Barriers and facilitators to conducting radiotherapy clinical trials: Findings from a UK survey.

INTRODUCTION: As an essential component of service delivery, radiotherapy clinical trials were championed within the NHS England service specifications. A call for a 15% increase in research and clinical trial activity, alongside a demand for equity of access for patients with cancer subsequently ensued. National understanding of current radiotherapy clinical trials operational practices is absent, but essential to help establish the current provision required to support the development of a strategic plan for implementation of NHS England's specifications. METHODS: A cross-sectional survey was developed by a multi-disciplinary team and distributed to therapeutic radiography clinical trial leads across the UK to ascertain the current provision of radiotherapy clinical trials only, including workforce resources and the trials management processes to establish a benchmark and identify potential barriers, enablers, and opportunities to increase access to clinical trials. RESULTS: Thirty-two complete responses were obtained equating to 49% of the total UK NHS departments and 74% of those departments invited. Four key findings were identified: 1) research strategy and systems, 2) participation and activity in radiotherapy clinical trials, 3) access to clinical trials at alternative departments and 4) facilitators & barriers. Overarchingly a lack of radiotherapy clinical trials strategy or supported processes were apparent across the UK, aggravating existing barriers to trial activity. CONCLUSION: It is essential for radiotherapy clinical trials to be embedded in to departmental and Trust strategy, this will help to ensure the processes and resources required for trial delivery are not only in place, but also recognised as imperative and important for patients with cancer as radiotherapy treatment delivery. IMPLICATIONS FOR PRACTICE: Failure to address the barriers or build upon the facilitators may result in UK radiotherapy departments facing challenges in achieving the 15% increase in radiotherapy clinical trial activity.

Introducing magnetic resonance imaging into the lung cancer radiotherapy workflow - An assessment of patient experience.

INTRODUCTION: Magnetic resonance imaging (MRI) offers superior soft tissue contrast to computed tomography (CT), the current standard imaging modality for planning radiotherapy treatment. Improved soft tissue contrast could reduce uncertainties in identifying tumour and surrounding healthy tissues, potentially leading to improved outcomes in patients with lung cancer. This study explored patient experience of MR treatment planning scans in addition to a CT scan. METHODS: Participants were recruited to the 'Magnetic Resonance Imaging for the Delineation of Organs At Risk and Target Volumes in Lung Cancer Patients (MR-Lung)' study at a UK specialist cancer centre. Participants completed their standard of care radiotherapy planning CT scan and two additional MRI scans. Baseline and post-scan questionnaires were completed assessing anxiety and claustrophobia. Motion artefact during MRI was assessed by a modified visual grading analysis. Sixteen participants completed semi-structured interviews; transcripts were analysed thematically. RESULTS: 29 people (66% female; aged 54-89 years) participated. Nineteen participants completed all imaging and 10 participants withdrew before completion. There was minimal adverse impact on state and scan-specific anxiety levels from completing the MRI scans. Completers experienced significantly less scan-specific anxiety during MRI 1 compared to non-completers (U = 33, z = -1.98, p < 0.05). 78% of those who withdrew during or post MRI 1 were positioned 'arms up'. Motion artefact negatively impacted image quality in 34% of scans. Participants commonly reported concerns during MRI; noise, claustrophobia and pain in upper limbs. CONCLUSION: Two thirds of participants tolerated two additional MR scans with minimal adverse impact on anxiety levels. IMPLICATIONS FOR PRACTICE: Patient arm positioning and comfort ought to be considered when introducing MR-Linac systems. A screening tool to identify those at high risk of non-completion should be developed.

Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer.

AIMS: The aims of this study were to assess the exposure and preservation of the abductor mechanism during primary total hip arthroplasty (THA) using the posterior approach, and to evaluate gluteus maximus transfer to restore abductor function of chronically avulsed gluteus medius and minimus. PATIENTS AND METHODS: A total of 519 patients (525 hips) underwent primary THA using the posterior approach, between 2009 and 2013. The patients were reviewed preoperatively and at two and five years postoperatively. Three patients had mild acute laceration of the gluteus medius caused by retraction. A total of 54 patients had mild chronic damage to the tendon (not caused by exposure), which was repaired with sutures through drill holes in the greater trochanter. A total of 41 patients had severe damage with major avulsion of the gluteus medius and minimus muscles, which was repaired with sutures through bone and a gluteus maximus flap transfer to the greater trochanter. RESULTS: Abductor strength was maintained in the normal hips, but lateral hip pain progressed significantly, five years postoperatively (p < 0.0001). In the 54 patients with mild abductor tendon damage treated with simple repair, lateral hip pain also increased significantly during follow-up (p = 0.002). In the 35 patients with severe avulsion but good muscle repaired using a gluteus maximus flap transfer, abductor function was restored. The six patients with complete avulsion and poor muscle did not regain strong abductor power, but lateral hip pain decreased. CONCLUSION: The posterior approach offered excellent exposure and preservation of the abductor mechanism during primary THA. Augmentation of the repair with a gluteus maximus flap provided stable reconstruction of the abductor muscles and seemed to restore function in the hips with functioning muscles. Cite this article: Bone Joint J 2019;101-B(6 Supple B):116-122.

The projected costs and benefits of a supervised injection facility in Seattle, WA, USA.

BACKGROUND: As one strategy to improve the health and survival of people who inject drugs, the King County Heroin & Opioid Addiction Task Force recommended the establishment of supervised injection facilities (SIF) where people can inject drugs in a safe and hygienic environment with clinical supervision. Analyses for other sites have found them to be cost-effective, but it is not clear whether these findings are transferable to other settings. METHODS: We utilized local estimates and other data sources deemed appropriate for our setting to implement a mathematical model that assesses the impact of a hypothetical SIF on overdose deaths, non-fatal overdose health service utilization, skin and soft tissue infections, bacterial infections, viral infections, and enrollment in medication assisted treatment (MAT). We estimated the costs and savings that would occur on an annual basis for a small-scale pilot site given current overdose rates, as well as three other scenarios of varying scale and underlying overdose rates. RESULTS: Assuming current overdose rates, a hypothetical Seattle SIF in a pilot phase is projected to annually reverse 167 overdoses and prevent 6 overdose deaths, 45 hospitalizations, 90 emergency department visits, and 92 emergency medical service deployments. Additionally, the site would facilitate the enrollment of 41 SIF clients in medication assisted treatment programs. These health benefits correspond to a monetary value of $5,156,019. The annual estimated cost of running the SIF is $1,222,332. The corresponding cost-benefit ratio suggests that the pilot SIF would generate $4.22 for every dollar spent on SIF operational costs. The pilot SIF is projected to save the healthcare system $534,453. If Seattle experienced elevated overdose rates and Seattle SIF program were scaled up, the health benefits and financial value would be considerably greater. CONCLUSION: This analysis suggests that a SIF program in Seattle would save lives and result in considerable health benefits and cost savings.

Prophylactic peri-operative local antibiotic irrigation.

An extensive review of the spinal and arthroplasty literature was undertaken to evaluate the effectiveness of local antibiotic irrigation during surgery. The efficacy of antibiotic irrigation for the prevention of acute post-operative infection after total joint arthroplasty was evaluated retrospectively in 2293 arthroplasties (1990 patients) between January 2004 and December 2013. The mean follow-up was 73 months (20 to 139). One surgeon performed all the procedures with minimal post-operative infection. The intra-operative protocol included an irrigation solution of normal saline with vancomycin 1000 mg/l and polymyxin 250,000 units/l at the rate of 2 l per hour. No patient required re-admission for primary infection or further antibiotic treatment. Two morbidly obese patients (two total hip arthroplasties) developed subcutaneous fat necrosis requiring debridement and one was revised because the deep capsular sutures were contaminated by the draining subcutaneous haematoma. One patient who had undergone total knee arthroplasty had unrecognised damage to the lateral superior geniculate artery and developed a haematoma that became infected secondarily four months after the surgery and underwent revision. The use of antibiotic irrigation during arthroplasty surgery has been highly effective for the prevention of infection in the author's practice. However, it should be understood that any routine prophylactic use of antibiotics may result in resistant organisms, and the wise stewardship of the use of antibiotics is an important part of surgical practice.

Intra-articular infusion: a direct approach to treatment of infected total knee arthroplasty.

Bactericidal levels of antibiotics are difficult to achieve in infected total joint arthroplasty when intravenous antibiotics or antibiotic-loaded cement spacers are used, but intra-articular (IA) delivery of antibiotics has been effective in several studies. This paper describes a protocol for IA delivery of antibiotics in infected knee arthroplasty, and summarises the results of a pharmacokinetic study and two clinical follow-up studies of especially difficult groups: methicillin-resistant Staphylococcus aureus and failed two-stage revision. In the pharmacokinetic study, the mean synovial vancomycin peak level was 9242 (3956 to 32 150; sd 7608 µg/mL) among the 11 patients studied. Serum trough level ranged from 4.2 to 25.2 µg/mL (mean, 12.3 µg/mL; average of 9.6% of the joint trough value), which exceeded minimal inhibitory concentration. The success rate exceeded 95% in the two clinical groups. IA delivery of antibiotics is shown to be safe and effective, and is now the first option for treatment of infected total joint arthroplasty in our institution.

Individual and Medical Characteristics of Adults Presenting to an Urban Emergency Department in Ghana.

BACKGROUND: The aims of this study were to characterize the patients seeking acute care for injury and non-injury complaints in an urban Emergency Department in Ghana in order to 1) inform the curriculum of the newly developed Emergency Medicine resident training program 2) improve treatment processes, and 3) direct future community-wide injury prevention policies. STUDY DESIGN: A prospective cross-sectional survey of patients 18 years or older seeking care in an urban Accident and Emergency Center (AEC) was conducted between 7/13/2009 and 7/30/2009. Questionnaires were administered by trained research staff and each survey took 10-15 minutes to complete. Patients were asked questions regarding demographics, overall health and chief complaint. RESULTS: 254 patients were included in the sample. Participants' chief complaints were classified as either medical or injury-related. Approximately one third (38%) of patients presented with injuries and 62% presented for medical complaints. The most common injury at presentation was due to a road traffic injury, followed by falls and assault/fight. The most common medical presentation was abdominal pain followed by difficulty breathing and fainting/ blackout. Only 13% arrived to AEC by ambulance and 51% were unable to ambulate at the time of presentation. CONCLUSION: Approximately one-third of non-fatal adult visits were for acute injury. Future research should focus on developing surveillance systems for both medical and trauma patients. Physicians that are specifically trained to manage both the acutely injured patient and the medical patient will serve this population well given the variety of patients that seek care at the AEC.

Bypassing proximal health care facilities for acute care: a survey of patients in a Ghanaian Accident and Emergency Centre.

OBJECTIVE: To characterise the population that presents to the Accident and Emergency Centre (AEC) at Komfo Anokye Teaching Hospital (KATH) and to identify risk factors associated with bypassing proximal care facilities. METHODS: A structured questionnaire was verbally administered to patients presenting to the AEC over 2 weeks. The questionnaire focused on the use of health care resources and characteristics of current illness or injury. Measures recorded include demographics, socioeconomic status, chief complaint, transportation and mobility, reasons for choosing KATH and health care service utilisation and cost. RESULTS: The total rate of bypassing proximal care was 33.9%. On multivariate analysis, factors positively associated with bypassing included age older than 38 years (OR: 2.18, P 0.04) and prior visits to facility (OR 2.88, P 0.01). Bypassers were less likely to be insured (OR 0.31, P 0.01), to be seeking care due to injury (OR 0.42, P 0.03) and to have previously sought care for the problem (OR 0.10, P < 0.001). CONCLUSIONS: Patients who bypass facilities near them to seek care at an urban AEC in Ghana do so for a combination of reasons including familiarity with the facility, chief complaint and insurance status. Understanding bypassing behaviour is important for guiding health care utilisation policy decisions and streamlining cost-effective, appropriate access to care for all patients.

Diamond-like carbon coatings enhance the hardness and resilience of bearing surfaces for use in joint arthroplasty.

The purpose of this study was to evaluate the potential of a hard diamond-like carbon (DLC) coating to enhance the hardness and resilience of a bearing surface in joint replacement. The greater hardness of a magnesium-stabilized zirconium (Mg-PSZ) substrate was expected to provide a harder coating-substrate composite microhardness than the cobalt-chromium alloy (CoCr) also used in arthroplasty. Three femoral heads of each type (CoCr, Mg-PSZ, DLC-CoCr and DLC-Mg-PSZ) were examined. Baseline (non-coated) and composite coating/substrate hardness was measured by Vickers microhardness tests, while nanoindentation tests measured the hardness and elastic modulus of the DLC coating independent of the Mg-PSZ and CoCr substrates. Non-coated Mg-PSZ heads were considerably harder than non-coated CoCr heads, while DLC coating greatly increased the microhardness of the CoCr and Mg-PSZ substrates. On the nanoscale the non-coated heads were much harder than on the microscale, with CoCr exhibiting twice as much plastic deformation as Mg-PSZ. The mechanical properties of the DLC coatings were not significantly different for both the CoCr and Mg-PSZ substrates, producing similar moduli of resilience and plastic resistance ratios. DLC coatings greatly increased hardness on both the micro and nano levels and significantly improved resilience and resistance to plastic deformation compared with non-coated heads. Because Mg-PSZ allows less plastic deformation than CoCr and provides a greater composite microhardness, DLC-Mg-PSZ will likely be more durable for use as a bearing surface in vivo.

Phase transformation, roughness, and microhardness of artificially aged yttria- and magnesia-stabilized zirconia femoral heads.

Yttria-stabilized zirconia ceramic (Y-TZP) has been used in total hip arthroplasty for many years but is susceptible to low-temperature aging. Medical-grade magnesia-stabilized zirconia (Mg-PSZ) is less commonly used; however, it has been shown to resist phase transformation. The purpose of this study was to directly compare the effects of artificial aging on phase transformation, surface roughness, and Vickers microhardness on Y-TZP and Mg-PSZ femoral heads. Y-TZP and Mg-PSZ heads were artificially aged in an autoclave in stages up to a total of 49 h. The surface roughness of Y-TZP significantly increased with each stage of artificial aging. Y-TZP heads aged for 49 h had a significantly higher monoclinic phase concentration and roughness, and a significantly lower microhardness, than nonaged Y-TZP heads. Artificial aging also caused the surface of Y-TZP to exhibit a lumpy "orange peel"-like appearance with a significantly higher mean peak height, suggesting that artificial aging causes individual grains to be pushed out of the surface. In contrast, artificial aging did not significantly affect the properties of Mg-PSZ heads. These findings suggest that Mg-PSZ is a satisfactory material for orthopaedic implant use, while Y-TZP, in the form tested, is not adequately stable for use as a bearing surface.

Caloric requirement for refeeding inpatients with anorexia nervosa: the contribution of anxiety exercise, and cigarette smoking.

BACKGROUND: Refeeding inpatients with anorexia nervosa (AN) is costly, stressful, and can precipitate the refeeding syndrome. Caloric intake is usually increased gradually from a low starting point until a steady weight gain is achieved. There is no reliable equation that predicts the number of calories required for a weight gain. It was our clinical suspicion that anxiety, exercise, and cigarette smoking might increase the caloric need for refeeding. METHOD: We conducted an observational cohort study of 17 females with AN admitted to an inpatient eating disorder unit for refeeding. We estimated the energy intake by observation, the caloric expenditure due to exercise with a triaxial accelerometer, the number of cigarettes smoked by history, and the anxiety by the Beck Anxiety Inventory (BAI). RESULTS: Neither anxiety, exercise, or cigarette smoking predicted the caloric requirement for refeeding, individually or in combination. DISCUSSION: Our data suggest that the caloric requirement for weight gain during refeeding is not predicted by the patient's anxiety, exercise or smoking habits. The standard methods of estimating caloric requirements for refeeding remain indirect calorimetry and previous history.

Stability after medial collateral ligament release in total knee arthroplasty.

Six knees from cadavers were tested for change in stability after release of the medial collateral ligament with posterior cruciate-retaining and substituting total knee replacements. Load deformation curves of the joint were recorded in full extension and 30 degrees, 60 degrees, and 90 degrees flexion under a 10 N-m varus and valgus torque, 1.5 N-m internal and external rotational torque, and a 35 N anterior and posterior force to test stability in each knee. The intact specimen and posterior cruciate ligament-retaining total joint replacement were tested for baseline comparisons. The superficial medial collateral ligament was released, followed by release of the posterior cruciate ligament. The knee then was converted to a posterior-stabilized implant. After medial collateral ligament release, valgus laxity was statistically significantly greater at 30 degrees, 60 degrees, and 90 degrees flexion after posterior cruciate ligament sacrifice than it was when the posterior cruciate ligament was retained. The posterior-stabilizing post added little to varus and valgus stability. Small, but significant, differences were seen in internal and external rotation before and after posterior cruciate ligament sacrifice. The posterior-stabilized total knee arthroplasty was even more rotationally constrained in full extension than the knee with intact medial collateral ligament and posterior cruciate ligament.

Long-term followup of the bone-ingrowth Ortholoc knee system without a metal-backed patella.

Between June 1981 and January 1984, 265 Ortholoc-I femoral and tibial components were implanted using bone-ingrowth technique in 202 patients. Five knees (five patients) were lost to followup and 66 knees were excluded because the patients died, leaving 184 knees (165 patients) with 15 to 18 years followup. One knee loosened during the 15- to 18-year followup period and was revised, and five knees were revised for infection. Survival rate at 18 years considering loosening was 98.6%. At 15 years after surgery, 79.9% of patients did not have pain, 10.1% had mild pain, 8% had moderate pain, and 2% had severe pain. At 18 years after surgery, 77.6% did not have pain, 7.2% had mild pain, 5.2% had moderate pain, and 1% had severe pain. Knee flexion was 110 degrees preoperatively and increased to a mean of 115 degrees at 2 years postoperative, then remained unchanged for the rest of the followup. Intramedullary alignment proved to be highly effective, and has become the standard for total knee arthroplasty instrumentation systems. Total knee replacement with bone-ingrowth technique was a reliable and effective means of treating the end-stage arthritic knee. In patients who required revision surgery, excellent bone stock remained and revision with bone-ingrowth technique was accomplished easily.

Fixation of the Quatroloc femoral component: a biomechanical and clinical study.

The current study was designed to test the hypothesis that press-fit femoral components with proximal press-fit and distal mechanical interlock can achieve fixation sufficient to allow bone ingrowth in osteoporotic and in normal bone. The addition of steps along the tapered distal stem improved fixation in osteoporotic bone enough to reduce micromotion to less than 20 microm in response to physiologic axial and torsional load. The clinical portion of the study included 226 consecutive hips (223 patients) with 2- to 4-year clinical results after total hip arthroplasty with a rectangular femoral component using proximal porous coating and distal mechanical interlock. Patient age ranged from 36 to 92 years. At 2 years postoperative, 4% of the patients with Type A (normal) femoral bone, 3% with Type B (intermediate) bone, and no patients with Type C (osteoporotic) bone had thigh pain. No clinical cases of loosening have occurred in normal or osteoporotic femurs.

Functional medical ligament balancing in total knee arthroplasty.

Function of the anterior and posterior oblique portions of the medial collateral ligament and the posterior capsule in flexion and extension was evaluated in eight knee specimens after posterior cruciate retaining total knee arthroplasty. The posterior oblique portion of the medial collateral ligament was released subperiosteally in four specimens, and the anterior portion was released in four specimens. The medial posterior capsule was released in each group, then the remaining portion of the medial collateral ligament was released. Release of the posterior oblique portion produced moderate laxity at full extension and at 30 degrees flexion, and posterior capsule release produced additional laxity in full extension. Release of the anterior portion produced major laxity at 60 degrees and 90 degrees flexion. Complete medial collateral ligament release increased laxity significantly in both groups in flexion and extension. This rationale was tested in a clinical study of 82 knees (76 patients) in which 62 (76%) required medial collateral ligament release to correct varus deformity during posterior cruciate retaining total knee arthroplasty. Twenty-two knees (35.5%) were tight medially in extension only, and were corrected by releasing the posterior oblique portion. Thirty-one knees (50%) were tight medially in flexion only, and were corrected by releasing the anterior portion. Nine knees (14.5%) were tight medially in flexion and extension and required complete medial collateral ligament release, but three knees (4.8%) remained tight in extension and required medial posterior capsule release to correct flexion contracture and medial ligament contracture. Seventeen (27%) had partial posterior cruciate ligament release to correct excessive rollback of the femoral component on the tibial surface.

Contact stresses with an unresurfaced patella in total knee arthroplasty: the effect of femoral component design.

Compressive contact stresses between the patella and the anterior femur were measured with a digital electronic sensor before and after total knee arthroplasty (TKA) in 10 cadaver knee specimens. Contact stresses were measured first in normal knees, then after TKA with the Insall-Burstein Total Condylar, Miller Galante II, Ortholoc II, Porous Coated Anatomic, and Profix knee prostheses implanted without resurfacing the patella. The Insall-Burstein, Miller-Galante II, and Ortholoc II prostheses had significantly higher contact stresses than the normal knee throughout the flexion arc. The Porous Coated Anatomic, which has a smooth patellar groove, maintained contact area as in the normal knee and did not have significantly higher contact stresses at flexion angles <90 degrees. At flexion angles > or =105 degrees, patellofemoral contact occurred in two small areas as the patella encountered the intercondylar notch in all components except the Profix. The Profix maintained full contact and low compressive stresses throughout the full flexion arc because of its posteriorly extended patellar groove. Design features of the patellofemoral portion of TKA components are important factors that affect contact stresses in the patellofemoral joint. These features likely will affect the clinical results of TKA with an unresurfaced patella.