Design of a Multicenter, Randomized Controlled Trial for the Treatment of Peripheral Neuropathic Pain (COMFORT Study) with a Micro-Implantable Pulse Generator.

Background: Peripheral Nerve Stimulation (PNS) is an established therapy for chronic neuropathic pain of peripheral origin, typically following nerve injury. However, there is a paucity of Randomized Controlled Trials (RCTs) demonstrating the therapeutic benefits of PNS. The goals of the current study (COMFORT Study) are to document the safety and efficacy of the Nalu Neurostimulation in a PNS RCT, compared to conventional medical management (CMM). Methods/Design: This is a prospective, multicenter, RCT evaluating the treatment of neuropathic pain with PNS therapy. One of the following four regions will be targeted for treatment: low back, shoulder, knee or foot/ankle. Consented subjects will undergo a baseline evaluation, after which they are randomized 2:1 (PNS+CMM arm to CMM arm). Subjects randomized to PNS+CMM arm will undergo a trial implant period using best clinical practices. Subjects who pass the trial phase, by showing a ≥ 50% reduction in pain relative to baseline, will receive the permanent implant. All subjects receiving a permanent implant will be followed for a total of 36 months. At the 3-month primary end point, subjects in CMM arm will be given the option to crossover into PNS+CMM arm, beginning with a trial implant. The study duration is expected to be 5.5 years from first enrollment to last follow-up of last subject and subsequent study closure. Adverse events will be captured throughout the study. Discussion: The COMFORT study, described here, has the potential to demonstrate the efficacy and safety of the Nalu Neurostimulation System in the treatment of peripheral neuropathy. Results of this study will be the first Level-I evidence, out to 36 months, validating the use of this PNS system in the treatment of chronic pain. This study is designed to enroll the largest cohort, to date, of subjects comparing PNS+CMM vs CMM alone.

Peripheral nerve stimulation (PNS) has been used for decades to treat neuropathic pain of peripheral origin. This therapy typically involves the placement small (~1 mm diameter) cylindrical electrodes (leads) near the nerve(s) in question, which is then followed by the delivery mild electrical pulses to the target, thereby blocking the pain signal from reaching the central nervous system. Despite the clinical success of this approach, there are few randomized controlled trials (RCTs) demonstrating PNS efficacy in the treatment of peripheral neuralgia/neuropathy. This may be, in large part, due to a paucity of PNS devices that are small enough to deliver this therapy at multiple locations in the extremities and the torso. For example, most implantable pulse generators (IPGs) range in size from 14 to 40 cm³ in volume. The purpose of this RCT is to demonstrate the safety and efficacy of an externally powered micro-IPG (<1.5 cm³ in volume), in the delivery of PNS to treat peripheral neuropathic pain. Active Arm subjects will receive therapy with the micro-IPG and continue to use conventional medical management (CMM); Control Arm subjects will be treated with CMM only. The primary endpoint is the responder rate at 3-months, in both arms, defined as the percentage of subjects with ≥50% pain reduction from baseline following implantation of the micro-IPG. Control Arm subjects will be given the option to crossover to the Active Arm at 3-months. Study subjects in both arms are followed out to 36 months.

Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial.

BACKGROUND: Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn-Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility. METHODS: EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent-child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is "school readiness", assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders' perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.  DISCUSSION: This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities. TRIAL REGISTRATION: The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).

Early childhood development strategy for the world's children with disabilities.

Early childhood is foundational for optimal and inclusive lifelong learning, health and well-being. Young children with disabilities face substantial risks of sub-optimal early childhood development (ECD), requiring targeted support to ensure equitable access to lifelong learning opportunities, especially in low- and middle-income countries. Although the Sustainable Development Goals, 2015-2030 (SDGs) emphasise inclusive education for children under 5 years with disabilities, there is no global strategy for achieving this goal since the launch of the SDGs. This paper explores a global ECD framework for children with disabilities based on a review of national ECD programmes from different world regions and relevant global ECD reports published since 2015. Available evidence suggests that any ECD strategy for young children with disabilities should consists of a twin-track approach, strong legislative support, guidelines for early intervention, family involvement, designated coordinating agencies, performance indicators, workforce recruitment and training, as well as explicit funding mechanisms and monitoring systems. This approach reinforces parental rights and liberty to choose appropriate support pathway for their children. We conclude that without a global disability-focussed ECD strategy that incorporates these key features under a dedicated global leadership, the SDGs vision and commitment for the world's children with disabilities are unlikely to be realised.

Experiences of identifying pre-school children with disabilities in resource limited settings - an account from Malawi, Pakistan and Uganda.

Although access to effective medical care for acutely sick children has improved globally, the number of children surviving but who may not be thriving due to disability, is increasing. This study aimed to understand the views of health professionals, educators and caregivers of pre-school children with disabilities in Malawi, Pakistan and Uganda regarding early identification, referral and support. Using applied thematic analysis, we identified themes relating to; limited 'demand' by caregivers for services; different local beliefs and community perceptions regarding the causes of childhood disability. Themes relating to 'supply' of services included inability to respond to community needs, and inadequate training among professionals for identification and referral. Stepwise, approaches provided to the families, community health worker and higher-level services could include training for community and primary care health workers on basic identification techniques and enhanced awareness for families and communities on the importance of early identification of children with disabilities.

Lack of collaboration between the community and health services may lead to entrenched pessimistic views of what can be done to support children with disabilities - generating a greater mistrust and low parental take-up of vital health services.If parents do not receive help at the community and clinic level, then, there is a need to move away from trying to provide a 'specific diagnosis' to working more on a level of assessing the child's functioning in terms of what their limitations are and how they can be addressed.Any identification and referral programme needs to consider the varying local beliefs, the stigma of having a child with a disability and feelings of blame, right from the start.A stepwise, incremental approaches, ranging from the provision of basic information, such as using brief materials highlighting 'red flag' milestones and conditions which are linked to guidance for support to families, community health workers, as well as higher levels of medical services, are likely to work best.

Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial.

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.

Intestinal intussusception-not just for kids.

Intussusception is a phenomenon commonly associated with the paediatric population. In adults, intussusception is frequently a result of a neoplastic process. We present the case of a 56-year-old gentleman who was diagnosed to the local Emergency Department with a 4-day history of worsening severe, left sided lower abdominal pain. The pain was colicky in nature. Computed tomography identified a long-segment intussusception involving distal small bowel, caecum, ascending colon, the entirety of transverse colon and its associated mesentery. The patient proceeded to theatre where a laparotomy and right hemicolectomy was performed. Histopathological analysis of the specimen identified an ileal myxoma as the lead-point of the intussusception. This report emphasises the value of prompt investigation in atypical clinical presentations.

Comparing neoadjuvant therapy followed by local excision to total mesorectal excision in the treatment of early stage rectal cancer: a systematic review and meta-analysis of randomised clinical trials.

INTRODUCTION: Total mesorectal excision (TME) is the standard-of-care in early, clinical stage (cT2-3 N0 M0) rectal cancer. Local excision (LE) may be an alternative after adequate response to neoadjuvant therapy (NAT), with either long-course chemoradiotherapy (nCRT) or short-course radiotherapy (SCRT), as a means of preserving the rectum and potentially obviating the morbidity of TME. METHODS: A systematic review was performed according to PRISMA guidelines for studies that randomly assigned patients with cT2-3 N0 M0 rectal cancer to either NAT + LE or TME that reported radiologic, oncologic, surgical, and morbidity outcomes. RESULTS: A total of 4 RCTs comprise 462 patients (232 patients receiving NAT + LE; nCRT n = 205; SCRT n = 27) and 230 undergoing TME, respectively. NAT compliance was 98.86%. The rate of early completion TME in the NAT + LE group was 22.3%, while the proportion of patients achieving durable organ preservation was 75.4% at mean follow-up of 5.6 years. There was no difference in disease-free survival (DFS) (HR [hazard ratio] 1.19; 95% CI 0.95, 1.49; p = 0.13) or overall survival (OS) (HR 0.94; 95% CI 0.72, 1.23; p = 0.63]) according to the assigned treatment arm. The local recurrence rate (LRR) (HR 1.22; 95% CI 0.5-3.02; p = 0.66) and distant metastases (HR 0.92; 95% CI 0.45, 1.90; p = 0.82) were also comparable between the groups. There was a significant reduction in major (OR 0.45; 95% CI 0.21, 0.95; p = 0.04) and minor morbidity (OR 0.45; 95% CI 0.24, 0.85; p = 0.01) for patients undergoing NAT + LE. Overall stoma formation was decreased in the NAT + LE group (OR 0.03; 95% CI 0.0, 0.23; p ≤ 0.00001). CONCLUSION: NAT + LE reduces adverse effects of TME, without any compromise in oncological outcomes, and the potential for an organ preserving strategy should be discussed with patients with T2-3N0 rectal cancers prior to treatment.

Is it possible to measure good science?

Metrics play a vital part in the valuation and funding of research for scientists worldwide. We review the challenges that metrics pose in providing a fair and equitable system for research funding. We highlight the attempts with declarations, including the San Francisco Declaration on Research Assessment (SF-DORA), to improve the research environment and specific impacts that metric choice can have on the evaluation and progression of Early Career Lecturers (ECLs). While there is much evidence that metrics will never be entirely satisfactory, we conclude there are opportunities that would benefit ECLs and reason for optimism for researchers.

Minimally Invasive Inferior Intra-Articular Sacroiliac Joint Fusion: Successful Application of Osseous Stabilization Using Allograft Bone.

Minimally invasive sacroiliac joint (SIJ) fusion is the preferred surgical method for managing patients with recalcitrant, chronically severe SIJ pain and dysfunction refractory to conservative medical measures. The primary surgical objective of all minimally invasive SIJ fusion procedures is to provide immediate stabilization within the joint space to support osseous consolidation and the development of a mechanically solid arthrodesis. The intra-articular surgical approach to the SIJ with allograft bone placement utilizes a trajectory and easily identifiable landmarks that allow the surgeon to control the risk of violating important neuro-vascular structures. The intra-articular approach can employ a superior or inferior operative trajectory, with the former restricted to allograft placement in the ligamentous portion of the SIJ. The inferior approach utilizes decortication to surgically create a channel originating in the purely articular portion of the joint space allowing for truly intra-articular implant placement within the osseous confines of the ilium and sacrum. Positioning the implant along the natural joint line and securing it within the underlying sub-chondral bone, mortise and tenon fashion provides stabilization and large surface area contact at the bone implant interface. The inferior, intra-articular approach also places the implant perpendicular to the S1 endplate, near the sacral axis of rotation, which addresses the most significant biomechanical forces across the joint. Short-term, post-surgical observational data from a 57 patient multi-center registry using the inferior, intra-articular approach show uniform and statistically significant improvement in all clinical outcomes (p < 0.001 for all comparisons), including an average 3-point improvement in back pain severity from 6.8 preoperatively to 3.8 at 6 months. Further clinical evaluation with longer-term follow-up of the inferior, intra-articular SIJ fusion procedure is encouraged.

Measuring the impact of a training intervention for early childhood centre staff on child development outcomes: Findings from a cluster randomized control field trial in rural Malawi.

BACKGROUND: Evidence from low-income settings around early education interventions that can improve young children's development is sparse, particularly with regard to the most marginalized children. This study used a two-arm parallel cluster randomized control design to evaluate the impact of an adapted staff training programme on the developmental outcomes of children attending community-based early learning centres in Thyolo district, rural Malawi. METHODS: At baseline we randomly selected 48 centres, from each of which 20 children were randomly selected, although data from one centre was incomplete resulting in 932 children from 47 centres. Centres were randomly allocated to either the intervention or control arm. Twelve months later, follow-up data were collected from 44 centres. At baseline and endline, community-based childcare centre (CBCC) managers provided information about the centre, and parents/guardians provided information on the children, including the primary outcomes of age-standardized development scores in the language and social domains, measured using the Malawi Developmental Assessment Tool. Children in the bottom 2.5 percentile of either domain were considered to have a delay; a third outcome variable, Any Delay, was developed to indicate children with a delay in either or both domains. Centre-level mean scores were calculated, and linear regression models were constructed to assess differences between baseline and endline and between allocation groups. RESULTS: Analysis of the difference between baseline and endline measures in the allocation groups shows a non-significant reduction in delay associated with the study intervention across all domains. Adjustment for baseline characteristics within the CBCCs showed little impact on the magnitude of the observed effect, and the difference remained non-significant. CONCLUSIONS: Despite no observed differences between allocation groups, the data did indicate a positive change in the intervention groups in both domains, particularly language. Community-based early learning in Malawi holds tremendous potential for promoting inclusive development and learning.

Estimated prevalence of disability and developmental delay among preschool children in rural Malawi: Findings from "Tikule Limodzi," a cross-sectional survey.

BACKGROUND: Early childhood development (ECD) is a critical stage in children's lives, influencing future development and social integration. ECD research among children with disability and developmental delay in low- and middle-income countries is limited but crucial to inform planning and delivery of inclusive services. This study is the first to measure and compare the prevalence of disability and developmental delay among children attending preschool centres in rural Malawi. METHODS: A cross-sectional survey was conducted in 48 preschool centres in Thyolo district, Malawi. Data were collected from parents or guardians of 20 children per centre. Disability was ascertained using the Washington Group/UNICEF Child Functioning Module. Child development was measured using the language and social domains of the Malawi Development Assessment Tool. RESULTS: A total of 960 children were enrolled; 935 (97.4%) children were assessed for disability and 933 (97.2%) for developmental delay; 100 (10.7%) children were identified as having a disability. The prevalence of disability was higher among children 5+ years (n = 60; 29.3%) than children 2-4 years (n = 40; 5.5%); 109 of 933 (11.7%) children were classified as having developmental delay, 41 (4.4%) in "language" and 77 (8·3%) in "social" domains. CONCLUSIONS: This study found that disability and developmental delays are common among preschool children in Malawi. It is one of the first to measure disability and delay among children in a preschool setting in Africa.

Encapsulation of in vitro Plectranthus amboinicus (Lour.) Spreng. shoot apices for propagation and conservation.

This investigation demonstrates an efficient method of propagation, short-term conservation, and germplasm exchange for Plectranthus amboinicus (Lour.) Spreng. encapsulated propagules. In vitro-derived shoot apices (shoot tips and nodal segments) which showed 100% survival on MS medium supplemented with 0.4 mg/L 6-benzylaminopurine were selected for encapsulation studies. Shoot apices measuring about 3-5 mm in size showed the ability to break the beads and exhibited 100% survival and regrowth. The combination of 3% (w/v) sodium alginate and 100 mM CaCl2 was found to be ideal for forming uniformally spherical beads, and successive preservation of encapsulated shoot apices into plantlets. The encapsulated shoot tips were relatively more effective than the nodal segments in terms of shoot growth and multiplication. Encapsulated shoot tips retained the ability to regrow (63.3%) for up to 40 days when maintained at 4 °C. Encapsulated shoot tips effectively converted into plantlets on agar medium (78%) and peat moss (58%) under in vitro conditions. Encapsulated shoot tips on agar medium showed a higher shoot regeneration (9.91 ± 0.15 shoots per explant) ability than the peat moss (5.71 ± 0.34 shoots per explant), while the highest rooting (12.16 ± 0.23 roots per explant) was observed on peat moss. Thus, calcium alginate encapsulation holds latent qualities that could be explored to develop a future alternative method of propagation, short-term storage and germplasm distribution for elite genotypes of Plectranthus sp.

Supporting Children with Disabilities in Low- and Middle- Income Countries: Promoting Inclusive Practice within Community-Based Childcare Centres in Malawi through a Bioecological Systems Perspective.

Given the narrow scope and conceptualisation of inclusion for young children with disabilities in research within low- and middle-income countries (LMICs) contexts, we draw on a bioecological systems perspective to propose the parameters for a broader unit of analysis. This perspective situates human development within a specific cultural context in which family, peers and schooling are regarded as key in responding to young children with disabilities in a given setting. We outline a new bioecological model to illustrate the proximal and distal factors that can influence inclusive early development for children with disabilities within LMICs. To illustrate the relevance of this model to early child development research, we consider its application, as a conceptual framework, with reference to a research study in Malawi. The study was designed to promote greater inclusive practice for young children with disabilities in Community-Based Childcare Centres (CBCCs) with a particular focus on the role of the CBCC volunteer 'caregiver' in rural Malawi. It has significance for educators, service providers and researchers concerned with facilitating inclusive early development across national boundaries and contexts.

L'étroitesse de la portée et de la conceptualisation de l'inclusion de jeunes enfants handicapés dans le corpus de recherche dans les pays à revenu faible et (PRFI) contextes intermédiaire, nous puisons dans une perspective de systèmes bioécologiques pour proposer des paramètres pour une unité d'analyse plus large. Notre perspective situe le développement humain dans un contexte culturel spécifique dans lequel la famille, les pairs et la scolarité sont considérés comme des éléments clés pour apporter une réponse à la question des jeunes enfants handicapés dans un contexte donné. Nous décrivons un nouveau modèle bioécologique pour illustrer les facteurs proximaux et distants qui peuvent influencer le développement des enfants handicapés dans les PRFI pendant leurs premières années. Pour illustrer la pertinence de ce modèle pour la recherche sur le développement des jeunes enfants, nous prenons en considération son application comme cadre conceptuel, en référence à une étude menée au Malawi. L'étude a été conçue aboutir de promouvoir des pratiques plus inclusives pour les enfants handicapés fréquentant des garderies communautaires, en mettant un accent particulier sur le rôle de l'«assistant ¼ bénévole dans les zones rurales du Malawi. Elle est importante pour les éducateurs, les prestataires de services et les chercheurs qui veulent faciliter un développement inclusif des jeunes enfants, au-delà des frontières et contextes nationaux.

Debido al poco alcance y la conceptualización limitada de la inclusión de niños de edad temprana con discapacidades en investigaciones realizadas en el contexto de países de ingresos bajos y medios, utilizamos una perspectiva de sistemas bio-ecológicos, con el fin de proponer parámetros más amplios de análisis. Esta perspectiva sitúa al desarrollo humano dentro de su contexto cultural específico en el cual la familia, los compañeros y la escuela son considerados como factores vitales en la atención a niños de edad temprana con discapacidades. Se describe un modelo bio-ecológico para ilustrar los factores proximales y distales que pueden influenciar el desarrollo temprano en contextos inclusivos para niños con discapacidades en países de ingresos bajos y medios. Con el fin de ilustrar la importancia de este modelo para la investigación del desarrollo infantil temprano, consideramos su aplicación, como marco conceptual, con referencia a una investigación llevada a cabo en Malaui. El estudio se diseñó con el objeto de promover mejores prácticas inclusivas para niños pequeños con discapacidades en Centros Infantiles Comunitarios (CICs) con un enfoque especial en el papel que juega el cuidador voluntario del CIC en zonas rurales de Malaui. Este estudio es relevante para educadores, centros de educación e investigadores interesados en brindar desarrollo temprano inclusivo en diferentes contextos y territorios.

Education and social inclusion of people with disabilities in five countries in West Africa: a literature review.

PURPOSE: An estimated 1 billion people worldwide live with some form of disability. With the adoption of the Sustainable Development Goals and the "Leave no one behind" agenda, there is a global momentum to ensure that disadvantaged groups, not least people with disabilities, are included and accounted for, in mainstream development efforts. However, in many low-income settings little is known about disability and the policies and programs in place to improve the lives of those affected. METHOD: This literature review describes the extent and quality of published and unpublished literature on education and social inclusion of people with disabilities in five West African countries: Cameroon, Liberia, Mali, Sierra Leone and Senegal. RESULTS: Fifty-four unique documents met inclusion criteria of the review and described related policy and legislation; national and international stakeholders; intervention programs and primary research related to disability and inclusion. The majority of documents were from Sierra Leone (19); and four described more than one country. Primary research included mainly qualitative studies and cross-sectional surveys; 33 sources were critically appraised with the majority being attributed unclear risk of bias (20). CONCLUSIONS: The findings call for (i) standardized tools for monitoring the implementation of programs and policies at national level; (ii) improved stakeholder coordination mechanisms; (iii) development and adoption of coordinated approaches to measuring disability and social exclusion; (iv) rigorous evaluations of the effectiveness of disability programs and (v) disaggregation of routine data by disability. Implication for Rehabilitation There is a need for standardized tools for monitoring the implementation of programs and policies at national level. Countries that have not yet ratified the UNCRPD or the protocol should be supported to do so. Stakeholder coordination mechanisms need to be improved. Improved coordination between stakeholders involved in disability at the country level could help improve the quality of services delivered. Development and adoption of coordinated approaches is key to measuring disability and social exclusion. There are few, if any, rigorous evaluation of the effectiveness of disability-specific evaluations in the five countries. There is a need for disaggregation of routine data from development programs by disability to inform implementation.

Is population flow an unintended consequence of alcohol management plans?

AIMS AND OBJECTIVES: The aim of this study was to gauge whether, and to what extent, population flow occurred as a result of the implementation of alcohol management plans in Indigenous communities. BACKGROUND: Alcohol management plans involving carriage limits and dry places were introduced into 15 Queensland Indigenous communities between 2002-2004. Controls on alcohol availability were further tightened between 2008-2010, seeing the closure of eight mainly remote community taverns/canteens. DESIGN: A retrospective observational study was undertaken using data from the Queensland Injury Surveillance Unit. METHODS: Population flow was measured by changing patterns of alcohol-related injuries in a mining region near dry Indigenous communities following the introduction of alcohol management plans and a control mining region distant from Indigenous communities with alcohol management plans. Data were analysed using descriptive and inferential statistics. Logistic regression was used for the comparison of the characteristics between the emergency department presentations. The rates of alcohol-related injury presentations per 1000/population were calculated and age-standardised to the Australian population. RESULTS: Between the five-year periods 2003-2007 and 2008-2012, alcohol-related injury presentations to the Mount Isa emergency department trebled from an age-adjusted average annual rate of 9·5/1000 in the region's population to 27·1/1000 population. In the control region, alcohol-related emergency department injury presentations did not increase to the same degree with age-adjusted average annual rates of 1·42/1000 and 2·21/1000, respectively. CONCLUSIONS: The 10-year pattern of emergency department presentations for alcohol-related injuries increased significantly in the Mount Isa region compared with the control region. Further research should investigate the impacts of population flow related to Indigenous community alcohol management plans. RELEVANCE TO CLINICAL PRACTICE: Although initiatives such as alcohol management plans have been implemented to reduce alcohol use and related consequences in Indigenous communities, there needs to be a greater consideration of the impact of these policies in nearby towns in the future.

Testing the Predictive Validity and Construct of Pathological Video Game Use.

Three studies assessed the construct of pathological video game use and tested its predictive validity. Replicating previous research, Study 1 produced evidence of convergent validity in 8th and 9th graders (N = 607) classified as pathological gamers. Study 2 replicated and extended the findings of Study 1 with college undergraduates (N = 504). Predictive validity was established in Study 3 by measuring cue reactivity to video games in college undergraduates (N = 254), such that pathological gamers were more emotionally reactive to and provided higher subjective appraisals of video games than non-pathological gamers and non-gamers. The three studies converged to show that pathological video game use seems similar to other addictions in its patterns of correlations with other constructs. Conceptual and definitional aspects of Internet Gaming Disorder are discussed.

The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee.

INTRODUCTION: The International Neuromodulation Society (INS) has determined that there is a need for guidance regarding safety and risk reduction for implantable neurostimulation devices. The INS convened an international committee of experts in the field to explore the evidence and clinical experience regarding safety, risks, and steps to risk reduction to improve outcomes. METHODS: The Neuromodulation Appropriateness Consensus Committee (NACC) reviewed the world literature in English by searching MEDLINE, PubMed, and Google Scholar to evaluate the evidence for ways to reduce risks of neurostimulation therapies. This evidence, obtained from the relevant literature, and clinical experience obtained from the convened consensus panel were used to make final recommendations on improving safety and reducing risks. RESULTS: The NACC determined that the ability to reduce risk associated with the use of neurostimulation devices is a valuable goal and possible with best practice. The NACC has recommended several practice modifications that will lead to improved care. The NACC also sets out the minimum training standards necessary to become an implanting physician. CONCLUSIONS: The NACC has identified the possibility of improving patient care and safety through practice modification. We recommend that all implanting physicians review this guidance and consider adapting their practice accordingly.