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Comparison Between Multimedia and Written Informed Consent for Lumbar Transforaminal Epidural Steroid Injection: A Randomized Controlled Pilot Trial

Pain Physician. 2024 Nov;27(8):529-535.

ABSTRACT

BACKGROUND: Informed consent is a crucial ethical and legal requirement in medical practice to ensure that patients understand the risks, benefits, and alternatives of medical procedures. Recent advances in multimedia technology have facilitated the exploration of multimedia consent, aiming to enhance patient understanding and satisfaction. Ascertaining that patients have full comprehension of the procedures before opting to undergo them is especially important now that instances of such procedures as lumbar transforaminal epidural steroid injections (TESIs) are increasing.

OBJECTIVES: To determine the effectiveness of multimedia consent forms for lumbar transforaminal steroid injections.

STUDY DESIGN: Randomized clinical trial.

SETTING: Outpatient multidisciplinary pain medicine center of a tertiary hospital.

METHODS: A randomized controlled trial was conducted with 30 patients who received lumbar TESIs for lumbar radiculopathy. Patients were randomly assigned to either the multimedia consent group (Group M) or the conventional paper consent group (Group C). This study evaluated patients’ comprehension of the procedure, their anxiety levels (using the State-Trait Anxiety Inventory short form), and the patients’ post-procedure satisfaction.

RESULTS: Group M showed significantly greater understanding of the procedure and reported lower levels of anxiety than did Group C (P = 0.041; P = 0.03). However, there were no statistically significant differences in post-procedure satisfaction between the groups (P = 0.25). These findings suggest that multimedia consent can effectively improve patient comprehension and reduce anxiety without significantly affecting patient satisfaction.

LIMITATIONS: First, the limited sample size of 30 patients restricts the applicability of our findings to a wider population, suggesting a need for larger studies to better assess the effects of multimedia consent. Second, conducting the study in a single hospital might have introduced bias. Multicenter research may provide a more diverse and accurate evaluation of the efficacy of multimedia consent.

CONCLUSION: This pilot study contributes to the growing evidence supporting the use of multimedia consent to enhance patient understanding and reduce anxiety, marking a promising direction for improving informed consent practices for less invasive procedures, such as lumbar TESIs. Further research is required to fully explore the benefits and limitations of multimedia consent forms in various medical settings.

PMID:39621978

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Mindfulness Meditation for Fibromyalgia Syndrome: A Systematic Review and Meta-analysis

Pain Physician. 2024 Nov;27(8):479-494.

ABSTRACT

BACKGROUND: The effectiveness of mindfulness meditation (MM) for the treatment of fibromyalgia syndrome (FMS) is unknown and needs to be updated.

OBJECTIVE: This study aimed at investigating the effectiveness of MM for the treatment of FMS.

STUDY DESIGN: A systematic review and meta-analysis.

METHODS: A comprehensive search of relevant studies published from the databases’ inception through April 12, 2023 was conducted within the following databases: Cochrane Library, Embase, MEDLINE, PubMed, Clinicaltrials.gov, and PsycINFO. We included randomized controlled trials that reported at least one of the following outcome indicators: the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburg Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), and the Perceived Stress Scale (PSS). Results are presented in terms of mean difference (MD), supplemented by 95% CIs The I2 statistic assessed heterogeneity across 3 distinct observational time frames. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to appraise the robustness of the evidence.

RESULTS: Ten randomized controlled trials were selected from 1,377 citations (n = 818). Various MM regimens were reported (type of mindfulness, duration, schemes, and ingredients). Among 818 patients, very low to moderate evidence indicated that MM could reduce FIQ in the short-term (MD = -6.20; 95% CI,-8.51 to -3.89; P < 0.05; GRADE: moderate); a lower PSQI score (MD = -1.84; 95% CI, -3.35 to -0.33; P < 0.05; GRADE: very low); a reduce BDI score (MD = -3.26; 95% CI, -5.77 to -0.76; P < 0.05; GRADE: moderate); and a decreased PSS score (MD = -4.85; 95% CI, -8.22 to -1.49; P < 0.05; GRADE: very low). At medium-term follow-up, MM consistently reduced the BDI score (MD = -2.88; 95% CI, -4.98 to -0.79; P < 0.05; GRADE: moderate) and decreased the PSS score (MD = -2.76; 95% CI, -4.82 to -0.70; P < 0.05; GRADE: moderate) but there was no significant difference in FIQ scores (MD = -2.78; 95% CI, -6.32 to 0.76; P > 0.05; GRADE: low) and PSQI scores (MD = -1.28; 95% CI, -3.35 to -0.80; P > 0.05; GRADE: very low). However, at long-term follow-up, MM still reduced FIQ scores (MD = -6.09; 95% CI, -9.01 to -3.16; P < 0.05; GRADE: moderate).

LIMITATIONS: The relatively small sample size and the average quality of the included studies may have introduced biases. The time and method of meditation in the included studies were not completely unified, and there were confounding factors. Additionally, the limited amount of available literature is a challenge. Despite focusing on randomized controlled trials, there is heterogeneity among these studies. Future research should aim for larger, higher-quality studies to address these limitations and provide a more comprehensive understanding of MM’s effectiveness in fibromyalgia management.

CONCLUSIONS: Very low to moderate evidence shows that MM improves quality of life, relieves stress, and relieves insomnia and depression in patients with FMS in the short-term. Notably, the improvement in depression and stress levels continued into the medium-term period. Furthermore, quality of life improvement was discernible at long-term follow-up. This suggests that MM can be used as an adjunct therapy for FMS.International Prospective Register of Systematic Reviews (PROSPERO) Registration Number: CRD42023442356.

PMID:39621973

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Effectiveness and Safety of Hydromorphone Compared to Morphine for Postoperative Analgesia: A Systematic Review and Meta-analysis

Pain Physician. 2024 Nov;27(8):469-478.

ABSTRACT

BACKGROUND: Because of its side effects, a morphine replacement has been searched for in the field of postoperative analgesia. Hydromorphone is a derivative of morphine with no active metabolites.

OBJECTIVES: We conducted a meta-analysis of hydromorphone and morphine to compare their clinical effects in postoperative analgesia.

STUDY DESIGN: Systematic review and meta-analysis.

METHODS: The methodological quality of the studies included in this meta-analysis was assessed according to the Cochrane risk-of-bias tool. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were used to evaluate the quality of evidence and recommendation grade for inclusion of randomized controlled trials. The primary outcome was postoperative pain score. Secondary outcomes were severe sedation, nausea, vomiting, and pruritus. The meta-analysis was performed using RevMan 5.4 (The Nordic Cochrane Centre for The Cochrane Collaboration).

RESULTS: Eight randomized controlled trials comprising 833 patients were found. There was no significant difference in pain scores between the hydromorphone and morphine groups at any measured postoperative time point: 8 hours (mean difference [MD] = -0.42; 95%CI, -2.08 to 1.24; P = 0.62); 12 hours (MD = -0.19; 95%CI, -0.62 to 0.24; P = 0.39); 24 hours (MD = -0.22; 95%CI, -0.54 to 0.09; P = 0.17); 36 hours (MD = 0.01; 95%CI, -0.67 to 0.69; P = 0.98) and 48 hours (MD = -0.14; 95%CI, -1.25 to 0.96; P = 0.80). There was no significant difference in the incidence of nausea and vomiting at 24 hours postoperative. The incidence of pruritus at 24 hours postoperative was lower in the hydromorphone group (relative risk = 0.24; 95%CI, 0.09 to 0.66; P = 0.005).

LIMITATIONS: The perioperative multimodal analgesia measures were varying in the included studies, such as different medication doses. The sample size was small for some outcomes and high heterogeneity was observed.

CONCLUSIONS: There was no significant statistical difference in postoperative analgesic effect between hydromorphone and morphine, as well as side effects, including severe sedation, nausea, and vomiting at 24 hours postoperative. However, the incidence of pruritus was lower in the hydromorphone group at 24 hours postoperative.

PMID:39621972

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Influence of Nucleophosmin (NPM1) Genotypes on Outcome of Patients With AML: An AIEOP-BFM and COG-SWOG Intergroup Collaboration

J Clin Oncol. 2024 Dec 2:JCO2401715. doi: 10.1200/JCO-24-01715. Online ahead of print.

ABSTRACT

PURPOSE: Several genomic subsets of NPM1 mutations with varying sequences (type A, B, D, etc) have been identified. Despite molecular heterogeneity, NPM1 mutations cumulatively portend a more favorable outcome, but biology and prognostic implications of different genomic subsets have not been extensively studied. In this multicentric study, we investigated the impact of NPM1 genotypes on patient’s outcomes and interrogated the underlying biology of the different subtypes.

MATERIALS AND METHODS: Of more than 4,000 patients enrolled in multiple pediatric cooperative (AIEOP, BFM, ELAM02, NOPHO, DCOG, and COG trials), or adult (SWOG) trials, 348 pediatric and 75 adult AML patients with known NPM1 genotype and available outcome were selected for this study. Diverse NPM1 variants were correlated with the probabilities of overall survival (OS) and event-free survival. Nuclear localization and translational efficiency of the NPM1 variants was studied.

RESULTS: Evaluation of clinical outcome on the basis of NPM1 genotypes showed that patients with type A, B, and other rare variants had similarly favorable outcomes, whereas those with type D had a significantly worse outcome (OS of 63% for type D v 86% for type non-D, P = .005). Multivariate analysis confirmed type D as an independent prognostic factor associated with inferior OS (hazard ratio, 3; P = .005). In vitro, we demonstrated that in type D versus type A synonymous variants, codon optimality plays major roles in determining gene expression levels, and translation efficiency, which resulted in a more expressed NPM1-D mRNA and protein, mediating peculiar mitochondrial gene expression.

CONCLUSION: The evaluation of specific NPM1 genotypes identified AML patients with type D mutations being significantly associated with inferior outcomes, suggesting a reclassification of D cases to higher-risk groups.

PMID:39621969 | DOI:10.1200/JCO-24-01715

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Development and Validation of the RSClinN+ Tool to Predict Prognosis and Chemotherapy Benefit for Hormone Receptor-Positive, Node-Positive Breast Cancer

J Clin Oncol. 2024 Dec 2:JCO2401507. doi: 10.1200/JCO-24-01507. Online ahead of print.

ABSTRACT

PURPOSE: Clinicopathological factors and the 21-gene Oncotype DX Breast Recurrence Score (RS) test both influence prognosis. Our goal was to develop a new tool, RSClinN+, to individualize recurrence risk and chemotherapy benefit predictions by menopausal status for patients with HR+/human epidermal growth factor receptor 2-negative, lymph node-positive breast cancer by integrating the RS result with clinicopathological factors (grade, tumor size, age).

METHODS: We used patient-level data from 5,283 patients treated with chemoendocrine therapy (CET) versus endocrine therapy alone (ET) in the S1007 (N = 4,916) and S8814 (N = 367) trials to develop the tool. Cox proportional hazards regression models stratified by trial were used to estimate 5-year invasive disease-free survival for pre- and postmenopausal woman, respectively. The integrated RSClinN+ model was compared with RS alone and clinicopathological models using likelihood ratio tests. Absolute CET benefit was estimated as the difference between ET and CET risk estimates. Validation of RSClinN+ was performed in 592 patients with node-positive disease in the Clalit Health Services registry.

RESULTS: RSClinN+ provides better prognostic information than RS model alone (premenopausal P = .034; postmenopausal P < .001) or clinicopathological model alone (premenopausal P = .002; postmenopausal, P < .001). In postmenopausal women, RS showed interaction with CET benefit (P = .016), with RSClinN+ absolute CET benefit ranging from <0.1% to 21.5% over RS ranges 0-50. In premenopausal patients with RS ≤25, there was no significant interaction between RS and CET benefit. In external validation, RSClinN+ risk estimates were prognostic (hazard ratio, 1.75 [95% CI, 1.38 to 2.20]) and concordant with observed risk (Lin’s concordance, 0.92).

CONCLUSION: RSClinN+ provides improved estimates of prognosis and absolute CET benefit for individual patients compared with RS or with clinical data alone and could be used in patient counseling.

PMID:39621968 | DOI:10.1200/JCO-24-01507

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Association Between Metabolic Syndrome and Physical Fitness in Firefighters in Cape Town, South Africa

J Occup Environ Med. 2024 Dec 1;66(12):e646-e652. doi: 10.1097/JOM.0000000000003250.

ABSTRACT

OBJECTIVE: To assess the relationship between metabolic syndrome (MetS) and physical fitness in firefighters.

METHODS: Firefighters (n = 309) were systematically recruited to participate in this study. A questionnaire and physical measures were used to collect data on firefighters’ cardiometabolic health and physical fitness levels. Data were analyzed using binary and multinomial logistic regressions.

RESULTS: The prevalence of MetS was 23.0%, which was most prevalent in station and platoon commanders. Multivariable analysis showed that age (P < 0.001), lean body mass (P < 0.001), absolute aerobic capacity (P < 0.001), and leg strength (P < 0.001) was significantly associated with MetS. In addition, relative aerobic capacity (P < 0.001), push-ups (P = 0.016), and sit-ups (P < 0.001) were inversely associated with MetS.

CONCLUSIONS: Firefighters with MetS had a higher absolute aerobic capacity and strength, and healthier fighters had a higher relative aerobic capacity, muscular endurance capacity, and flexibility.

PMID:39621962 | DOI:10.1097/JOM.0000000000003250

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Incidence of Neoplasms in Endemic Fight Agents: Results of a Retrospective Cohort

J Occup Environ Med. 2024 Dec 1;66(12):e642-e645. doi: 10.1097/JOM.0000000000003249.

ABSTRACT

OBJECTIVE: The aim of the study is to measure cancer’s incidence in endemic fight agents in a Brazil’s Northeast state.

METHODS: This is a historical cohort with 1053 endemic fight agents. A survival analysis was performed using Kaplan-Meier method.

RESULTS: The overall neoplasm incidence rate has been 5508 cases per 105, and 4843 cases per 105 when nonmelanoma skin tumors were excluded. The increase in incidence of neoplasms occurred in 2019 and has conferred a risk of neoplasms 20 times higher than the national and state incidence.

CONCLUSIONS: We believe in an occupational factor for these results: the chronic exposure to insecticides used in public health campaigns. The peak incidence of neoplasms, in 2019, may corroborate with long induction period of these compounds, in addition to consistency with specialized literature.

PMID:39621961 | DOI:10.1097/JOM.0000000000003249

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Adult Work Ability Following Diagnosis of Bacterial Meningitis in Childhood

JAMA Netw Open. 2024 Dec 2;7(12):e2445497. doi: 10.1001/jamanetworkopen.2024.45497.

ABSTRACT

IMPORTANCE: A diagnosis of bacterial meningitis in childhood can lead to permanent neurological disabilities. Few studies have examined long-term consequences for work ability in adulthood.

OBJECTIVE: To compare earnings, work loss, and educational attainment between adults diagnosed with bacterial meningitis in childhood and population comparators.

DESIGN, SETTING, AND PARTICIPANTS: This nationwide registry-based matched cohort study included individuals in Sweden diagnosed with bacterial meningitis in childhood (aged <18 years) from January 1, 1987, to December 31, 2019, and general population comparators matched 1:9 on age, sex, and place of residence. Follow-up was completed December 31, 2020. Data were analyzed from February 7 to September 12, 2023.

EXPOSURE: A diagnosis of bacterial meningitis in childhood recorded in the National Patient Register.

MAIN OUTCOMES AND MEASURES: Annual taxable earnings (in 2020 US dollars), work loss (sum of sick leave and disability insurance), and educational attainment.

RESULTS: The cohort included 2534 individuals diagnosed with bacterial meningitis in childhood (mean [SD] age at diagnosis, 4.7 [5.3] years) and 22 806 comparators (13 510 [53.3%] male). Among those with childhood bacterial meningitis, 812 (32.0%) were diagnosed at younger than 1 year and 1351 (53.3%) were male. From 18 to 34 years of age, those with childhood meningitis had lower adjusted earnings relative to comparators and higher adjusted work loss. When pooling observations for individuals 28 years or older, the annual mean reduction in earnings was -$1295 (95% CI, -$2587 to -$4), representing a 4.0% (95% CI, 0%-8.0%) reduction relative to comparators, and the annual increase in work loss was 13.5 (95% CI, 8.6-18.5) days. There was a larger reduction in earnings for those with childhood meningitis relative to comparators with pneumococcal (Streptococcus pneumoniae) vs meningococcal (Neisseria meningitidis) meningitis. For work loss, there was a difference among all 3 major causes of meningitis, with the largest increase for pneumococcal meningitis. Individuals diagnosed at a younger age (below the median) had lower earnings relative to comparators and higher work loss than individuals diagnosed at an older age (above the median). Fewer individuals with childhood meningitis relative to comparators had obtained a high school degree at age 30 years (adjusted odds ratio, 0.68 [95% CI, 0.56-0.81]).

CONCLUSIONS AND RELEVANCE: In this cohort study of adults diagnosed with bacterial meningitis in childhood, findings suggest that work ability decreases relative to population comparators, with lower earnings and higher work loss, especially among adults diagnosed with pneumococcal meningitis or diagnosed at a young age, with long-lasting costs for the individual patient and society at large.

PMID:39621349 | DOI:10.1001/jamanetworkopen.2024.45497

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Home-Based Exercise and Self-Management After Lung Cancer Resection: A Randomized Clinical Trial

JAMA Netw Open. 2024 Dec 2;7(12):e2447325. doi: 10.1001/jamanetworkopen.2024.47325.

ABSTRACT

IMPORTANCE: Patients with lung cancer have poor physical functioning and quality of life. Despite promising outcomes for those who undertake exercise programs, implementation into practice of previously tested hospital-based programs is rare.

OBJECTIVE: To evaluate a home-based exercise and self-management program for patients after lung resection.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial with assessor blinding was conducted among 116 patients undergoing surgery for non-small cell lung cancer from November 23, 2017, to July 31, 2023, at tertiary hospitals in Australia. Patients were followed up for 12 months postoperatively.

INTERVENTION: Patients randomized to the intervention group received a postoperative 3-month home-based exercise and self-management program, supported by weekly physiotherapist-led telephone consultations. Patients randomized to the control group received usual care.

MAIN OUTCOMES AND MEASURES: The primary outcome was self-reported physical function (30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30] score) at 3 months. Secondary outcomes included objective measures of physical function and exercise capacity (at 3 and 6 months) and patient-reported outcomes including quality of life (at 3 and 6 months, with some questionnaires completed at 12 months). Analysis was performed on an intent-to-treat basis.

RESULTS: A total of 1370 patients were screened, with 177 eligible and 116 consented (mean [SD] age, 66.4 [9.6] years; 68 women [58.6%]). Of these 116 patients, 58 were randomized to the intervention and 58 to the control. A total of 103 patients (88.8%) completed assessments at 3 months, 95 (81.9%) at 6 months, and 95 (81.9%) at 12 months. There were no statistically significant differences between the intervention and control groups for self-reported physical function (EORTC QLQ-C30 physical functioning domain score) at the 3-month primary end point (mean [SD] score, 77.3 [20.9] vs 76.3 [18.8]; mean difference, 1.0 point [95% CI, -6.0 to 8.0 points]). Patients in the intervention group, compared with the control group, had significantly greater exercise capacity (6-minute walk distance: mean difference, 39.7 m [95% CI, 6.8-72.6 m]), global quality of life (mean difference, 7.1 points [95% CI, 0.4-13.8 points]), and exercise self-efficacy (mean difference, 16.0 points [95% CI, 7.0-24.9 points]) at 3 months as well as greater objectively measured physical function (Short Physical Performance Battery score: mean difference, 0.8 points [95% CI, 0.1-1.6 points]), exercise capacity (6-minute walk distance: mean difference, 50.9 m [95% CI, 6.7-95.1 m]), and exercise self-efficacy (mean difference, 10.1 points [95% CI, 1.9-18.2 points]) at 6 months. One minor adverse event and no serious adverse events occurred.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a postoperative home-based exercise and self-management program did not improve self-reported physical function in patients with lung cancer. However, it did improve other important clinical outcomes. Implementation of this program into lung cancer care should be considered.

TRIAL REGISTRATION: http://anzctr.org.au Identifier: ACTRN12617001283369.

PMID:39621348 | DOI:10.1001/jamanetworkopen.2024.47325

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Age at First Fracture and Later Fracture Risk in Older Adults Undergoing Osteoporosis Assessment

JAMA Netw Open. 2024 Dec 2;7(12):e2448208. doi: 10.1001/jamanetworkopen.2024.48208.

ABSTRACT

IMPORTANCE: Fragility fractures are often defined as those that occur after a certain age (eg, 40-50 years). Whether fractures occurring in early adulthood are equally associated with future fractures is unclear.

OBJECTIVE: To examine whether the age at which a prior fracture occurred is associated with future fracture risk.

DESIGN, SETTING, AND PARTICIPANTS: This observational, population-based cohort study included individuals from the Manitoba Bone Mineral Density Registry with a first bone mineral density (BMD) measurement between January 1, 1996, and March 31, 2018, with and without prior fracture in adulthood. Data analysis was completed between April 1, and May 31, 2023.

EXPOSURE: Individuals with fractures before their first dual-energy x-ray absorptiometry were stratified by the age at first fracture (10-year intervals from 20-29 to ≥80 years of age).

MAIN OUTCOMES AND MEASURES: Incident fractures occurring after dual-energy x-ray absorptiometry (index date) and before March 31, 2021, were identified using linked provincial administrative health data.

RESULTS: The cohort included 88 696 individuals (80 066 [90.3%] female; mean [SD] age, 64.6 [11.0] years) with a mean (SD) femoral neck T score of -1.4 (1.0). A total of 21 105 individuals (23.8%) had sustained a prior fracture at a mean (SD) age of 57.7 (13.6) years (range, 20.0-102.4 years) at the time of first prior fracture. During a mean (SD) of 9.0 (5.5) years of follow-up, incident fractures occurred in 13 239 individuals (14.6%), including 12 425 osteoporotic fractures (14.0%), 9440 major osteoporotic fractures (MOFs) (10.6%), and 3068 hip fractures (3.5%). The sex- and age-adjusted hazard ratios for all incident fractures, osteoporotic fractures, and MOFs, according to age at first fracture, were all significantly elevated, with point estimates ranging from 1.55 (95% CI, 1.28-1.88) to 4.07 (95% CI, 2.99-5.52). After adjusting for the additional covariates, the effect estimates were similar and remained significantly elevated, with point estimates ranging from fully adjusted hazard ratios of 1.51 (95% CI, 1.42-1.60) to 2.12 (95% CI, 1.67-2.71) across age categories. Sensitivity analyses examining age at last prior fracture and in those with multiple prior fractures showed similar results.

CONCLUSIONS AND RELEVANCE: In this cohort study, fractures in adulthood were associated with future fractures regardless of the age at which they occurred. Thus, fractures in early adulthood should not be excluded when assessing an individual’s ongoing fracture risk.

PMID:39621347 | DOI:10.1001/jamanetworkopen.2024.48208