Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice.

In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs.

This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public.

NCT05214144; Pre-results.

Muscle strengthening training (MST) and behavioural graded activity (BGA) show comparable effects on knee osteoarthritic (KOA) pain, but the mechanisms of action remain unclear. Both exercise-induced anti-inflammation and central sensitisation are promising pathways for pain relief in response to exercise therapy in patients with KOA: MST has the potential to decrease inflammation and BGA has the potential to decrease central sensitisation. Hence, this study aims to examine inflammation and central sensitisation as mediators for the effect of MST and/or BGA on pain in patients with KOA.

The Knee OsteoArthritis PAIN trial started on 10 January 2020 (anticipated end: April 2024). The three-arm clinical trial aims to recruit 90 KOA patients who will be randomly allocated to 12 weeks of (1) MST, (2) BGA or (3) care as usual. Assessments will be performed at baseline, 13 and 52 weeks after finishing the intervention. Outcomes, including pain (Knee injury and Osteoarthritis Outcome Score), were chosen in line with the OARSI recommendations for clinical trials of rehabilitation interventions for OA and the IMMPACT/OMERACT recommendations for the assessment of physical function in chronic pain clinical trials. Inflammation as well as features of central sensitisation (including conditioned pain modulation, offset analgesia, temporal summation of pain and event-related potentials following electrical stimulation), will be considered as treatment mediators. A multiple mediators model will be estimated with a path-analysis using structural equation models. In July 2023, all 90 KOA patients have been included and 42 participants already finished the study.

This study obtained ethics approval (B.U.N. 143201941843). Unravelling the mechanisms of action of exercise therapy in KOA will not only be extremely valuable for researchers, but also for exercise immunology and pain scientists and clinicians.

NCT04362618.

To investigate the association between older patients’ willingness to have one or more medications deprescribed and: (1) change in medications, (2) change in the appropriateness of medications and (3) implementation of prescribing recommendations generated by the electronic decision support system tested in the ‘Optimising PharmacoTherapy In the Multimorbid Elderly in Primary CAre’ (OPTICA) trial.

A longitudinal sub-study of the OPTICA trial, a cluster randomised controlled trial.

Swiss primary care settings.

Participants were aged ≥65 years, with ≥3 chronic conditions and ≥5 regular medications recruited from 43 general practitioner (GP) practices.

Patients’ willingness to have medications deprescribed was assessed using three questions from the ‘revised Patient Attitudes Towards Deprescribing’ (rPATD) questionnaire and its concerns about stopping score.

Medication-related outcomes were collected at 1 year follow-up. Aim 1 outcome: change in the number of long-term medications between baseline and 12 month follow-up. Aim 2 outcome: change in medication appropriateness (Medication Appropriateness Index). Aim 3 outcome: binary variable on whether any prescribing recommendation generated during the OPTICA medication review was implemented. We used multilevel linear regression analyses (aim 1 and aim 2) and multilevel logistic regression analyses (aim 3). Models were adjusted for sociodemographic variables and the clustering effect at GP level.

298 patients completed the rPATD, 45% were women and 78 years was the median age. A statistically significant association was found between the concerns about stopping score and the change in the number of medications over time (per 1-unit increase in the score the average number of medications use was 0.65 higher; 95% CI: 0.08 to 1.22). Other than that we did not find evidence for statistically significant associations between patients’ agreement with deprescribing and medication-related outcomes.

We did not find evidence for an association between most measures of patient agreement with deprescribing and medication-related outcomes over 1 year.

NCT03724539.

Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.

Ethical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

NCT06025942.

This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured.

Systematic review of systematic reviews (umbrella review).

Cochrane Database of Systematic Reviews.

Systematic reviews attempt to compare surgical to drug interventions.

We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review.

The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger’s test and excess significance were assessed.

Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance.

Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.

Evidence on the effectiveness of prostate cancer screening based on prostate-specific antigen is inconclusive and suggests a questionable balance between benefits and harms due to overdiagnosis, and complications from biopsies and overtreatment. However, diagnostic accuracy studies have shown that detection of clinically insignificant prostate cancer can be reduced by MRI combined with targeted biopsies.

The aim of the paper is to describe the analysis of the ProScreen randomised trial to assess the performance of the novel screening algorithm in terms of the primary outcome, prostate cancer mortality and secondary outcomes as intermediate indicators of screening benefits and harms of screening.

The trial aims to recruit at least 111 000 men to achieve sufficient statistical power for the primary outcome. Men will be allocated in a 1:3 ratio to the screening and control arms. Interim analysis is planned at 10 years of follow-up, and the final analysis at 15 years. Difference between the trial arms in prostate cancer mortality will be assessed by Gray’s test using intention-to-screen analysis of randomised men. Secondary outcomes will be the incidence of prostate cancer by disease aggressiveness, progression to advanced prostate cancer, death due to any cause and cost-effectiveness of screening.

The trial protocol was reviewed by the ethical committee of the Helsinki University Hospital (2910/2017). Results will be disseminated through publications in international peer-reviewed journals and at scientific meetings.

NCT03423303

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

This study used a prospective, longitudinal, participatory action research approach.

The study was conducted in primary care practices across Hampshire, UK.

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

NCT03096509.

To explore trauma patients’ experiences of the long-term recovery pathway during 18 months following hospital discharge.

Longitudinal qualitative study.

Thirteen trauma patients with injuries associated with pain that had been interviewed 6 weeks after discharge from Oslo University Hospital in Norway, were followed up with an interview 18 months postdischarge.

The illness trajectory framework informed the data collection, with semistructured, in-depth interviews that were analysed thematically.

Compared with the subacute phase 6 weeks postdischarge, several participants reported exacerbated mental and physical health, including increased pain during 18 months following discharge. This, andalternating periods of deteriorated health status during recovery, made the pathway unpredictable. At 18 months post-discharge, participants were coping with experiences of reduced mental and physical health and socioeconomic losses. Three main themes were identified: (1) coping with persistent pain and reduced physical function, (2) experiencing mental distress without access to mental healthcare and (3) unmet needs for follow-up care. Moreover, at 18 months postdischarge, prescribed opioids were found to be easily accessible from GPs. In addition to relieving chronic pain, motivations to use opioids were to induce sleep, reduce withdrawal symptoms and relieve mental distress.

The patients’ experiences from this study establish knowledge of several challenges in the trauma population’s recovery trajectories, which may imply that subacute health status is a poor predictor of long-term outcomes. Throughout recovery, the participants struggled with physical and mental health needs without being met by the healthcare system. Therefore, it is necessary to provide long-term follow-up of trauma patients’ health status in the specialist health service based on individual needs. Additionally, to prevent long-term opioid use beyond the subacute phase, there is a need to systematically follow-up and reassess motivations and indications for continued use throughout the recovery pathway.

This study was conducted to evaluate the ability of risk assessment to predict healthcare resource utilisation (HCRU), costs, treatments, health-related quality of life (HRQoL) and survival in patients diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH).

Retrospective observational study.

Pulmonary hypertension referral centre in the UK.

Adults diagnosed with CTEPH between 1 January 2012 and 30 June 2019 were included. Cohorts were retrospectively defined for operated patients (received pulmonary endarterectomy (PEA)) and not operated; further subgroups were defined based on risk score (low, intermediate or high risk for 1-year mortality) at diagnosis.

Demographics, clinical characteristics, comorbidities, treatment patterns, HRQoL, HCRU, costs and survival outcomes were analysed.

Overall, 683 patients were analysed (268 (39%) operated; 415 (61%) not operated). Most patients in the operated and not-operated cohorts were intermediate risk (63%; 53%) or high risk (23%; 31%) at diagnosis. Intermediate-risk and high-risk patients had higher HCRU and costs than low-risk patients. Outpatient and accident and emergency visits were lower postdiagnosis for both cohorts and all risk groups versus prediagnosis. HRQoL scores noticeably improved in the operated cohort post-PEA, and less so in the not-operated cohort at 6–18 months postdiagnosis. Survival at 5 years was 83% (operated) and 49% (not operated) and was lower for intermediate-risk and high-risk patients compared with low-risk patients.

Findings from this study support that risk assessment at diagnosis is prognostic for mortality in patients with CTEPH. Low-risk patients have better survival and HRQoL and lower HCRU and costs compared with intermediate-risk and high-risk patients.

In a small percentage of patients, pulmonary nodules found on CT scans are early lung cancers. Lung cancer detected at an early stage has a much better prognosis. The British Thoracic Society guideline on managing pulmonary nodules recommends using multivariable malignancy risk prediction models to assist in management. While these guidelines seem to be effective in clinical practice, recent data suggest that artificial intelligence (AI)-based malignant-nodule prediction solutions might outperform existing models.

This study is a prospective, observational multicentre study to assess the clinical utility of an AI-assisted CT-based lung cancer prediction tool (LCP) for managing incidental solid and part solid pulmonary nodule patients vs standard care. Two thousand patients will be recruited from 12 different UK hospitals. The primary outcome is the difference between standard care and LCP-guided care in terms of the rate of benign nodules and patients with cancer discharged straight after the assessment of the baseline CT scan. Secondary outcomes investigate adherence to clinical guidelines, other measures of changes to clinical management, patient outcomes and cost-effectiveness.

This study has been reviewed and given a favourable opinion by the South Central—Oxford C Research Ethics Committee in UK (REC reference number: 22/SC/0142).

Study results will be available publicly following peer-reviewed publication in open-access journals. A patient and public involvement group workshop is planned before the study results are available to discuss best methods to disseminate the results. Study results will also be fed back to participating organisations to inform training and procurement activities.

NCT05389774.

This study aims to evaluate the Language Access Systems Improvement (LASI) initiative’s impact on professional interpreter utilisation in primary care and to explore patient and clinician perspectives on professional interpreter use.

Multi methods: Quantitative natural experiment pre-LASI and post-LASI, qualitative semistructured interviews with clinicians and focus groups with patients post-LASI.

Large, academic primary care practice.

Cantonese, Mandarin, Spanish, English-speaking adult patients and their clinicians.

LASI initiative: Implementation of a clinician language proficiency test and simultaneous provision of on-demand access to professional interpreters via video medical interpretation.

Quantitative: Proportion of language discordant primary care visits which were professionally interpreted. Qualitative: Salient themes related to professional interpreter use and non-use.

The researchers categorised language concordance for 1475 visits with 152 unique clinicians; 698 were not fully language concordant (202 pre-LASI and 496 post-LASI). Professional interpreter utilisation increased (pre-LASI 57% vs post-LASI 66%; p=0.01); the visits with the lowest percentage of profssional interpreter use post-LASI were those in which clinicians and patients had partial language concordance. In inverse probability weighted analysis, restricting to 499 visits with strict estimated propensity score overlap (100% common support), post-LASI visits had higher odds of using a professional interpreter compared with pre-LASI visits (OR 2.39; 95% CI 1.04 to 5.48). Qualitative results demonstrate video interpretation was convenient and well liked by both clinicians and patients. Some partially bilingual clinicians reported frustration with patient refusal of interpreter services; others reported using the video interpreters as a backup during visits. Views of the care-partner role differed for clinicians and patients. Clinicians reported sometimes having family interpret out of convenience or habit, whereas patients reported wanting family members present for support and advocacy, not interpretation.

LASI increased utilisation of professional interpreters; however, this was least prominent for partially language concordant visits. Health systems wishing to implement LASI or similar interventions will need to support clinicians and patients with partial bilingual skills in their efforts to use professional interpreters.

HSRP20153367.