Converting habits of antibiotic use for respiratory tract infections in German primary care (CHANGE-3) - process evaluation of a complex intervention.

BACKGROUND: Antimicrobial resistance remains a global challenge. In Germany, the national health agenda supports measures that enhance the appropriate, guideline-oriented use of antibiotics. The study "Converting Habits of Antibiotic Use for Respiratory Tract Infections in German Primary Care (CHANGE-3)" aimed at a sustainable reduction of antimicrobial resistance through converting patterns of prescribing practice and use of antibiotics and an increase in health literacy in primary care patients, practice teams, and in the general public. Embedded in a cluster-randomized trial of a multifaceted implementation program, a process evaluation focused on the uptake of program components to assess the fidelity of the implementation program in the CHANGE-3 study and to understand utilization of its educational components. METHODS: A mix of qualitative and quantitative methods was used. Semi-structured telephone interviews were conducted with General Practitioners, Medical Assistants, patients treated for respiratory tract infection and outreach visitors who had carried out individual outreach visits. A two-wave written survey (T1: 5 months after start, T2: 16 months after start) was conducted in general practitioners and medical assistants. Qualitative data were analyzed using thematic framework analysis. Descriptive statistics were used to analyze survey data. RESULTS: Uptake of intervention components was heterogenous. Across all components, the uptake reported by General Practitioners varied from 20 to 88% at T1 and 31 to 63% at T2. Medical Assistants reported uptake from 22 to 70% at T1 and 6 to 69% at T2. Paper-based components could by and large be integrated in daily practice (64 to 90% in T1; 41 to 93% in T2), but uptake of digital components was low. A one-time outreach visit provided thematic information and feedback regarding actual prescribing, but due to time constraints were received with reluctance by practice teams. Patients were largely unaware of program components, but assumed that information and education could promote health literacy regarding antibiotics use. CONCLUSIONS: The process evaluation contributed to understanding the applicability of the delivered educational components with regards to the appropriate use of antibiotics. Future research efforts need to identify the best mode of delivery to reach the targeted population. TRIAL REGISTRATION: ISRCTN, ISRCTN15061174 . Registered 13 July 2018 - Retrospectively registered.

Association between hospital and surgeon procedure volume and outcomes of total hip replacement in the United States medicare population.

BACKGROUND: The mortality and complication rates of many surgical procedures are inversely related to hospital procedure volume. The objective of this study was to determine whether the volumes of primary and revision total hip replacements performed at hospitals and by surgeons are associated with rates of mortality and complications. METHODS: We analyzed claims data of Medicare recipients who underwent elective primary total hip replacement (58,521 procedures) or revision total hip replacement (12,956 procedures) between July 1995 and June 1996. We assessed the relationship between surgeon and hospital procedure volume and mortality, dislocation, deep infection, and pulmonary embolus in the first ninety days postoperatively. Analyses were adjusted for age, gender, arthritis diagnosis, comorbid conditions, and income. Analyses of hospital volume were adjusted for surgeon volume, and analyses of surgeon volume were adjusted for hospital volume. RESULTS: Twelve percent of all primary total hip replacements and 49% of all revisions were performed in centers in which ten or fewer of these procedures were carried out in the Medicare population annually. In addition, 52% of the primary total hip replacements and 77% of the revisions were performed by surgeons who carried out ten or fewer of these procedures annually. Patients treated with primary total hip replacement in hospitals in which more than 100 of the procedures were performed per year had a lower risk of death than those treated with primary replacement in hospitals in which ten or fewer procedures were performed per year (mortality rate, 0.7% compared with 1.3%; adjusted odds ratio, 0.58; 95% confidence interval, 0.38, 0.89). Patients treated with primary total hip replacement by surgeons who performed more than fifty of those procedures in Medicare beneficiaries per year had a lower risk of dislocation than those who were treated by surgeons who performed five or fewer of the procedures per year (dislocation rate, 1.5% compared with 4.2%; adjusted odds ratio, 0.49; 95% confidence interval, 0.34, 0.69). Patients who had revision total hip replacement done by surgeons who performed more than ten such procedures per year had a lower rate of mortality than patients who were treated by surgeons who performed three or fewer of the procedures per year (mortality rate, 1.5% compared with 3.1%; adjusted odds ratio, 0.65; 95% confidence interval, 0.44, 0.96). CONCLUSIONS: Patients treated at hospitals and by surgeons with higher annual caseloads of primary and revision total hip replacement had lower rates of mortality and of selected complications. These analyses of Medicare claims are limited by a lack of key clinical information such as operative details and preoperative functional status.

Water and soil pollution in vineyards of central Thailand.

Very intensive cultivation systems have been developed in the delta of the Chao Phraya River for about a century. The objective of the study was to determine the fate of the fertilisers and pesticides applied to vineyards grown on raised beds. Water samples were collected from the outlet of a vineyard to determine the discharge of pollutants in the canal. The accumulation of elements in the soil was investigated by analysing soil samples from different fields. Fertilisation was estimated at 670 kg N, 300 kg P, and 560 kg K year(-1) ha(-1). Insecticides and fungicides were applied every four days on average, using up to 23 different molecules. Little N and no P were discharged in the canals in solution and discharge in suspension was minor. Pesticides were detected in 36% of the water samples. The topsoil contained 1600 mg kg(-1) Bray II P, 936 mg kg(-1) exchangeable K, 170 mg kg(-1) total Cu, and 167 mg kg(-1) total Zn. Pesticides were detected in 62% of the fruits after peeling. Overuse of fertilisers did not lead to water pollution, but overuse of pesticides resulted in pollution of the water bodies and of the fruits. Most applied elements accumulated in the soil, resulting in high values of P, K, Cu, and Zn.

Development of a virtual reality arthroscopic knee simulator.

The virtual reality arthroscopic knee simulator (VR-AKS) consists of a computer platform, a video display, and two force-feedback (haptic) interfaces which also monitor the position of the instruments in the user's hands. The forces that the user would normally apply to the lower limb during arthroscopy are directed through an instrumented surrogate leg. Proprietary software furnishes the mathematical representation of the physical world and replicates the visual, mechanical, and behavioral aspects of the knee while task-oriented programs monitor and record specific areas of user performance. A prototype has demonstrated the feasibility of the system and work on the first, fully functional simulator will begin soon.

Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery.

BACKGROUND: Cardiac complications are important causes of morbidity after noncardiac surgery. The purpose of this prospective cohort study was to develop and validate an index for risk of cardiac complications. METHODS AND RESULTS: We studied 4315 patients aged > or = 50 years undergoing elective major noncardiac procedures in a tertiary-care teaching hospital. The main outcome measures were major cardiac complications. Major cardiac complications occurred in 56 (2%) of 2893 patients assigned to the derivation cohort. Six independent predictors of complications were identified and included in a Revised Cardiac Risk Index: high-risk type of surgery, history of ischemic heart disease, history of congestive heart failure, history of cerebrovascular disease, preoperative treatment with insulin, and preoperative serum creatinine >2.0 mg/dL. Rates of major cardiac complication with 0, 1, 2, or > or = 3 of these factors were 0.5%, 1.3%, 4%, and 9%, respectively, in the derivation cohort and 0.4%, 0.9%, 7%, and 11%, respectively, among 1422 patients in the validation cohort. Receiver operating characteristic curve analysis in the validation cohort indicated that the diagnostic performance of the Revised Cardiac Risk Index was superior to other published risk-prediction indexes. CONCLUSIONS: In stable patients undergoing nonurgent major noncardiac surgery, this index can identify patients at higher risk for complications. This index may be useful for identification of candidates for further risk stratification with noninvasive technologies or other management strategies, as well as low-risk patients in whom additional evaluation is unlikely to be helpful.

Kinematic total knee arthroplasty: a 10- to 14-year prospective follow-up review.

To understand better the type and incidence of long-term complications in total knee replacement, 306 primary Kinematic total knee arthroplasties performed between June 1978 and December 1982 were prospectively reviewed in detail. The Kinematic knee is a nonconstrained, posterior cruciate-retaining prosthesis that has right and left femoral components to afford anatomic tracking of the patella. The overall revision rate was 6.5%. The most common cause for revision surgery was patellar complications. Ten revisions (3.06%) were for patellar component loosening. Two knees were revised for patella subluxation (0.65%); 1 was in a resurfaced rheumatoid patella, and 1 in an unsurfaced osteoarthritic patella. Stair climbing was better with an unsurfaced patella. Anterior knee pain was 21.8% in the unsurfaced patella and 11.2% in the replaced patella. These data suggest patella replacement is not appropriate with this design.

Posterior approach to total hip replacement using enhanced posterior soft tissue repair.

The two senior authors (PMP, RP) independently began using an identical enhanced posterior soft tissue repair after total hip replacement through a posterior approach. In the first author's experience, a dislocation rate of 4% in 395 patients before using the enhanced closure was reduced to 0% in 395 patients in whom the enhanced closure was performed. In the second author's experience, 160 total hip replacements had a dislocation rate of 6.2% before the enhanced closure whereas 124 total hip replacements had a dislocation rate of 0.8% after the enhanced closure. These results are highly statistically significant.

Preoperative education for total hip and knee replacement patients.

OBJECTIVE: Psychoeducational preparation is known to improve postoperative outcome. We tested two common psychoeducational procedures in elderly orthopedic patients, examining how best to match interventions to patients by psychological type. METHODS: Two hundred twenty-two elderly patients undergoing total hip or knee replacement were randomly assigned to 1) a slide-tape with information on the postoperative, in-hospital rehabilitation experience, or 2) training in Benson's Relaxation Response with a bedside audiotape, in a 2 x 2 factorial design. RESULTS: The relaxation response did not influence postoperative outcomes. The educational intervention reduced length of stay and pain medication use for patients who exhibited most denial (tendency to avoid thinking about unpleasant events), and reduced postoperative anxiety and cognitive errors on the Mini-Mental State Exam for patients with most baseline anxiety. There was no effect on postoperative pain. CONCLUSIONS: The importance of attending to the patient's psychological state and level of preparation before orthopedic surgery is reinforced. Patients who exhibit most denial and highest anxiety may benefit from educational interventions, but patients' directly expressing desire for information may be a poor guide in deciding which patients would benefit, compared with more formal psychological testing for denial and anxiety.

Health-related quality of life after elective surgery: measurement of longitudinal changes.

OBJECTIVE: To examine the responsiveness of the 36-Item Short Form Health Survey (SF-36) to clinical changes in three surgical groups and to study how health-related quality of life (HRQL) changes with time among patients who undergo total hip arthroplasty, thoracic surgery for treatment of non-small-cell lung cancer, or abdominal aortic aneurysm (AAA) repair. DESIGN: Prospective cohort study with serial evaluations of HRQL preoperatively and at 1, 6, and 12 months after surgery. SETTING: University tertiary care hospital. PATIENTS: Of 528 patients, more than 50 years of age, who were admitted for these elective procedures, 454 (86%) provided preoperative health status data and are members of the study cohort. At 12 months after surgery, 439 (93%) of the cohort was successfully contacted and 390 (90%) provided follow-up interviews. MEASUREMENTS AND MAIN RESULTS: The Medical Outcomes Study SF-36, the Specific Activity Scale, five validated health transition questions, and a 0 to 100 scale measure of global health were used to assess changes in health status at 1, 6, and 12 months after surgery. Change in health status as measured by the SF-36 demonstrated that physical function and role limitations due to physical health problems were worse 1 month after these three surgeries. However, by 6 months after surgery, most patients experienced significant gains in the majority of the dimensions of health, and these gains were sustained at 12 months after surgery. Longitudinal changes in the SF-36 were positively associated with responses to the five health transition questions, to changes on the Specific Activity Scale and global health rating question, and to clinical parameters for persons who had AAA repair. These findings indicate that the SF-36 has evidence of validity and is responsive to expected changes in HRQL after elective surgery for these procedures. CONCLUSIONS: For the total hip arthroplasty patients, responsiveness was greatest for the SF-36 scales that measure physical constructs. However, for the two other procedures and at various points of recovery, significant changes were observed for all eight subscales, suggesting that responsiveness was dependent on the type of surgery and the timing of follow-up, and that multidimensional measures are needed to fully capture changes in HRQL after surgery.

Complications of total hip arthroplasty associated with the use of an acetabular component with a Hylamer liner.

We observed early failure and radiographic signs of accelerated wear as early as one to three years after insertion, without cement, of a metal-backed acetabular component with a liner made of Hylamer (DePuy). This finding prompted us to review a larger cohort of patients in whom that liner had been used. Two hundred and thirty-three components with a Hylamer liner, evaluated at a minimum of two years, had a mean rate of wear of 0.27 millimeter per year compared with 0.12 millimeter per year for a contemporaneous group of fifty acetabular cups with a conventional ultra-high molecular weight polyethylene liner made by another manufacturer. At a mean of 3.2 years, we found a significant difference (p < 0.000000006) between the mean rate of wear (0.20 millimeter per year) when the Hylamer liner articulated with a DePuy modular cobalt-chromium femoral head and the mean rate (0.29 millimeter per year) when the liner articulated with an Osteonics modular cobalt-chromium femoral head. Radiographic evaluation revealed a significant correlation between the total linear wear and the prevalence of osteolytic lesions (r2 = 0.76, linear regression analysis). We found that wear of 1.5 millimeters or more could be detected by the unaided eye. Because of the positive correlation between osteolysis and wear of 1.5 millimeters or more, we defined a hip with a liner that had that amount of wear as a hip at risk. We concluded that the wear characteristics of a Hylamer liner in vivo are inferior to those of a conventional ultra-high molecular weight polyethylene liner. Also, the rate of wear of the liner is greater when the femoral head is from a manufacturer other than DePuy. A patient who has a total hip replacement that includes a Hylamer liner should be monitored frequently for signs of wear and osteolytic changes. Additional investigations, with longer durations of follow-up and larger populations, are needed to understand fully the importance of our findings.

Body mass index as a correlate of postoperative complications and resource utilization.

PURPOSE: To describe the relationship of body mass index (BMI) with postoperative complications and resource utilization. PATIENTS AND METHODS: Two thousand nine hundred and sixty-four patients 50 years or older undergoing elective noncardiac surgery with an expected length of stay > or = 2 days were enrolled in a prospective cohort study to measure major cardiac complications, noncardiac complications, length of stay, and costs. The setting was an urban teaching hospital. A preoperative history, physical, electrocardiogram (ECG), and chart review were performed by study personnel. Postoperative complications were detected by ECGs, creatine kinase and creatine kinase MB levels, and daily chart review. Total costs were obtained from the hospital's computerized database. RESULTS: Complication rates were not different among BMI groups (underweight < 20, normal 20 to 29, overweight 30 to 34, most overweight > 34), but patients with BMI 30 to 34 and > 34 who underwent abdominal or gynecologic procedures had significantly higher wound infection rates (11% each) than normal weight patients (4.7%) or the underweight (0%). After adjusting for age, race, gender, smoking history, comorbid diseases, procedure type, and insurance status, there were nonsignificant trends toward increased resource utilization by the most overweight patients (BMI > 34). These patients stayed 0.8 days longer (P = 0.13) and had total costs that were $843 higher (P = 0.17) than patients of normal weight (BMI 20 to 29). The underweight patients stayed 0.9 days longer (P = 0.23) and had total costs that were $3,150 higher (P = 0.04) than patients of normal weight. Quadratic models to test for a U-shaped relationship found no correlation between BMI and length of stay, but did find that BMI was significantly correlated with total costs (P = 0.04). This relationship persisted when patients who had complications were excluded from the analysis. CONCLUSIONS: Overall, BMI was not significantly correlated with postoperative complications or length of stay. However, overweight patients who underwent abdominal or gynecologic procedures had higher wound infection rates, and patients with the highest and lowest BMIs had significantly higher adjusted total costs.

Isolated proximal femoral osteotomy for treatment of residua of congenital dysplasia or idiopathic osteoarthrosis of the hip. Five to ten-year results.

We retrospectively reviewed the five to ten-year results of an isolated proximal femoral osteotomy in two groups of patients. One group consisted of seventeen patients (eighteen hips) who had a residual deformity resulting from congenital dysplasia of the hip; there were fifteen women and two men, and the mean age was thirty-three years (range, twenty-four to fifty-eight years). The other group included sixteen patients (sixteen hips) who had idiopathic osteoarthrosis; there were three women and thirteen men, and the mean age was forty-eight years (range thirty-eight to fifty-seven years). Both groups were evaluated clinically and radiographically, at a mean of 6.1 years (the patients who had residua of congenital dysplasia) and 6.7 years (the patients who had idiopathic osteoarthrosis). Of the seventeen patients who had residual deformity resulting from congenital dysplasia, eight (eight hips) were completely satisfied with the result of the osteotomy at least five years postoperatively; the joint space was improved in five of these patients (five hips) at the latest radiographic evaluation. Nine patients (ten hips) were not satisfied with the result of the osteotomy at the time of the most recent follow-up; four of the (four hips) had a subsequent total hip arthroplasty. Of the sixteen patients who had idiopathic osteoarthrosis, six were completely satisfied with the result of the osteotomy at least five years postoperatively. The joint space was improved in only two patients at the latest radiographic evaluation. The osteotomy did not provide lasting pain relief for seven patients, all of whom had a subsequent total hip arthroplasty. In both diagnostic groups, the most enduring clinical improvement occurred in hips that had the least evidence of osteoarthrotic changes on the preoperative radiographs. In addition, in the group that had residual deformity resulting from congenital dysplasia, the best outcomes were seen in hips with the least degree of acetabular dysplasia.

A safety and efficacy comparison study of two dosing regimens of epoetin alfa in patients undergoing major orthopedic surgery.

Previous studies have demonstrated the efficacy of perioperative Epoetin alfa in decreasing allogeneic transfusion exposure in patients undergoing orthopedic surgery. A randomized, multicenter trial was conducted comparing the safety and efficacy of a weekly Epoetin alfa dosing regimen in patients with hemoglobin levels > or = 10 to < or = 13 g/dL scheduled to undergo major elective orthopedic arthroplasty, with a daily regimen previously shown to be effective. patients on the weekly regimen showed a greater baseline-to-presurgery hemoglobin increase versus the daily regimen group (1.44 +/- 1.029 g/dL versus 0.73 +/- 0.867 g/dL). Moreover, the weekly 600 IU/kg regimen was similar to the daily 300 IU/kg regimen with respect to safety and the avoidance of allogeneic transfusion. These data showed the weekly Epoetin alfa regimen to be at least as efficacious as the daily regimen and more convenient.

Early failure of Hylamer acetabular inserts due to eccentric wear.

The authors performed a retrospective review of the survivorship of Hylamer (DePuy Dupont Orthopaedics, Warsaw, IN) acetabular liners following primary arthroplasty of the acetabulum. Between 1990 and 1992, 193 total hip arthroplasties were performed in which Hylamer acetabular liners were implanted. One hundred forty-three of these hips (74%) were available for clinical and radio-graphic follow-up evaluation after a minimum of 2 years. The mean follow-up period was 2.5 years. Five Hylamer liners have been revised for eccentric wear at a mean of 37 months postimplantation and one additional liner is scheduled to be revised at the 34-month follow-up evaluation (total, 4.2% failure rate due to wear). Survivorship of the Hylamer liner, with failure defined as revision due to eccentric wear, was calculated to be 86% (SE, 5.5%) at 4 years. The authors have discontinued the use of Hylamer acetabular liners because of this high early failure rate.