Worst Pain Score Research Articles

Spica Casting of Pediatric Femur Fractures: The Pain Management Experience at One Institution.

ObjectivesCurrently, very little literature exists regarding the "fifth vital sign" in pediatric orthopedics, pain. Multiple studies have highlighted the utility of non-narcotic pain medications in treating acute pain. The objective of this study is to determine the type and amount of pain medication(s) administered and subsequently prescribed to pediatric patients ages six months to five years old with femur fractures treated with spica casting in the ER (emergency room) and OR (operative room). We also determined the incidence of spica cast change necessary for the two groups as a secondary outcome.MethodsA retrospective review was completed at a single level 1 pediatric trauma center, evaluating 82 patients who met the inclusion criteria between six months to five years of age with isolated femoral shaft fractures requiring intervention at one institution. Descriptive statistics and Wilcoxon Rank-Sum or Fisher'sFisher's Exact test were used to assess differences between OR and ER groups for either continuous or categorical variables, respectively. The electronic medical record was then queried for demographic information, location of spica cast placement, hours in the hospital, and amount and type of analgesic medications administered and prescribed.ResultsOverall, we noted a preponderance of femur fractures in young males (72%), with the mean age of our cohort being 2.3 years old. Our patients spent a median of 20.9 hours in the hospital and had a median worst pain score of 7/10 during their hospital stay. No difference was found between standardized amounts of morphine equivalent administration between groups in the hospital. Upon discharge from the hospital, most patients received opioid and acetaminophen prescriptions (72% and 83%), but few received an ibuprofen prescription (24.4%). More spica casts placed in the ER needed to be revised in the OR compared to spica casts placed in the OR (57% vs. 8%, p<0.01).ConclusionsThere are various medication regimens for patients with femoral shaft fractures treated with spica casting at one institution. Our study revealed that patients received more prescription opioids if treated in the OR. Additionally, spica casting in the ER did not significantly decrease hospital stay, and it significantly increased the risk of needing a reduction in the OR in our institution.

A Randomized Controlled Pilot Study Using Ultrasound-Guided Percutaneous Cryoneurolysis of the Infrapatellar Branch of the Saphenous Nerve for Analgesia Following Total Knee Arthroplasty.

Total knee arthroplasty (TKA) is frequently associated with severe, prolonged postsurgical pain, and therefore local anesthetic-based peripheral nerve blocks are commonly used for postoperative analgesia. Cryoneurolysis involves the use of freezing temperatures to provide a reversible sensory (and motor) block with a duration measured in weeks and months, more commensurate with the typical period of post-TKA pain. We therefore conducted a randomized controlled pilot study to evaluate the use of this modality for the treatment of pain following TKA to (1) determine the feasibility of and optimize the study protocol for a subsequent definitive clinical trial; and (2) estimate analgesia and opioid reduction within the first 3 postoperative weeks. A convenience sample of 16 patients undergoing primary TKA with a single-injection and/or continuous adductor canal nerve block were randomized to receive either active cryoneurolysis or a sham procedure targeting the infrapatellar branch of the saphenous nerve, in a participant-masked fashion. This was a pilot study with a relatively small number of participants, and therefore resulting data were not analyzed statistically. Compared with participants receiving sham, the active treatment group reported slightly lower average and worst pain scores as well as opioid consumption and sleep disturbances due to pain at a majority of postoperative time points between postoperative days (POD) 4-21. Preoperative ultrasound-guided cryoneurolysis of the infrapatellar branch of the saphenous nerve is feasible and may provide analgesic benefits for multiple weeks following TKA. A definitive randomized controlled trial appears warranted.

Disease burden in patients with acute hepatic porphyria: experience from the phase 3 ENVISION study

BackgroundAcute hepatic porphyria (AHP) is a family of four rare genetic diseases, each involving deficiency in a hepatic heme biosynthetic enzyme. Resultant overproduction of the neurotoxic intermediates δ-aminolevulinic acid (ALA) and porphobilinogen (PBG) leads to disabling acute neurovisceral attacks and progressive neuropathy. We evaluated the AHP disease burden in patients aged ≥ 12 years in a post hoc analysis of the Phase 3, randomized, double-blind, placebo-controlled ENVISION trial of givosiran (NCT03338816), an RNA interference (RNAi) therapeutic that targets the enzyme ALAS1 to decrease ALA and PBG production. We analyzed baseline AHP severity via chronic symptoms between attacks, comorbidities, concomitant medications, hemin-associated complications, and quality of life (QOL) and evaluated givosiran (2.5 mg/kg monthly) in patients with and without prior hemin prophylaxis on number and severity of attacks and pain scores during and between attacks.ResultsParticipants (placebo, n = 46; givosiran, n = 48) included patients with low and high annualized attack rates (AARs; range 0–46). At baseline, patients reported chronic symptoms (52%), including nausea, fatigue, and pain; comorbidities, including neuropathy (38%) and psychiatric disorders (47%); concomitant medications, including chronic opioids (29%); hemin-associated complications (eg, iron overload); and poor QOL (low SF-12 and EuroQol visual analog scale scores). A linear relationship between time since diagnosis and AAR with placebo suggested worsening of disease over time without effective treatment. Givosiran reduced the number and severity of attacks, days with worst pain scores above baseline, and opioid use versus placebo.ConclusionsPatients with AHP, regardless of annualized attack rates, have considerable disease burden that may partly be alleviated with givosiran.

Pericapsular nerve group (PENG) block for hip arthroscopy: a randomized, double-blinded, placebo-controlled trial

IntroductionArthroscopic hip surgery is associated with significant postoperative pain. Femoral nerve blocks have been shown to improve postoperative analgesia at the expense of quadriceps weakness. The pericapsular nerve group (PENG)...

Development and validation of a multivariable prognostic model in de novo metastatic castrate sensitive prostate cancer.

Metastatic castrate sensitive prostate cancer (mCSPC) is a heterogeneous disease state with variable prognosis. Although several life-prolonging systemic agents are available, there is no robust multivariable model to predict prognosis and improve risk stratification in mCSPC. The objective of this study was to build and validate a multivariable prognostic model to predict overall survival (OS) in mCSPC. We used data from LATITUDE, a phase III randomized controlled trial in which men with de novo mCSPC were randomly allocated to either ADT plus abiraterone or ADT with placebo. Patients with non-missing data (n = 1,058) were randomly split in a 70:30 ratio to training (n = 743) and testing (n = 315) sets. Elastic net regression was used for variable selection. A multivariable Cox regression model for OS was then fitted using the selected variables. The predictive accuracy of the model was assessed on the testing set using the time-dependent area under curve (tAUC) with bootstrapped confidence intervals [CI] primarilyfor OS and secondarily forradiographic progression-free survival (rPFS). The 11 prognostic variables in the final model were performance status, number of skeletal metastases, Gleason score, presence of liver metastasis, worst pain score, albumin, lactate dehydrogenase, prostate-specific antigen, hemoglobin, and treatment regimen. The tAUC for predicting OS at 2- and 3-years was 0.74 (95%CI, 0.67-0.80) and 0.72 (95%CI, 0.65-0.77), respectively. The tAUC for rPFS at 2- and 3-years was 0.72 (95%CI, 0.65-0.77) and 0.77 (95%CI, 0.70-0.82), respectively. A prognostic model for men with de novo mCSPC was developed and validated in an independent testing set. Our model had high accuracy for predicting OS and rPFS. The model includes commonly used clinical and laboratory parameters and can guide risk stratification of these patients for participation in future trials.

Health-related quality of life (HRQoL) and pain in the MAGNITUDE study of niraparib (NIRA) with abiraterone acetate and prednisone (AAP) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations.

5060 Background: Results from the international, randomized, double-blind, phase 3 MAGNITUDE study demonstrated that NIRA + AAP improved radiographic progression-free survival, time to cytotoxic chemotherapy, and time to symptomatic progression, with manageable toxicity in pts with mCRPC and HRR alterations (9-gene panel). Here, we report HRQoL and pain in MAGNITUDE. Methods: Eligible pts with mCRPC and HRR alterations were randomized 1:1 to NIRA + AAP or placebo (PBO) + AAP orally daily in 28-day cycles. Pts had ECOG status ≤1 and a Brief Pain Inventory–Short Form (BPI-SF) worst pain score ≤3 in prescreening. HRQoL assessments on day 1 of specified cycles included Functional Assessment of Cancer Therapy–Prostate (FACT-P) and BPI-SF. Changes from baseline were compared between treatment arms using repeated measures analysis. Proportional hazards regression models were used to compare time to deterioration (TTD) in worst pain intensity between arms. Results: Compliance for FACT-P and BPI-SF was &gt; 80%. Most pts maintained low pain levels over time. Repeated measures analyses showed no clinically meaningful differences in pain over time or between arms. Median TTD in pain intensity was not reached in either arm. At the 25th percentile, there was a trend toward longer TTD in pain intensity with NIRA + AAP vs PBO + AAP (11.1 vs 10.1 mo; HR, 0.87; 95% CI, 0.61-1.24). HRQoL was maintained with NIRA + AAP, with no clinically meaningful differences in FACT-P total score over time or between arms. There was a trend toward greater worsening in early cycles on FACT-P physical wellbeing with NIRA + AAP vs PBO + AAP, driven by events within the known safety profile of NIRA + AAP (worsening of side effect bother, lack of energy, and nausea); however, overall, most pts reported minimal side effect burden (Table). Conclusions: In MAGNITUDE, most pts maintained low pain levels and positive HRQoL over time, with no clinically meaningful differences between treatment arms, further supporting the use of NIRA + AAP in pts with mCRPC and HRR alterations. Side effect burden was perceived as low in both arms. Although more pts on NIRA+AAP reported worsening side effects, the symptoms were generally perceived as mild. Clinical trial information: NCT03748641. [Table: see text]

Hospitalized Children With Limited English Proficiency: The Strive to Improve Analgesia.

Hospitalized Children With Limited English Proficiency: The Strive to Improve Analgesia.

Inequities in Pain Assessment and Care of Hospitalized Children With Limited English Proficiency

To examine inequities in pain assessment and management of hospitalized children with limited English proficiency (LEP) as assessed by (1) self-reported pain prevalence and intensity, and (2) nurse-documented pain assessments and analgesia. A cross-sectional survey of hospitalized children and parent proxies examined preferred language and pain prevalence, intensity, and etiology; subsequent electronic medical record chart review examined demographics, nurse-documented pain scores, and analgesia prescribed for children aged ≤21 years at a tertiary care children's hospital. The primary outcome was a difference of ≥3 points between self-reported and nurse-documented worst pain scores. Descriptive statistics, Fisher's exact tests, and multivariable logistic regression were used to identify differences in outcomes between children with and without LEP. A total of 155 patients (50% children and 50% parental proxies) were interviewed (96% response rate). Of those, 60% (n = 93) reported pain in the previous 24 hours, most frequently because of acute illnesses. Of patients reporting pain, 65% (n = 60) reported a worst pain score of ≥3 points higher than nurse-documented scores; this discrepancy affected more patients with LEP (82%, n = 27) than English-proficient patients (55%, n = 33) (P = .01) with an adjusted odds ratio of 3.2 (95% confidence interval: 1.13-10.31). Patients with LEP were also less likely than English-proficient patients to receive medications at the time of their worst pain (60% vs 82%, P = .03), particularly opioid analgesia (9% vs 22%, P = .04). Children with LEP were more likely to self-report pain scores that exceeded nurse-documented scores and received less medications, particularly opiates. This population may be particularly vulnerable to underassessment and inadequate management of pain.

A multicenter prospective study on quality of life and pain relief for cancer patient after 125I seed implantation

ObjectiveTo prospectively explore the efficacy of 125I seed implantation on quality of life and pain relief in cancer patient. MethodsConsecutive cancer patients who underwent 125I seed implantation in three centers in China between October 1, 2020 and March 31, 2021, were assessed. The Functional Assessment of Cancer Therapy and Brief Pain Inventory were used to evaluate patients’ quality of life and pain relief on the day before, 1 week, 1 month, and 3 months after seed implantation. ResultsA total of 104 cancer patients were enroled. Total score of quality of life was not statistically different 3 months after seed implantation compared with before implantation, while patients' quality of life was worse one week after seed implantation but then recovered. A total of 43 (41.3%) patients had pain before seed implantation, of which 16 (37.2%) patients had severe pain and 27 (62.8%) had mild-to-moderate pain. In patients with severe pain, the worst pain scores decreased significantly 3 months after implantation. In patients with mild-to-moderate pain, pain severity and pain interference score increased significantly after implantation compared with pre-implantation. Compared with pain before implantation, patients’ quality of life of patients without pain was higher. Conclusions125I seed implantation maintains the quality of life of patients within 3 months. For patients with severe pain, seed implantation has obvious pain relief, which improves the quality of life of the patients. Nurses should provide personalized guidance for patients with different degrees of pain.

Qualitative Analysis of Pain in Patients With Locally Advanced or Metastatic Urothelial Carcinoma.

Pain is not well described in patients with locally advanced or metastatic urothelial cancer (la/mUC). To characterize pain and assess the content validity of the Brief Pain Inventory Short Form (BPI-SF) worst pain item in patients with la/mUC receiving first-line treatment in the US. Qualitative interviews were conducted in patients aged≥45 years with confirmed la/mUC, self-reported la/mUC-attributed pain before enrollment, and no major surgery≤3 months prior to being interviewed. Interview participants were asked open-ended questions about their la/mUC symptoms and pain. "Think aloud" cognitive debriefing was conducted for the BPI-SF worst pain item. Ten participants with laUC and six (38%) with mUC were interviewed. First-line treatments included cisplatin (n = 14; 88%) or carboplatin (n = 2; 13%). The average past-week worst pain score (0-10 scale) was 6.2 (range, 3-10); seven (44%) participants reported severe pain (score≥7). Pain was most frequently reported in the back (n = 14; 88%) and/or pelvic/lower abdominal area (n = 10; 63%). Pain impacted all participants' physical and daily activities; 81% reported it impacted their overall quality of life. All participants interpreted and completed the BPI-SF worst pain item without difficulty; 15 (94%) reported it was relevant to their la/mUC experience. Participants understood the 24-hour recall period; most supported daily (n = 13; 81%) or weekly (n = 14; 88%) assessment, preferring electronic administration using their phone (n = 14; 88%). Pain attributed to la/mUC impacted physical and daily activities in all participants undergoing first-line treatment for la/mUC. Content validity was demonstrated for the BPI-SF worst pain item in this population.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial

BackgroundSingle-injection interscalene brachial plexus blocks are used for analgesia for rotator cuff repair (RCR) but have limited duration. The value of adding liposomal bupivacaine (LB) to prolong single-injection interscalene blocks...

Effect of Cancer Pain Guideline Implementation on Pain Outcomes Among Adult Outpatients With Cancer-Related Pain

An evidence-practice gap exists for cancer pain management, and cancer pain remains prevalent and disabling. To evaluate the capacity of 3 cancer pain guideline implementation strategies to improve pain-related outcomes for patients attending oncology and palliative care outpatient services. A pragmatic, stepped wedge, cluster-randomized, nonblinded, clinical trial was conducted between 2014 and 2019. The clusters were cancer centers in Australia providing oncology and palliative care outpatient clinics. Participants included a consecutive cohort of adult outpatients with advanced cancer and a worst pain severity score of 2 or more out of 10 on a numeric rating scale (NRS). Data were collected between August 2015 and May 2019. Data were analyzed July to October 2019 and reanalyzed November to December 2021. Guideline implementation strategies at the cluster, health professional, and patient levels introduced with the support of a clinical champion. The primary measure of effect was the percentage of participants initially screened as having moderate to severe worst pain (NRS ≥ 5) who experienced a clinically important improvement of 30% or more 1 week later. Secondary outcomes included mean average pain, patient empowerment, fidelity to the intervention, and quality of life and were measured in all participants with a pain score of 2 or more 10 at weeks 1, 2, and 4. Of 8099 patients screened at 6 clusters, 1564 were eligible, and 359 were recruited during the control phase (mean [SD] age, 64.2 [12.1] years; 196 men [55%]) and 329 during the intervention phase (mean [SD] age, 63.6 [12.7] years; 155 men [47%]), with no significant differences between phases on baseline measures. The mean (SD) baseline worst pain scores were 5.0 (2.6) and 4.9 (2.6) for control and intervention phases, respectively. The mean (SD) baseline average pain scores were 3.5 (2.1) for both groups. For the primary outcome, the proportions of participants with a 30% or greater reduction in a pain score of 5 or more of 10 at baseline were similar in the control and intervention phases (31 of 280 participants [11.9%] vs 30 of 264 participants [11.8%]; OR, 1.12; 95% CI, 0.79-1.60; P = .51). No significant differences were found in secondary outcomes between phases. Fidelity to the intervention was low. A suite of implementation strategies was insufficient to improve pain-related outcomes for outpatients with cancer-related pain. Further evaluation is needed to determine the required clinical resources needed to enable wide-scale uptake of the fundamental elements of cancer pain care. Ongoing quality improvement activities should be supported to improve sustainability.

Association of Outcomes of Spinal Cord Stimulation for Chronic Low Back Pain and Psoas Measurements Based on Size of Iliopsoas Muscles

IntroductionPatients experience variable long-term improvement in chronic back pain despite successful spinal cord stimulation (SCS) trials. Iliopsoas (IP) size has been shown to differ between patients with low back pain and healthy controls. In this study, we examine whether the IP muscle cross-sectional area (CSA) is associated with SCS outcomes. Materials and MethodsWe examined patients for whom we had lumbar MRIs 6.3 years prior to SCS and baseline and one-year outcome data. Percent change from baseline to one year was calculated for Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), and McGill Pain Questionnaire (MPQ). Correlations between IP muscle CSA, ratio of iliopsoas muscle size to the vertebral body area (P/VBA), and the ratio of iliopsoas muscle size to BMI (P/BMI) were examined. Sex differences were considered. ResultsA total of 73 subjects were included in this study, including 30 females and 43 males. Males had significantly larger IP (males 15.70 ± 0.58, females 9.72 ± 0.43; p < 0.001), P/VBA (males 1.00 ± 0.04, females 0.76 ± 0.03; p < 0.001), and P/BMI ratio (males 0.51 ± 0.02, females 0.32 ± 0.01; p < 0.001) than females. In females, P/VBA predicted NRS worst pain scores (β = 0.82, p = 0.004, r2 = 0.55) and BDI (β = 0.59, p = 0.02, r2 = 0.24). In males, P/BMI was a significant predictor of BDI outcome scores (β = 0.45, p = 0.03, r2 = 0.16). Males who had more muscle mass measured by iliopsoas size had more depression as measured using BDI (p = 0.03, r = 0.61). Females with less muscle mass measured by P/VBA also experienced more depression (p = 0.02, r = 0.74). ConclusionsOur study showed that psoas measurements correlated with various pain outcomes specifically. P/VBA was most predictive in females and P/BMI in males. Depression correlated with P/BMI, reinforcing the complex relationship between depression and constant chronic pain. Tertile analyses further showed a relationship between iliopsoas CSA and depression in males and females. We provide preliminary data of sex-specific psoas measurements as a risk factor for worse SCS outcomes.

Effect of melatonin on paclitaxel-associated acute and chronic pain: a randomized, double-blind, placebo-controlled clinical trial

Background: Taxane-induced pain is a disabling condition. This trial was conducted to assess the effects of melatonin on preventing paclitaxel-associated acute and chronic pain or decreasing its severity in patients with breast cancer. Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on breast cancer women who received weekly paclitaxel (80 mg/m2) with or without trastuzumab after using doxorubicin + cyclophosphamide. The intervention group randomly received oral melatonin (10 mg/day) or placebo, which started from the first night of chemotherapy and continued through the planned 12 weeks of chemotherapy. The level of arthralgia-myalgia as acute pain was assessed every day in both groups using the Brief Pain Inventory (BPI). The Douleur Neuropathique 4 questionnaire (DN4) and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 were used to measure chemotherapy-induced peripheral neuropathy as chronic pain. Results: Seventeen patients were enrolled in each group randomly. The incidence of neuropathy according to a DN4 score ≥ 4 was significantly lower in the melatonin group versus the placebo group at week 12 compared to baseline (5 vs 11, P-value= 0.039). In addition, the mean neuropathy severity was significantly lower in the melatonin group over time (β= -0.051, P-value= 0.01). However, there were no significant differences in the mean worst and least pain scores over the twelve cycles of treatment between arms (P-value= 0.633, 0.341 respectively). Conclusion: Co-administration of melatonin in women with breast cancer decreased the incidence of severe paclitaxel-associated neuropathy but melatonin was not effective against acute pain.

Postdischarge pain, nausea and patient satisfaction after diagnostic and breast-conserving ambulatory surgery for breast cancer: A cross-sectional study.

The aims of this study were to assess first day postdischarge pain, nausea and patient satisfaction in ambulatory breast cancer surgical patients, after diagnostic and breast conserving procedures. A total of 781 women, aged 18-85years were included in this prospective, cross-sectional study. All patients received standardized multimodal pain prophylaxis with paracetamol, COX-II inhibitor, dexamethasone and wound infiltration with local anaesthetics. Nausea prophylaxis was provided with ondansetron. Most patients received general anaesthesia with propofol and remifentanil. Data were collected using a validated questionnaire during telephone follow-up on the first postoperative day. The response rate was 94.5%. NRS≥4 was reported by 5.3% at rest, by 17% during activity and by 30.7% as the worst pain score. Young age was strongly associated with more pain both at rest, during activity and regarding worst pain since discharge. Postdischarge nausea was present in 17.8%, and vomiting in 1.2%. High pain score during activity and higher level of worst pain, were associated with nausea. There was no association between nausea and age, type of anaesthesia, surgical procedure or pain at rest. Patient satisfaction was high (97.8%-99.7%) regarding information, time for discharge and overall satisfaction. Pain scores and incidence of nausea were generally low on the day after surgery. Young age was a strong predictor for postdischarge pain. A high worst pain score and high pain score during the activity were associated with postdischarge nausea. Patient satisfaction was high.

Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery

In adults undergoing hip fracture surgery, regional anesthesia may reduce postoperative delirium, but there is uncertainty about its effectiveness. To investigate, in older adults undergoing surgical repair for hip fracture, the effects of regional anesthesia on the incidence of postoperative delirium compared with general anesthesia. A randomized, allocation-concealed, open-label, multicenter clinical trial of 950 patients, aged 65 years and older, with or without preexisting dementia, and a fragility hip fracture requiring surgical repair from 9 university teaching hospitals in Southeastern China. Participants were enrolled between October 2014 and September 2018; 30-day follow-up ended November 2018. Patients were randomized to receive either regional anesthesia (spinal, epidural, or both techniques combined with no sedation; n = 476) or general anesthesia (intravenous, inhalational, or combined anesthetic agents; n = 474). Primary outcome was incidence of delirium during the first 7 postoperative days. Secondary outcomes analyzed in this article include delirium severity, duration, and subtype; postoperative pain score; length of hospitalization; 30-day all-cause mortality; and complications. Among 950 randomized patients (mean age, 76.5 years; 247 [26.8%] male), 941 were evaluable for the primary outcome (6 canceled surgery and 3 withdrew consent). Postoperative delirium occurred in 29 (6.2%) in the regional anesthesia group vs 24 (5.1%) in the general anesthesia group (unadjusted risk difference [RD], 1.1%; 95% CI, -1.7% to 3.8%; P = .48; unadjusted relative risk [RR], 1.2 [95% CI, 0.7 to 2.0]; P = .57]). Mean severity score of delirium was 23.0 vs 24.1, respectively (unadjusted difference, -1.1; 95% CI, -4.6 to 3.1). A single delirium episode occurred in 16 (3.4%) vs 10 (2.1%) (unadjusted RD, 1.1%; 95% CI, -1.7% to 3.9%; RR, 1.6 [95% CI, 0.7 to 3.5]). Hypoactive subtype in 11 (37.9%) vs 5 (20.8%) (RD, 11.5; 95% CI, -11.0% to 35.7%; RR, 2.2 [95% CI, 0.8 to 6.3]). Median worst pain score was 0 (IQR, 0 to 20) vs 0 (IQR, 0 to 10) (difference 0; 95% CI, 0 to 0). Median length of hospitalization was 7 days (IQR, 5 to 10) vs 7 days (IQR, 6 to 10) (difference 0; 95% CI, 0 to 0). Death occurred in 8 (1.7%) vs 4 (0.9%) (unadjusted RD, -0.8%; 95% CI, -2.2% to 0.7%; RR, 2.0 [95% CI, 0.6 to 6.5]). Adverse events were reported in 106 episodes in the regional anesthesia group and 102 in the general anesthesia group; the most frequently reported adverse events were nausea and vomiting (47 [44.3%] vs 34 [33.3%]) and postoperative hypotension (13 [12.3%] vs 10 [9.8%]). In patients aged 65 years and older undergoing hip fracture surgery, regional anesthesia without sedation did not significantly reduce the incidence of postoperative delirium compared with general anesthesia. ClinicalTrials.gov Identifier: NCT02213380.

23. ZOE-50 and ZOE-70 Placebo Groups Data Shows that Burden of Pain Associated with Herpes Zoster Interferes with Activities of Daily Living

Abstract Background Adults ≥ 50 years of age (YOA) are at increased risk of herpes zoster (HZ), a condition which can cause long-term pain and discomfort. In this analysis, we assessed the burden of pain associated with HZ and its interference with activities of daily living (ADL) in patients ≥ 50 YOA. Methods ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) were phase III, observer-blind, placebo-controlled, 1:1 randomized studies in adults ≥ 50 YOA (ZOE-50) and ≥ 70 YOA (ZOE-70) who received 2 doses of the adjuvanted recombinant zoster vaccine or placebo, 2 months apart. To correctly evaluate HZ pain, the analysis was performed only on the placebo groups data of ZOE-50 (≥ 50 YOA) and pooled ZOE-50/70 (≥ 70 YOA pooled data) in the modified total vaccinated cohort (mTVC, primary population for efficacy analysis) HZ-confirmed cases. HZ pain and interference with ADL was assessed by the Zoster Brief Pain Inventory (ZBPI) instrument completed daily by patients for the first 28 days and then weekly until resolution. Time to resolution of clinically significant pain was analyzed using Kaplan Meier methods. We estimated the cumulative area under curve (AUC) of the ZBPI worst pain score and the ZBPI ADL score up to 182 days post-HZ rash onset. A high AUC reflects a higher severity/longer duration of pain. Results Overall, 254 patients ≥ 50 YOA and 284 patients ≥ 70 YOA were included in the mTVC HZ-confirmed cases for the ZOE-50 and ZOE-70 pooled analysis, respectively. In HZ patients ≥ 50 YOA, 94.6% reported any pain (ZBPI pain score &amp;gt; 0), 87.6% clinically significant pain (ZBPI pain score ≥ 3) and 65.1% severe pain (ZBPI pain score ≥ 7). Similarly, in HZ patients ≥ 70 YOA, 93.2% reported any pain, 90.9% clinically significant pain and 68.4% severe pain. It was estimated that 11.6% and 18.3% of patients aged ≥ 50 and ≥ 70 YOA, respectively, had clinically significant pain 3 months after the onset of HZ. The mean AUC at 182 days was 137.24 (≥ 50 YOA) and 190.68 (≥ 70 YOA), for the ZBPI worst pain score and 92.75 (≥ 50 YOA) and 130.89 (≥ 70 YOA), for the ZBPI ADL score. Conclusion Analysis of data provided by patients with confirmed HZ shows that the burden of HZ pain is high and is associated with interference on patients’ ADL. Funding GlaxoSmithKline Biologicals SA Acknowledgment M Maior/S Hulsmans provided medical writing/editorial support (Modis c/o GSK) Disclosures Eliazar Sabater Cabrera, MSc, GSK (Employee, Shareholder) Desmond Curran, PhD, The GSK group of companies (Employee, Shareholder) Sean Matthews, MSc, GSK (Independent Contractor) Céline Boutry, PhD, GSK (Employee) Nicolas Lecrenier, Ing, PhD, The GSK group of companies (Employee, Shareholder) Anthony L. Cunningham, F.A.H.M.S., MD, M.B.B.S., B. Med. Sci. (Hons), F.R.A.C.P., F.R.C.P.A., F.A.S.M., GSK group of companies (Grant/Research Support, Advisor or Review Panel member, Speaker’s Bureau)

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19

BackgroundThe Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we...

Musculoskeletal Features in Adults With X-linked Hypophosphatemia: An Analysis of Clinical Trial and Survey Data.

ContextPatients with X-linked hypophosphatemia (XLH) experience multiple musculoskeletal manifestations throughout adulthood.ObjectiveTo describe the burden of musculoskeletal features and associated surgeries across the lifespan of adults with XLH.MethodsThree groups of adults were analyzed: subjects of a clinical trial, participants in an online survey, and a subgroup of the online survey participants considered comparable to the clinical trial subjects (according to Brief Pain Inventory worst pain scores of ≥ 4). In each group, the adults were categorized by age: 18-29, 30-39, 40-49, 50-59, and ≥ 60 years. Rates of 5 prespecified musculoskeletal features and associated surgeries were investigated across these age bands for the 3 groups.ResultsData from 336 adults were analyzed. In all 3 groups, 43% to 47% had a history of fracture, with the proportions increasing with age. The overall prevalence of osteoarthritis was > 50% in all 3 groups, with a rate of 23% to 37% in the 18- to 29-year-old group, and increasing with age. Similar patterns were observed for osteophytes and enthesopathy. Hip and knee arthroplasty was reported even in adults in their 30s. Spinal stenosis was present at a low prevalence, increasing with age. The proportion of adults with ≥ 2 musculoskeletal features was 59.1%, 55.0%, and 61.3% in the clinical trial group, survey group, and survey pain subgroup, respectively.ConclusionThis analysis confirmed high rates of multiple musculoskeletal features beginning as early as age 20 years among adults with XLH and gradually accumulating with age.