Comparative effect of different mindfulness-based intervention types and deliveries on depression in patients with breast cancer: a protocol for a systematic review and network meta-analysis.

INTRODUCTION: Breast cancer has become the most common cancer worldwide. Various types of mindfulness-based interventions (e.g., mindfulness-based cognitive therapy, mindfulness-based stress reduction) have been conducted in different delivery methods (including face to face and internet delivered) to help patients with breast cancer mitigate their depression. However, at present, there are no studies that compare the effectiveness of all these types and deliveries of mindfulness-based interventions. Therefore, this protocol aims to conduct a systematic review and network meta-analysis to assess the effectiveness of various types and deliveries of mindfulness-based interventions in mitigating depression in patients with breast cancer. METHODS: This protocol is according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The electronic databases, including PubMed, Web of Science, the Cochrane Library, Embase, Google Scholar, The China National Knowledge Infrastructure and OpenGrey, will be comprehensively retrieved for related randomised controlled trials (RCTs) from inception to December 2023. Two reviewers will independently assess the risk of bias using the Cochrane Risk of Bias Tool for Randomised Trials 2.0 (RoB 2.0). The network meta-analysis will be performed using the STATA V.16.0, and the assessment of heterogeneity, inconsistency, publication bias, evidence quality, subgroup analyses and sensitivity analyses will be conducted. ETHICS AND DISSEMINATION: This protocol does not require approval from an ethics committee as it is based on previous research findings. The results will be disseminated via peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42024495996.

Experiences of children with bronchiectasis and their parents in a novel play-based therapeutic exercise programme: a qualitative analysis.

OBJECTIVES: To explore the experiences and perceptions of children with bronchiectasis and their parents regarding an 8-week play-based therapeutic exercise programme. DESIGN: Qualitative study with inductive content analysis. SETTING: Individual semistructured interviews were conducted. Interview recordings were transcribed verbatim, and coding was guided by the content. Content categories were established via consensus moderation. PARTICIPANTS: 10 parents and 10 children with bronchiectasis aged 5-12 years. RESULTS: From the perspective of children, the most important components of the programme were fun with friends and being active at home as a family. Parents valued the community-based sessions, perceived the programme to be engaging and motivating. Parents perceived improvements in their child's endurance, coordination and physical activity level. They described the home programme as fun but noted that finding time was difficult. Both parents and children thought that in-person exercise sessions would be better than exercise sessions delivered online. CONCLUSIONS: Children who participated in the play-based exercise programme, found it fun, motivating and accessible. Parents perceived positive impacts on fitness, coordination and physical activity. TRIAL REGISTRATION NUMBER: The trial was registered with, Australian and New Zealand Clinical Trials Register (ACTRN12619001008112).

Palliative Rehabilitation in Patients with Cancer: Definitions, Structures, Processes and Outcomes.

PURPOSEOF REVIEW: This review examines the literature on palliative rehabilitation for patients with advanced cancer, focusing on definitions, structures, processes, and outcomes. RECENT FINDINGS: Palliative cancer rehabilitation targets comfort and functional improvement for patients with limited rehabilitation potential across various settings. The palliative cancer rehabilitation team, typically led by a physician, coordinates symptom management and referrals to rehabilitation and other allied healthcare professionals as needed. The outcomes of palliative cancer rehabilitation varied widely by goals, settings, and interventions. Studies in hospice settings generally reported improved symptom control; inpatient rehabilitation had mixed functional outcomes; and outpatient palliative rehabilitation may contribute to enhanced functional and symptom outcomes, especially among patients with higher baseline function. Palliative cancer rehabilitation emphasizes a collaborative approach that integrates palliative care with rehabilitation interventions, aiming to enhance quality of life and address diverse patient needs. Further research and standardization are necessary to realize its full potential.

Fatigue and physical activity in post-CABG patients: the parallel mediation model of kinesiophobia and self-efficacy : a prospective multicentre and cross-sectional study in China.

OBJECTIVES: The objective of this study was to investigate how kinesiophobia and self-efficacy explain the relationship between fatigue and physical activity (PA) in post-coronary artery bypass grafting (post-CABG) patients over the age of 45. DESIGN: A prospective multicentre and cross-sectional study. SETTING: The study was conducted in four public tertiary hospitals in China. PARTICIPANTS: A total of 1278 patients who underwent CABG surgery were selected from the case pool, with their surgeries occurring between 3 and 19 months prior to selection. Out of 1038 patients who met the inclusion criteria and were invited to participate in the study, 759 patients agreed to participate and complete the questionnaire. Ultimately, 376 questionnaires were deemed eligible and included in the analysis. PRIMARY AND SECONDARY OUTCOME MEASURES: The questionnaire included the following scales: the Chinese version of the Multidimensional Fatigue Inventory (MFI-20), the Tampa Scale for Kinesiophobia Heart (TSK-SV Heart), the Cardiac Exercise Self-Efficacy Instrument (CESEI) and the International Physical Activity Questionnaire-Long (IPAQ-L). A serial mediation model was used to test whether the association between fatigue and PA was mediated by kinesiophobia and self-efficacy, in the overall sample and subsamples defined by age. RESULTS: The results confirmed that fatigue was directly (95% CI (-5.73 to -3.02)) associated with PA. Higher kinesiophobia (95% CI (-0.16 to -0.05)) or lower PA self-efficacy (95% CI (-0.11 to -0.02)) were parallel pathways through which higher fatigue impediment reduced PA levels. In both subgroups, the street pathways of kinesiophobia and self-efficacy were altered. In the age, 45-60 years group, kinesiophobia (Boot 95% CI (-0.19 to-0.05)) was a mediator of fatigue on PA levels, while in the 61-75 years age group, self-efficacy (Boot 95% CI (-0.17 to -0.04)) was a mediator of fatigue on PA levels. CONCLUSIONS: A clear relationship between fatigue and PA was mediated by both kinesiophobia and self-efficacy. Furthermore, our findings highlight the importance of adapting the intervention according to the age of the patients, mainly by reducing patients' kinesiophobia in patients aged 45-60 years and increasing patients' self-efficacy in patients aged 61-75 years. It may be possible to improve PA levels in post-CABG patients over 45 years of age by eliminating kinesiophobia and increasing self-efficacy.

Photobiomodulation therapy for chronic knee pain in obese patients in pre-rehabilitation for bariatric surgery: randomised, placebo-controlled, double-blinded, clinical trial protocol.

INTRODUCTION: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery. METHODS AND ANALYSES: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways. ETHICS AND DISSEMINATION: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.

Evaluation of the effect of low-intensity pulsed ultrasound in pain and dysfunction for knee osteoarthritis: a double-blind, randomised controlled trial protocol.

INTRODUCTION: Osteoarthritis (OA) is the most common joint disorder among musculoskeletal conditions. Non-surgical treatment is the standard therapy for knee OA (KOA). Ultrasound therapy is recommended for alleviating pain and dysfunction from OA, but high-quality scientific evidence for its effectiveness in OA treatment is still lacking.Therefore, we want to analyse whether combining conventional physical therapy with low-intensity pulsed ultrasound (LIPUS) can enhance the efficacy of conventional therapy, thus improving symptoms in patients with KOA. METHODS AND ANALYSIS: This randomised controlled trial aims to recruit 200 patients diagnosed with KOA, aged 38 years or above, who meet the clinical diagnostic criteria for KOA. Patients will be randomly assigned in a 1:1 ratio to either a LIPUS treatment group or a sham ultrasound treatment control group. The 2-week treatment will consist of five sessions per week and evaluations will take place at baseline, on the day of the last intervention and 1 month post intervention. The main outcome measures will be the Western Ontario and McMaster Universities' scores. Secondary outcome indicators will be the Numerical Pain Rating Scale, the Lequesne scale, the time up and go test and the range of motion of the knee. An intention-to-treat analysis will be performed for dropouts and missing data. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of Shengjing Hospital of China Medical University (2023PS592K). Findings will be disseminated to participants and made available to peer-reviewed journals. TRIAL REGISTRATION NUMBER: The trial was registered on the Chinese Clinical Trial Registry platform (chictr.org.cn) on 22 March 2023, with the registration ID ChiCTR2300069643.

Is home-based, virtually delivered, group exercise feasible and acceptable for older patients with hepatocellular carcinoma? A non-randomised feasibility study (TELEX-Liver Cancer).

OBJECTIVES: The study aimed to assess the feasibility, acceptability and safety of delivering a home-based telehealth exercise intervention to older patients with hepatocellular carcinoma (HCC). DESIGN: Non-randomised feasibility study. SETTING: Patients were recruited from UK outpatient liver cancer clinics. PARTICIPANTS: Patients were aged ≥60 years with HCC, with post-treatment imaging reporting a complete response, partial response or stable disease. INTERVENTION AND DATA COLLECTION: Patients were invited to attend synchronous online exercise sessions, twice weekly for 10 weeks. Physical function and patient-reported outcomes were assessed pre-intervention and post-intervention. Qualitative data were collected via semistructured interviews after intervention completion. PRIMARY OUTCOME MEASURES: Recruitment, retention, exercise adherence and safety. RESULTS: 40 patients were invited to participate and 19 (mean age 74 years) provided consent (recruitment rate 48%). Patients completed 76% of planned exercise sessions and 79% returned to the clinic for follow-up. Hand grip strength (95% CI 1.0 to 5.6), Liver Frailty Index (95% CI -0.46 to -0.23) and time taken to perform five sit-to-stands (95% CI -3.2 to -1.2) improved from pre-intervention to post-intervention. Patients reported that concerns they had relating to their cancer had improved following the intervention (95% CI 0.30 to 5.85). No adverse events occurred during exercise sessions.Qualitative data highlighted the importance of an instructor in real time to ensure that the sessions were achievable, tailored and well balanced, which helped to foster motivation and commitment within the group. Patients reported enjoying the exercise intervention, including the benefits of peer support and highlighted perceived benefits to both their physical and mental health. Patients felt that the online sessions overcame some of the barriers to exercise participation and preferred attending virtual sessions over face-to-face classes. CONCLUSIONS: It is feasible, acceptable and safe to deliver supervised group exercise via videoconferencing to patients with HCC in their own homes. These findings will inform the design of a future, adequately powered randomised controlled trial to evaluate the efficacy of the intervention. TRIAL REGISTRATION NUMBER: ISRCTN14411809.

Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2): a study protocol.

INTRODUCTION: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective. METHODS AND ANALYSIS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. TRIAL REGISTRATION NUMBER: ISRCTN87336549.

Management and prevention strategies for osteoarthritis in tactical athletes.

Osteoarthritis (OA) affects over 600 million worldwide, is one of the leading causes of disability and has a significant burden of morbidity. There are multiple modifiable and non-modifiable risk factors, with professional and tactical athletes at higher risk than other occupational groups. Without specific anti-OA pharmacological agents, clinicians may feel helpless. However, primary, secondary and tertiary preventative strategies can slow or prevent OA development or progression. There are many modifiable risk factors which, if targeted, can contribute to an improvement in the experience of people living with OA. Radiological features of OA may signify the presence of 'the disease'; however, the pain and symptoms experienced may be more accurately described as 'the illness'. Targeting both, using a combination of the medical and biopsychosocial models of care, will improve the overall experience.This paper outlines some easily adoptable general and specific strategies to help manage this common and disabling condition, focused on improving joint healthspan, not just joint lifespan. They include education and communication, empowering individuals to confidently self-manage their condition with access to healthcare resources when required. A holistic package, including support for sleep, diet and weight loss, physical activity and specific home-based exercise routines, with appropriate analgesia when needed, can all improve OA illness and potentially slow OA disease development or progression. Clinicians should feel confident that there are many opportunities to intervene and mitigate the risk factors of OA, using various preventative strategies, especially in a young, physically active population with functional occupational or recreational demands.

Impact of physiotherapy access on health-related quality of life following hip fracture: an observational study on 30 752 hip fractures from the Norwegian Hip Fracture Register 2014-2018.

OBJECTIVES: The main objective of this study was to investigate the characteristics of patients receiving private community physiotherapy (PT) the first year after a hip fracture. Second, to determine whether utilisation of PT could improve health-related quality of life (HRQoL). METHODS: In an observational cohort study, 30 752 hip fractures from the Norwegian Hip Fracture Register were linked with data from Statistics Norway and the Norwegian Control and Payment of Health Reimbursements Database. Association between covariates and utilisation of PT in the first year after fracture, the association between covariates and EQ-5D index score and the probability of experiencing 'no problems' in the five dimensions of the EQ-5D were assessed with multiple logistic regression models. RESULTS: Median age was 81 years, and 68.4% were females. Most patients with hip fracture (57.7%) were classified as American Society of Anesthesiologists classes 3-5, lived alone (52.4%), and had a low or medium level of education (85.7%). In the first year after injury, 10 838 of 30 752 patients with hip fracture (35.2%) received PT. Lower socioeconomic status (measured by income and level of education), male sex, increasing comorbidity, presence of cognitive impairment and increasing age led to a lower probability of receiving postoperative PT. Among those who used PT, EQ-5D index score was 0.061 points (p<0.001) higher than those who did not. Correspondingly, the probability of having 'no problems' in three of the five dimensions of EQ-5D was greater. CONCLUSIONS: A minority of the patients with hip fracture had access to private PT the first year after injury. This may indicate a shortcoming in the provision of beneficial post-surgery rehabilitative care reducing post-treatment HRQoL. The findings underscore the need for healthcare policies that address disparities in PT access, particularly for elderly patients, those with comorbidities and reduced health, and those with lower socioeconomic status.

Personalised functional imaging-guided multitarget continuous theta burst stimulation for post-stroke aphasia: study protocol for a randomised controlled trial.

INTRODUCTION: Continuous theta burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), targeting the language network in the right hemisphere of post-stroke aphasia (PSA) patients shows promising results in clinical trials. However, existing PSA studies have focused on single-target rTMS, leaving unexplored the potential benefits of multitarget brain stimulation. Consequently, there is a need for a randomised clinical trial aimed to evaluate the efficacy and safety of cTBS targeting on multiple critical nodes in the language network for PSA. METHODS AND ANALYSIS: This is a prospective, multicentre, double-blind, two-arm parallel-group, sham-controlled randomised trial. The study will include a total of 60 participants who will be randomly assigned in a 1:1 ratio to either the active cTBS group or the sham cTBS group. Using precision resting-state functional MRI for each participant, we will map personalised language networks and design personalised targets in the inferior frontal gyrus, superior temporal gyrus and superior frontal gyrus. Participants will undergo a 3-week cTBS intervention targeting the three personalised targets, coupled with speech and language therapy. The primary outcome is the change in the Western Aphasia Battery-Revised aphasia quotient score among participants after a 3-week treatment. Secondary outcomes include Boston Diagnostic Aphasia Examination severity ratings, Token Test and the Chinese-version of the Stroke and Aphasia Quality of Life Scale 39-generic version. ETHICS AND DISSEMINATION: The study has been approved by the ethics committees of Affiliated Hospital of Hebei University, Hebei General Hospital and Affiliated Hospital of Chengde Medical University. The findings of this study will be reported in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: The study has been registered on ClinicalTrials.gov (NCT05957445).

Robot-assisted oesophagectomy (Ivor-Lewis) for a complex stenosis previously managed by open gastrostomy tube placement.

A man in his late 50s presented with severe dysphagia caused by a complex refractory benign stenosis that was completely obstructing the middle oesophagus. The patient was unsatisfied with the gastrostomy tube placed via laparotomy as a long-term solution. Therefore, we performed robot-assisted minimally invasive oesophagectomy (video). Mobilisation of the stomach and gastric conduit preparation were more difficult due to the previously inserted gastrostomy tube; thus, the conduit blood supply was assessed using indocyanine green fluorescence. After an uncomplicated course, the patient was referred directly to inpatient rehabilitation on the 16th postoperative day. At 9 months after surgery, the motivated patient returned to full-time work and achieved level 7 on the functional oral intake scale (total oral diet, with no restrictions). At the 1-year follow-up, he positively confirmed all nine key elements of a good quality of life after oesophagectomy.

Pulmonary rehabilitation in Iranian outpatients with mustard gas lung disease: a randomised controlled trial.

OBJECTIVE: People with mustard gas lung disease experience cough, sputum, breathlessness and exercise limitation. We hypothesised that pulmonary rehabilitation (PR) would be beneficial in this condition. DESIGN: An assessor-blind, two-armed, parallel-design randomised controlled clinical trial. SETTING: Secondary care clinics in Iran. PARTICIPANTS: 60 men with breathlessness due to respiratory disease caused by documented mustard gas exposure, mean (SD) age 52.7 (4.36) years, MRC dyspnoea score 3.5 (0.7), St. George's Respiratory Questionnaire (SGRQ) 72.3 (15.2). INTERVENTIONS: Participants were allocated either to a 6-week course of thrice-weekly PR (n=31) or to usual care (n=29), with 6-week data for 28 and 26, respectively. OUTCOME MEASURES: Primary endpoint was change in cycle endurance time at 70% baseline exercise capacity at 6 weeks. Secondary endpoints included 6 min walk distance, quadriceps strength and bulk, body composition and health status. For logistical reasons, blood tests that had been originally planned were not performed and 12-month follow-up was available for only a small proportion. RESULTS: At 6 weeks, cycle endurance time increased from 377 (140) s to 787 (343) s with PR vs 495 (171) s to 479 (159) s for usual care, effect size +383 (231) s (p<0.001). PR also improved 6 min walk distance+103.2 m (63.6-142.9) (p<0.001), MRC dyspnoea score -0.36 (-0.65 to -0.07) (p=0.016) and quality of life; SGRQ -8.43 (-13.38 to -3.48) p<0.001, as well as quadriceps strength+9.28 Nm (1.89 to 16.66) p=0.015. CONCLUSION: These data suggest that PR can improve exercise capacity and quality of life in people with breathlessness due to mustard gas lung disease and support the wider provision of this form of care. TRIAL REGISTRATION NUMBER: IRCT2016051127848N1.

Prognostic factors for the development of upper limb dysfunctions after breast cancer: the UPLIFT-BC prospective longitudinal cohort study protocol.

INTRODUCTION: Upper limb (UL) dysfunctions are highly prevalent in people after breast cancer and have a great impact on performing activities in daily living. To improve care, a more comprehensive understanding of the development and persistence of UL dysfunctions is needed. Therefore, the UPLIFT-BC study will primarily examine the prognostic value of different factors at the body functions and structures, environmental and personal level of the International Classification of Functioning, Disability and Health (ICF) framework at 1-month post-surgery for persisting UL dysfunctions at 6 months after finishing cancer treatment. METHODS AND ANALYSIS: A prospective longitudinal cohort study, running from 1-week pre-surgery to 6 months post-local cancer treatment, is performed in a cohort of 250 women diagnosed with primary breast cancer. Different potentially prognostic factors to UL dysfunctions, covering body functions and structures, environmental and personal factors of the ICF, are assessed pre-surgically and at different time points post-surgery. The primary aim is to investigate the prognostic value of these factors at 1-month post-surgery for subjective UL function (ie, QuickDASH) at 6 months post-cancer treatment, that is, 6 months post-radiotherapy or post-surgery (T3), depending on the individuals' cancer treatment trajectory. In this, factors with relevant prognostic value pre-surgery are considered as well. Similar analyses are performed with an objective measure for UL function (ie, accelerometry) and a composite score of the combination of subjective and objective UL function. Second, in the subgroup of participants who receive radiotherapy, the prognostic value of the same factors is explored at 1-month post-radiotherapy and 6 months post-surgery. A forward stepwise selection strategy is used to obtain these multivariable prognostic models. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of UZ/KU Leuven (reference number s66248). The results of this study will be published in peer-reviewed journals and will be presented at several research conferences. TRIAL REGISTRATION NUMBER: NCT05297591.

Efficiency assessment of follow-up methodology of patients with knee replacement to predict post-surgical functionality: a protocol for randomised control PROKnee trial.

INTRODUCTION: Even when total knee arthroplasty (TKA) is an extended treatment, most patients experience a suboptimal evolution after TKA. The objectives of this study are the following: (1) to determine the effectiveness of two different prosthesis stabilisation systems on the functionality in activities of daily life, and (2) to determine prognostic biomarkers of knee prosthesis function based on radiological information, quantification of cytokines, intra-articular markers and biomechanical functional evaluation to predict successful evolution. METHODS AND ANALYSIS: The PROKnee trial was designed as a randomised controlled patient-blinded trial with two parallel groups that are currently ongoing. The initial recruitment will be 99 patients scheduled for their first TKA, without previous prosthesis interventions in lower limbs, who will be randomly divided into two groups that differed in the stabilisation methodology incorporated in the knee prosthesis: the MEDIAL-pivot group and the CENTRAL-pivot group. The maximum walking speed will be reported as the primary outcome, and the secondary results will be patient-reported questionnaires related to physical status, cognitive and mental state, radiological test, laboratory analysis and biomechanical instrumented functional performance, such as the 6-minute walking test, timed up-and-go test, gait, sit-to-stand, step-over, and ability to step up and down stairs. All the results will be measured 1 week before TKA and at 1.5, 3, 6 and 12 months after surgery. ETHICS AND DISSEMINATION: All procedures were approved by the Ethical Committee for Research with Medicines of the University Clinical Hospital of Valencia on 8 October 2020 (order no. 2020/181). Participants are required to provide informed consent for the study and for the surgical procedure. All the data collected will be treated confidentially since they will be blinded and encrypted. The results from the trial will be published in international peer-reviewed scientific journals, regardless of whether these results are negative or inconclusive. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04850300).

Qualitative study exploring the views of patients and healthcare providers on current rehabilitation practices after lumbar fusion surgery.

OBJECTIVES: To explore the views of patients and healthcare providers on current rehabilitation after lumbar fusion surgery (LFS) to fuel the development of a novel rehabilitation care pathway. DESIGN: A cross-sectional, qualitative study with an interpretive descriptive design. SETTING: Academic and non-academic hospital setting in Belgium. PARTICIPANTS: 31 caregivers from (non)-academic settings and 5 patients with LFS were purposefully sampled and in-depth interviewed. RESULTS: Out of the data of all interviews, participants reported opinions on 23 thematic clusters that were expressed in a time-contingent manner from the preoperative, perioperative to postoperative phase. Afterwards, themes were mapped to the Consolidated Framework for Implementation Research, with a larger role for concepts related to the innovation, inner and individual domain. As an overarching theme, the importance of an 'individualised, patient-centred rehabilitation built on a strong therapeutic alliance with an accessible interprofessional team' was stressed for patients undergoing LFS. Specifically, participants stated that a biopsychosocial approach to rehabilitation should start in the preoperative phase and immediately be continued postoperatively. No consensus was observed for movement restrictions postoperatively. Uniform communication between the involved caregivers was considered essential for optimal therapeutic alliance and clinical outcome. The precise role and competence of each member of the interprofessional team needs, therefore, to be clearly defined, respected and discussed. An accessible case manager to guide the patient trajectory and tackle problems could further support this. Interestingly, only patients, psychologists and physiotherapists addressed return to work as an important outcome after LFS. CONCLUSIONS: This qualitative study identified key experiences and points to consider in the current and future rehabilitation pathway for LFS. Future research should incorporate these findings to build a novel rehabilitation pathway for LFS and evaluate its feasibility and cost-effectiveness. TRIAL REGISTRATION NUMBER: This study was registered at clinicaltrials.gov (NCT03427294).

Rehabilitation interventions to modify physical frailty in adults before lung transplantation: a systematic review protocol.

INTRODUCTION: Lung transplantation is the gold-standard treatment for end-stage lung disease for a small group of patients meeting strict acceptance criteria after optimal medical management has failed. Physical frailty is prevalent in lung transplant candidates and has been linked to worse outcomes both on the waiting list and postoperatively. Exercise has been proven to be beneficial in optimising exercise capacity and quality of life in lung transplant candidates, but its impact on physical frailty is unknown. This review aims to assess the effectiveness of exercise interventions in modifying physical frailty for adults awaiting lung transplantation. METHODS AND ANALYSIS: This protocol was prospectively registered on the PROSPERO database. We will search four databases plus trial registries to identify primary studies of adult candidates for lung transplantation undertaking exercise interventions and assessing outcomes pertaining to physical frailty. Studies must include at least 10 participants. Article screening will be performed by two researchers independently at each stage. Extraction will be performed by one reviewer and checked by a second. The risk of bias in studies will be assessed by two independent reviewers using tools appropriate for the research design of each study; where appropriate, we will use Cochrane Risk of Bias 2 or ROBINS-I. At each stage of the review process, discrepancies will be resolved through a consensus or consultation with a third reviewer. Meta-analyses of frailty outcomes will be performed if possible and appropriate as will prespecified subgroup and sensitivity analyses. Where we are unable to perform meta-analysis, we will conduct narrative synthesis following Synthesis without Meta-analysis guidance. The review will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. ETHICS AND DISSEMINATION: No ethical issues are predicted due to the nature of this study. Dissemination will occur via conference abstracts, professional networks, peer-reviewed journals and patient support groups. PROSPERO REGISTRATION NUMBER: CRD42022363730.

Feasibility study of rehabilitation for cardiac patients aided by an artificial intelligence web-based programme: a randomised controlled trial (RECAP trial)-a study protocol.

INTRODUCTION: Cardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a reduction in cardiac mortality and recurrent myocardial infarction. This trial assesses the feasibility of a home-based CR programme delivered using a mobile application (app). METHODS: The Rehabilitation through Exercise prescription for Cardiac patients using an Artificial intelligence web-based Programme (RECAP) randomised controlled feasibility trial is a single-centre prospective study, in which patients will be allocated on a 1:1 ratio to a home-based CR programme delivered using a mobile app with accelerometers or standard hospital-based rehabilitation classes. The home-based CR programme will employ artificial intelligence to prescribe exercise goals to the participants on a weekly basis. The trial will recruit 70 patients in total. The primary objectives are to evaluate participant recruitment and dropout rates, assess the feasibility of randomisation, determine acceptability to participants and staff, assess the rates of potential outcome measures and determine hospital resource allocation to inform the design of a larger randomised controlled trial for clinical efficacy and health economic evaluation. Secondary objectives include evaluation of health-related quality of life and 6 minute walk distance. ETHICS AND DISSEMINATION: RECAP trial received a favourable outcome from the Berkshire research ethics committee in September 2022 (IRAS 315483).Trial results will be made available through publication in peer-reviewed journals and presented at relevant scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN97352737.

Development of a patient decision aid for children and adolescents following anterior cruciate ligament rupture: an international mixed-methods study.

AIM: To develop and user test an evidence-based patient decision aid for children and adolescents who are considering anterior cruciate ligament (ACL) reconstruction. DESIGN: Mixed-methods study describing the development of a patient decision aid. SETTING: A draft decision aid was developed by a multidisciplinary steering group (including various types of health professionals and researchers, and consumers) informed by the best available evidence and existing patient decision aids. PARTICIPANTS: People who ruptured their ACL when they were under 18 years old (ie, adolescents), their parents, and health professionals who manage these patients. Participants were recruited through social media and the network outreach of the steering group. PRIMARY AND SECONDARY OUTCOMES: Semistructured interviews and questionnaires were used to gather feedback on the decision aid. The feedback was used to refine the decision aid and assess acceptability. An iterative cycle of interviews, refining the aid according to feedback and further interviews, was used. Interviews were analysed using reflexive thematic analysis. RESULTS: We conducted 32 interviews; 16 health professionals (12 physiotherapists, 4 orthopaedic surgeons) and 16 people who ruptured their ACL when they were under 18 years old (7 were adolescents and 9 were adults at the time of the interview). Parents participated in 8 interviews. Most health professionals, patients and parents rated the aid's acceptability as good-to-excellent. Health professionals and patients agreed on most aspects of the decision aid, but some health professionals had differing views on non-surgical management, risk of harms, treatment protocols and evidence on benefits and harms. CONCLUSION: Our patient decision aid is an acceptable tool to help children and adolescents choose an appropriate management option following ACL rupture with their parents and health professionals. A clinical trial evaluating the potential benefit of this tool for children and adolescents considering ACL reconstruction is warranted.