Maternity service reconfigurations for intrapartum and postnatal midwifery staffing shortages: modelling of low-risk births in England

Introduction
Choice of birth setting is important and it is valuable to know how reconfiguring available settings may affect midwifery staffing needs. COVID-19-related health system pressures have meant restriction of community births. We aimed to model the potential of service reconfigurations to offset midwifery staffing shortages.

Methods
We adapted the Birthrate Plus method to develop a tool that models the effects on intrapartum and postnatal midwifery staffing requirements of changing service configurations for low-risk births. We tested our tool on two hypothetical model trusts with different baseline configurations of hospital and community low-risk birth services, representing those most common in England, and applied it to scenarios with midwifery staffing shortages of 15%, 25% and 35%. In scenarios with midwifery staffing shortages above 15%, we modelled restricting community births in line with professional guidance on COVID-19 service reconfiguration. For shortages of 15%, we modelled expanding community births per the target of the Maternity Transformation programme.

Results
Expanding community births with 15% shortages required 0.0 and 0.1 whole-time equivalent more midwives in our respective trusts compared with baseline, representing 0% and 0.1% of overall staffing requirements net of shortages. Restricting home births with 25% shortages reduced midwifery staffing need by 0.1 midwives (–0.1% of staffing) and 0.3 midwives (–0.3%). Suspending community births with 35% shortages meant changes of –0.3 midwives (–0.3%) and –0.5 midwives (–0.5%) in the two trusts. Sensitivity analysis showed that our results were robust even under extreme assumptions.

Conclusion
Our model found that reconfiguring maternity services in response to shortages has a negligible effect on intrapartum and postnatal midwifery staffing needs. Given this, with lower degrees of shortage, managers can consider increasing community birth options where there is demand. In situations of severe shortage, reconfiguration cannot recoup the shortage and managers must decide how to modify service arrangements.

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Settembre 2022

Disparities and implicit bias in the management of low-risk febrile infants: a mixed methods study protocol

Introduction
The management of low-risk febrile infants presents a model population for exploring how implicit racial bias promotes inequitable emergency care for children who belong to racial, ethnic and language minority groups. Although widely used clinical standards guide the clinical care of febrile infants, there remains substantial variability in management strategies. Deviations from recommended care may be informed by the physician’s assessment of the family’s values, risk tolerance and access to supportive resources. However, in the fast-paced emergency setting, such assessments may be influenced by implicit racial bias. Despite significant research to inform the clinical care of febrile infants, there is a dearth of knowledge regarding health disparities and clinical guideline implementation. The proposed mixed methods approach will (1) quantify the extent of disparities by race, ethnicity and language proficiency and (2) explore the role of implicit bias in physician–patient communication when caring for this population.

Methods and analysis
With 42 participating sites from the Pediatric Emergency Medicine Collaborative Research Committee, we will conduct a multicenter, cross-sectional study of low-risk febrile infants treated in the emergency department (ED) and apply multivariable logistic regression to assess the association between (1) race and ethnicity and (2) limited English proficiency with the primary outcome, discharge to home without lumbar puncture or antibiotics. We will concurrently perform an interpretive study using purposive sampling to conduct individual semistructured interviews with (1) minority parents of febrile infants and (2) paediatric ED physicians. We will triangulate or compare perspectives to better elucidate disparities and bias in communication and medical decision-making.

Ethics and dissemination
This study has been approved by the University of Florida Institutional Review Board. All participating sites in the multicenter analysis will obtain local institutional review board approval. The results of this study will be presented at academic conferences and in peer-reviewed publications.

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Settembre 2022

Level of knowledge on low-dose CT lung cancer screening in Sichuan province, China: a cross-sectional study

Objectives
Low-dose CT (LDCT) can help determine the early stage of lung cancer and reduce mortality. However, knowledge of lung cancer and lung cancer screening among community residents and medical workers, and potential factors that may affect medical institutions to set up LDCT are limited.

Design
A cross-sectional study was conducted in Sichuan province, China, in 2021. Community residents, medical workers and medical institutions were randomly selected, and participants responded to related questionnaires. Knowledge of lung cancer and LDCT lung cancer screening was evaluated. Data analyses were performed using SAS V.9.4.

Results
A total of 35 692 residents, 6350 medical workers and 81 medical institutions were recruited; 4.05% of the residents were very familiar with lung cancer and 37.89% were (completely) unfamiliar. Characteristics, such as age and level of education, were significantly related to residents who were very familiar with lung cancer. Furthermore, 22.87% of the residents knew that LDCT can effectively screen for early-stage lung cancer, which was correlated with smoking (OR 1.1300; 95% CI 1.0540 to 1.2110; p=0.006) and family history of cancer (OR 1.2210; 95% CI 1.1400 to 1.3080; p

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Settembre 2022

Association between physical activity and musculoskeletal pain: an analysis of international data from the ASAP survey

Objective
To explore the association of physical activity (PA) with musculoskeletal pain (MSK pain).

Design
Cross-sectional study

Setting
14 countries (Argentina, Australia, Austria, Brazil, Chile, France, Germany, Italy, the Netherlands, Singapore, South Africa, Spain, Switzerland and the USA).

Participants
Individuals aged 18 or older.

Primary and secondary outcome measures
PA volumes were assessed with an adapted version of the Nordic Physical Activity Questionnaire-short. Prevalence of MSK pain was captured by means of a 20-item checklist of body locations. Based on the WHO recommendation on PA, participants were classified as non-compliers (0–150 min/week), compliers (150–300 min/week), double compliers (300–450 min/week), triple compliers (450–600 min/week), quadruple compliers (600–750 min/week), quintuple compliers (750–900 min/week) and top compliers (more than 900 min/week). Multivariate logistic regression was used to obtain adjusted ORs of the association between PA and MSK pain for each body location, correcting for age, sex, employment status and depression risk.

Results
A total of 13 741 participants completed the survey. Compared with non-compliers, compliers had smaller odds of MSK pain in one location (thoracic pain, OR 0.77, 95% CI 0.64 to 0.93). Double compliance was associated with reduced pain occurrence in six locations (elbow, OR 0.70, 95% CI 0.50 to 0.98; forearm, OR 0.63, 95% CI 0.40 to 0.99; wrist, OR 0.74, 95% CI 0.57 to 0.98; hand, OR 0.57, 95% CI 0.40 to 0.79; fingers, OR 0.72, 95% CI 0.52 to 0.99; abdomen, OR 0.61, 95% CI 0.41 to 0.91). Triple to top compliance was also linked with lower odds of MSK pain (five locations in triple compliance, three in quadruple compliance, two in quintuple compliance, three in top compliance), but, at the same time, presented increased odds of MSK pain in some of the other locations.

Conclusion
A dose of 300–450 min WHO-equivalent PA/week was associated with lower odds of MSK pain in six body locations. On the other hand, excessive doses of PA were associated with higher odds of pain in certain body locations.

Leggi
Settembre 2022

Determinants of responsiveness to multidisciplinary chronic pain management interventions: protocol for a systematic review and meta-analysis

Introduction
The current manuscript presents a protocol for a systematic review and meta-analysis of the evidence regarding the determinants of responsiveness to multidisciplinary management of chronic pain, with pain intensity, pain-related interference, physical functioning and health-related quality of life as the main outcomes, with consideration to multiple secondary outcomes.

Methods and analysis
To identify relevant studies, the Ovid MEDLINE, PubMed, Ovid PsycINFO, EBSCO CINAHL and Scopus databases will be searched for all studies exploring factors associated with responsiveness to multidisciplinary pain management from study inception to the present. Cohorts, case–control studies and randomised controlled trials will be included. Independent screening for eligible studies will be completed by a total of four researchers using defined criteria. Data extraction will be executed by two researchers. Study heterogeneity will be estimated using the I2 index. A meta-analysis will be performed using random effects models. Publication bias will be evaluated by means of funnel plots and Egger’s test.

Ethics and dissemination
The proposed study does not involve collection of primary data. Therefore, no ethical approval is required. The results of the systematic review and meta-analysis will be presented in a peer-reviewed journal and at conferences.

PROSPERO registration number
CRD42021236424.

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Settembre 2022

Study protocol for a phase II, double-blind, randomised controlled trial of cannabidiol (CBD) compared with placebo for reduction of brain neuroinflammation in adults with chronic low back pain

Introduction
Chronic pain is a debilitating medical problem that is difficult to treat. Neuroinflammatory pathways have emerged as a potential therapeutic target, as preclinical studies have demonstrated that glial cells and neuroglial interactions play a role in the establishment and maintenance of pain. Recently, we used positron emission tomography (PET) to demonstrate increased levels of 18 kDa translocator protein (TSPO) binding, a marker of glial activation, in patients with chronic low back pain (cLBP). Cannabidiol (CBD) is a glial inhibitor in animal models, but studies have not assessed whether CBD reduces neuroinflammation in humans. The principal aim of this trial is to evaluate whether CBD, compared with placebo, affects neuroinflammation, as measured by TSPO levels.

Methods and analysis
This is a double-blind, randomised, placebo-controlled, phase II clinical trial. Eighty adults (aged 18–75) with cLBP for >6 months will be randomised to either an FDA-approved CBD medication (Epidiolex) or matching placebo for 4 weeks using a dose-escalation design. All participants will undergo integrated PET/MRI at baseline and after 4 weeks of treatment to evaluate neuroinflammation using [11C]PBR28, a second-generation radioligand for TSPO. Our primary hypothesis is that participants randomised to CBD will demonstrate larger reductions in thalamic [11C]PBR28 signal compared with those receiving placebo. We will also assess the effect of CBD on (1) [11C]PBR28 signal from limbic regions, which our prior work has linked to depressive symptoms and (2) striatal activation in response to a reward task. Additionally, we will evaluate self-report measures of cLBP intensity and bothersomeness, depression and quality of life at baseline and 4 weeks.

Ethics and dissemination
This protocol is approved by the Massachusetts General Brigham Human Research Committee (protocol number: 2021P002617) and FDA (IND number: 143861) and registered with ClinicalTrials.gov. Results will be published in peer-reviewed journals and presented at conferences.

Trial registration number
NCT05066308; ClinicalTrials.gov.

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Settembre 2022

Occupational therapy lifestyle intervention added to multidisciplinary treatment for adults living with chronic pain: a feasibility study

Objectives
To evaluate the feasibility and outcomes of an occupational therapy lifestyle intervention for adults living with chronic pain.

Design
This one-group pre-post interventional study investigated the feasibility and outcomes of the Redesign Your Everyday Activities and Lifestyle with Occupational Therapy (REVEAL(OT)) intervention targeting meaningful activities and lifestyle.

Settings
The occupational therapist-led intervention was added to standard multidisciplinary chronic pain treatment at a Danish pain centre.

Participants
Of the 40 adult participants aged 18–64 (mean 46.6±10.9 years old, 85% females, chronic pain duration ≥3 months), there were 31 completers.

Intervention
Three feasibility rounds were carried out in 2019–2021. The intervention focused on meaningful activities, healthy eating habits and daily physical activity. Methods of didactical presentations, group discussions, personal reflection and experiential learning were used in the intervention composed both of individual and group sessions.

Outcomes
Primary outcomes were predefined research progression criteria evaluated by the red-amber-green method. Secondary outcomes measured pre-post changes in health-related quality of life and occupational performance and satisfaction.

Results
The study demonstrated satisfactory programme adherence (77.5%), patients’ self-perceived relevance (97%), timing and mode of delivery (97%) and assessment procedure acceptance (95%). No adverse events causing discontinuation occurred. Recruitment rate (n=5.7 monthly), retention (77.5%) and the fidelity of delivery (83.3%) needed improvement. We observed no improvement in health-related quality of life (mean=0.04, 95% CI –0.03 to 0.12) but positive change in occupational performance (mean=1.80, 95% CI 1.25 to 2.35) and satisfaction (mean=1.95, 95% CI 1.06 to 2.84). The participants reached the minimal clinically important difference for occupational performance (≥3.0 points in 13.8%) and satisfaction (≥3.2 points in 24.0%).

Conclusions
The REVEAL(OT) intervention was feasible to deliver and beneficial for the participants’ occupational performance and satisfaction. The interventions’ recruitment, retention and delivery strategies need optimisation in a future definitive trial.

Trial registration number
NCT03903900

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Settembre 2022

Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy

Introduction
Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination.

Methods and analysis
This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage.

Ethics and dissemination
This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media.

Trial registration number
NCT05079984.

Leggi
Settembre 2022

Low level light therapy/photobiomodulation for diabetic peripheral neuropathy: protocol of a systematic review and meta-analysis

Introduction
Diabetic peripheral neuropathy (DPN) is one of the most common complications of diabetes that strongly impact the patients’ quality of life and working ability. Evidence indicated that low level light therapy (LLLT)/photobiomodulation might be effective for neuropathy. However, the effect of LLLT for DPN is not clear. The objective of this systematic review and meta-analysis is to determine the effects and safety of LLLT/photobiomodulation for DPN, in comparison with other methods such as sham light, no treatment, other active treatment and LLLT as an additional treatment compared with another treatment alone.

Methods and analysis
We will search eight databases from their inception to the date before the review submission. Randomised controlled trials (RCTs) will be included. Two reviewers will independently extract data using a structured data extraction method and assess the risk of bias in the included studies. Data will be synthesised using standardised mean difference or risk ratio with 95% CIs for continuous and dichotomous data, respectively. The primary outcome will be change in pain and secondary outcomes will include global symptom improvement, functional impairment and disability, impairment of sensation, quality of life, nerve conduction, and adverse events. Sensitivity and subgroup analysis will be employed to explore the influence of possible clinical and methodological characteristics. Publication bias will be assessed using funnel plot. We will conduct meta-analysis with RevMan V.5.4 and evaluate quality of the evidence using GRADE approach.

Ethics and dissemination
This study does not require ethics approval. Our findings will be disseminated in the peer-reviewed publications.

PROSPERO registration number
CRD42021276056.

Leggi
Settembre 2022