The Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug Delivery Guidance on Safety and Therapy Optimization When Treating Chronic Noncancer Pain.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians and scientists based on expertise with international representation to establish evidence-based guidance on intrathecal drug delivery in treating chronic pain. This Polyanalgesic Consensus Conference (PACC)® project, created more than two decades ago, intends to provide evidence-based guidance for important safety and efficacy issues surrounding intrathecal drug delivery and its impact on the practice of neuromodulation. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when PACC® last published guidelines) to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence is scant. RESULTS: The PACC® examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The PACC® recommends best practices regarding intrathecal drug delivery to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Network Meta-analysis and Economic Evaluation of Neurostimulation Interventions for Chronic Nonsurgical Refractory Back Pain.

OBJECTIVES: Different types of spinal cord stimulation (SCS) have been evaluated for the management of chronic nonsurgical refractory back pain (NSRBP). A direct comparison between the different types of SCS or between closed-loop SCS with conventional medical management (CMM) for patients with NSRBP has not been previously conducted, and therefore, their relative effectiveness and cost-effectiveness remain unknown. The aim of this study was to perform a systematic review, network meta-analysis (NMA) and economic evaluation of closed-loop SCS compared with fixed-output SCS and CMM for patients with NSRBP. METHODS: Databases were searched to September 8, 2023. Randomized controlled trials of SCS for NSRBP were included. The results of the studies were combined using fixed-effect NMA models. A cost-utility analysis was performed from the perspective of the UK National Health Service with results reported as incremental cost per quality-adjusted life-year (QALY). RESULTS: Closed-loop SCS resulted in statistically and clinically significant reductions in pain intensity (mean difference [MD] 32.72 [95% CrI 15.69-49.78]) and improvements in secondary outcomes (Oswestry Disability Index [ODI] and health-related quality of life [HRQoL]) compared with fixed-output SCS at 6-month follow-up. Compared with CMM, both closed-loop and fixed-output SCS resulted in statistically and clinically significant reductions in pain intensity (closed-loop SCS vs. CMM MD 101.58 [95% CrI 83.73-119.48]; fixed-output SCS versus CMM MD 68.86 [95% CrI 63.43-74.31]) and improvements in secondary outcomes (ODI and HRQoL). Cost-utility analysis showed that closed-loop SCS dominates fixed-output SCS and CMM, and fixed-output SCS also dominates CMM. DISCUSSION: Current evidence showed that closed-loop and fixed-output SCS provide more benefits and cost-savings compared with CMM for patients with NSRBP.

Estimated health effects from domestic use of gaseous fuels for cooking and heating in high-income, middle-income, and low-income countries: a systematic review and meta-analyses.

BACKGROUND: Exposure to household air pollution from polluting domestic fuel (solid fuel and kerosene) represents a substantial global public health burden and there is an urgent need for rapid transition to clean domestic fuels. Gas for cooking and heating might possibly affect child asthma, wheezing, and respiratory health. The aim of this review was to synthesise the evidence on the health effects of gaseous fuels to inform policies for scalable clean household energy. METHODS: In this systematic review and meta-analysis, we summarised the health effects from cooking or heating with gas compared with polluting fuels (eg, wood or charcoal) and clean energy (eg, electricity and solar energy). We searched PubMed, Scopus, Web of Science, MEDLINE, Cochrane Library (CENTRAL), Environment Complete, GreenFile, Google Scholar, Wanfang DATA, and CNKI for articles published between Dec 16, 2020, and Feb 6, 2021. Studies eligible for inclusion had to compare gas for cooking or heating with polluting fuels (eg, wood or charcoal) or clean energy (eg, electricity or solar energy) and present data for health outcomes in general populations. Studies that reported health outcomes that were exacerbations of existing underlying conditions were excluded. Several of our reviewers were involved in screening studies, data extraction, and quality assessment (including risk of bias) of included studies; 20% of studies were independently screened, extracted and quality assessed by another reviewer. Disagreements were reconciled through discussion with the wider review team. Included studies were appraised for quality using the Liverpool Quality Assessment Tools. Key health outcomes were grouped for meta-analysis and analysed using Cochrane's RevMan software. Primary outcomes were health effects (eg, acute lower respiratory infections) and secondary outcomes were health symptoms (eg, respiratory symptoms such as wheeze, cough, or breathlessness). This study is registered with PROSPERO, CRD42021227092. FINDINGS: 116 studies were included in the meta-analysis (two [2%] randomised controlled trials, 13 [11%] case-control studies, 23 [20%] cohort studies, and 78 [67%] cross-sectional studies), contributing 215 effect estimates for five grouped health outcomes. Compared with polluting fuels, use of gas significantly lowered the risk of pneumonia (OR 0·54, 95% CI 0·38-0·77; p=0·00080), wheeze (OR 0·42, 0·30-0·59; p<0·0001), cough (OR 0·44, 0·32-0·62; p<0·0001), breathlessness (OR 0·40, 0·21-0·76; p=0·0052), chronic obstructive pulmonary disease (OR 0·37, 0·23-0·60; p<0·0001), bronchitis (OR 0·60, 0·43-0·82; p=0·0015), pulmonary function deficit (OR 0·27, 0·17-0·44; p<0·0001), severe respiratory illness or death (OR 0·27, 0·11-0·63; p=0·0024), preterm birth (OR 0·66, 0·45-0·97; p=0·033), and low birth weight (OR 0·70, 0·53-0·93; p=0·015). Non-statistically significant effects were observed for asthma in children (OR 1·04, 0·70-1·55; p=0·84), asthma in adults (OR 0·65, 0·43-1·00; p=0·052), and small for gestational age (OR 1·04, 0·89-1·21; p=0·62). Compared with electricity, use of gas significantly increased risk of pneumonia (OR 1·26, 1·03-1·53; p=0·025) and chronic obstructive pulmonary disease (OR 1·15, 1·06-1·25; p=0·0011), although smaller non-significant effects were observed for higher-quality studies. In addition, a small increased risk of asthma in children was not significant (OR 1·09, 0·99-1·19; p=0·071) and no significant associations were found for adult asthma, wheeze, cough, and breathlessness (p>0·05). A significant decreased risk of bronchitis was observed (OR 0·87, 0·81-0·93; p<0·0001). INTERPRETATION: Switching from polluting fuels to gaseous household fuels could lower health risk and associated morbidity and mortality in resource-poor countries where reliance on polluting fuels is greatest. Although gas fuel use was associated with a slightly higher risk for some health outcomes compared with electricity, gas is an important transitional option for health in countries where access to reliable electricity supply for cooking or heating is not feasible in the near term. FUNDING: WHO.

Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain.

INTRODUCTION: A novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spinal cord measurements is essential to increase the transparency and reproducibility of SCS therapy. Here, we report a cohort of the EVOKE double-blind randomized controlled trial treated with CL-SCS for 36 months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements. METHODS: 41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36 months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with ≥50% and ≥80% reduction in overall back and leg pain. RESULTS: The performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4µV of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was >98%, and the ECAP dose was ≥19.3µV. Most patients obtained ≥50% reduction (83%) and ≥80% reduction (59%) in overall back and leg pain with a sustained response observed in the rates between 3-month and 36-month follow-up (p=0.083 and p=0.405, respectively). CONCLUSION: The results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up.

The Influence of Schmorl Nodes in Spinal Sagittal Balance in Young Adults / A Influência dos nódulos de Schmorl no equilíbrio sagital de adultos jovens

Abstract Objectives The present study aims to characterize the spinal balance (SB) in young adults with Schmorl nodes (SN). Methods A cross-sectional study was conducted on a sample of 47 young adults. Lumbar magnetic resonance imaging (MRI) was used to divide the patients into an SN group and a control group. Standing full spine radiographs were used to compare the spinopelvic SB parameters between groups: sagittal vertical axis, thoracic kyphosis, lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS). Results The LL and SS values were significantly lower in patients with SN when compared with the control group (54.5° versus 64.3°; 36.2° versus 41.4°, respectively). No significant differences were observed for the other parameters. Significant correlations were found in both groups between LL and SS; PI and PT; and PI and SS. Conclusions Young adults with SN have associated SB modifications, particularly lower LL and SS values, when compared with a control group. This flatter profile resembles that observed in patients with lower back pain and early disc pathology. We believe that SNs are relevant clinical findings that should prompt the study of the SB of a patient, as it may uncover variations associated with early disc degeneration. Level of Evidence III

Resumo Objetivos O presente estudo tem como objetivo caracterizar o equilíbrio sagital (SB, na sigla em inglês) espinhal em adultos jovens com nódulos de Schmorl (NS). Métodos Este é um estudo transversal de uma amostra composta por 47 adultos jovens. Ressonância magnética (RM) lombar foi usada para separar os pacientes em um grupo com NS e um grupo controle. Radiografias da coluna vertebral em pé foram usadas para comparar os parâmetros espinopélvicos do SB entre os grupos: eixo vertical sagital, cifose torácica, lordose lombar (LL), incidência pélvica (PI, na sigla em inglês), inclinação pélvica (PT, na sigla em inglês) e inclinação sacral (SS, na sigla em inglês). Resultados Os valores de LL e SS foram significativamente menores nos pacientes com NS em comparação com o grupo controle (54,5° versus 64,3°; 36,2° versus 41,4°, respectivamente). Não foram observadas diferenças significativas nos demais parâmetros. Os dois grupos apresentaram correlações significativas entre LL e SS, PI e PT e PI e SS. Conclusões Adultos jovens com NS apresentam modificações associadas ao SB, principalmente valores menores de LL e SS, em comparação com o grupo controle. Este perfil mais plano assemelha-se ao observado em pacientes com lombalgia e patologia discal em estágio inicial. Acreditamos que o NS seja um achado clínico relevante que deve levar ao estudo do SB de um paciente por poder revelar variações associadas aos primeiros estágios de degeneração discal. Nível de Evidência III

Corticoterapia em altas doses no traumatizado medular: benefício ou prejuízo?: [revisão] / Altas dosis de corticoterapía para lesiones de la médula espinal: ¿es un beneficio o no?: [revisión] / High dose of corticotherapy for spinal cord injuries: is it a benefit or not?: [review]

As sequelas das lesões traumáticas da espinal medula representam um elevado prejuízo pessoal, familiar e social. Desde 1984, foi investigado e proposto o tratamento com succinato sódico metilprednisolona em altas doses, como forma de reverter ou prevenir o agravamento dessas lesões. Apresentamos uma revisão da literatura sobre essa temática. Sabe-se que essa terapêutica tem uma elevada taxa de complicações, mas, acerca das suas vantagens e real eficácia, não existe concordância entre autores de trabalhos. Enquanto uns a defendem, outros chegam a considerar provada a sua total contraindicação nessa patologia. Já existem, em nível mundial, alguns centros que não fazem a sua administração. Em Portugal é prática generalizada a sua utilização. Não o fazer poderia mesmo ser difícil de defender em situação de litígio. Mas será que estamos mesmo a ajudar os nossos doentes?.

Sequelae of the traumatic injuries to the spinal cord represent a high personal, family and social damage. Since 1984, it has been investigated and considered that the treatment with sodium succinate methylprednisolone in high doses was a solution to revert or to prevent the aggravation of such injuries. We present a revision of literature on this subject. It is well established that this therapeutic has a high rate of complications, but concerning its advantages and real effectiveness, there is no agreement between paper authors. While some defend it, others state that this is a total contraindication in this pathology. There are already some medical centers worldwide that do not use it. In Portugal, the practice of its administration is generalized. Not to do it could be difficult to defend in a litigation situation. But are we really helping our patients with it?.

Las secuelas de las lesiones traumáticas de la médula espinal representan una gran pérdida personal, familiar y social. Desde el 1984, se investigó y se ofreció tratamiento con succinato sódico de metilprednisolona en altas dosis, como una forma de revertir o prevenir el empeoramiento de estas lesiones. Los autores presentan una revisión de la literatura sobre este tema. Se sabe que esta terapia tiene un alto índice de complicaciones. Sin embargo, sobre sus ventajas y eficacia real, no hay acuerdo entre las publicaciones. Mientras que algunas la defienden y otros llegan a tomar como prueba de su contraindicación total en esta patología.Ahora, existen en todo el mundo, algunos centros que no hacen su administración. En Portugal, se encuentra en uso generalizado. No hacerlo sería difícil de defender en situaciones de conflicto. ¿Pero, es esto una real ayuda a nuestros pacientes?.

Dermatomicosis en las extremidades inferiores de pacientes diabéticos seguidos en una consulta de podología / Dermatomycosis in lower limbs of diabetic patients followed by podiatry consultation

Antecedentes. Los pacientes diabéticos son especialmente vulnerables a las micosis debido a las modificaciones inducidas por la enfermedad en su sistema inmunitario. Estas modificaciones comprometen los sistemas de defensa naturales, como la piel y las uñas, sobre todo en las extremidades inferiores. Objetivos. Evaluar la presencia de dermatomicosis en los miembros inferiores de pacientes diabéticos portugueses seguidos en consultas de podología y determinar los posibles factores predisponentes y las especies de hongos más frecuentes asociadas a los casos incluidos en el estudio. Métodos. Se realizó un estudio prospectivo de seis meses de duración en 163 pacientes diabéticos con signos y síntomas de dermatomicosis, atendidos por el servicio de podología de la Asociación Portuguesa de Diabetes en Lisboa. Se obtuvieron muestras de piel y/o de uñas de las extremidades inferiores y se registraron los datos demográficos y clínicos de los pacientes. Resultados. Trichophyton rubrum fue el dermatofito más frecuentemente aislado (12,1%), seguido por Trichophyton mentagrophytes (7,7%) y Trichophyton tonsurans (4,4%). En el presente estudio ha quedado demostrada la asociación entre la diabetes de tipo 2 y la presencia de dermatomicosis en la población estudiada (p=0,013); y así mismo entre la incidencia de dermatomicosis y la localización de la lesión corporal (p=0,000). Para ningún otro factor predisponente analizado se identificó una asociación positiva con la infección (p > 0,05). Conclusiones. En Portugal apenas se dispone de datos sobre micosis superficiales en pacientes diabéticos. El presente estudio proporciona información sobre la caracterización de las dermatomicosis en miembros inferiores de estos pacientes(AU)

Background. Diabetic patients are particularly susceptible to fungal infections due to modifications that occur in their immunological system. These modifications compromise natural defences, such as skin and nails, especially from lower limbs. Aims. Assessing the presence of dermatomycosis in lower limbs of Portuguese diabetic patients followed on Podiatry consultation. Determination of possible predisposing factors and the most frequent fungal species associated with the cases are included in the study. Methods. A six-month prospective study was carried out in 163 diabetic patients with signs and symptoms of dermatomycosis followed by Podiatry at the Portuguese Diabetes Association in Lisbon. Samples from the skin and/or nails of the lower limbs were collected and demographic and clinical data of those patients were recorded. Results. Trichophyton rubrum was the most frequently isolated dermatophyte (12.1%), followed by Trichophyton mentagrophytes (7.7%) and Trichophyton tonsurans (4.4%). Our study showed positive associations between type 2 diabetes and the presence of dermatomycosis in the studied population (p=0.013); this association was also shown between the occurrence of dermatomycosis and the localization of the body lesion (p=0.000). No other predisposing factor tested was positively associated with infection (p>0.05). Conclusions. Data on superficial fungal infections in diabetic patients are scarce in Portugal. This study provides information on the characterization of dermatomycosis in lower limbs of diabetic patients(AU)