Opioids for Acute Musculoskeletal Pain: A Systematic Review with Meta-Analysis.

OBJECTIVE: To evaluate the efficacy of opioids for people with acute musculoskeletal pain against placebo. STUDY DESIGN: Systematic review and meta-analyses of randomised, placebo-controlled trials of opioid analgesics for acute musculoskeletal pain in any setting. The primary outcomes were pain and disability at the immediate timepoint (< 24 h). DATA SOURCES: Multiple databases were searched from their inception to February 22nd, 2023. DATA SYNTHESIS: Continuous outcomes were converted to a 0-100 scale. Dichotomous outcomes were presented as risk differences. Risk of bias and certainty of evidence was assessed. RESULTS: We located 17 trials (1 intravenous and 16 oral route of administration). For adults, high certainty evidence from 11 comparisons shows that oral opioids provide small benefits relative to placebo in the immediate term for pain (mean difference [MD] - 8.8 95% confidence interval [CI] - 12.0 to - 5.6). For disability, the difference is uncertain (MD - 6.2, 95% CI - 17.8 to 5.4). Opioid groups were at higher risk of adverse events (MD 14.3%, 95% CI 8.3-20.4%, very low certainty). There was moderate certainty evidence of a large effect of IV morphine on sciatica pain (MD -42.5, 95% CI - 49.9 to - 35.1, n = 197, 1 study). In paediatric populations, moderate certainty evidence from 3 trials shows that oral opioids probably do not provide benefit beyond that of placebo for pain (MD 6.1, 95% CI - 1.7 to 12.8) and there was no evidence for disability. There was low certainty evidence that there may be no difference in adverse events (MD 10.4%, 95% CI - 0.6 to 21.4%). DISCUSSION: Intravenous morphine likely offers benefits, but oral opioids may not provide clinically meaningful benefits. PROSPERO REGISTRATION: CRD42021249346.

Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets.

OBJECTIVE: To develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. METHODS: We identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. RESULTS: One-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. CONCLUSION: Using a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

The relationship between frailty and social vulnerability: a systematic review.

Both frailty (reduced physiological reserve) and social vulnerability (scarcity of adequate social connections, support, or interaction) become more common as people age and are associated with adverse consequences. Analyses of the relationships between these constructs can be limited by the wide range of measures used to assess them. In this systematic review, we synthesised 130 observational studies assessing the association between frailty and social vulnerability, the bidirectional longitudinal relationships between constructs, and their joint associations with adverse health outcomes. Frailty, across assessment type, was associated with increased loneliness and social isolation, perceived inadequacy of social support, and reduced social participation. Each of these social vulnerability components was also associated with more rapid progression of frailty and lower odds of improvement compared with the absence of that social vulnerability component (eg, more rapid frailty progression in people with social isolation vs those who were not socially isolated). Combinations of frailty and social vulnerability were associated with increased mortality, decline in physical function, and cognitive impairment. Clinical and public health measures targeting frailty or social vulnerability should, therefore, account for both frailty and social vulnerability.

Evolving and evaluating the OMERACT fellows program: insights and implications from OMERACT 2023 fellows.

OBJECTIVE: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program. METHODS: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program. RESULTS: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions. CONCLUSION: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT.

Exploring the complexities of pain phenotypes: OMERACT 2023 chronic pain working group workshop.

OBJECTIVE: To educate and discuss pain mechanisms (nociceptive, neuropathic, nociplastic) illuminating its possible impact when measuring different outcomes, which may modify, confound and potentially bias the outcome measures applied across various aspects of Rheumatic Musculoskeletal Diseases (RMDs) clinical trials. METHODS: In the plenary presentations, PM lectured on different pain mechanisms and impact on disease activity assessment. Data from two data sets of RMDs patients, which assessed the prevalence and impact of nociplastic pain were presented and reviewed. Audience breakout group sessions and polling were conducted. RESULTS: Mixed pain etiologies may differentially influence disease activity assessment and therapeutic decision-making. Polling demonstrated a consensus on the need to assess different types of pain as a phenotype, as it constitutes an important contextual factor (a variable that is not an outcome of the trial, but needs to be recognized [and measured] to understand the study results), and to standardize across RMDs. CONCLUSION: There is need for a standardized pain measure that can differentiate underlying pain mechanisms.

An optimization case study for solving a transport robot scheduling problem on quantum-hybrid and quantum-inspired hardware.

We present a comprehensive case study comparing the performance of D-Waves' quantum-classical hybrid framework, Fujitsu's quantum-inspired digital annealer, and Gurobi's state-of-the-art classical solver in solving a transport robot scheduling problem. This problem originates from an industrially relevant real-world scenario. We provide three different models for our problem following different design philosophies. In our benchmark, we focus on the solution quality and end-to-end runtime of different model and solver combinations. We find promising results for the digital annealer and some opportunities for the hybrid quantum annealer in direct comparison with Gurobi. Our study provides insights into the workflow for solving an application-oriented optimization problem with different strategies, and can be useful for evaluating the strengths and weaknesses of different approaches.

General practitioners' decision-making process to prescribe pain medicines for low back pain: a qualitative study.

BACKGROUND: Pain medicines are widely prescribed by general practitioners (GPs) when managing people with low back pain (LBP), but little is known about what drives decisions to prescribe these medicines. OBJECTIVES: The aim of this study was to investigate what influences GPs' decision to prescribe pain medicines for LBP. DESIGN: Qualitative study with in-depth interviews. SETTING: Australian primary care. PARTICIPANTS: We interviewed 25 GPs practising in Australia experienced in managing LBP (mean (SD) age 53.4 (9.1) years, mean (SD) years of experience: 24.6 (9.3), 36% female). GPs were provided three vignettes describing common LBP presentations (acute exacerbation of chronic LBP, subacute sciatica and chronic LBP) and were asked to think aloud how they would manage the cases described in the vignettes. DATA ANALYSIS: We summarised GP's choices of pain medicines for each vignette using content analysis and used framework analysis to investigate factors that affected GP's decision-making. RESULTS: GPs more commonly prescribed opioid analgesics. Anticonvulsants and antidepressants were also commonly prescribed depending on the presentation described in the vignette. GP participants made decisions about what pain medicines to prescribe for LBP largely based on previous experiences, including their own personal experiences of LBP, rather than guidelines. The choice of pain medicine was influenced by a range of clinical factors, more commonly the patient's pathoanatomical diagnosis. While many adhered to principles of judicious use of pain medicines, polypharmacy scenarios were also common. Concerns about drug-seeking behaviour, adverse effects, stigma around opioid analgesics and pressure from regulators also shaped their decision-making process. CONCLUSIONS: We identified several aspects of decision-making that help explain the current profile of pain medicines prescribed for LBP by GPs. Themes identified by our study could inform future implementation strategies to improve the quality use of medicines for LBP.

Adding Brief Pain Science or Ergonomics Messages to Guideline Advice Did Not Increase Feelings of Reassurance in People With Acute Low Back Pain: A Randomized Experiment.

OBJECTIVE: To investigate the effects of adding pain science or ergonomics messages to guideline advice on feelings of reassurance and management intentions among people with acute low back pain (LBP). DESIGN: Three-arm parallel-group randomized experiment. METHODS: We recruited people with acute LBP (pain for ≤6 weeks) to participate in an online experiment. Participants were randomized at a 1:1:1 ratio to one of three groups: guideline advice alone or guideline advice with the addition of brief pain science or ergonomics messages. The intervention was delivered via prerecorded videos in all 3 groups. Coprimary outcomes were reassurance that (1) no serious condition is causing LBP and (2) continuing with daily activities is safe. Secondary outcomes were perceived risk of developing chronic pain, management intentions (bed rest, see a health professional, see a specialist, and imaging), credibility, and relevance of the advice in addressing the participant's concerns. RESULTS: Two thousand two hundred ninety-seven responses (99.3% of 2,313 randomized) were analyzed. Adding brief pain science or ergonomics messages to guideline advice did not change reassurance that LBP was not caused by serious disease. The addition of ergonomics advice provided worse reassurance that it is safe to continue with daily activities compared to guideline advice (mean difference [MD], -0.33; 95% CI: 0.13, 0.53). There was no difference between groups on management intentions. CONCLUSION: Adding pain science or ergonomics messages to guideline advice did not increase reassurance or change management intentions in people with acute LBP. Ergonomics messages may lead to reduced feelings of reassurance. J Orthop Sports Phys Ther 2023;53(12)1-11. Epub 26 September 2023. doi:10.2519/jospt.2023.12090.

Are Physician Assistants Able to Correctly Identify Prescribing Errors? A Cross-Sectional Study.

PURPOSE: (1) To describe how often physician assistant (PA) students correctly identify prescribing errors and (2) examine between-cohort differences on ability to correctly identify prescribing errors. METHODS: This was a cross-sectional study of 2 cohorts of PA students at one institution. Students were presented with 3 hypothetical prescriptions, 2 of which contained a prescribing error. For each prescription, students were asked to (1) identify whether an error occurred and (2) indicate the type of error. A simple Poisson regression model analyzed the data. RESULTS: We received responses from 130 students (72.6% response rate). Approximately 12% (12.3%, n = 16) correctly identified whether all 3 prescriptions were correct. The median number of correctly identified prescriptions was 1 (interquartile range = 1). There was not a statistically significant between-cohort difference identifying the correct number of prescriptions (ß = 0.27, P = .10). CONCLUSION: Physician assistant students' prescribing error identification was similar to previous research in medical and nursing students. Efforts to improve prescribing training are critical to ensure patient safety.

Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial.

BACKGROUND: Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain. METHODS: OPAL was a triple-blinded, placebo-controlled randomised trial that recruited adults (aged ≥18 years) presenting to one of 157 primary care or emergency department sites in Sydney, NSW, Australia, with 12 weeks or less of low back or neck pain (or both) of at least moderate pain severity. Participants were randomly assigned (1:1) using statistician-generated randomly permuted blocks to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks. The primary outcome was pain severity at 6 weeks measured with the pain severity subscale of the Brief Pain Inventory (10-point scale), analysed in all eligible participants who provided at least one post-randomisation pain score, by use of a repeated measures linear mixed model. Safety was analysed in all randomly assigned eligible participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000775516). FINDINGS: Between Feb 29, 2016, and March 10, 2022, 347 participants were recruited (174 to the opioid group and 173 to the placebo group). 170 (49%) of 346 participants were female and 176 (51%) were male. 33 (19%) of 174 participants in the opioid group and 25 (15%) of 172 in the placebo group had discontinued from the trial by week 6, due to loss to follow-up and participant withdrawals. 151 participants in the opioid group and 159 in the placebo group were included in the primary analysis. Mean pain score at 6 weeks was 2·78 (SE 0·20) in the opioid group versus 2·25 (0·19) in the placebo group (adjusted mean difference 0·53, 95% CI -0·00 to 1·07, p=0·051). 61 (35%) of 174 participants in the opioid group reported at least one adverse event versus 51 (30%) of 172 in the placebo group (p=0·30), but more people in the opioid group reported opioid-related adverse events (eg, 13 [7·5%] of 174 participants in the opioid group reported constipation vs six [3·5%] of 173 in the placebo group). INTERPRETATION: Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions. FUNDING: National Health and Medical Research Council, University of Sydney Faculty of Medicine and Health, and SafeWork SA.

Treatment burden for people experiencing homelessness with a recent non-fatal overdose: a questionnaire study.

BACKGROUND: People experiencing homelessness (PEH) who have problem drug use have complex medical and social needs, with barriers to accessing services and treatments. Their treatment burden (workload of self-management and impact on wellbeing) remains unexplored. AIM: To investigate treatment burden in PEH with a recent non-fatal overdose using a validated questionnaire, the Patient Experience with Treatment and Self-management (PETS). DESIGN AND SETTING: The PETS questionnaire was collected as part of a pilot randomised control trial (RCT) undertaken in Glasgow, Scotland; the main outcome is whether this pilot RCT should progress to a definitive RCT. METHOD: An adapted 52-item, 12-domain PETS questionnaire was used to measure treatment burden. Greater treatment burden was indicated by higher PETS scores. RESULTS: Of 128 participants, 123 completed PETS; mean age was 42.1 (standard deviation [SD] 8.4) years, 71.5% were male, and 99.2% were of White ethnicity. Most (91.2%) had >5 chronic conditions, with an average of 8.5 conditions. Mean PETS scores were highest in domains focusing on the impact of self-management on wellbeing: physical and mental exhaustion (mean 79.5, SD 3.3) and role and social activity limitations (mean 64.0, SD 3.5) Scores were higher than those observed in studies of patients who are not homeless. CONCLUSION: In a socially marginalised patient group at high risk of drug overdose, the PETS showed a very high level of treatment burden and highlights the profound impact of self-management work on wellbeing and daily activities. Treatment burden is an important person-centred outcome to help compare the effectiveness of interventions in PEH and merits inclusion in future trials as an outcome measure.

Developing a patient decision aid for Achilles tendon rupture management: a mixed-methods study.

OBJECTIVE: To develop and user-test a patient decision aid portraying the benefits and harms of non-surgical management and surgery for Achilles tendon ruptures. DESIGN: Mixed methods. SETTING: A draft decision aid was developed using guidance from a multidisciplinary steering group and existing patient decision aids. Participants were recruited through social media. PARTICIPANTS: People who have previously sustained an Achilles tendon rupture and health professionals who manage these patients. PRIMARY AND SECONDARY OUTCOMES: Semi-structured interviews and questionnaires were used to gather feedback on the decision aid from health professionals and patients who had previously suffered an Achilles tendon rupture. The feedback was used to redraft the decision aid and assess acceptability. An iterative cycle of interviews, redrafting according to feedback and further interviews was used. Interviews were analysed using reflexive thematic analysis. Questionnaire data were analysed descriptively. RESULTS: We interviewed 18 health professionals (13 physiotherapists, 3 orthopaedic surgeons, 1 chiropractor, 1 sports medicine physician) and 15 patients who had suffered an Achilles tendon rupture (median time since rupture was 12 months). Most health professionals and patients rated the aid's acceptability as good-excellent. Interviews showcased agreement among health professionals and patients on most aspects of the decision aid: introduction, treatment options, comparing benefits and harms, questions to ask health professionals and formatting. However, health professionals had differing views on details about Achilles tendon retraction distance, factors that modify the risk of harms, treatment protocols and evidence on benefits and harms. CONCLUSION: Our patient decision aid is an acceptable tool to both patients and health professionals, and our study highlights the views of key stakeholders on important information to consider when developing a patient decision aid for Achilles tendon rupture management. A randomised controlled trial evaluating the impact of this tool on the decision-making of people considering Achilles tendon surgery is warranted.

Neuropsychological deficit profiles for service members with mild traumatic brain injury.

BACKGROUND: Neuropsychological deficits are generally assessed in terms of absolute level of functioning, e.g. high average, average, low average, although there is increased interest in calculating indices of relative degree of decline, e.g. mild, moderate, severe. OBJECTIVE: To examine differences in demographic, psychiatric, and military-specific characteristics for relative degree of decline in neuropsychological profiles attributed to traumatic brain injuries (TBIs) among service members (SMs). METHODS: Data were drawn from an existing clinical database of 269 SMs who received neuropsychological evaluations for TBI (Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale, California Verbal Learning Test, Delis-Kaplan Executive Function System) at a military treatment facility between 2013 and 2018. Independent sample t-tests and one-way ANOVA tests with pairwise comparisons were performed. RESULTS: Memory and problem-solving abilities were the most and least affected domains, respectively. Greater relative decline was observed among male and White SMs and those with post-traumatic stress disorder (PTSD). By contrast, there were no differences in relative decline according to military rank or work status. CONCLUSION: Relative degree of decline after TBI among SMs is differentially impacted according to neuropsychological domain, with greater impairment among male and White SMs as well as those with PTSD.

Baseline characteristics of people experiencing homelessness with a recent drug overdose in the PHOENIx pilot randomised controlled trial.

BACKGROUND: Drug-related deaths in Scotland are the highest in Europe. Half of all deaths in people experiencing homelessness are drug related, yet we know little about the unmet health needs of people experiencing homelessness with recent non-fatal overdose, limiting a tailored practice and policy response to a public health crisis. METHODS: People experiencing homelessness with at least one non-fatal street drug overdose in the previous 6 months were recruited from 20 venues in Glasgow, Scotland, and randomised into PHOENIx plus usual care, or usual care. PHOENIx is a collaborative assertive outreach intervention by independent prescriber NHS Pharmacists and third sector homelessness workers, offering repeated integrated, holistic physical, mental and addictions health and social care support including prescribing. We describe comprehensive baseline characteristics of randomised participants. RESULTS: One hundred and twenty-eight participants had a mean age of 42 years (SD 8.4); 71% male, homelessness for a median of 24 years (IQR 12-30). One hundred and eighteen (92%) lived in large, congregate city centre temporary accommodation. A quarter (25%) were not registered with a General Practitioner. Participants had overdosed a mean of 3.2 (SD 3.2) times in the preceding 6 months, using a median of 3 (IQR 2-4) non-prescription drugs concurrently: 112 (87.5%) street valium (benzodiazepine-type new psychoactive substances); 77 (60%) heroin; and 76 (59%) cocaine. Half (50%) were injecting, 50% into their groins. 90% were receiving care from Alcohol and Drug Recovery Services (ADRS), and in addition to using street drugs, 90% received opioid substitution therapy (OST), 10% diazepam for street valium use and one participant received heroin-assisted treatment. Participants had a mean of 2.2 (SD 1.3) mental health problems and 5.4 (SD 2.5) physical health problems; 50% received treatment for physical or mental health problems. Ninety-one per cent had at least one mental health problem; 66% had no specialist mental health support. Participants were frail (70%) or pre-frail (28%), with maximal levels of psychological distress, 44% received one or no daily meal, and 58% had previously attempted suicide. CONCLUSIONS: People at high risk of drug-related death continue to overdose repeatedly despite receiving OST. High levels of frailty, multimorbidity, unsuitable accommodation and unmet mental and physical health care needs require a reorientation of services informed by evidence of effectiveness and cost-effectiveness. Trial registration UK Clinical Trials Registry identifier: ISRCTN 10585019.