Regulation Of Clinical Research Research Articles

O IMPACTO DA REGULAÇÃO DO SISTEMA ENDOCANABINOIDE NA FARMACOTERAPIA DA ANSIEDADE E DO ESTRESSE

This article addresses the impact of regulation of the endocannabinoid system on the pharmacotherapy of anxiety and stress, topics of increasing relevance in neuroscience and pharmacology. The endocannabinoid system, composed of receptors, endocannabinoids and enzymes responsible for their synthesis and degradation, plays a fundamental role in modulating several physiological functions, including the regulation of stress and anxiety. Cannabidiol (CBD), a phytocannabinoid, has stood out for its anxiolytic and modulating effects on the endocannabinoid system, presenting itself as a promising therapeutic alternative for anxiety disorders. The objective of the study was to analyze the therapeutic effects of regulating the endocannabinoid system in the treatment of anxiety and stress, focusing on the benefits and limitations of using CBD. To this end, a bibliographic review of studies published between 2010 and 2024 was carried out, using databases such as PubMed, SciELO and Google Scholar. Inclusion criteria involved peer-reviewed studies that addressed the relationship between the endocannabinoid system and anxiety disorders. The results showed that CBD can significantly reduce symptoms of anxiety and stress, with few side effects. However, there are still gaps regarding optimal dosage and drug interactions, which limits its widespread clinical adoption. Regulation of the medicinal use of cannabis has also proven to be an obstacle in several countries. It is concluded that, despite the challenges, the use of cannabinoids such as CBD represents a promising approach, requiring greater investment in clinical research and adequate regulation.

Promoting equity in clinical research: The role of social determinants of health

ObjectiveThis study aims to investigate the association between social determinants of health (SDoH) and clinical research recruitment outcomes and recommends evidence-based strategies to enhance equity. Materials and MethodsData were collected from the internal clinical study manager database, clinical data warehouse, and clinical research registry. Study characteristics (e.g., study phase) and sociodemographic information were extracted. Median neighborhood income, distance from the study location, and Area Deprivation Index (ADI) were calculated. Mixed effect generalized regression was used for clustering effects and false discovery rate adjustment for multiple testing. A stratified analysis was performed to examine the impact in distinct medical departments. ResultsThe study sample consisted of 3,962 individuals, with a mean age of 61.5 years, 53.6 % male, 54.2 % White, and 49.1 % non-Hispanic or Latino. Study characteristics revealed a variety of protocols across different departments, with cardiology having the highest percentage of participants (46.4 %). Industry funding was the most common (74.5 %), and digital advertising and personal outreach were the main recruitment methods (58.9 % and 90.8 %). DiscussionThe analysis demonstrated significant associations between participant characteristics and research participation, including biological sex, age, ethnicity, and language. The stratified analysis revealed other significant associations for recruitment strategies. SDoH is crucial to clinical research recruitment, and this study presents evidence-based solutions for equity and inclusivity. Researchers can tailor recruitment strategies to overcome barriers and increase participant diversity by identifying participant characteristics and research involvement status. ConclusionThe findings highlight the relevance of clinical research inequities and equitable representation of historically underrepresented populations. We need to improve recruitment strategies to promote diversity and inclusivity in research.

Blueprint for destigmatizing depression and increasing openness to treatment among adolescents using brief social contact-based videos: a qualitative study

BackgroundDepression is a major public health concern for adolescents, who exhibit low rates of connection to care despite significant needs. Although barriers to help-seeking such as stigma are well documented, interventions to address stigma and to increase help-seeking behavior are insufficient. Dissemination of short videos in social media offer a promising approach, but designing effective stimuli requires better insight into adolescents’ perspectives of their own experiences, barriers, and possible interventions.MethodsWe conducted 20 semi-structured interviews with adolescents recruited online via RecruitMe, a Columbia University clinical research registry, to explore their perceptions of depression stigma, barriers to care, the role of schools, and the role of brief video interventions. Thematic analysis guided our analytic approach.ResultsWe developed a model consisting of three major domains: (1) Barriers to Help-Seeking, which depicts participants debating their locus of control, naming social, parental, and peer stigma, and acknowledging systemic barriers; (2) Importance of School Systems, in which participants elaborated on the role of schools filling unmet needs and the importance of being taken care of; and (3) Role of Social Media Videos, characterized by adolescents who are seeking legitimacy, finding cultural authenticity, and working towards creating an accessible blueprint for better mental healthcare.DiscussionWe provide insights into adolescents’ perceptions of help-seeking for depression and what nuances they would hope to see reflected in future interventions, most notably school-based interventions and peer social media videos. Our study offers a steppingstone towards the creation of brief, social contact-based video interventions focused on destigmatizing depression and promoting openness to treatment among adolescents.

Comparison of intra-articular platelet-rich plasma injection versus placebo for clinical outcomes in patients with knee osteoarthritis; a double-blind, randomized trial

Introduction: Osteoarthritis (OA) is a progressively debilitating condition that leads to musculoskeletal pain, particularly in the knee joint. Most clinical guidelines recommend platelet-rich plasma (PRP) for knee OA. However, the use of PRP in knee OA is increasing. Objectives: This study aimed to investigate the effects of intra-articular administration of PRP on the symptoms, lower limb function, and daily living activities in patients with knee OA. Patients and Methods: A double-blind, randomized, controlled clinical trial was conducted and 34 patients with grade 2 or 3 knee OA were enrolled. The knees of each participant were randomly allocated to receive either 3cc PRP injection (PRP knees) or needling only (control knees). Patients were evaluated by a general practitioner before, three, and six months after the intervention using the EuroQol-visual analog scales (EQ-VAS), the International Knee Documentation Committee (IKDC), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the Tegner Activity Score (TAS). Results: The mean (±SD) age of patients with knee OA was 56.6 ± 10.2 years. Seventy-point-six percent of patients were female. 67.6% and 32.4% of patients were in stages 2 and 3 of the disease, respectively. IKDC, WOMAC, TAS, and EQ-VAS scores in knees under PRP injection and control of knees, three and six months after injection showed significant improvement. Three and six months after the intervention, IKDC, WOMAC, TAS, and EQ-VAS scores in the PRP and control knees were not significant (P > 0.05). Inter-group comparison indicated that the IKDC score significantly increased six months in comparison to three months (P = 0.048) in PRP knees, but not significant in the control knees (P = 0.133). TAS score in PRP and control knees significantly increased six months compared to three months after injection. WOMAC and EQ-VAS score in PRP and control knees was not significant at six months in comparison to three months after the intervention. Conclusion: Our findings could suggest safety and feasibility data for the intra-articular administration of PRP in patients with knee OA that may help to appraise a larger clinical trial. Findings show that PRP injection improves IKDC, WOMAC, TAS, and EQ-VAS scores, however, there was no significant difference with needling only (control knees). Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trial (identifier: IRCT2015010112823N2; https://en.irct.ir/trial/12827, Ethics committee reference number: 93/551664) and Research Registry (Research Registry Unique Identifying Number: researchregistry9843).

Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial

BackgroundBio Farma has developed a recombinant protein subunit vaccine (IndoVac) that is indicated for active immunization in population of all ages. This article reported the results of the phase 3 immunogenicity and safety study in Indonesian adults aged 18 years and above. MethodsWe conducted a randomized, active-controlled, multicenter, prospective intervention study to evaluate the immunogenicity and safety of IndoVac in adults aged 18 years and above. Participants who were SARS-CoV-2 vaccine-naïve received two doses of either IndoVac or control (Covovax) with 28 days interval between doses and were followed up until 12 months after complete vaccination. ResultsA total of 4050 participants were enrolled from June to August 2022 and received at least one dose of vaccine. The geometric mean ratio (GMR) of neutralizing antibody at 14 days after the second dose was 1.01 (95 % confidence interval (CI) 0.89–1.16), which met the WHO non-inferiority criteria for immunobridging (95 % CI lower bound > 0.67). The antibody levels were maintained through 12 months after the second dose. The incidence rate of adverse events (AEs) were 27.95 % in IndoVac group and 32.15 % in Covovax group with mostly mild intensity (27.70 %). The most reported solicited AEs were pain (14.69 %) followed by myalgia (7.48 %) and fatigue (6.77 %). Unsolicited AEs varied, with each of the incidence rate under 5 %. There were no serious AEs assessed as possibly, probably, or likely related to vaccine. ConclusionsIndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9).

Abstract P349: Physical Activity Perceptions and Engagement of Patients Prescribed an Anti-Obesity Medication in a Medical Weight Loss Clinic

Introduction: Physical activity (PA) may elicit important health benefits when coupled with contemporary anti-obesity medications (AOM). However, currently there is little known about perceptions of PA and associated PA engagement of patients receiving these AOM therapies. Hypothesis: We assessed the hypothesis that PA would differ by perceptions of confidence to engage in PA, current and future importance of PA, and PA amount in patients receiving AOM treatment within the context of a medical weight loss clinic. Methods: An electronic survey was distributed to patients in a clinical research registry who were receiving treatment with an AOM at a university medical center-based weight loss clinic. The survey included questions about their perceived confidence to do structured PA or exercise regularly (PA-CONFIDENCE) and perceived importance of structured PA or exercise for management of their body weight currently (PA-IMPORTANCE) or in the future (PA-FUTURE). Participants also reported their current level of PA. Results: Survey responses were received from 96 patients. For these analyses, data were examined for patients currently prescribed a GLP-1 AOM (83 patients). High PA-CONFIDENCE was reported by 44.6% of participants, with 34.9% and 20.5% reporting moderate and low PA-CONFIDENCE, respectively. PA was 154±117 min/wk, 107±105 min/wk, and 76±77 min/wk for high, moderate, and low PA-CONFIDENCE (p=0.033). Participating in ≥150 min/wk of PA was reported by 54.1% with high, 20.7% with moderate, and 11.8% with low PA-CONFIDENCE (p=0.002). Ratings of PA-IMPORTANCE were 63.9% for high, 28.9% for moderate, and 7.2% for low. Participating in ≥150 min/wk of PA was reported by 48.2% with high, 12.5% with moderate, and 0% with low PA-IMPORTANCE (p=0.002). Ratings of PA-FUTURE were 79.5% for high, 18.1% for moderate, and 2.4% for low. Current participation in ≥150 min/wk of PA was reported by 33.7% with high, 12.5% with moderate, and 0% with low PA-FUTURE (p=0.002). Conclusions: Less than one-half of patients prescribed an AOM report confidence to engage in regular structured PA, and of those with high confidence only approximately one-half achieve current public health recommendations for PA. While more than one-half of patients report that PA is important, less than one-half engage in the recommended amount of PA. Strategies are needed to increase perceived confidence to perform and importance of PA in AOM treated patients, and to increase PA participation.

Updating and evaluating a research best practices training course for social and behavioral research professionals.

The clinical and translational research workforce involved in social and behavioral research (SBR) needs to keep pace with clinical research guidance and regulations. Updated information and a new module on community and stakeholder engagement were added to an existing SBR training course. This article presents evaluation findings of the updated course for the Social and Behavioral Workforce. Participants working across one university were recruited. Course completers were sent an online survey to evaluate the training. Some participants were invited to join in a focus group to discuss the application of the training to their work. We performed descriptive statistics and conducted a qualitative analysis on focus group data. There were 99 participants from diverse backgrounds who completed the survey. Most reported the training was relevant to their work or that of the study teams they worked with. Almost half (46%) indicated they would work differently after participating. Respondents with community or stakeholder engaged research experience vs. those without were more likely to report that the new module was relevant to study teams they worked with (t = 5.61, p = 0.001), and that they would work differently following the training (t = 2.63, p = 0.01). Open-ended survey responses (n = 99) and focus group (n = 12) data showed how participants felt their work would be affected by the training. The updated course was rated highly, particularly by those whose work was related to the new course content. This course provides an up-to-date resource for the training and development for the Social and Behavioral Workforce.

Clinical research and drug regulation in the challenging times of individualized therapies: A pivotal role of clinical pharmacology

Since the 1980s, medical specialists in Clinical Pharmacology have been playing a crucial role in the development of drug regulation in Spain. In this article we report on the activities carried out and the prospects for development in three very relevant areas from the regulatory perspective: 1) the development of stable public infrastructures to facilitate non-commercial clinical research with medicines, 2) the regulatory aspects of individual access to medicines in special situations, beyond their regular access after marketing approval and funding by the National Health System, and 3) the challenges of development and access to advanced therapies, with special reference to the figure of the hospital exemption.

Pre-oxygenation with high-flow oxygen through the nasopharyngeal airway compared to facemask on carbon dioxide clearance in emergency adults: a prospective randomized non-blinded clinical trial

IntroductionBefore tracheal intubation, it is essential to provide sufficient oxygen reserve for emergency patients with full stomachs. Recent studies have demonstrated that high-flow nasal oxygen (HFNO) effectively pre-oxygenates and prolongs apneic oxygenation during tracheal intubation. Despite its effectiveness, the use of HFNO remains controversial due to concerns regarding carbon dioxide clearance. The air leakage and unknown upper airway obstruction during HFNO therapy cause reduced oxygen flow above the vocal cords, possibly weaken the carbon dioxide clearance.MethodsPatients requiring emergency surgery who had fasted < 8 h and not drunk < 2 h were randomly assigned to the high-flow group, who received 100% oxygen at 30–60 L/min through nasopharyngeal airway (NPA), or the mask group, who received 100% oxygen at 8 L/min. PaO2 and PaCO2 were measured immediately before pre-oxygenation (T0), anesthesia induction (T1), tracheal intubation (T2), and mechanical ventilation (T3). The gastric antrum’s cross-sectional area (CSA) was measured using ultrasound technology at T0, T1, and T3. Details of complications, including hypoxemia, reflux, nasopharyngeal bleeding, postoperative pulmonary infection, postoperative nausea and vomiting (PONV), and postoperative nasopharyngeal pain, were recorded. The primary outcomes were PaCO2 measured at T1, T2, and T3. The secondary outcomes included PaO2 at T1, T2, and T3, CSA at T1 and T3, and complications happened during this trial.ResultsPre-oxygenation was administered by high-flow oxygen through NPA (n = 58) or facemask (n = 57) to 115 patients. The mean (SD) PaCO2 was 32.3 (6.7) mmHg in the high-flow group and 34.6 (5.2) mmHg in the mask group (P = 0.045) at T1, 45.0 (5.5) mmHg and 49.4 (4.6) mmHg (P < 0.001) at T2, and 47.9 (5.1) mmHg and 52.9 (4.6) mmHg (P < 0.001) at T3, respectively. The median ([IQR] [range]) PaO2 in the high-flow and mask groups was 404.5 (329.1–458.1 [159.8–552.9]) mmHg and 358.9 (274.0–413.3 [129.0–539.1]) mmHg (P = 0.007) at T1, 343.0 (251.6–428.7 [73.9–522.1]) mmHg and 258.3 (162.5–347.5 [56.0–481.0]) mmHg (P < 0.001) at T2, and 333.5 (229.9–411.4 [60.5–492.4]) mmHg and 149.8 (87.0–246.6 [51.2–447.5]) mmHg (P < 0.001) at T3, respectively. The CSA in the high-flow and mask groups was 371.9 (287.4–557.9 [129.0–991.2]) mm2 and 386.8 (292.0–537.3 [88.3–1651.7]) mm2 at T1 (P = 0.920) and 452.6 (343.7–618.4 [161.6–988.1]) mm2 and 385.6 (306.3–562.0 [105.5–922.9]) mm2 at T3 (P = 0.173), respectively. The number (proportion) of complications in the high-flow and mask groups is shown below: hypoxemia: 1 (1.7%) vs. 9 (15.8%, P = 0.019); reflux: 0 (0%) vs. 0 (0%); nasopharyngeal bleeding: 1 (1.7%) vs. 0 (0%, P = 1.000); pulmonary infection: 4 (6.9%) vs. 3 (5.3%, P = 1.000); PONV: 4 (6.9%) vs. 4 (7.0%, P = 1.000), and nasopharyngeal pain: 0 (0%) vs. 0 (0%).ConclusionsCompared to facemasks, pre-oxygenation with high-flow oxygen through NPA offers improved carbon dioxide clearance and enhanced oxygenation prior to tracheal intubation in patients undergoing emergency surgery, while the risk of gastric inflation had not been ruled out.Trial registrationThis trial was registered prospectively at the Chinese Clinical Research Registry on 26/4/2022 (Registration number: ChiCTR2200059192).

An international study to explore the feasibility of collecting standardised outcome data for Complex Regional Pain Syndrome: recommendations for an international clinical research registry.

Complex Regional Pain Syndrome (CRPS) is a persistent pain condition with low prevalence. Multi-centre collaborative research is needed to attain sufficient sample sizes for meaningful studies. This international observational study: (1) tested the feasibility and acceptability of collecting outcome data using an agreed core measurement set (2) tested and refined an electronic data management system to collect and manage the data. Adults with CRPS, meeting the Budapest diagnostic clinical criteria, were recruited to the study from 7 international research centres. After informed consent, a questionnaire comprising the core set outcome measures was completed: on paper at baseline (T1), and at 3 or 6 months (T2) using a paper or e-version. Participants and clinicians provided feedback on the data collection process. Clinicians completed the CRPS severity score at T1 and optionally, at T2. Ethical approval was obtained at each international centre. Ninety-eight adults were recruited (female n=66; mean age 46.6 years, range 19-89), of whom 32% chose to receive the T2 questionnaire in an electronic format. Fifty-five participants completed both T1 and T2. Eighteen participants and nine clinicians provided feedback on their data collection experience. This study confirmed the questionnaire core outcome data are feasible and practicable to collect in clinical practice. The electronic data management system provided a robust means of collecting and managing the data across an international population. The findings have informed the final data collection tools and processes which will comprise the first international, clinical research registry and data bank for CRPS.

Predicting 30-day readmission following total knee arthroplasty using machine learning and clinical expertise applied to clinical administrative and research registry data in an Australian cohort

BackgroundThirty-day readmission is an increasingly important problem for total knee arthroplasty (TKA) patients. The aim of this study was to develop a risk prediction model using machine learning and clinical insight for 30-day readmission in primary TKA patients.MethodData used to train and internally validate a multivariable predictive model were obtained from a single tertiary referral centre for TKA located in Victoria, Australia. Hospital administrative data and clinical registry data were utilised, and predictors were selected through systematic review and subsequent consultation with clinicians caring for TKA patients. Logistic regression and random forest models were compared to one another. Calibration was evaluated by visual inspection of calibration curves and calculation of the integrated calibration index (ICI). Discriminative performance was evaluated using the area under the receiver operating characteristic curve (AUC-ROC).ResultsThe models developed in this study demonstrated adequate calibration for use in the clinical setting, despite having poor discriminative performance. The best-calibrated readmission prediction model was a logistic regression model trained on administrative data using risk factors identified from systematic review and meta-analysis, which are available at the initial consultation (ICI = 0.012, AUC-ROC = 0.589). Models developed to predict complications associated with readmission also had reasonable calibration (ICI = 0.012, AUC-ROC = 0.658).ConclusionDiscriminative performance of the prediction models was poor, although machine learning provided a slight improvement. The models were reasonably well calibrated, meaning they provide accurate patient-specific probabilities of these outcomes. This information can be used in shared clinical decision-making for discharge planning and post-discharge follow up.

Stepped Behavioral and Biological Screening for Oral Oncogenic HPV DNA in Middle-aged and Elderly Adults: A Feasibility Study.

Novel preventive interventions are needed to address the rising incidence of HPV+ OPC. In this feasibility study, we characterized barriers to a two-step, behavioral and biological screening program for oral oncogenic HPV infection, an intermediate outcome for HPV+ OPC.

Clinical research and related regulations

Clinical research and related regulations

Regulation of Clinical Research for Cellular and Gene Therapy Products in India.

The understanding of disease biology and advances in cellular and molecular biology platforms have ushered in a new era of cell and gene based therapeutic products. The US-FDA refers to this category of products as Cellular and Gene Therapy Products (CGTPs), while the European Medicines Agency, Europe, refers to them as Advanced Therapy Medicinal Products (ATMPs). The research and development (R&D) and final commercialization of these products have thus picked up pace, especially in the last decade. This emerging scenario necessitates framing regulations and guidelines that take into consideration the unique biological nature of these products. Regulators and government agencies of different countries across the globe have come up with regulations and guidance documents to guide, monitor, and regulate the research and development in this field. India, given its powerful resources of skilled scientific manpower and infrastructure, is also contributing to development of these innovative therapeutic products. Keeping in line with the international counterparts, the Indian regulators and government agencies have developed regulations and guidelines for stakeholders. This chapter summarizes the regulatory landscape for research and development of CGTP in India. It provides an overview of the government agencies and committees overseeing this field and their roles that a stakeholder working in this field needs to have knowledge of. Furthermore, the chapter outlines the salient features of rules, regulations, and guidelines relevant to CGTP, the approval process, the current approved products in Indian market, and finally, the challenges and way forward for CGTP in India.

Clinical studies of dapagliflozin in pediatric patients: a rapid review.

The oral sodium-glucose cotransporter 2 inhibitor, dapagliflozin, is used to treat kidney disease, heart failure, and diabetes in adults, but has not been well studied in pediatrics, and does not have a recognized place in therapy in current practice guidelines. The purpose of this review is to summarize studies that have investigated the efficacy of dapagliflozin in pediatric patients. A systematic review was performed to identify clinical studies of oral dapagliflozin in children 0 to 17 years. Studies were identified through searches of Scopus, Web of Science, PubMed, Google Scholar, Embase, clinical trial registries, research registries, and key journals through August 2022. The Cochrane scoring system was used to assess the methodological quality of the included randomized trials. Five studies were reviewed and included in this analysis. Dapagliflozin at a dose of 5 to 10 mg was utilized in adolescents and young adults with heart failure, chronic kidney disease with proteinuria, type 1 diabetes, or type 2 diabetes. Studies evaluating dapagliflozin in type 1 diabetes evaluated single doses while the other studies monitored long-term use. Dapagliflozin was overall considered to be safe and effective in the studies included in this review, but further studies in larger populations and over extended periods of time are necessary.

Importance of Prospective Registries and Clinical Research Networks in the Evolution of Spinal Cord Injury Care.

Only 100 years ago, traumatic spinal cord injury (SCI) was commonly lethal. Today, most people who sustain SCI survive with continual efforts to improve their quality of life and neurological outcomes. SCI epidemiology is changing as preventative interventions reduce injuries in younger individuals, and there is an increased incidence of incomplete injuries in aging populations. Early treatment has become more intensive with decompressive surgery and proactive interventions to improve spinal cord perfusion. Accurate data, including specialized outcome measures, are crucial to understanding the impact of epidemiological and treatment trends. Dedicated SCI clinical research and data networks and registries have been established in the United States, Canada, Europe, and several other countries. We review four registry networks: the North American Clinical Trials Network (NACTN) SCI Registry, the National Spinal Cord Injury Model Systems (SCIMS) Database, the Rick Hansen SCI Registry (RHSCIR), and the European Multi-Center Study about Spinal Cord Injury (EMSCI). We compare the registries' focuses, data platforms, advanced analytics use, and impacts. We also describe how registries' data can be combined with electronic health records (EHRs) or shared using federated analysis to protect registrants' identities. These registries have identified changes in epidemiology, recovery patterns, complication incidence, and the impact of practice changes such as early decompression. They've also revealed latent disease-modifying factors, helped develop clinical trial stratification models, and served as matched control groups in clinical trials. Advancing SCI clinical science for personalized medicine requires advanced analytical techniques, including machine learning, counterfactual analysis, and the creation of digital twins. Registries and other data sources help drive innovation in SCI clinical science.

Thrombolysis in Stroke Mimics: Comprehensive Stroke Centers vs Telestroke Sites.

Hyperacute treatment of acute stroke may lead to thrombolysis in stroke mimics (SM). Our aim was to determine the frequency of thrombolysis in SM in primary stroke centers (PSC) dependent on telestroke versus comprehensive stroke centers (CSC). Retrospective review of prospectively collected data from the Quality improvement and Clinical Research (QuICR) registry, the Discharge Abstract Database (DAD), and The National Ambulatory Care Reporting System (NACRS) of consecutive patients treated with intravenous thrombolysis for acute ischemic stroke in Alberta (Canada) from April 2016 to March 2021. A total of 2471 patients who received thrombolysis were included. Linking the QuICR registry to DAD 169 (6.83%) patients were identified as SM; however, on our review of the records, only 112 (4.53%) were actual SM. SMs were younger with a mean age of 61.66 (±16.15) vs 71.08 (±14.55) in stroke. National Institute of Health Stroke Scale was higher in stroke with a median (IQR) of 10 (5-17) vs 7 (5-10) in SM. Only one patient (0.89 %) in SM groups had a small parenchymal hemorrhage versus 155 (6.57%) stroke patients had a parenchymal hemorrhage. There was no death among patients of thrombolysed SM during hospitalization versus 276 (11.69%) in stroke. There was no significant difference in the rate of SM among thrombolysed patients between PSC 27 (5.36%) versus CSC 85 (4.3%) (P = 0.312). The most responsible diagnosis of SM was migraine/migraine equivalent, functional disorder, seizure, and delirium. The diagnosis of SM may not always be correct when the information is extracted from databases. The rate of thrombolysis in SM via telestroke is similar to treatment in person at CSC.

Psychometric properties of the Viking Speech Scale-Turkish version for children with cerebral palsy aged 4-18 years based on live and video-based observation.

Speech is the most common method of communication. Video-based clinical communication evaluation is a requirement for children with speech-language impairments living in rural areas, and those who have limited mobility. To determine the validity and reliability of the Turkish version of the Viking Speech Scale (VSS-T) via live and video-based observation for children with cerebral palsy (CP) aged 4-18 years. A total of 142 children (mean age 8.18 ± 3.98 years; 68 female) with CP were included in this study. Their motor, communication, visual and eating-drinking function levels and comorbidities (dental, swallowing, cognitive impairments and epilepsy) were recorded. The Intelligibility in Context Scale (ICS), the Pediatric Evaluation of Disability Inventory-Social Function (PEDI-SF), and the Functional Independence Measure for Children-Communication (WeeFIM-C) were assessed to examine the concurrent validity of the VSS-T. The interrater reliability of the VSS-T was analysed between parents, physical therapists, and speech and language therapists from live and video-based observation. Intra-rater reliability was calculated from ratings made from live and video-based observations taken 3 weeks apart. The VSS-T was strongly related to the ICS (r = -0.830), PEDI-SF (r = -0.819), WeeFIM-C (r = -0.643), other functional classifications (r > 0.432), and the comorbidities (Cramer's V > 0.284, p < 0.001). Good to excellent interrater reliability (κw ≥ 0.838) and intra-rater reliability (intraclass correlation coefficient (ICC) = 0.848-0.995) were found between parents and therapists. Speech and language therapists, physical therapists, and parents can use the VSS-T as a valid and reliable classification system to describe speech intelligibility of 4-18-year-old children with CP. Both live and video-based observations can be used to administer the VSS-T. What is already known on the subject The English version of the VSS has been shown to be a valid and reliable tool used to classify the speech of children with CP aged 4-13 years. The scale can be administered by means of live observation of the child or based on clinicians' notes on the case by parents, SLTs, physiotherapists and paediatricians. What this paper adds to existing knowledge The VSS-T is valid and reliable for children with CP aged 4-18 years. Video-based observation is a suitable method for evaluating the VSS-T levels. The VSS-T has a moderate association with the CFCS. What are the potential or actual clinical implications of this work? The VSS-T is a valid and reliable method of categorizing the severity of motor speech impairment for Turkish children with CP in clinical research studies, registry systems or epidemiological studies. Both experienced and inexperienced therapists can use either live or video-based observation methods to administer the VSS-T. This study extended the validity and reliability of the scale in children with CP aged up to 18 years. The VSS-T is also associated with the Visual Functional Classification System (VFCS), which has been recently developed for describing the visual abilities of children with CP in daily life. In addition, the VSS-T is associated with the presence of dental, swallowing, cognitive problems and epilepsy.

The effect of long-term opioid use on back-specific disability and health-related quality of life in patients with chronic low back pain.

Opioids are commonly utilized for the treatment of chronic pain. However, research regarding the long-term (≥12months) outcomes of opioid therapy remains sparse. This study aims to evaluate the effects of long-term opioid therapy on measures of back-specific disability and health-related quality of life in patients with chronic low back pain. In this retrospective cohort study, patients with chronic low back pain who reported consistent opioid use or abstinence for at least 12months while enrolled in the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation Pain Research Registry were classified as long-term opioid users or nonusers, respectively. For comparison, intermediate-term and short-term opioid users and nonusers were also identified. Multiple linear regression analysis was performed to compare back-specific disability (Roland-Morris Disability Questionnaire [RMDQ]) and health-related quality of life (29-item Patient-Reported Outcomes Measurement Information System [PROMIS]) between opioid users and nonusers while controlling for pain intensity, depression, age, body mass index (BMI), and eight common comorbid conditions (herniated disc, sciatica, osteoporosis, osteoarthritis, heart disease, hypertension, diabetes, and asthma). Statistically significant findings were assessed for clinical relevance. There were 96 long-term opioid users and 204 long-term opioid nonusers. After controlling for potential confounders, long-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.85, p<0.001), physical function (adjusted mean difference=-2.90, p=0.001), fatigue (adjusted mean difference=4.32, p=0.001), participation in social roles (adjusted mean difference=-4.10, p<0.001), and pain interference (adjusted mean difference=3.88, p<0.001) outcomes. Intermediate-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.41, p<0.001), physical function (adjusted mean difference=-2.26, p=0.003), fatigue (adjusted mean difference=3.70, p=0.002), and sleep disturbance outcomes (adjusted mean difference=3.03, p=0.004), whereas short-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.42, p<0.001) and physical function outcomes (adjusted mean difference=-1.90, p<0.001). The findings of this study are largely consistent with existing literature regarding the outcomes of long-term opioid therapy. Taken in conjunction with the well-established risks of opioid medications, these findings draw into question the utility of long-term opioid therapy for chronic low back pain.

Delphi study to define core clinical outcomes for inclusion in a complex regional pain syndrome international research registry and data bank.

Complex regional pain syndrome (CRPS) clinical trials have historically captured a diverse range of outcomes. A minimum set of CRPS patient-reported outcomes has been agreed for inclusion in a future CRPS international clinical research registry and data bank. This study aimed to identify a complementary set of core clinical outcomes. Clinicians and researchers from the international CRPS community informed the content of a 2-round electronic Delphi study. Participation was invited from members of the International Association for the Study of Pain CRPS Special Interest Group and the International Research Consortium for CRPS. In round 1, participants rated the relevance of 59 clinical outcomes in relation to the question "What is the clinical presentation and course of CRPS, and what factors influence it?" (1 = not relevant and 9 = highly relevant). In round 2, participants rerated each outcome in the light of the round 1 median scores. The criterion for consensus was median score ≥7, agreed by 75% of respondents. The core study team considered the feasibility of data collection of each identified outcome in agreeing final selections. Sixty respondents completed both survey rounds, with responses broadly consistent across professions. Nine outcomes met the consensus criterion. Final outcomes recommended for inclusion in the core clinical set were record of medications, presence of posttraumatic stress disorder, extent of allodynia, and skin temperature difference between limbs. Study findings provide robust recommendations for core clinical outcome data fields in the future CPRS international clinical research registry. Alongside patient-reported outcomes, these data will enable a better understanding of CRPS.