Pain neuroscience education, blended exercises and booster sessions as an effective therapy for pain, functional and psychological factors in patients with knee osteoarthritis: a study protocol for a single-blind randomised controlled trial with 22 factorial design during 6-month follow-up

Introduction
This study aims to investigate whether a pain neuroscience education (PNE) combined with a blended exercises programme including aerobic, resistance, neuromuscular, breathing, stretching and balance exercises and diet education provides greater pain relief and improvement in functional and psychological factors than PNE and blended exercises alone and whether ‘exercise booster sessions (EBS)’ approach may improve outcomes and increase adherence in patients with knee osteoarthritis (KOA) (by telerehabilitation (TR)).

Methods and analysis
In this single-blind randomised controlled trial, 129 patients (both genders; age >40) diagnosed with KOA will be randomly assigned to one of the 22 treatment combinations as: (1) blended exercises alone (36 sessions over 12 weeks), (2) PNE alone (three sessions over 2 weeks), (3) combination of PNE with blended exercises (exercise three times a week for 12 weeks combined with three sessions of PNE) and (4) a control group. Outcome assessors will be blinded towards group allocation. The primary outcome variables are the visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis (WOMAC) score. Secondary outcomes include Pain Self-Efficacy Questionnaire (PSEQ), Depression, Anxiety and Stress Scale (DASS), Tampa Scale for Kinesiophobia (TSK), Short Falls Efficacy Scale International (FES-I), Pain Catastrophising Scale (PCS), Short Form Health Survey (SF-12) and Exercise Adherence Rating Scale (EARS), 30 s sit-to-stand test (30CST), Timed Up and Go (TUG), lower limbs’ muscle strength and lower limb joints’ active range of motion (AROM) will be performed at baseline, 3 and 6 months’ postinterventions. The primary and secondary outcomes will assess at baseline, 3 months and 6 months postinterventions.
The findings will be useful in establishing an effective treatment strategy covering multiple aspects behind KOA. The study protocol is conducted in clinical settings, thereby enhancing the possibility of future implementation of the treatments in the healthcare systems and self-care management. Results in comparison between groups will help to clarify the most effective of mixed-method TR (blended exercise, PNE, EBS with diet education) on more improvement in pain, functional and psychological factors in patients with KOA. This study will combine some of the most critical interventions, to be able to introduce a ‘gold standard therapy’ in the treatment of KOA.

Ethics and dissemination
The trial has been approved by the ethics committee for research involving human subjects of the Sport Sciences Research Institute of Iran (IR.SSRC.REC.1401.021). The study findings will be published in international peer-reviewed journals.

Trial registration number
IRCTID: IRCT20220510054814N1.

Leggi
Maggio 2023

Multimodal individualised intervention to prevent functional decline after stroke: protocol of a randomised controlled trial on long-term follow-up after stroke (LAST-long)

Introduction
Multimodal interventions have emerged as new approaches to provide more targeted intervention to reduce functional decline after stroke. Still, the evidence is contradictory. The main objective of the Life After Stroke (LAST)-long trial is to investigate if monthly meetings with a stroke coordinator who offers a multimodal approach to long-term follow-up can prevent functional decline after stroke.

Methods and analysis
LAST-long is a pragmatic single-blinded, parallel-group randomised controlled trial recruiting participants living in six different municipalities, admitted to four hospitals in Norway. The patients are screened for inclusion and recruited into the trial 3 months after stroke. A total of 300 patients fulfilling the inclusion criteria will be randomised to an intervention group receiving monthly follow-up by a community-based stroke coordinator who identifies the participants’ individual risk profile and sets up an action plan based on individual goals, or to a control group receiving standard care. All participants undergo blinded assessments at 6-month, 12-month and 18-month follow-up. Modified Rankin Scale at 18 months is primary outcome. Secondary outcomes are results of blood tests, blood pressure, adherence to secondary prophylaxis, measures of activities of daily living, cognitive function, physical function, physical activity, patient reported outcome measures, caregiver’s burden, the use and costs of health services, safety measures and measures of adherence to the intervention. Mixed models will be used to evaluate differences between the intervention and control group for all endpoints across the four time points, with treatment group, time as categorical covariates and their interaction as fixed effects, and patient as random effect.

Ethics and dissemination
This trial was approved by the Regional Committee of Medical and Health Research Ethics, REC no. 2018/1809. The main results will be published in international peer-reviewed open access scientific journals and to policy-makers and end users in relevant channels.

Trial registration number
ClincalTrials.gov Identifier: NCT03859063, registered on 1 March 2019.

Leggi
Maggio 2023

Does recommended mental health follow-up care occur after postdeployment screening in the Canadian Armed Forces? A retrospective cohort study

Objective
To determine Canadian service members’ level of adherence to a recommendation for mental health services follow-up that was assigned by clinicians during postdeployment screening.

Design
Retrospective cohort study.

Setting
Canadian military population.

Participants
The cohort consisted of personnel (n=28 460) with a deployment within the 2009–2014 time frame. A stratified random sample (n=3004) was selected for medical chart review. However, we restricted our analysis to individuals whose completed screening resulted in a recommendation for mental health services follow-up (sample n=316 (weighted n=2034) or 11.2% of screenings.

Interventions
Postdeployment health screening.

Primary outcome measure
The outcome was adherence to a screening-indicated mental health services follow-up recommendation, assessed within 90 days, a preferred delay, and within 365 days, a delay considered partially associated with the screening recommendation.

Results
Adherence within 90 days of screening was 71.1% (95% CI 59.7% to 82.5%) for individuals with ‘major’ mental health concerns, 36.1% (95% CI 23.9% to 48.4%) for those with ‘minor’ mental health concerns, and 46.8% (95% CI 18.6% to 75.0%), for those with psychosocial mental health concerns; the respective 365-day adherence fractions were 85.3% (95% CI 76.1% to 94.5%), 55.7% (95% CI 42.0% to 69.4%) and 48.6% (95% CI 20.4% to 76.9%). Logistic regression indicated that a 90-day adherence among those with a ‘major’ mental health concern was higher among those screening after 2012 (adjusted OR (AOR) 5.45 (95% CI 1.08 to 27.45)) and lower, with marginal significance, among those with deployment durations greater than 180 days (AOR 0.35 (95% CI 0.11 to 1.06)).

Conclusions
On an individual level, screening has the potential to identify when a care need is present and a follow-up assessment can be recommended; however, we found that adherence to this recommendation is not absolute, suggesting that administrative checks and possibly, process refinements would be beneficial to ensure that care-seeking barriers are minimised.

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Maggio 2023

Reversibility of Diffusion-Weighted Imaging Lesions in Patients With Ischemic Stroke in the WAKE-UP Trial

Stroke, Ahead of Print. BACKGROUND:Reversibility of the diffusion-weighted imaging (DWI) lesion means that not all of the DWI lesion represents permanently injured tissue. We investigated DWI reversibility and the association with thrombolysis, reperfusion and functional outcome in patients from the WAKE-UP trial (Efficacy and Safety of Magnetic Resonance Imaging–Based Thrombolysis in Wake-Up Stroke).METHODS:In this retrospective analysis of WAKE-UP, a randomized controlled trial (RCT) between September 2012 and June 2017 in Belgium, Denmark, France, Germany, Spain and United Kingdom, a convolutional neural network segmented the DWI lesions (b=1000 s/mm2) at baseline and follow-up (24 hours). We calculated absolute and relative DWI reversibility in 2 ways: first, a volumetric (baseline volume−24-hour volume >0) and second, a voxel-based (part of baseline lesion not overlapping with 24-hour lesion) approach. We additionally defined relative voxel-based DWI-reversibility >50% to account for coregistration inaccuracies. We calculated the odds ratio for reversibility according to treatment arm. We analyzed the association of reversibility with excellent functional outcome (modified Rankin Scale score of 0–1), in a multivariable model.RESULTS:In 363 patients, the median DWI volume was 3 (1–10) mL at baseline and 6 (2–20) mL at follow-up. Volumetric DWI reversibility was present in 19% (69/363) with a median absolute reversible volume of 1 mL (0–2) or 28% (14–50) relatively. Voxel-based DWI reversibility was present in 358/363 (99%) with a median absolute volume of 1 mL (0–2), or 22% (9–38) relatively. In 18% of the patients (67/363), relative voxel-based DWI reversibility >50% was present. Volumetric DWI reversibility and relative voxel-based DWI reversibility >50% was more frequent in patients treated with alteplase versus placebo (OR, 1.86 [95% CI, 1.09–3.17] and OR, 2.03 [95% CI, 1.18–3.50], respectively). Relative voxel-based DWI reversibility >50% was associated with excellent functional outcome (OR, 2.30 [95% CI, 1.17–4.51]).CONCLUSIONS:Small absolute volumes of DWI reversibility were present in a large proportion of randomized patients in the WAKE-UP trial. Reversibility was more often present after thrombolysis.

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Maggio 2023

Picking up microbial clues in early-onset colorectal cancer

The recognition that early-onset colorectal cancer (EO-CRC) rates are rising has sent shockwaves through the field of gastroenterology in recent years. Cases of celebrities affected by EO-CRC have similarly shocked the broader public and have drawn attention to the importance of screening. After television anchor Katie Couric’s husband died of EO-CRC at age 42, she underwent an on-air colonoscopy in 2000, which led to a significant increase in screening colonoscopy rates that was dubbed ‘the Katie Couric effect’.1 More recently, the acclaimed actor Chadwick Boseman tragically died of EO-CRC at age 43, again increasing awareness and discussion of the need for screening. Colonoscopy is an excellent screening tool but of limited utility to individuals younger than the recommended age of initiation of screening, which is 50 in many parts of the world.2 While overall CRC rates have progressively decreased over time due to systematic screening,…

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Maggio 2023

Incidence and predictors of perioperative mortality in a low-resource country, Ethiopia: a prospective follow-up study

Objective
This study aimed to assess the incidence and identify predictors of perioperative mortality among the adult age group at Tibebe Ghion Specialised Hospital.

Design
A single-centre prospective follow-up study.

Setting
A tertiary hospital in North West Ethiopia.

Participants
We enrolled 2530 participants who underwent surgery in the current study. All adults aged 18 and above were included except those with no telephone.

Primary outcome measures
The primary outcome was time to death measured in days from immediate postoperative time up to the 28th day following surgery.

Result
A total of 2530 surgical cases were followed for 67 145 person-days. There were 92 deaths, with an incidence rate of 1.37 (95% CI 1.11 to 1.68) deaths per 1000 person-day observations. Regional anaesthesia was significantly associated with lower postoperative mortality (adjusted hazard ratio (AHR) 0.18, 95% CI 0.05 to 0.62). Patients aged ≥65 years (AHR 3.04, 95% CI 1.65 to 5.75), American Society of Anesthesiologist (ASA) physical status III (AHR 2.41, 95% CI 1.1.13 to 5.16) and IV (AHR 2.74, 95% CI 1.08 to 6.92), emergency surgery (AHR 1.85, 95% CI 1.02 to 3.36) and preoperative oxygen saturation

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Maggio 2023

Effectiveness of warm-up interventions on work-related musculoskeletal disorders, physical and psychosocial functions among workers: a systematic review

Objectives
The aim of this systematic review was to identify from published literature the available evidence regarding the effects of warm-up intervention implemented in the workplace on work -related musculoskeletal disorders (WMSDs) and physical and psychosocial functions.

Design
Systematic review.

Data sources
The following four electronic databases were searched (from inception onwards to October 2022): Cochrane Central Register of Controlled Trials (CENTRAL), PubMed (Medline), Web of Science and Physiotherapy Evidence Database (PEDro).

Eligibility criteria
Randomised and non-randomised controlled studies were included in this review. Interventions should include a warm-up physical intervention in real-workplaces.

Data extraction and synthesis
The primary outcomes were pain, discomfort, fatigue and physical functions. This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and used the Grading of Recommendations, Assessment, Development and Evaluation evidence synthesis. To assess the risk of bias, the Cochrane ROB2 was used for randomised controlled trial (RCT) and the Risk Of Bias In Non-randomised Studies-of Interventions was used for the non-RCT studies.

Results
Three studies met the inclusion criterion, one cluster RCT and two non-RCTs. There was an important heterogeneity in the included studies principally concerning population and warm-up intervention exercises. There were important risks of bias in the four selected studies, due to blinding and confounding factors. Overall certainty of evidence was very low.

Conclusion
Due to the poor methodological quality of studies and conflicting results, there was no evidence supporting the use of warm-up to prevent WMSDs in the workplace. The present findings highlighted the need of good quality studies targeting the effects of warm-up intervention to prevent WMSDs.

PROSPERO registration number
CRD42019137211.

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Maggio 2023

Protocol for a bandit-based response adaptive trial to evaluate the effectiveness of brief self-guided digital interventions for reducing psychological distress in university students: the Vibe Up study

Introduction
Meta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity.

Methods and analysis
The Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions.

Ethics and dissemination
Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP).

Trial registration number
ACTRN12621001223820.

Leggi
Aprile 2023

Psychological recovery and well-being of spouses of patients with prostate cancer 5 years after primary treatment in Finland: a follow-up survey

Objective and setting
To study longitudinally cancer-related experiences of spouses of patients with prostate cancer and the predictors of their psychological recovery and quality of life (QOL) by following the participants of our previous survey at primary cancer treatment in a university hospital.

Design
A 5-year longitudinal cohort design.

Participants and procedure
A follow-up questionnaire was mailed to the female spouses/partners who participated in our previous survey (n=104). We quantitatively explored the spouses’ prostate cancer-related experiences since the previous survey and measured their current psychological symptom distress and well-being/QOL. Seventy-seven (74%) of the initial participants responded.

Outcomes
The main outcome measures were the spouses’ psychological recovery (psychological symptoms at the initial survey vs currently) and well-being/QOL (depressive symptoms, domains of QOL) at 5 years. We analysed their predictors with regression analyses.

Results
The treatment had been prostatectomy in 70% of the patients. Psychological distress had alleviated in 76% of spouses (p

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Aprile 2023

Long-term psychosocial consequences of false-positive screening mammography: a cohort study with follow-up of 12-14 years in Denmark

Objective
To compare the long-term psychosocial consequences of mammography screening among women with breast cancer, normal results and false-positive results.

Design
A matched cohort study with follow-up of 12–14 years.

Setting
Denmark from 2004 to 2019.

Participants
1170 women who participated in the Danish mammography screening programme in 2004–2005.

Intervention
Mammography screening for women aged 50–69 years.

Outcome measures
We assessed the psychosocial consequences with the Consequences Of Screening–Breast Cancer, a condition-specific questionnaire that is psychometrically validated and encompasses 14 psychosocial dimensions.

Results
Across all 14 psychosocial outcomes, women with false-positive results averagely reported higher psychosocial consequences compared with women with normal findings. Mean differences were statistically insignificant except for the existential values scale: 0.61 (95% CI (0.15 to 1.06), p=0.009). Additionally, women with false-positive results and women diagnosed with breast cancer were affected in a dose–response manner, where women diagnosed with breast cancer were more affected than women with false-positive results.

Conclusion
Our study suggests that a false-positive mammogram is associated with increased psychosocial consequences 12–14 years after the screening. This study adds to the harms of mammography screening. The findings should be used to inform decision-making among the invited women and political and governmental decisions about mammography screening programmes.

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Aprile 2023

Implementing SARS-CoV-2 antigen testing scale-up in Rwanda: retrospective analysis of national programme data and qualitative findings

Objectives
Reverse transcriptase PCR is the most sensitive test for SARS-CoV-2 diagnosis. However, the scale-up of these tests in low-income and middle-income countries (LMICs) has been limited due to infrastructure and cost. Antigen rapid diagnostic tests are an alternative option for diagnosing active infection that may allow for faster, easier, less expensive and more widespread testing. We compared the implementation of antigen and PCR testing programmes in Rwanda.

Design
We retrospectively reviewed routinely collected PCR and antigen testing data for all reported tests conducted nationally. We administered semiquantitative surveys to healthcare workers (HCWs) involved in COVID-19 testing and care and clients receiving antigen testing.

Setting
Rwanda, November 2020–July 2021.

Participants
National SARS-CoV-2 testing data; 49 HCWs involved in COVID-19 testing and care; 145 clients receiving antigen testing.

Interventions
None (retrospective analysis of programme data).

Primary and secondary outcome measures
Test volumes, turnaround times, feasibility and acceptability of antigen testing.

Results
Data from 906 204 antigen tests and 445 235 PCR tests were included. Antigen testing increased test availability and case identification compared with PCR and had a median results return time of 0 days (IQR: 0–0). In contrast, PCR testing time ranged from 1 to 18 days depending on the sample collection site/district. Both HCWs and clients indicated that antigen testing was feasible and acceptable. Some HCWs identified stockouts and limited healthcare staff as challenges.

Conclusions
Antigen testing facilitated rapid expansion and decentralisation of SARS-CoV-2 testing across lower tier facilities in Rwanda, contributed to increased case identification, reduced test processing times, and was determined to be feasible and acceptable to clients and providers. Antigen testing will be an essential component of SARS-CoV-2 test and treat programmes in LMICs.

Leggi
Aprile 2023