Patient Preferences for Time and Location of Infusible Therapies in Multiple Sclerosis and Neuroimmunologic Disorders.

BACKGROUND: People with multiple sclerosis and neuroimmunologic disorders (herein referred to as patients) are increasingly treated with infusible monoclonal antibodies. This rise in demand has placed increased loads on current infusion services and mandates careful strategic planning. This study examined patient preferences for the timing and location of infusions and their association with demographic and disease variables to facilitate patient-focused strategic planning. METHODS: Ninety-one patients receiving an infusible therapy at an infusion service during March 2019 were asked to complete a questionnaire exploring eight domains, including preferences for time of infusions and location of infusion centers. Potential access to home-based treatment was included as an option. Unstructured (free-text) feedback on current service was also obtained. RESULTS: Eighty-three patients completed the survey (mean age, 42 years; 75% women). Infusions were predominantly natalizumab (66%) and ocrelizumab (25%). Of these patients, 71% were engaged in some form of work or study, and 83% of this group had to arrange time off from work or study to attend treatment. Seventy percent of patients would prefer their infusion before noon, and 60% would consider home-based infusions. Most used a car as their transport to the infusion service. CONCLUSIONS: These results suggest that patients are more likely to prefer infusible treatment in the morning and are open to home-based infusions. This study provides information for health services to target service delivery at peak preference times and consider alternate ways of delivering infusible treatments.

Pilot Randomized Controlled Trial of a Standard Versus a Modified Low-Phosphorus Diet in Hemodialysis Patients.

INTRODUCTION: The standard low-phosphorus diet restricts pulses, nuts, and whole grains and other high phosphorus foods to control hyperphosphatemia. We conducted a randomized controlled trial to evaluate the effectiveness, safety, and tolerability of the modified diet, which introduced some pulses and nuts, increased the use of whole grains, increased focus on the avoidance of phosphate additives, and introduced the prescription of low-biological-value protein such as bread. METHODS: We conducted a multicenter, pragmatic, parallel-arm, open-label, randomized controlled trial of modified versus standard diet in 74 adults on hemodialysis with hyperphosphatemia over 1 month. Biochemistry was assessed using monthly laboratory tests. Dietary intake was assessed using a 2-day record of weighed intake of food, and tolerability was assessed using a patient questionnaire. RESULTS: There was no significant difference in the change in serum phosphate between the standard and modified diets. Although total dietary phosphorus intake was similar, phytate-bound phosphorus, found in pulses, nuts, and whole grains, was significantly higher in the modified diet (P < 0.001). Dietary fiber intake was also significantly higher (P < 0.003), as was the percentage of patients reporting an increase in bowel movements while following the modified diet (P = 0.008). There was no significant difference in the change in serum potassium or in reported protein intake between the 2 diets. Both diets were similarly well tolerated. CONCLUSION: The modified low phosphorus diet was well tolerated and was associated with similar phosphate and potassium control but with a wider food choice and greater fiber intake than the standard diet.

A comparison of the analgesic efficacy of local infiltration analgesia vs. intrathecal morphine after total knee replacement: A randomised controlled trial.

BACKGROUND: Local infiltration analgesia (LIA) is an effective pain management technique following total knee arthroplasty (TKA). OBJECTIVE: To investigate if LIA provides better analgesia for patients undergoing unilateral TKA than intrathecal morphine. DESIGN: Randomised controlled trial. SETTING: Single tertiary referral centre. PATIENTS: Consecutive American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo unilateral TKA were randomised to two groups. INTERVENTION: The control group received spinal anaesthesia with intrathecal bupivacaine and preservative-free morphine 0.3 mg. The intervention group received opioid-free spinal anaesthesia with bupivacaine, followed by intra-operative infiltration of the knee with levobupivacaine 2 mg kg and adrenaline 0.5 mg diluted to a volume of 100 ml with 0.9% saline. An intra-articular catheter was placed during surgery and used to give a bolus of 15 ml of levobupivacaine 0.5% on the morning of the first postoperative day. MAIN OUTCOME MEASURES: Visual analogue scale (VAS) scores for pain were assessed repeatedly for 48 h postoperatively, at rest and on passive knee flexion to 30°. The primary outcome was VAS scores for pain at rest and on movement at 24 postoperative hours. Secondary outcomes were VAS scores at rest and on movement at 2, 6, 12 and 48 postoperative hours, opioid consumption, degree of active flexion of operative knee achieved in the first 48 h and the incidence of opioid-related side effects. RESULTS: Forty three patients completed the study. Mean (± SD) VAS scores for pain at 24 h were lower in the intervention group than the control group at rest; 16.43 (± 20.3) vs. 37.2 (± 33.6), (P = 0.029). VAS scores for pain at 24 h on movement were also lower in the intervention group vs. the control group; 39.1 (± 22.8) vs. 57.0 (± 30.9), (P = 0.037). VAS scores were also lower on movement; 25.9 (± 16.8) vs. 40.5 (± 24.0), (P = 0.028) at 48 h. CONCLUSION: We conclude that LIA conferred superior analgesia compared with intrathecal morphine 0.3 mg at 24 and 48 h following TKA. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01312415.

Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children.

BACKGROUND: Administration of dexmedetomidine (DEX) in the pediatric population for its sedative, analgesic, and anxiolytic properties has been widely reported, despite there being no label indication approved by the U.S. Food and Drug Administration for pediatric patients. Infusions of DEX, rather than bolus administration, are recommended to attenuate the hemodynamic response caused by the α2-adrenoreceptor agonist. In this prospective, double-blind, randomized study, we examined the effect of rapid IV bolus injection of DEX on emergence agitation and the hemodynamic response in a large sample of children undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion. METHODS: Four hundred patients, aged 4 to 10 years, undergoing tonsillectomy with or without adenoidectomy, with or without myringotomy, and/or tympanostomy tube insertion, were randomized at a 1:1 ratio into 1 of the 2 treatment groups in a double-blinded fashion. After a standardized anesthetic regimen and approximately 5 minutes before the end of surgery, patients in group DEX were administered a rapid IV bolus of 4 µg·mL DEX at a dose of 0.5 µg·kg, whereas patients in group saline received a rapid IV bolus of equivalent volume saline. Baseline measurements of heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and blood oxygen saturation were collected immediately before study drug administration and every minute thereafter for 5 minutes. In the postanesthesia care unit, vital signs were measured, emergence agitation (EA) was assessed using the Pediatric Anesthesia Emergence Delirium scale, and postoperative opioid use and complications were recorded. RESULTS: The incidence of EA in group DEX was significantly lower than that in group saline, regardless of whether EA was defined as a Pediatric Anesthesia Emergence Delirium score >10 (36% vs 66%, respectively; P < 0.0001; relative risk [95% confidence interval] = 0.527 [0.421-0.660]; number needed to treat = 3.33) or >12 (30% vs 61%, respectively; P < 0.0001; relative risk [95% confidence interval] = 0.560 [0.458-0.684]; number needed to treat = 3.23). Both groups exhibited similar baseline vital signs before study drug injection (all P ≥ 0.602). After injection, group DEX experienced a significant decrease in heart rate for all time points in comparison with group saline (all P < 0.0001). A significant, biphasic blood pressure response was observed in group DEX, specifically, a transient increase in systolic blood pressure at 1 minute after injection (P < 0.0001) and a subsequent decrease below baseline for 3, 4, and 5 minutes (all P < 0.0001). No patients required treatment for bradycardia, hypertension, or hypotension. A significantly smaller percentage of patients in group DEX received postoperative, supplemental opioid medication compared with group saline (48% vs 73%, respectively; P < 0.0001). Group DEX appeared to experience fewer adverse events than group saline as well (9% vs 17%, respectively; P = 0.025). CONCLUSIONS: Rapid IV bolus administration of DEX in children improved their recovery profile by reducing the incidence of EA. A statistically significant change in hemodynamics was observed, but no patients required any intervention for hemodynamic changes. Furthermore, DEX reduced the incidence of postoperative opioid administration, and a trend of fewer adverse events was observed in group DEX.

A multicenter, randomized, double-blind placebo-controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy.

BACKGROUND: Tonsillectomy is one of the most common pediatric procedures in the United States. An optimal perioperative pain control regimen remains a challenge. Intravenous ibuprofen administered at induction of anesthesia may be a safe and efficacious option for postoperative tonsillectomy pain. OBJECTIVES: To determine whether preoperative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease the number of doses of postoperative fentanyl when compared with placebo in pediatric tonsillectomy surgical patients. METHODS: This was a multicenter, randomized, double-blind placebo-controlled trial conducted at six hospitals in the United States. A total of 161 pediatric patients aged 6-17 years undergoing tonsillectomy were randomized to receive either a single preoperative dose of 10 mg·kg(-1) IV-ibuprofen or placebo (normal saline). Postoperative pain was managed with intravenous fentanyl (0.5 µg·kg(-1)) on an as needed basis when the visual analog scale (VAS) was >30 mm and deemed appropriate by recovery room nurse/physician. The primary endpoint was the number of doses and amount of postoperative fentanyl administered postoperatively for rescue analgesia. RESULTS: There was a significant reduction in the number of postoperative doses and the amount of fentanyl administered after surgery in the IV-ibuprofen group compared with the placebo group (P = 0.021). There were no differences in the time to first analgesia request or the number of patients who required postoperative analgesia. There were no significant differences in the incidence of serious adverse events, surgical blood loss (P = 0.662), incidence of postoperative bleeding, or a need for surgical re-exploration between the treatment groups. CONCLUSION: Administration of IV-ibuprofen, 10 mg·kg(-1) , significantly reduced fentanyl use in pediatric tonsillectomy patients.

Local Infiltration Analgesia for Postoperative Pain Control following Total Hip Arthroplasty: A Systematic Review.

Local infiltration analgesia (LIA) is an analgesic technique that has gained popularity since it was first brought to widespread attention by Kerr and Kohan in 2008. The technique involves the infiltration of a large volume dilute solution of a long-acting local anesthetic agent, often with adjuvants (e.g., epinephrine, ketorolac, an opioid), throughout the wound at the time of surgery. The analgesic effect duration can then be prolonged by the placement of a catheter to the surgical site for postoperative administration of further local anesthetic. The technique has been adopted for use for postoperative analgesia following a range of surgical procedures (orthopedic, general, gynecological, and breast surgeries). The primary objective of this paper was to determine, based on the current evidence, if LIA is superior when compared to no intervention, placebo, and alternative analgesic methods in patients following total hip arthroplasty, in terms of certain outcome measures. The outcomes considered were postoperative analgesia scores, joint function/rehabilitation, and length of hospital stay. Secondary objectives were to review available evidence and current knowledge regarding the pharmacokinetics of local anesthetic and adjuvant drugs when administered in this way and the occurrence of adverse events.

Standard computed tomography of the chest, abdomen, and pelvis is sensitive and cost-effective for the detection of fractures of the shoulder girdle.

Computed tomography of the chest, abdomen, and pelvis (CTCAP) has become the mainstay of diagnosis in stable blunt trauma patients. The purpose of this study was to investigate whether standard CTCAP has adequate sensitivity to identify fractures of the scapula, clavicle, and humeral head to replace routine radiographs of the shoulder. A retrospective chart review was carried out from January 1, 2004, to December 31, 2007, at Morristown Memorial Hospital. Inclusion criteria were all shoulder fracture patients in our trauma registry who underwent both a CTCAP and plain radiographs of the injured shoulder. Data were collected for patient age, sex, Injury Severity Score, mechanism of injury, and fracture location. Sensitivity was calculated for each diagnostic modality as well as hospital costs and radiation dose of plain radiographs. A total of 374 charts were reviewed and 98 patients were included in the study with a total of 117 fractures. The sensitivity of trauma CTCAP for scapula fractures was 100 per cent, clavicle fractures 98 per cent, and humeral head fractures 100 per cent. The sensitivity of the shoulder series for scapula fractures was 60 per cent, clavicle fractures 85 per cent, and humeral head fractures 100 per cent. The plain radiographs added $298 in hospital charges and 0.191 mSv of radiation per patient. CTCAP is a sensitive tool for identifying fractures in the shoulder girdle. Therefore, CTCAP can replace the routine radiographs of the shoulder resulting in less total radiation exposure of the trauma patients. This also would lead to lower healthcare cost and better diagnostic workflow.

Computer simulations of patellofemoral joint surgery. Patient-specific models for tuberosity transfer.

BACKGROUND: Variable clinical outcomes of tibial tuberosity transfer surgery have been reported. HYPOTHESES: The biomechanical outcome of surgery is patient-specific; no single procedure produces superior results for all patients. Use of patient-specific computer models can optimize choice of procedure. STUDY DESIGN: Computer simulation study using clinical data. METHODS: We used patient-specific multibody models of the patellofemoral joints of 20 patients with a diagnosis of patellar subluxation and osteoarthritis. Four tibial tuberosity transfer procedures (two anterior and two anteromedial) were simulated for each patient and compared with their preoperative model. RESULTS: When results for all patients were averaged, all simulated operations produced a statistically significant decrease in surface-wide mean contact stress, although no significant difference was found among them. CONCLUSIONS: The simulated surgical outcomes were patient-specific: no single procedure was consistently superior at decreasing peak or mean stress and each procedure produced a potentially detrimental outcome, an increase in either mean stress or peak stress, in at least one patient. CLINICAL RELEVANCE: Computer simulation may serve as a valuable tool for tailoring procedures to specific patients.