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Clinical Orthopaedics and Related... May 2024Pain after orthopaedic trauma is complex, and many patients who have experienced orthopaedic trauma are at increased risk for prolonged opioid utilization after the...
BACKGROUND
Pain after orthopaedic trauma is complex, and many patients who have experienced orthopaedic trauma are at increased risk for prolonged opioid utilization after the injury. Patient-centered interventions capable of delivering enhanced education and opioid-sparing pain management approaches must be implemented and evaluated in trauma care settings to improve pain outcomes and minimize opioid-related risks.
QUESTIONS/PURPOSES
Does personalized pain education and management delivered by coaches (1) improve pain-related outcomes, (2) reduce opioid consumption, and (3) improve patient-reported outcome measures (Patient-Reported Outcomes Measurement Information System [PROMIS] scores) compared to written discharge instructions on pain management and opioid safety?
METHODS
This clinical trial aimed to examine the effect of a personalized pain education and management intervention, delivered by paraprofessional coaches, on pain-related outcomes and opioid consumption compared with usual care (written discharge instructions on pain management and opioid safety). Between February 2021 and September 2022, 212 patients were randomized to the intervention (49% [104]) or control group (51% [108]). A total of 31% (32 of 104) and 47% (51 of 108) in those groups, respectively, were lost before the minimum study follow-up of 12 weeks or had incomplete datasets, leaving 69% (72 of 104) and 53% (57 of 108) for analysis in the intervention and control group, respectively. Patients randomized to the intervention worked with the paraprofessional coaches throughout hospitalization after their orthopaedic injury and at their 2-, 6-, and 12-week visits with the surgical team after discharge to implement mindfulness-based practices and nonpharmacological interventions. Most participants in the final sample of 129 identified as Black (73% [94 of 129]) and women (56% [72 of 129]), the mean Injury Severity score was 8 ± 4, and one-third of participants were at medium to high risk for an opioid-use disorder based on the Opioid Risk Tool. Participants completed surveys during hospitalization and at the 2-, 6-, and 12-week follow-up visits. Surveys included average pain intensity scores over the past 24 hours measured on the pain numeric rating scale from 0 to 10 and PROMIS measures (physical functioning, pain interference, sleep disturbance). Opioid utilization, measured as daily morphine milligram equivalents, was collected from the electronic health record, and demographic and clinical characteristics were collected from self-report surveys. Groups were compared in terms of mean pain scores at at the 12-week follow-up, daily morphine milligram equivalents both during inpatient and at discharge, and mean PROMIS scores at 12 weeks of follow-up. Additionally, differences in the proportion of participants in each group achieving minimum clinically important differences (MCID) on pain and PROMIS scores were examined. For pain scores, an MCID of 2 points on the pain numeric rating scale assessing past 24-hour pain intensity was utilized.
RESULTS
We found no difference between the intervention and control in terms of mean pain score at 12 weeks nor in the proportions of patients who achieved the MCID of 2 points for 24-hour average pain scores (85% [61 of 72] versus 72% [41 of 57], respectively, OR 2.2 [95% confidence interval (CI) 0.9 to 5.3]; p = 0.08). No differences were noted in daily morphine milligram equivalents utilized between the intervention and control groups during hospitalization, at discharge, or in prescription refills. Similarly, we observed no differences in the proportions of patients in the intervention and control groups who achieved the MCID on PROMIS Physical Function (81% [58 of 72] versus 63% [36 of 57], respectively, OR 2.2 [95% CI 0.9 to 5.2]; p = 0.06). We saw no differences in the proportions of patients who achieved the MCID on PROMIS Sleep Disturbance between the intervention and control groups (58% [42 of 72] versus 47% [27 of 57], respectively, OR 1.4 [95% CI 0.7 to 3.0]; p = 0.31). The proportion of patients who achieved the MCID on PROMIS Pain Interference scores did not differ between the intervention and the control groups (39% [28 of 72] versus 37% [21 of 57], respectively, OR 1.1 [95% CI 0.5 to 2.1]; p = 0.95).
CONCLUSION
In this trial, we observed no differences between the intervention and control groups in terms of pain outcomes, opioid medication utilization, or patient-reported outcomes after orthopaedic trauma. However, future targeted research with diverse samples of patients at increased risk for poor postoperative outcomes is warranted to ascertain a potentially meaningful patient perceived effect on pain outcomes after working with coaches. Other investigators interested in this interventional approach may consider the coach program as a framework at their institutions to increase access to evidence-based nonpharmacological interventions among patients who are at increased risk for poor postoperative pain outcomes. Smaller, more focused programs connecting patients to coaches to learn about nonpharmacological pain management interventions may deliver a larger impact on patient's recovery and outcomes.
LEVEL OF EVIDENCE
Level I, therapeutic study.
PubMed: 38843502
DOI: 10.1097/CORR.0000000000003121 -
The Cochrane Database of Systematic... Jun 2024Persistent visceral pain is an unpleasant sensation coming from one or more organs within the body. Visceral pain is a common symptom in those with advanced cancer.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Persistent visceral pain is an unpleasant sensation coming from one or more organs within the body. Visceral pain is a common symptom in those with advanced cancer. Interventional procedures, such as neurolytic sympathetic nerve blocks, have been suggested as additional treatments that may play a part in optimising pain management for individuals with this condition.
OBJECTIVES
To evaluate the benefits and harms of neurolytic sympathetic nerve blocks for persistent visceral pain in adults with inoperable abdominopelvic cancer compared to standard care or placebo and comparing single blocks to combination blocks.
SEARCH METHODS
We searched the following databases without language restrictions on 19 October 2022 and ran a top-up search on 31 October 2023: CENTRAL; MEDLINE via Ovid; Embase via Ovid; LILACS. We searched trial registers without language restrictions on 2 November 2022: ClinicalTrials.gov; WHO International Clinical Trials Registry Platform (ICTRP). We searched grey literature, checked reference lists of reviews and retrieved articles for additional studies, and performed citation searches on key articles. We also contacted experts in the field for unpublished and ongoing trials. Our trial protocol was preregistered in the Cochrane Database of Systematic Reviews on 21 October 2022.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) comparing any sympathetic nerve block targeting sites commonly used to treat abdominal pelvic pain from inoperable malignancies in adults to standard care or placebo.
DATA COLLECTION AND ANALYSIS
We independently selected trials based on predefined inclusion criteria, resolving any differences via adjudication with a third review author. We used a random-effects model as some heterogeneity was expected between the studies due to differences in the interventions being assessed and malignancy types included in the study population. We chose three primary outcomes and four secondary outcomes of interest. We sought consumer input to refine our review outcomes and assessed extracted data using Cochrane's risk of bias 2 tool (RoB 2). We assessed the certainty of evidence using the GRADE system.
MAIN RESULTS
We included 17 studies with 1025 participants in this review. Fifteen studies with a total of 951 participants contributed to the quantitative analysis. Single block versus standard care Primary outcomes No included studies reported our primary outcome, 'Proportion of participants reporting no worse than mild pain after treatment at 14 days'. The evidence is very uncertain about the effect of sympathetic nerve blocks on reducing pain to no worse than mild pain at 14 days when compared to standard care due to insufficient data (very low-certainty evidence). Sympathetic nerve blocks may provide small to 'little to no' improvement in quality of life (QOL) scores at 14 days after treatment when compared to standard care, but the evidence is very uncertain (standardised mean difference (SMD) -0.73, 95% confidence interval (CI) -1.70 to 0.25; I² = 87%; 4 studies, 150 participants; very low-certainty evidence). The evidence is very uncertain about the risk of serious adverse events as defined in our review as only one study contributed data to this outcome. Sympathetic nerve blocks may have an 'increased risk' to 'no additional risk' of harm compared with standard care (very low-certainty evidence). Secondary outcomes Sympathetic nerve blocks showed a small to 'little to no' effect on participant-reported pain scores at 14 days using a 0 to 10 visual analogue scale (VAS) for pain compared with standard care, but the evidence is very uncertain (mean difference (MD) -0.44, 95% CI -0.98 to 0.11; I² = 56%; 5 studies, 214 participants; very low-certainty evidence). There may be a 'moderate to large' to 'little to no' reduction in daily consumption of opioids postprocedure at 14 days with sympathetic nerve blocks compared with standard care, but the evidence is very uncertain (change in daily consumption of opioids at 14 days as oral milligrams morphine equivalent (MME): MD -41.63 mg, 95% CI -78.54 mg to -4.72 mg; I² = 90%; 4 studies, 130 participants; very low-certainty evidence). The evidence is very uncertain about the effect of sympathetic nerve blocks on participant satisfaction with procedure at 0 to 7 days and time to need for retreatment or treatment effect failure (or both) due to insufficient data. Combination block versus single block Primary outcomes There is no evidence about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks on the proportion of participants reporting no worse than mild pain after treatment at 14 days because no studies reported this outcome. There may be a small to 'little to no' effect on QOL score at 14 days after treatment, but the evidence is very uncertain (very low-certainty evidence). The evidence is very uncertain about the risk of serious adverse events with combination sympathetic nerve blocks compared with single sympathetic nerve blocks due to limited reporting in the included studies (very low-certainty evidence). Secondary outcomes The evidence is very uncertain about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks on participant-reported pain score and change in daily consumption of opioids postprocedure, at 14 days. There may be a small to 'little to no' effect, but the evidence is very uncertain (very low-certainty evidence). There is no evidence about the effect on participant satisfaction with procedure at 0 to 7 days and time to need for retreatment or treatment effect failure (or both) due to these outcomes not being measured by the studies. Risk of bias The risk of bias was predominately high for most outcomes in most studies due to significant concerns regarding adequate blinding. Very few studies were deemed as low risk across all domains for any outcome.
AUTHORS' CONCLUSIONS
There is limited evidence to support or refute the use of sympathetic nerve blocks for persistent abdominopelvic pain due to inoperable malignancy. We are very uncertain about the effect of combination sympathetic nerve blocks compared with single sympathetic nerve blocks. The certainty of the evidence is very low and these findings should be interpreted with caution.
Topics: Humans; Randomized Controlled Trials as Topic; Autonomic Nerve Block; Adult; Bias; Pelvic Neoplasms; Abdominal Neoplasms; Cancer Pain; Abdominal Pain; Pain Management; Nerve Block; Quality of Life
PubMed: 38842054
DOI: 10.1002/14651858.CD015229.pub2 -
BMC Palliative Care Jun 2024Palliative care (PC) in most African countries remains under-assessed. Benin has piloted the implementation of a set of indicators proposed by the WHO to measure PC...
CONTEXT
Palliative care (PC) in most African countries remains under-assessed. Benin has piloted the implementation of a set of indicators proposed by the WHO to measure PC development.
OBJECTIVES
To examine the current status of PC in Benin.
METHODS
A workshop with stakeholders was organized to assess the WHO indicators in the Beninese context. Indicators were rated based on relevance and feasibility, data sources were agreed upon, and a survey was adapted. Data were collected between March and May 2023.
RESULTS
There is emerging community involvement in PC through the presence of patients' rights promoters, as well as a political commitment expressed in the National PC strategy, the inclusion of PC services in the list of basic health services, and an assigned national authority -within the Ministry of Health-responsible for PC. Although no PC-oriented research has been documented, the celebration of the National PC Conference represents the first step to ground PC delivery in evidence. The reported annual consumption of opioids is 0.18 (ME) milligrams per capita, 34% of healthcare establishments have essential medicines for pain and PC, and 16.5% of patients with palliative needs have access to oral morphine. To date, no medical or paramedical schools offer PC training, and there is no official specialization in palliative medicine for doctors. PC is provided by 11 specialist teams (0.08/100,000 inhabitants), none of which provides pediatric care.
CONCLUSION
Despite growing political, professional, and community commitments to palliative care, there are challenges in education, research, essential medicines, and access to PC services.
Topics: Benin; Humans; Palliative Care; World Health Organization; Surveys and Questionnaires; Quality Indicators, Health Care
PubMed: 38840116
DOI: 10.1186/s12904-024-01473-9 -
Journal of General Internal Medicine Jun 2024Practice guidelines recommend nonpharmacologic and nonopioid therapies as first-line pain treatment for acute pain. However, little is known about their utilization...
BACKGROUND
Practice guidelines recommend nonpharmacologic and nonopioid therapies as first-line pain treatment for acute pain. However, little is known about their utilization generally and among individuals with opioid use disorder (OUD) for whom opioid and other pharmacologic therapies carry greater risk of harm.
OBJECTIVE
To determine the association between a pre-existing OUD diagnosis and treatment of acute low back pain (aLBP).
DESIGN
Retrospective cohort study using 2016-2019 Medicare data.
PARTICIPANTS
Fee-for-service Medicare beneficiaries with a new episode of aLBP.
MAIN MEASURES
The main independent variable was OUD diagnosis measured prior to the first LBP claim (i.e., index date). Using multivariable logistic regressions, we assessed the following outcomes measured within 30 days of the index date: (1) nonpharmacologic therapies (physical therapy and/or chiropractic care), and (2) prescription opioids. Among opioid recipients, we further assessed opioid dose and co-prescription of gabapentin. Analyses were conducted overall and stratified by receipt of physical therapy, chiropractic care, opioid fills, or gabapentin fills during the 6 months before the index date.
KEY RESULTS
We identified 1,263,188 beneficiaries with aLBP, of whom 3.0% had OUD. Two-thirds (65.8%) did not receive pain treatments of interest at baseline. Overall, nonpharmacologic therapy receipt was less prevalent and opioid and nonopioid pharmacologic therapies were more common among beneficiaries with OUD than those without OUD. Beneficiaries with OUD had lower odds of receiving nonpharmacologic therapies (aOR = 0.62, 99%CI = 0.58-0.65) and higher odds of prescription opioid receipt (aOR = 2.24, 99%CI = 2.17-2.32). OUD also was significantly associated with increased odds of opioid doses ≥ 90 morphine milligram equivalents/day (aOR = 2.43, 99%CI = 2.30-2.56) and co-prescription of gabapentin (aOR = 1.15, 99%CI = 1.09-1.22). Similar associations were observed in stratified groups though magnitudes differed.
CONCLUSIONS
Medicare beneficiaries with aLBP and OUD underutilized nonpharmacologic pain therapies and commonly received opioids at high doses and with gabapentin. Complementing the promulgation of practice guidelines with implementation science could improve the uptake of evidence-based nonpharmacologic therapies for aLBP.
PubMed: 38829451
DOI: 10.1007/s11606-024-08799-3 -
Science Advances May 2024Antibody drug conjugates (ADCs) have made impressive strides in the clinic in recent years with 11 Food and Drug Administration approvals, including 6 for the treatment... (Review)
Review
Antibody drug conjugates (ADCs) have made impressive strides in the clinic in recent years with 11 Food and Drug Administration approvals, including 6 for the treatment of patients with solid tumors. Despite this success, the development of new agents remains challenging with a high failure rate in the clinic. Here, we show that current approved ADCs for the treatment of patients with solid tumors can all show substantial efficacy in some mouse models when administered at a similar weight-based [milligrams per kilogram (mg/kg)] dosing in mice that is tolerated in the clinic. Mechanistically, equivalent mg/kg dosing results in a similar drug concentration in the tumor and a similar tissue penetration into the tumor due to the unique delivery features of ADCs. Combined with computational approaches, which can account for the complex distribution within the tumor microenvironment, these scaling concepts may aid in the evaluation of new agents and help design therapeutics with maximum clinical efficacy.
Topics: Animals; Immunoconjugates; Mice; Neoplasms; Humans; Xenograft Model Antitumor Assays; Translational Research, Biomedical; Disease Models, Animal; Tumor Microenvironment; Cell Line, Tumor; Antineoplastic Agents; Drug Evaluation, Preclinical
PubMed: 38820153
DOI: 10.1126/sciadv.adk1894 -
JAMA Network Open May 2024Direct-to-consumer education reduces chronic sedative use. The effectiveness of this approach for prescription opioids among patients with chronic noncancer pain remains... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Direct-to-consumer education reduces chronic sedative use. The effectiveness of this approach for prescription opioids among patients with chronic noncancer pain remains untested.
OBJECTIVES
To evaluate the effectiveness of a government-led educational information brochure mailed to community-dwelling, long-term opioid consumers to reduce prescription opioid use compared with usual care.
DESIGN, SETTING, AND PARTICIPANTS
This cluster randomized clinical trial was conducted from July 2018 to January 2019 in Manitoba, Canada. All adults with long-term opioid prescriptions were enrolled (n = 4225). Participants were identified via the Manitoba Drug Program Information Network. Individuals receiving palliative care or with a diagnosis of cancer or dementia were excluded. Data were analyzed from July 2019 to March 2020.
INTERVENTION
Participants were clustered according to their primary care clinic and randomized to the intervention (a codesigned direct-to-consumer educational brochure sent by mail) or usual care (comparator group).
MAIN OUTCOMES AND MEASURES
The main outcome was discontinuation of opioid prescriptions at the participant level after 6 months, ascertained by pharmacy drug claims. Secondary outcomes included dose reduction (in morphine milligram equivalents [MME]) and/or therapeutic switch. Reduction in opioid use was assessed using generalized estimating equations to account for clustering, with prespecified subgroup analyses by age and sex. Analysis was intention to treat.
RESULTS
Of 4206 participants, 2409 (57.3%) were male; mean (SD) age was 60.0 (14.4) years. Mean (SD) baseline opioid use was comparable between groups (intervention, 157.7 [179.7] MME/d; control, 153.4 [181.8] MME/d). After 6 months, 235 of 2136 participants (11.0%) in 127 clusters in the intervention group no longer filled opioid prescriptions compared with 228 of 2070 (11.0%) in 124 clusters in the comparator group (difference, 0.0%; 95% CI, -1.9% to 1.9%). More participants in the intervention group than in the control group reduced their dose (1410 [66.0%] vs 1307 [63.1%]; difference, 2.8% [95% CI, 0.0%-5.7%]). Receipt of the brochure led to greater dose reductions for participants who were male (difference, 3.9%; 95% CI, 0.1%-7.7%), aged 18 to 64 years (difference, 3.7%; 95% CI, 0.2%-7.2%), or living in urban areas (difference, 5.9%; 95% CI, 1.9%-9.9%) compared with usual care.
CONCLUSIONS AND RELEVANCE
In this cluster randomized clinical trial, no significant difference in the prevalence of opioid cessation was observed after 6 months between the intervention and usual care groups; however, the intervention resulted in more adults reducing their opioid dose compared with usual care.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03400384.
Topics: Humans; Male; Female; Middle Aged; Analgesics, Opioid; Aged; Patient Education as Topic; Adult; Manitoba; Chronic Pain; Cluster Analysis; Opioid-Related Disorders
PubMed: 38809554
DOI: 10.1001/jamanetworkopen.2024.13698 -
Expert Opinion on Investigational Drugs May 2024
PubMed: 38807572
DOI: 10.1080/13543784.2024.2337736 -
Vascular and Endovascular Surgery May 2024Transcarotid artery revascularization (TCAR) is growing in popularity. Although major clinical end-points such as stroke rate and mortality are well-known, patient...
BACKGROUND
Transcarotid artery revascularization (TCAR) is growing in popularity. Although major clinical end-points such as stroke rate and mortality are well-known, patient reported outcomes such as pain, and length of stay are among the purported benefits that are as yet untested. We sought to determine if there are differences in pain and other clinical outcomes when comparing carotid endarterectomy (CEA) and TCAR.
METHODS
We performed a retrospective review of 326 patients undergoing TCAR (n = 50) or CEA (n = 276) from 2019-2023. Primary outcomes of interest were maximum pain numeric rating scales (NRS) reported in the post-anesthesia care unit (PACU) and on postoperative days (POD) zero and 1, and oral morphine milligram equivalents (OMMEs) received intraoperatively through POD1. Secondary outcomes included length of stay (LOS), complications, and 30-day emergency department (ED) returns/readmissions.
RESULTS
Fifty TCAR and 150 CEA patients were included in the propensity score matched cohorts. TCAR patients reported lower pain-NRS in PACU ( < .001) and on POD0 ( = .002), but similar pain scores on POD1 ( = .112). Postoperatively, TCAR patients were less likely to receive opioids (52% vs 75.3%, = .003) and received less OMME from PACU through POD1 (12.8 ± 16.2 vs 23.2 ± 27.2, = .001). After adjusting for age, sex, BMI, prior chronic opioid use, and prior carotid surgery, TCAR patients were approximately 70% less likely to receive post-operative opioids. No significant differences in LOS, 30-day ED returns/readmissions, or complications were observed between groups.
CONCLUSIONS
Compared with CEA, patients undergoing TCAR reported lower pain scores and consumed fewer narcotics overall. However, the absolute difference was modest, and pain scores were low in both cohorts. Differences in pain and post-operative narcotic use may be of less importance when deciding between TCAR and CEA. Total non-opioid protocols may be feasible in both approaches.
PubMed: 38797875
DOI: 10.1177/15385744241257153 -
Surgery May 2024To combat the opioid epidemic, several strategies were implemented to limit the unnecessary prescription of opioids in the postoperative period. However, this leaves a...
BACKGROUND
To combat the opioid epidemic, several strategies were implemented to limit the unnecessary prescription of opioids in the postoperative period. However, this leaves a subset of patients who genuinely require additional opioids with inadequate pain control. Deep learning models are powerful tools with great potential of optimizing health care delivery through a patient-centered focus. We sought to investigate whether deep learning models can be used to predict patients who would require additional opioid prescription refills in the postoperative period after elective surgery.
METHODS
This is a retrospective study of patients who received elective surgical intervention at the Mayo Clinic. Adult English-speaking patients ≥18 years old, who underwent an elective surgical procedure between 2013 and 2019, were eligible for inclusion. Machine learning models, including deep learning, random forest, and eXtreme Gradient Boosting, were designed to predict patients who require opioid refills after discharge from hospital.
RESULTS
A total of 9,731 patients with mean age of 62.1 years (51.4% female) were included in the study. Deep learning and random forest models predicted patients who required opioid refills with high accuracy, 0.79 ± 0.07 and 0.78 ± 0.08, respectively. Procedure performed, highest pain score recorded during hospitalization, and total oral morphine milligram equivalents prescribed at discharge were the top 3 predictors for requiring opioid refills after discharge.
CONCLUSION
Deep learning models can be used to predict patients who require postoperative opioid prescription refills with high accuracy. Other machine learning models, such as random forest, can perform equal to deep learning, increasing the applicability of machine learning for combating the opioid epidemic.
PubMed: 38796387
DOI: 10.1016/j.surg.2024.03.054 -
The Cleft Palate-craniofacial Journal :... May 2024To determine the effect of ketorolac on opiate requirement and hospital length of stay after palatoplasty.
OBJECTIVE
To determine the effect of ketorolac on opiate requirement and hospital length of stay after palatoplasty.
DESIGN
This was a retrospective chart review.
SETTING
This study was completed at an urban tertiary medical center.
PATIENTS
Those who underwent palatoplasty with a pediatric otolaryngologist between 2010-2020.
INTERVENTIONS
Incorporation of standing Ketorolac into the immediate post-operative pain regimen.
MAIN OUTCOME MEASURES
T-test analysis was performed to determine whether initiation of ketorolac within 24 h post-palatoplasty was correlated with shorter length hospitalization or reduced opiate requirement.
RESULTS
A total of 55 pediatric subjects (49.1% female) were included in this study. Average age at time of surgery was 13 months (range 9.9-33.9 months). On two tailed t-test, use of ketorolac within the first 24 h after palatoplasty was associated with shorter length of stay (mean of 1.68 vs 2.57 days, t = 2.58, = .01) and lower total opiate dosage during hospitalization (mean of 2.8 vs 9.16 morphine milligram equivalents, t = 3.37, = .001).
CONCLUSIONS
Among patients undergoing palatoplasty, there is a significant relationship between the early utilization of ketorolac and decreased length of hospitalization as well as decreased opiate requirement. This has important consequences to help improve pain control with reduced opiates requirement as well as length of stay. Future prospective studies can help elicit the causative effect of Ketorolac on these parameters and can investigate whether use of Ketorolac has an effect on long term recovery and post-discharge opiate requirements as well.
PubMed: 38794844
DOI: 10.1177/10556656241250138