Effectiveness of a coordinated support system linking public hospitals to a health coaching service compared with usual care at discharge for patients with chronic low back pain: protocol for a randomised controlled trial

Background Although many people with chronic low back pain (LBP) improve following conservative treatment, one in five will experience worsening symptoms after discharge from treatment and seek health care again. The current LBP clinical care pathway in many health services lacks a well-integrated, systematic approach to support patients to remain physically active and self-manage their symptoms following discharge from treatment. Health coaching can support people to improve physical activity levels and may potentially reduce health care utilisation for LBP. The primary aim of this study is to evaluate the effect of introducing a coordinated support system (linking hospital outpatient physiotherapy services to a public health coaching service) at discharge from LBP treatment, on the future use of hospital, medical, and health services for LBP, compared with usual care provided at discharge. Methods Three hundred and seventy-four adults with chronic non-specific LBP will be recruited from the outpatient physiotherapy departments of public hospitals in New South Wales, Australia. Participants will be individually randomised to a support system (n = 187) or usual care group (n = 187). All participants will receive usual care provided at discharge from treatment. Participants allocated to the support system will also receive up to 10 telephone-based health coaching sessions, delivered by the Get Healthy Service®, over a 6-month period. Health coaches will monitor and support participants to improve physical activity levels and achieve personal health-related goals. The primary outcome is the total number of encounters with hospital, medical, and health services for LBP, at 12 months from baseline. A within-trial economic evaluation will quantify the incremental costs and benefits of the support system from a health system perspective, to support reimbursement decision making. Discussion This study will establish the effect of a coordinated support system, introduced at discharge from treatment, on the future use of hospital, medical, and health services for LBP and various health outcomes. Conclusion Innovative community-driven solutions to support people with chronic LBP after discharge from treatment are urgently needed. Study findings will help inform health care policy and clinical practice in Australia

Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease

Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. RESULTS: At 48 months, the median reduction from baseline in the high-sensitivity C-reactive protein level was 26 percentage points greater in the group that received the 50-mg dose of canakinumab, 37 percentage points greater in the 150-mg group, and 41 percentage points greater in the 300-mg group than in the placebo group. Canakinumab did not reduce lipid levels from baseline. At a median follow-up of 3.7 years, the incidence rate for the primary end point was 4.50 events per 100 person-years in the placebo group, 4.11 events per 100 person-years in the 50-mg group, 3.86 events per 100 person-years in the 150-mg group, and 3.90 events per 100 person-years in the 300-mg group. The hazard ratios as compared with placebo were as follows: in the 50-mg group, 0.93 (95% confidence interval [CI], 0.80 to 1.07; P = 0.30); in the 150-mg group, 0.85 (95% CI, 0.74 to 0.98; P = 0.021); and in the 300-mg group, 0.86 (95% CI, 0.75 to 0.99; P = 0.031). The 150-mg dose, but not the other doses, met the prespecified multiplicity-adjusted threshold for statistical significance for the primary end point and the secondary end point that additionally included hospitalization for unstable angina that led to urgent revascularization (hazard ratio vs. placebo, 0.83; 95% CI, 0.73 to 0.95; P = 0.005). Canakinumab was associated with a higher incidence of fatal infection than was placebo. There was no significant difference in all-cause mortality (hazard ratio for all canakinumab doses vs. placebo, 0.94; 95% CI, 0.83 to 1.06; P = 0.31). Conclusions: Antiinflammatory therapy targeting the interleukin-1β innate immunity pathway with canakinumab at a dose of 150 mg every 3 months led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. (Funded by Novartis; CANTOS ClinicalTrials.gov number, NCT01327846.

Evaluating the Use of PROMs in Paediatric Orthopaedic Registries

Patient-reported outcome measures (PROMs) provide structured information on the patient’s health experience and facilitate shared clinical decision-making. Registries that collect PROMs generate essential information about the clinical course and efficacy of interventions. Whilst PROMs are increasingly being used in adult orthopaedic registries, their use in paediatric orthopaedic registries is not well known. The purpose of this systematic review was to identify the frequency and scope of registries that collect PROMs in paediatric orthopaedic patient groups. In July 2023, six databases were systematically searched to identify studies that collected PROMs using a registry amongst patients aged under 18 years with orthopaedic diagnoses. Of 3190 identified articles, 128 unique registries were identified. Three were exclusively paediatric, 27 were majority paediatric, and the remainder included a minority of paediatric patients. One hundred and twenty-eight registries collected 72 different PROMs, and 58% of these PROMs were not validated for a paediatric population. The largest group of orthopaedic registries collected PROMs on knee ligament injuries (21%). There are few reported dedicated orthopaedic registries collecting PROMs in paediatric populations. The majority of PROMs collected amongst paediatric populations by orthopaedic registries are not validated for patients under the age of 18 years. The use of non-validated PROMs by registries greatly impedes their utility and impact. Dedicated orthopaedic registries collecting paediatric-validated PROMs are needed to increase health knowledge, improve decision-making between patients and healthcare providers, and optimise orthopaedic management

Influence of family history on prognosis of spinal pain and the role of leisure time physical activity and body mass index: A prospective study using family-linkage data from the Norwegian HUNT study

Objectives To investigate the influence of parental chronic spinal pain on prognosis of chronic spinal pain in adult offspring, and whether offspring physical activity level and body mass index (BMI) modified this association. Design Prospective cohort study. Setting We used family-linked longitudinal data from the Norwegian HUNT study collected in HUNT2 (1995–1997) and HUNT3 (2006–2008). Participants A total of 1529 offspring who reported spinal pain in HUNT2 were linked with parental data and followed up in HUNT3. Outcomes We estimated relative risk (RR) with 95% CI for recovery from chronic spinal pain, and also from activity limiting spinal pain, in offspring related to chronic spinal pain in parents. We also investigated whether offspring leisure time physical activity and BMI modified these intergenerational associations in spinal pain. Results A total of 540 (35%) offspring were defined as recovered after approximately 11 years of follow-up. Offspring with both parents reporting chronic spinal pain were less likely to recover from chronic spinal pain (RR 0.83, 95% CI 0.69 to 0.99) and activity limiting spinal pain (RR 0.71, 95% CI 0.54 to 0.94), compared with offspring of parents without chronic spinal pain. Analyses stratified by BMI and physical activity showed no strong evidence of effect modification on these associations. However, offspring who were overweight/obese and with both parents reporting chronic spinal pain had particularly low probability of recovery from activity limiting spinal pain, compared with those who were normal weight and had parents without chronic spinal pain (RR 0.57, 95% CI 0.39 to 0.84). Conclusion Offspring with chronic spinal pain are less likely to recover if they have parents with chronic spinal pain, particularly if offspring are overweight/obese

Integrating Mobile-health, health coaching, and physical activity to reduce the burden of chronic low back pain trial (IMPACT): a pilot randomised controlled trial

Abstract Background Low back pain is one of the most prevalent musculoskeletal conditions and the highest contributor to disability in the world. It is characterized by frequent relapses leading to additional care-seeking. Engagement in leisure physical activity is associated with lower recurrences and better prognosis and potentially reduced care-seeking. Our aim was to investigate the feasibility and preliminary efficacy of a patient-centred physical activity intervention, supported by health coaching and mobile health, to reduce care-seeking, pain and disability in patients with chronic low back pain after treatment discharge. Methods We conducted a pilot randomised controlled trial with blinded outcome assessment. Sixty-eight participants were recruited from four public outpatient physiotherapy departments and the general community in Sydney. The intervention group received a physical activity information booklet, plus one face-to-face and 12 telephone-based health coaching sessions. The intervention was supported by an internet-based application and an activity tracker (Fitbit). Control group (standard care) received the physical activity information booklet and advice to stay active. Feasibility measures included recruitment rate, intervention compliance, data completeness, and participant satisfaction. Primary outcomes were care-seeking, pain levels and activity limitation. Outcomes were assessed at baseline, 6-month follow-up and weekly for 6 months. Results Ninety potential participants were invited over 15 months, with 68 agreeing to take part (75%). Overall, 903 weekly questionnaires were answered by participants from a total of 1107 sent (89%). Participants were largely satisfied with the intervention (mean = 8.7 out of 10 on satisfaction scale). Intervention group participants had a 38% reduced rate of care-seeking (Incidence Rate Ratio (IRR): 0.62, 95% CI: 0.32 to 1.18, p = 0.14, using multilevel mixed-effects Poisson regression analysis) compared to standard care, although none of the estimates was statistically significant. No between groups differences were found for pain levels or activity limitation. Conclusion The health coaching physical activity approach trialed here is feasible and well accepted by participants and may reduce care-seeking in patients with low back pain after treatment discharge, although further evaluation with an adequately powered trial is needed. Trial registration Australian and New Zealand Trial Registry ACTRN12615000189527. Registered prospectively on 26–02–2015

Impact of the COVID-19 pandemic on patients with paediatric cancer in low-income, middle-income and high-income countries: a multicentre, international, observational cohort study

OBJECTIVES: Paediatric cancer is a leading cause of death for children. Children in low-income and middle-income countries (LMICs) were four times more likely to die than children in high-income countries (HICs). This study aimed to test the hypothesis that the COVID-19 pandemic had affected the delivery of healthcare services worldwide, and exacerbated the disparity in paediatric cancer outcomes between LMICs and HICs. DESIGN: A multicentre, international, collaborative cohort study. SETTING: 91 hospitals and cancer centres in 39 countries providing cancer treatment to paediatric patients between March and December 2020. PARTICIPANTS: Patients were included if they were under the age of 18 years, and newly diagnosed with or undergoing active cancer treatment for Acute lymphoblastic leukaemia, non-Hodgkin's lymphoma, Hodgkin lymphoma, Wilms' tumour, sarcoma, retinoblastoma, gliomas, medulloblastomas or neuroblastomas, in keeping with the WHO Global Initiative for Childhood Cancer. MAIN OUTCOME MEASURE: All-cause mortality at 30 days and 90 days. RESULTS: 1660 patients were recruited. 219 children had changes to their treatment due to the pandemic. Patients in LMICs were primarily affected (n=182/219, 83.1%). Relative to patients with paediatric cancer in HICs, patients with paediatric cancer in LMICs had 12.1 (95% CI 2.93 to 50.3) and 7.9 (95% CI 3.2 to 19.7) times the odds of death at 30 days and 90 days, respectively, after presentation during the COVID-19 pandemic (p<0.001). After adjusting for confounders, patients with paediatric cancer in LMICs had 15.6 (95% CI 3.7 to 65.8) times the odds of death at 30 days (p<0.001). CONCLUSIONS: The COVID-19 pandemic has affected paediatric oncology service provision. It has disproportionately affected patients in LMICs, highlighting and compounding existing disparities in healthcare systems globally that need addressing urgently. However, many patients with paediatric cancer continued to receive their normal standard of care. This speaks to the adaptability and resilience of healthcare systems and healthcare workers globally

Characterisation of microbial attack on archaeological bone

As part of an EU funded project to investigate the factors influencing bone preservation in the archaeological record, more than 250 bones from 41 archaeological sites in five countries spanning four climatic regions were studied for diagenetic alteration. Sites were selected to cover a range of environmental conditions and archaeological contexts. Microscopic and physical (mercury intrusion porosimetry) analyses of these bones revealed that the majority (68%) had suffered microbial attack. Furthermore, significant differences were found between animal and human bone in both the state of preservation and the type of microbial attack present. These differences in preservation might result from differences in early taphonomy of the bones. © 2003 Elsevier Science Ltd. All rights reserved