Preventing adverse events during paediatric cancer treatment: protocol for a multi-site hybrid randomised controlled trial of catheter lock solutions (the CLOCK trial).

INTRODUCTION: Central venous access devices (CVADs) are commonly used for the treatment of paediatric cancer patients. Catheter locking is a routine intervention that prevents CVAD-associated adverse events, such as infection, occlusion and thrombosis. While laboratory and clinical data are promising, tetra-EDTA (T-EDTA) has yet to be rigorously evaluated or introduced in cancer care as a catheter lock. METHODS AND ANALYSIS: This is a protocol for a two-arm, superiority type 1 hybrid effectiveness-implementation randomised controlled trial conducted at seven hospitals across Australia and New Zealand. Randomisation will be in a 3:2 ratio between the saline (heparinised saline and normal saline) and T-EDTA groups, with randomly varied blocks of size 10 or 20 and stratification by (1) healthcare facility; (2) CVAD type and (3) duration of dwell since insertion. Within the saline group, there will be a random allocation between normal and heparin saline. Participants can be re-recruited and randomised on insertion of a new CVAD. Primary outcome for effectiveness will be a composite of CVAD-associated bloodstream infections (CABSI), CVAD-associated thrombosis or CVAD occlusion during CVAD dwell or at removal. Secondary outcomes will include CABSI, CVAD-associated-thrombosis, CVAD failure, incidental asymptomatic CVAD-associated-thrombosis, other adverse events, health-related quality of life, healthcare costs and mortality. To achieve 90% power (alpha=0.05) for the primary outcome, data from 720 recruitments are required. A mixed-methods approach will be employed to explore implementation contexts from the perspective of clinicians and healthcare purchasers. ETHICS AND DISSEMINATION: Ethics approval has been provided by Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC) (HREC/22/QCHQ/81744) and the University of Queensland HREC (2022/HE000196) with subsequent governance approval at all sites. Informed consent is required from the substitute decision-maker or legal guardian prior to participation. In addition, consent may also be obtained from mature minors, depending on the legislative requirements of the study site. The primary trial and substudies will be written by the investigators and published in peer-reviewed journals. The findings will also be disseminated through local health and clinical trial networks by investigators and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000499785.

The Relationship between Physical Activity and Motor Competence of Foundation Phase Children in Wales during the School Day.

Early childhood is a crucial time for children to develop their fundamental motor skills (FMS), serving as a foundation for engagement in lifelong physical activity (PA). With increasing concerns over the declining levels of PA and motor competence (MC), the aim of this study was to explore the predictors of PA in children in a play-based curriculum. A secondary purpose was to explore levels of PA and MC during the school day. The final aim was to explore whether there were sex differences. Children (N = 94; Mage = 68.96 months, SD = 8.25) in five classes from four different schools in Wales were tested on the TGMD-2, standing long jump, and MABC-2. Levels of PA were measured using ActiGraph GT3X-BT accelerometers, and 85 children met the wear time criteria. Object control (OC) skills, standing long jump, and age significantly predicted the percentage of time spent performing sedentary behaviours F(10,73) = 3.026, p = 0.003, R2 = 0.29 (adj R2 = 0.20) and time spent on MVPA F(10,73) = 3.597, p < 0.001, R2 = 0.33 (adj R2 = 0.24). Children spent an average of 48.7% of the school day performing sedentary behaviours and 9.1% performing moderate to vigorous physical activity (MVPA) and did not achieve 60 min of MVPA. The MABC revealed that 67% were below the 15th percentile. Girls spent more time than boys performing sedentary behaviours (p = 0.014), and boys spent more time than girls on MVPA (p = 0.004). Boys outperformed girls at OC skills (p < 0.001), while girls outperformed boys at locomotor skills (p < 0.001). These findings reinforce the pivotal role teachers and parents play in providing opportunities for children to be PA. OC skills and jump were positively associated with PA, emphasising the importance of developing FMS in early childhood. There were also sex disparities for both PA and MC, along with low levels of MC, highlighting the need for investing in comprehensive programmes and initiatives that prioritise the development of FMS during early childhood.

MiniMovers: An Initial Pilot and Feasibility Study to Investigate the Impact of a Mobile Application on Children's Motor Skills and Parent Support for Physical Development.

The MiniMovers (MM) APP combines motor development theory with creativity expertise and has been designed to provide parents with developmentally appropriate activities to support children's motor skills. This study investigates how MiniMovers activities enabled parents to support their children's physical development. Families participated in an 8-week MM programme of activities from the MM APP (Mini, Mighty and Mega levels), with pre- and post-intervention data collected using multiple tools (e.g., motion capture system, force plate, eye-tracking glasses, and videos). Mixed research methods were applied among children (N = 8; aged 21-79 months) and their parents, providing quantitative analysis on children's performance (running, throwing, jumping, kicking, balancing and catching), as well as qualitative analysis on parents' attitude and behaviour (two-weekly feedback surveys and interviews). Lab-based measures showed significant improvements in run time, underarm throwing distance, and horizontal jump distance. Test of Gross Motor Development-3 showed a significant gain in running, underarm and overarm throwing, horizontal jump and kicking. Further, developmental stages indicated significant improvements in running, kicking and catching. Parents reported increased enjoyment and knowledge, children's enjoyment, independence and confidence. This pilot study provides support for the research and development of the MM App and suggests more research into the use of APPs to support home activities among families with young children.

Fibromyalgia: A clinical update.

ABSTRACT: Fibromyalgia (FM) is a chronic pain disorder commonly encountered by advanced practice registered nurses in primary and specialty care. Knowing how to recognize FM and its multiple pain and nonpain symptoms facilitates diagnosis. We propose a four-step approach to diagnosis that can reduce costly referrals and treatment delays, and describe evidence-based interventions.

Chronic Pain Clinical and Prescriptive Practices in the Cannabis Era.

BACKGROUND: To explore how health care providers in the United States are adapting clinical recommendations and prescriptive practices in response to patient use of medical cannabis (MC) for chronic pain symptoms. DESIGN: Literature searches queried MeSH/Subject terms "chronic pain," "clinician," "cannabis," and Boolean text words "practice" and "analgesics" in EBSCOHost, EMBASE, PubMed, and Scopus, published 2010-2021 in the United States. Twenty-one primary, peer-reviewed studies met criteria. METHODS: Studies are synthesized under major headings: recommending MC for chronic pain; MC and prescription opioids; and harm reduction of MC. RESULTS: MC is increasingly utilized by patients for chronic pain symptoms. Clinical recommendations for or against MC are influenced by scopes of practice, state or federal laws, institutional policies, education, potential patient harm (or indirect harm of others), and perceived confidence. Epidemiologic and cohort studies show downward trajectories of opioid prescribing and consumption in states with legal cannabis. However, clinicians' recommendations and prescription practices are nonuniform. Impacts of cannabis laws are clear between nongovernmental and governmental institutions. Strategies addressing MC and opioid use include frequent visits, and, to reduce harm, suggesting alternative therapies and treating substance use disorders. CONCLUSIONS: MC use for chronic pain is increasing with cannabis legalization. Provider practices are heterogenous, demonstrating a balance of treating chronic pain using available evidence, while being aware of potential harms associated with MC and opioids.

Which symptoms best distinguish fibromyalgia patients from those with other chronic pain disorders?

RATIONALE, AIMS AND OBJECTIVES: The primary purpose of this study was to test both classic and novel FM pain and non-pain symptoms to determine their practical efficacy in aiding clinicians to distinguish FM pain from other chronic pain disorders. METHODS: 158 pain patients from two primary care clinics were evaluated with history, physical exam, chart review, and a questionnaire containing 26 exploratory symptoms (10 from the Symptom Impact Questionnaire (SIQR) and 16 from the FM literature)). The symptoms were rated on a 0-10 VAS for severity by those patients reporting pain over the past week. Somers' D and mean severity differences between FM and chronic pain patients without FM were used to rank the discriminatory and diagnostic contributions of symptoms. RESULTS: Fifty patients (14.2%) carried a chart diagnosis of FM, 108 (30.7%) had pain but not FM, and 192 (54.5%) who had neither pain nor FM. Comparing means between the two pain groups, the 5 best differentiating symptoms (all, P < .0001) were: a persistent deep aching over most of my body, poor balance (7.4 vs 3.1), environmental sensitivity (6.8 vs 3.0), tenderness to touch (6.8 vs 3.6) and pain after exercise (8.1 vs 4.1). Notably, VAS pain though significantly higher for FM was least discriminatory (6.5 vs 5.1, P < .001). The five best symptoms generated a ROC = 0.85 and Somers' D = 0.69, an accuracy of 81%, and an odd's ratio of 14.4. CONCLUSIONS: Our results herein suggest that clinicians may be well-served to consider symptoms in addition to those contained in current diagnostic criteria when recognizing FM in their chronic pain patients.

Validating the revised Symptom Impact Questionnaire with a proposed fibromyalgia phenotype using experimentally-induced pain and patient self-reports.

OBJECTIVES: The Symptom Impact Questionnaire (SIQR), now used for over a decade, has strong psychometric properties based on patients' subjective questionnaire data and correlations with other general measures of severity. However, the construct validity of the SIQR in assessing the central features of fibromyalgia (FM) has not been tested specifically with more objective measures. This study examined the construct validity of the SIQR using clinical examination of prominent features of FM, as well as patient questionnaire data. METHODS: We determined if SIQR severity groups (low, moderate, high severity) in 158 chronic pain patients (50 FM, 108 Pain/No FM) predicted four central features of FM tenderness and pain: digital palpation tenderness, blood pressure cuff evoked pain, widespread pain locations, and a persistent deep ache question. RESULTS: Low, moderate, and high SIQR severity groups showed concomitant increases in tenderness in response to digital evoked palpation (F=23.5; p<0.0000; ηp2=0.23; MR=.54), blood pressure cuff evoked pain (F=17.0; p<0.0000; ηp2=0.18; MR=0.48) and number of pain location (F=38.8; p<0.0000; ηp2=0.33; MR.59). Strongest differences in SIQR severity were found in response to the question, "I have a persistent deep aching over most of my body" (F=87.5; p<0.0000; ηp2=0.53; MR=0.74). CONCLUSIONS: The SIQR strongly predicts the central features of FM tenderness and pain including its widespreadness and its multifaceted character. We propose that tenderness, both locally and over most of the body, attendant to the SIQR is the hallmark of the FM phenotype: tenderness is focal, diffuse, deep, and superficial.

A simple screening test to recognize fibromyalgia in primary care patients with chronic pain.

RATIONALE, AIMS, AND OBJECTIVES: Primary care providers are increasingly expected to recognize and treat fibromyalgia (FM) without significant interaction with rheumatologists. The purpose of this study was to evaluate the potential usefulness of 3 simple measures (tenderness to digital pressure, BP cuff-evoked pain, and a single patient question) as a screening test for possible FM in a patient with chronic pain. METHODS: A total of 352 patients (mean age 50 ± 16.3 years, 70% female) scheduled for routine examination in 2 primary care practices were studied. They were comprised of 52 patients (14.8%) who carried a chart diagnosis of FM, 108 (30.7%) with chronic pain but not FM, and 192 who had neither pain nor FM (54.5%). Subjects were assessed for tenderness to digital pressure at 10 locations, BP cuff-evoked pain, and a single question, "I have a persistent deep aching over most of my body" (0-10). RESULTS: FM patients endorsed the single deep ache question substantially more than those with chronic pain but without FM (7.4 ± 2.9 vs 3.2 ± 3.4; P < .0001) and exhibited greater bilateral digital evoked tenderness (6.1 ± 3.1 vs 2.4 ± 2.4, P < 0.0001), and BP-evoked pressure pain (132.6 mmHg ±45.5 vs 169.2 mmHg ±48.0, P < 0.0001). However, on multivariate logistic regressions, the BP cuff-evoked pain became non-significant. On further analyses, a useful screening test was provided by: (1) pain on pinching the Achilles tendon at 4 kg/pressure over 4 seconds, and (2) and positive endorsement of the question "I have a persistent deep aching over most of my body". CONCLUSION: These results suggest that 2 tests, taking less than 1 minute, can indicate a probable diagnosis of FM in a chronic pain patient. In the case of a positive screen, a follow-up examination is required for confirmation or refutation.