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1.
Neurology ; 102(12): e209449, 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38820488

ABSTRACT

BACKGROUND AND OBJECTIVES: Spinal CSF leaks lead to spontaneous intracranial hypotension (SIH). While International Classification of Headache Disorders, Third Edition (ICHD-3) criteria necessitate imaging confirmation or low opening pressure (OP) for SIH diagnosis, their sensitivity may be limited. We offered epidural blood patches (EBPs) to patients with symptoms suggestive of SIH, with and without a documented low OP or confirmed leak on imaging. This study evaluates the efficacy of this strategy. METHODS: We conducted a prospective cohort study with a nested case-control design including all patients who presented to a tertiary headache clinic with clinical symptoms of SIH who completed study measures both before and after receiving an EBP between August 2016 and November 2018. RESULTS: The mean duration of symptoms was 8.7 ± 8.1 years. Of 85 patients assessed, 69 did not meet ICHD-3 criteria for SIH. At an average of 521 days after the initial EBP, this ICHD-3-negative subgroup experienced significant improvements in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health score of +3.3 (95% CI 1.5-5.1), PROMIS Global Mental Health score of +1.8 (95% CI 0.0-3.5), Headache Impact Test (HIT)-6 head pain score of -3.8 (95% CI -5.7 to -1.8), Neck Disability Index of -4.8 (95% CI -9.0 to -0.6) and PROMIS Fatigue of -2.3 (95% CI -4.1 to -0.6). Fifty-four percent of ICHD-3-negative patients achieved clinically meaningful improvements in PROMIS Global Physical Health and 45% in HIT-6 scores. Pain relief following lying flat prior to treatment was strongly associated with sustained clinically meaningful improvement in global physical health at an average of 521 days (odds ratio 1.39, 95% CI 1.1-1.79; p < 0.003). ICHD-3-positive patients showed high rates of response and previously unreported, treatable levels of fatigue and cognitive deficits. DISCUSSION: Patients who did not conform to the ICHD-3 criteria for SIH showed moderate rates of sustained, clinically meaningful improvements in global physical health, global mental health, neck pain, fatigue, and head pain after EBP therapy. Pre-treatment improvement in head pain when flat was associated with later, sustained improvement after EBP therapy among patients who did not meet the ICHD-3 criteria. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that epidural blood patch is an effective treatment of suspected CSF leak not conforming to ICHD-3 criteria for SIH.


Subject(s)
Blood Patch, Epidural , Cerebrospinal Fluid Leak , Intracranial Hypotension , Humans , Female , Male , Blood Patch, Epidural/methods , Middle Aged , Adult , Cerebrospinal Fluid Leak/therapy , Intracranial Hypotension/therapy , Prospective Studies , Case-Control Studies , Treatment Outcome , Cohort Studies , Patient Reported Outcome Measures
2.
Reg Anesth Pain Med ; 2024 May 31.
Article in English | MEDLINE | ID: mdl-38821535

ABSTRACT

BACKGROUND: We report the results from the first large, postmarket, multicentre, randomised controlled trial (RCT) evaluating peripheral nerve stimulation (PNS) for the treatment of chronic peripheral pain with a micro-implantable pulse generator (micro-IPG). METHODS: Subjects meeting eligibility were randomised (2:1) to either the active arm receiving PNS and conventional medical management (CMM) or the control arm receiving CMM alone. Treatments were limited to the following areas: lower back, shoulder, knee and foot/ankle. RESULTS: At 6 months, the active arm achieved an 88% responder rate with a 70% average reduction in pain. At the 3-month primary endpoint, the active arm achieved an 84% responder rate with an average pain reduction of 67% compared with the control arm, which achieved a 3% responder rate with an average pain reduction of 6%. Both responder rate and pain reduction in the active arm were significantly better than in the control arm (p<0.001). A majority of patient-reported outcomes also reached statistical significance. There have been no reports of pocket pain and no serious adverse device effects. 81% of subjects found the external wearable component of the PNS system to be comfortable. CONCLUSIONS: This study successfully reached its primary endpoint-the active arm achieved a statistically significant superior responder rate as compared with the control arm at 3 months. These RCT results demonstrated that PNS, with this micro-IPG, is efficacious and safe. This ongoing study will follow subjects for 3 years, the results of which will be reported as they become available.

3.
Neurol Clin Pract ; 14(3): e200290, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38699599

ABSTRACT

Purpose of Review: This review focuses on the challenges of diagnosing and treating spontaneous intracranial hypotension (SIH), a condition caused by spinal CSF leakage. It emphasizes the need for increased awareness and advocates for early and thoughtful use of empirical epidural blood patches (EBPs) in suspected cases. Recent Findings: SIH diagnosis is hindered by variable symptoms and inconsistent imaging results, including normal brain MRI and unreliable spinal opening pressures. It is crucial to consider SIH in differential diagnoses, especially in patients with connective tissue disorders. Early EBP intervention is shown to improve outcomes. Summary: SIH remains underdiagnosed and undertreated, requiring heightened awareness and understanding. This review promotes proactive EBP use in managing suspected SIH and calls for continued research to advance diagnostic and treatment methods, emphasizing the need for innovative imaging techniques for accurate diagnosis and timely intervention.

4.
PLoS One ; 18(8): e0287697, 2023.
Article in English | MEDLINE | ID: mdl-37616195

ABSTRACT

BACKGROUND: Opioids are commonly prescribed for postoperative pain, but may lead to prolonged use and addiction. Diabetes impairs nerve function, complicates pain management, and makes opioid prescribing particularly challenging. METHODS: This retrospective observational study included a cohort of postoperative patients from a multisite academic health system to assess the relationship between diabetes, pain, and prolonged opioid use (POU), 2008-2019. POU was defined as a new opioid prescription 3-6 months after discharge. The odds that a patient had POU was assessed using multivariate logistic regression controlling for patient factors (e.g., demographic and clinical factors, as well as prior pain and opiate use). FINDINGS: A total of 43,654 patients were included, 12.4% with diabetes. Patients with diabetes had higher preoperative pain scores (2.1 vs 1.9, p<0.001) and lower opioid naïve rates (58.7% vs 68.6%, p<0.001). Following surgery, patients with diabetes had higher rates of POU (17.7% vs 12.7%, p<0.001) despite receiving similar opioid prescriptions at discharge. Patients with Type I diabetes were more likely to have POU compared to other patients (Odds Ratio [OR]: 2.22; 95% Confidence Interval [CI]:1.69-2.90 and OR:1.44, CI: 1.33-1.56, respectively). INTERPRETATION: In conclusion, surgical patients with diabetes are at increased risk for POU even after controlling for likely covariates, yet they receive similar postoperative opiate therapy. The results suggest a more tailored approach to diabetic postoperative pain management is warranted.


Subject(s)
Diabetes Mellitus , Opiate Alkaloids , Opioid-Related Disorders , Humans , Analgesics, Opioid/adverse effects , Pain Management , Practice Patterns, Physicians' , Pain, Postoperative/drug therapy , Diabetes Mellitus/drug therapy
5.
Pain Ther ; 12(5): 1253-1269, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37556071

ABSTRACT

INTRODUCTION: The evolution of pre- versus postoperative risk factors remains unknown in the development of persistent postoperative pain and opioid use. We identified preoperative versus comprehensive perioperative models of delayed pain and opioid cessation after total joint arthroplasty including time-varying postoperative changes in emotional distress. We hypothesized that time-varying longitudinal measures of postoperative psychological distress, as well as pre- and postoperative use of opioids would be the most significant risk factors for both outcomes. METHODS: A prospective cohort of 188 patients undergoing total hip or knee arthroplasty at Stanford Hospital completed baseline pain, opioid use, and emotional distress assessments. After surgery, a modified Brief Pain Inventory was assessed daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 1 year. Emotional distress and pain catastrophizing were assessed weekly to 6 months, then monthly thereafter. Stepwise multivariate time-varying Cox regression modeled preoperative variables alone, followed by all perioperative variables (before and after surgery) with time to postoperative opioid and pain cessation. RESULTS: The median time to opioid and pain cessation was 54 and 152 days, respectively. Preoperative total daily oral morphine equivalent use (hazard ratio-HR 0.97; 95% confidence interval-CI 0.96-0.98) was significantly associated with delayed postoperative opioid cessation in the perioperative model. In contrast, time-varying postoperative factors: elevated PROMIS (Patient-Reported Outcomes Measurement Information System) depression scores (HR 0.92; 95% CI 0.87-0.98), and higher Pain Catastrophizing Scale scores (HR 0.85; 95% CI 0.75-0.97) were independently associated with delayed postoperative pain resolution in the perioperative model. CONCLUSIONS: These findings highlight preoperative opioid use as a key determinant of delayed postoperative opioid cessation, while postoperative elevations in depressive symptoms and pain catastrophizing are associated with persistent pain after total joint arthroplasty providing the rationale for continued risk stratification before and after surgery to identify patients at highest risk for these distinct outcomes. Interventions targeting these perioperative risk factors may prevent prolonged postoperative pain and opioid use.

6.
Anesthesiol Clin ; 41(2): 395-470, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37245950

ABSTRACT

This article summarizes clinical expert recommendations and findings for the application of ultrasound-guided procedures in chronic pain management. Data on analgesic outcomes and adverse effects were collected and analyzed and are reported in this narrative review. Ultrasound guidance offers opportunities for the treatment of pain, with focus in this article on greater occipital nerve, trigeminal nerves, sphenopalatine ganglion, stellate ganglion, suprascapular nerve, median nerve, radial nerve, ulnar nerve, transverse abdominal plane block, quadratus lumborum, rectus sheath, anterior cutaneous abdominal nerves, pectoralis and serratus plane, erector spinae plane, illioinguinal/iliohypogastric/genitofemoral nerve, lateral femoral cutaneous nerve, genicular nerve, and foot and ankle nerves.


Subject(s)
Chronic Pain , Humans , Chronic Pain/therapy , Abdominal Muscles/diagnostic imaging , Abdominal Muscles/innervation , Ultrasonography , Abdomen , Ultrasonography, Interventional/methods , Pain, Postoperative/drug therapy
7.
Article in English | MEDLINE | ID: mdl-36203857

ABSTRACT

Opiates used for acute pain are an established risk factor for chronic opioid use (COU). Patient characteristics contribute to progression from acute opioid use to COU, but most are not clinically modifiable. To develop and validate machine-learning algorithms that use claims data to predict progression from acute to COU in the Medicaid population, Adult opioid naïve Medicaid patients from 6 anonymized states who received an opioid prescription between 2015 and 2019 were included. Five machine learning (ML) Models were developed, and model performance assessed by area under the receiver operating characteristic curve (auROC), precision and recall. In the study, 29.9% (53820/180000) of patients transitioned from acute opioid use to COU. Initial opioid prescriptions in COU patients had increased morphine milligram equivalents (MME) (33.2 vs. 23.2), tablets per prescription (45.6 vs. 36.54), longer prescriptions (26.63 vs 24.69 days), and higher proportions of tramadol (16.06% vs. 13.44%) and long acting oxycodone (0.24% vs 0.04%) compared to non- COU patients. The top performing model was XGBoost that achieved average precision of 0.87 and auROC of 0.63 in testing and 0.55 and 0.69 in validation, respectively. Top-ranking prescription-related features in the model included quantity of tablets per prescription, prescription length, and emergency department claims. In this study, the Medicaid population, opioid prescriptions with increased tablet quantity and days supply predict increased risk of progression from acute to COU in opioid-naïve patients. Future research should evaluate the effects of modifying these risk factors on COU incidence.

8.
Int J Gen Med ; 15: 4535-4549, 2022.
Article in English | MEDLINE | ID: mdl-35528286

ABSTRACT

Perioperative pain management is a unique challenge in patients undergoing spine surgery due to the increased incidence of both pre-existing chronic pain conditions and chronic postsurgical pain. Peri-operative planning and counseling in spine surgery should involve an interdisciplinary approach that includes consideration of patient-level risk factors, as well as pharmacologic and non-pharmacologic pain management techniques. Consideration of psychological factors and patient focused education as an adjunct to these measures is paramount in developing a personalized perioperative pain management plan. Understanding the currently available body of knowledge surrounding perioperative opioid management, management of opioid use disorder, regional/neuraxial anesthetic techniques, ketamine/lidocaine infusions, non-opioid oral analgesics, and behavioral interventions can be useful in developing a comprehensive, multi-modal treatment plan among patients undergoing spine surgery. Although many of these techniques have proved efficacious in the immediate postoperative period, long-term follow-up is needed to define the impact of such approaches on persistent pain and opioid use. Future techniques involving the use of precision medicine may help identify phenotypic and physiologic characteristics that can identify patients that are most at risk of developing persistent postoperative pain after spine surgery.

9.
J Pain Res ; 15: 1325-1354, 2022.
Article in English | MEDLINE | ID: mdl-35546905

ABSTRACT

Introduction: Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice. Results: The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented. Discussion: The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety. Conclusion: ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.

10.
Pain Ther ; 11(2): 683-699, 2022 Jun.
Article in English | MEDLINE | ID: mdl-35467268

ABSTRACT

INTRODUCTION: Abdominal pain frequently co-occurs with pain in other body sites. Chronic overlapping pain conditions (COPCs) represent a group of widespread pain diagnoses. Our study characterized how patterns of somatic pain distribution are associated with COPCs and aimed to characterize predictors of widespread pain among patients with chronic abdominal pain. METHODS: This retrospective cohort study included adults presenting to a tertiary pain clinic, reporting abdominal pain at their initial visit, and with a follow-up visit at 12 months. Body maps divided patients into localized, intermediate, and widespread pain distribution patterns. Diagnostic and psychosocial measures were assessed across groups at the initial and follow-up visits. We analyzed the association of baseline diagnoses and demographics and time-varying changes in psychosocial measures from initial to follow-up visit with changes in pain distribution over time with alternating logistic regression (ALR). RESULTS: Among 258 patients, most were female (91.5%) and reported widespread pain (61.5%). Those with widespread pain at baseline reported elevated anger and 60.0% of patients remained in the same pain category at follow-up. Multivariable ALR demonstrated higher pain interference (AOR 1.06, 95% CI 1.02-1.10, P = 0.002), higher anxiety (AOR 1.05, 95% CI 1.01-1.09, P = 0.01), more than one COPC at initial visit (AOR 2.85, 95% CI 1.59-5.11, P = 0.0005), and initial visit widespread pain categorization (AOR 4.18, 95% CI 2.20-8.00, P < 0.0001) were associated with an increased risk of widespread pain at the follow-up visit. CONCLUSION: Most patients with abdominal pain report additional pain locations at multiple other body sites, and non-localized pain persists 12 months after pain treatment. Screening for widespread pain and COPC at the initial visit may identify patients at higher risk for persistent or new-onset widespread pain, and interventions to reduce pain interference and anxiety may promote reversal of widespread pain.

12.
Surgery ; 171(2): 453-458, 2022 02.
Article in English | MEDLINE | ID: mdl-34538340

ABSTRACT

BACKGROUND: The goal of this study was an assessment of availability postoperative pain management quality measures and National Quality Forum-endorsed measures. Postoperative pain is an important clinical timepoint because poor pain control can lead to patient suffering, chronic opiate use, and/or chronic pain. Quality measures can guide best practices, but it is unclear whether there are measures for managing pain after surgery. METHODS: The National Quality Forum Quality Positioning System, Agency for Healthcare Research and Quality Indicators, and Centers for Medicare and Medicaid Services Measures Inventory Tool databases were searched in November 2019. We conducted a systematic literature review to further identify quality measures in research publications, clinical practice guidelines, and gray literature for the period between March 11, 2015 and March 11, 2020. RESULTS: Our systematic review yielded 1,328 publications, of which 206 were pertinent. Nineteen pain management quality measures were identified from the quality measure databases, and 5 were endorsed by National Quality Forum. The National Quality Forum measures were not specific to postoperative pain management. Three of the non-endorsed measures were specific to postoperative pain. CONCLUSION: The dearth of published postoperative pain management quality measures, especially National Quality Forum-endorsed measures, highlights the need for more rigorous evidence and widely endorsed postoperative pain quality measures to guide best practices.


Subject(s)
Pain Management/statistics & numerical data , Pain, Postoperative/therapy , Practice Patterns, Physicians'/statistics & numerical data , Professional Practice Gaps/statistics & numerical data , Centers for Medicare and Medicaid Services, U.S./statistics & numerical data , Databases, Factual/statistics & numerical data , Humans , Medicare/statistics & numerical data , Pain Management/standards , Practice Guidelines as Topic , Practice Patterns, Physicians'/organization & administration , United States , United States Agency for Healthcare Research and Quality/statistics & numerical data
13.
Reg Anesth Pain Med ; 47(1): 3-59, 2022 01.
Article in English | MEDLINE | ID: mdl-34764220

ABSTRACT

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.


Subject(s)
Neck Pain , Zygapophyseal Joint , Arthralgia , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/surgery , Humans , Injections, Intra-Articular , Zygapophyseal Joint/diagnostic imaging , Zygapophyseal Joint/surgery
14.
Pain Med ; 22(11): 2443-2524, 2021 Nov 26.
Article in English | MEDLINE | ID: mdl-34788462

ABSTRACT

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.


Subject(s)
Chronic Pain , Zygapophyseal Joint , Arthralgia , Cervical Vertebrae , Chronic Pain/therapy , Humans , Injections, Intra-Articular
15.
Int J Surg ; 95: 106100, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34600123

ABSTRACT

BACKGROUND: We aimed to identify preoperative psychosocial factors associated with return-to-work (RTW) and the associated cost of productivity loss due to work absenteeism following surgery. Research demonstrates a high economic burden from productivity loss after surgery, but the comparative cost of productivity loss relative to income across different operations has not been examined. MATERIALS AND METHODS: A mixed surgical cohort recruited for a randomized controlled trial were prospectively followed for up to two years following surgery with daily phone assessments to three months, weekly assessments thereafter to six months, then monthly assessments thereafter to determine RTW status, opioid use and pain. RESULTS: 183 of 207 (88.3%) patients in paid employment prior to surgery, who provided at least one day of follow-up, were included in this analysis. The average cost of productivity loss due to work absenteeism was $13 761 (median $9064). Patients who underwent total knee replacement incurred the highest income loss. Medical claims filed before surgery were significantly associated with relative income loss (AOR 5.09; 95% CI 1.73-14.96; p < 0.01) and delayed postoperative RTW. Elevated preoperative PTSD symptoms were associated with delayed RTW (HR 0.78; 95%CI 0.63-0.96; p-value = 0.02) while male gender (HR 1.63; 95%CI 1.11-2.38; p-value = 0.01) was associated with faster postoperative RTW. CONCLUSION: Surgery places a high economic burden on individuals due to postoperative productivity loss. Multidisciplinary approaches, such as pathways, that facilitate the operation and recovery may mitigate the economic consequences for patients, employers, and the healthcare system.


Subject(s)
Arthroplasty, Replacement, Knee , Return to Work , Cost-Benefit Analysis , Employment , Humans , Male , Postoperative Period
16.
N Engl J Med ; 385(21): 1951-1960, 2021 11 18.
Article in English | MEDLINE | ID: mdl-34407339

ABSTRACT

BACKGROUND: Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19. METHODS: In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause. RESULTS: A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups. CONCLUSIONS: The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).


Subject(s)
COVID-19/therapy , Disease Progression , SARS-CoV-2/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19/complications , COVID-19/immunology , COVID-19/mortality , Emergency Service, Hospital , Female , Hospitalization , Humans , Immunization, Passive , Infusions, Intravenous , Male , Middle Aged , Risk Factors , Single-Blind Method , Treatment Failure , Young Adult , COVID-19 Serotherapy
18.
Pain Med ; 22(7): 1669-1675, 2021 07 25.
Article in English | MEDLINE | ID: mdl-33944948

ABSTRACT

OBJECTIVE: The 22-item PROMIS®-Rx Pain Medication Misuse item bank (Bank-22) imposes a high response burden. This study aimed to characterize the performance of the Bank-22 in a computer adaptive testing (CAT) setting based on varied stopping rules. METHODS: The 22 items were administered to 288 patients. We performed a CAT simulation using default stopping rules (CATPROMIS). In 5 other simulations, a "best health" response rule was added to decrease response burden. This rule stopped CAT administration when a participant selected "never" to a specified number of initial Bank-22 items (2-6 in this study, designated CATAlt2-Alt6). The Bank-22 and 7-item short form (SF-7) scores were compared to scores based on CATPROMIS, and the 5 CAT variations. RESULTS: Bank-22 scores correlated highly with the SF-7 and CATPROMIS, Alt5, Alt6 scores (r=0.87-0.95) and moderately with CATAlt2- Alt4 scores (r=0.63-0.74). In all CAT conditions, the greatest differences with Bank-22 scores were at the lower end of misuse T-scores. The smallest differences with Bank-22 and CATPROMIS scores were observed with CATAlt5 and CATAlt6. Compared to the SF-7, CATAlt5 and CATAlt6 reduced overall response burden by about 42%. Finally, the correlations between PROMIS-Rx Misuse and Anxiety T-scores remained relatively unchanged across the conditions (r=0.31-0.43, Ps < .001). CONCLUSIONS: Applying a stopping rule based on number of initial "best health" responses reduced response burden for respondents with lower levels of misuse. The tradeoff was less measurement precision for those individuals, which could be an acceptable tradeoff when the chief concern is in discriminating higher levels of misuse.


Subject(s)
Chronic Pain , Chronic Pain/drug therapy , Computer Simulation , Computers , Humans , Prescriptions , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
19.
Pain Ther ; 10(2): 1105-1119, 2021 Dec.
Article in English | MEDLINE | ID: mdl-33870479

ABSTRACT

INTRODUCTION: Chronic postsurgical pain (CPSP) is a global issue with high prevalence. This study compared acute pain descriptors among patients undergoing carpal tunnel release (CTR) or trigger finger release (TFR). We hypothesized worst pain intensity on postoperative day (POD) 10 would be best to predict the time to pain resolution. METHODS: In this secondary analysis of a negative, randomized, double-blind placebo-controlled trial, adult veterans undergoing CTR or TFR were enrolled January 2012-January 2014, with data analysis February 2020-October 2020. Participants were randomized to receive minocycline 200 mg or placebo 2 h prior to the operation, then minocycline 100 mg or placebo twice daily for 5 days. The Brief Pain Inventory, assessed daily, captured three pain scores: average and worst pain over the past 24 h, and current pain intensity. Fifteen acute pain descriptors based on the pain scores (clusters, mean, median, pain scores on POD 10, and linear slopes) were compared as predictors of time to pain resolution. RESULTS: Of 131 randomized participants, 114 (83 CTR, 31 TFR) were included. Average pain over the last 24 h reported on POD 10 best predicted time to pain cessation. Every one-point increase in the average pain score was associated with a 36.0% reduced rate of pain cessation (HR, 0.64, 95% CI 0.55-0.74, p < 0.001). Average pain on POD 10 was significantly associated with the development of CPSP at 90 days (OR 1.74, 95% CI 1.30-2.33, p value < 0.001). The optimal cutoff score for the high-risk group was determined as average pain on POD 10 ≥ 3. CONCLUSIONS: This study validates prior work and demonstrates the importance of assessing pain severity on POD 10 to identify patients at high risk for CPSP who are most likely to benefit from early pain intervention. Future research in diverse surgical cohorts is needed to further validate pain assessment on POD 10 as a significant predictor of CPSP.

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