohort study. Patients who were sixty years of age or older and underwent elective primary total hip or knee arthroplasty were included. The study variable was the type of arthroplasty: total hip, total knee, or two joints. Inpatient pulmonary embolism was the primary outcome; mortality was secondary. Logistic regression determined the adjusted odds ratios of inpatient pulmonary embolism by procedure, adjusting for age, sex, Charlson Comorbidity Index, atrial fibrillation, and surgical indication. RESULTS: Records represented 5,044,403 hospital discharges after primary total hip or knee arthroplasty. Total knee arthroplasty comprised 66% of the admissions. Less than 5% of patients had two joint procedures. The overall incidence of pulmonary embolism was 0.358% (95% confidence interval [CI], 0.338, 0.378). The incidence of pulmonary embolism differed by procedure and was highest among patients who had two-joint arthroplasty (0.777%; 95% CI, 0.677, 0.876), was lowest in recipients of total hip arthroplasty (0.201%; 95% CI, 0.179, 0.223), and was intermediate in patients who had total knee arthroplasty (0.400%; 95% CI, 0.377, 0.423). The adjusted odds ratios of pulmonary embolism in patients who had two joint procedures were 3.89 times higher than among patients who had total hip arthroplasty, controlling for other factors. CONCLUSIONS: Elective total knee arthroplasty is associated with a higher incidence and odds of inpatient pulmonary embolism than is total hip arthroplasty; multiple procedures pose the highest risk for pulmonary embolism and associated mortality.

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BACKGROUND: There is a growing body of literature on surgical treatments for elderly patients with a hip fracture and the effects of various surgical procedures on complications and postoperative outcomes. No single review has previously summarized the literature on the effects of surgical procedures on outcomes after treatment across all types of hip fractures. We conducted a comprehensive systematic literature review to organize the clinical evidence for patient-centered outcomes across all types of geriatric hip fractures. METHODS: We searched MEDLINE, the Cochrane Database of Systematic Reviews, Scirus, and ClinicalTrials.gov for randomized clinical trials and observational studies published between 1985 and 2008. We also manually searched reference lists from relevant systematic reviews. RESULTS: We found eighty-four [corrected] articles representing seventy-four [corrected] unique, randomized, controlled trials, including thirty-three [corrected] on femoral neck fractures, forty on intertrochanteric fractures, and one on subtrochanteric fractures. Nine observational studies addressed the link between patient characteristics and outcome variables by fracture type. Age, sex, prefracture functioning, and cognitive impairment are related to mortality and functional outcomes. Fracture type does not appear to be independently related to patient outcomes. Mortality, pain, function, and quality of life did not differ by surgical implant class, or by implants within a class. Neither the randomized controlled trials nor the observational literature include the full complement of potential covariates that can impact treatment outcomes after treatment. CONCLUSIONS: The broader questions about the relationship of patient factors, fracture type, and specific treatments to the outcomes of mortality, functional status, and quality of life cannot be addressed with the existing literature. Research should include comprehensive conceptual models that capture complete sets of important independent variables. Studies of musculoskeletal outcomes, including hip fracture, require well-defined patient groups and consistent use of validated outcome measures.

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BACKGROUND: Intramedullary nails provide no clear outcomes benefit in the majority of patients with intertrochanteric hip fracture, yet their use in the United States continues to increase. Non-patient factors that are associated with intramedullary nail use among Medicare patients have not been examined. The goal of this study was to identify the surgeon and hospital characteristics that were associated with the use of intramedullary nails compared with plate-and-screw devices among elderly Medicare patients with intertrochanteric hip fractures. METHODS: Medicare beneficiaries who were sixty-five years of age or older and underwent inpatient surgery to treat an intertrochanteric femoral fracture with use of an intramedullary nail or a plate-and-screw device were identified from the United States Medicare files for 2000 to 2002. Surgeon and hospital characteristics from the Medicare provider enrollment files were merged with the claims. Generalized linear mixed models with fixed and random effects modeled the association between surgeon and hospital factors and intramedullary nail use (compared with plate and screws), controlling for patient age, sex, and race; subtrochanteric fracture; Charlson comorbidity score; nursing home residence; and Medicaid-administered assistance. The adjusted odds ratios of receiving an intramedullary nail by year, surgeon, and hospital factors are reported. RESULTS: There were 192,365 claims for surgery to treat an intertrochanteric hip fracture that met the inclusion criteria and matched with surgeon and hospital information. There were 15,091 surgeons who performed intertrochanteric hip fracture surgeries in Medicare patients in 3480 hospitals between March 1, 2000, and December 31, 2002. The surgeon factors associated with intramedullary nail use include younger surgeon age (less than forty-five years old), an osteopathy degree, and operating at more than one hospital. The hospital factors associated with intramedullary nail use include a higher volume of intertrochanteric hip fracture surgeries, teaching hospital status, and having resident assistance during surgery. Surgeon factors improved the model fit more than hospital factors. CONCLUSIONS: The use of intramedullary nails was strongly associated with early-career surgeons and surgeon training programs. Our findings suggest that orthopaedic faculty at teaching hospitals and younger surgeons may be selecting orthopaedic implants on the basis of factors other than clinical outcomes evidence. We expect that intramedullary nail use will continue to increase as long as new surgeons are preferentially trained in intramedullary nailing procedures and surgeon reimbursement remains insulated from the treating hospital's burden of their choices for higher cost devices under the Medicare payment system.

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BACKGROUND: Research on the relationship between orthopaedic volume and outcomes has focused almost exclusively on elective arthroplasty procedures. Geriatric patients who have sustained an intertrochanteric hip fracture are older and have a heavier comorbidity burden in comparison with patients undergoing elective arthroplasty; therefore, any advantage of provider volume in terms of mortality could be overwhelmed by the severity of the hip fracture condition itself. This study examined the association between surgeon and hospital volumes of procedures performed for the treatment of intertrochanteric hip fractures in Medicare beneficiaries and inpatient through ninety-day postoperative mortality. METHODS: The Medicare 100% files of hospital and physician claims plus the beneficiary enrollment files for 2000 through 2002 identified beneficiaries who were sixty-five years of age or older and who underwent inpatient surgery for the treatment of an intertrochanteric hip fracture with internal fixation. Provider volumes of intertrochanteric hip fracture cases were calculated with use of unique surgeon and hospital provider numbers in the claims. Fixed effects regression analysis using generalized estimating equations was used to model the association between hospital and surgeon intertrochanteric hip fracture volume and inpatient through ninety-day mortality, controlling for age, sex, race, Charlson comorbidity score, subtrochanteric fracture, prefracture nursing home residence, Medicaid-administered assistance, surgical device, and year. The unadjusted inpatient, thirty, sixty, and ninety-day mortality rates and adjusted relative risks are reported. RESULTS: Between March 1, 2000, and December 31, 2002, 192,365 claims met inclusion criteria and matched with provider information. The unadjusted inpatient, thirty-day, sixty-day, and ninety-day mortality rates were 2.91%, 7.92%, 12.34%, and 15.19%, respectively. Patients managed at lower-volume hospitals had significantly higher (10% to 20%) adjusted risks of inpatient mortality than those managed at the highest-volume hospitals. By sixty days postoperatively, the increased mortality risk persisted only among patients managed at the lowest-volume hospitals (six cases per year or fewer). Patients who were managed by surgeons who treated an average of two or three cases per year had the highest mortality risks when compared with patients managed by the highest-volume surgeons. CONCLUSIONS: Only the highest-volume hospitals showed an inpatient mortality benefit for Medicare patients with intertrochanteric hip fractures. Unlike the situation with elective arthroplasty procedures, our findings do not indicate a need to direct patients with routine hip fractures exclusively to high-volume centers, although the higher mortality rates found in the lowest-volume hospitals warrant further investigation.

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