Explore the vast range of titles available.

Objective To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis.Design Multicentre single blind non-inferiority randomised controlled trial.Setting Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre.Participants Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg.Interventions Continuation or cessation of ECS 12 months after deep venous thrombosis.Main outcome measures The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym).Results 518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups.Conclusion Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial.Trial registration Netherlands Trial Register NTR1442.

IntroductionTertiary prevention through physical activity and psychosocial support can positively impact patient outcomes, such as physical function and quality of life (QoL). However, more research is required on the effectiveness of strategies designed to increase the uptake of tertiary prevention programmes among cancer patients. Here, we present the protocol for a single-centre, randomised controlled pilot trial testing the preliminary effectiveness of social prescription and virtual patient information in increasing tertiary prevention among cancer patients and support persons (SPs) (ESPRIT “Effectiveness of a social prescription and virtual patient information in increasing tertiary prevention” pilot trial).Methods and analysisCancer patients attending medical oncology units at a university hospital in southern Germany and their SPs will be randomly allocated as a dyad to group A (social prescription (n=36)), group B (virtual patient information (n=36)) or group C (usual care (n=36)). The hospital is part of a Comprehensive Cancer Centre mainly treating patients living in rural areas. Primary outcomes are the uptake of physical activity, participation in social activities and psychosocial support. Secondary outcomes are overall QoL, knowledge of the health benefits of physical activity and psychosocial support and self-efficacy of patients. The outcomes will be assessed at baseline and after 3, 6 and 12 months of follow-up. Physical activity will be assessed using accelerometers and measured by average steps per day within the last 2 weeks after recruitment and at follow-up visits (3, 6 and 12 months). Cost-effectiveness and the time spent in the consultation, as well as potential implementation barriers and facilitators, will also be explored as part of a mixed-methods hybrid design. All data will be summarised descriptively. Regarding the analysis of primary endpoints, the average number of steps per day, as well as the summary score of the social activity log and self-report on the use of psychosocial support, will be compared between the groups (A, B and C) using analysis of variance, followed by Dunnett’s test for pairwise comparisons of the intervention groups against the control group. Mean differences and 95% CIs will be presented as effect estimates. The analysis of secondary endpoints will include appropriate statistical methods such as the χ2 test of independence or linear regression models, which will be used to analyse secondary endpoints and to investigate factors influencing preliminary effectiveness.Ethics and disseminationThis trial has been approved by the ethics committee of the University of Regensburg (reference: 23-3317-101). Signed written informed consent is required from all study participants. The results of the study will be used to inform the power calculation for future confirmatory trials and will be submitted for publication.Trial registration numberDRKS00033771.

The importance of expanding cancer treatment to include the promotion of overall long-term health is emphasized in the Institute of Medicine report on delivering quality oncology care. Weight management, physical activity, and a healthy diet are key components of tertiary prevention but may be areas in which the oncologist and/or the oncology care team may be less familiar. This article reviews current diet and physical activity guidelines, the evidence supporting those recommendations, and provides an overview of practical interventions that have resulted in favorable improvements in lifestyle behavior change in cancer survivors. It also describes current lifestyle practices among cancer survivors and the role of the oncologist in helping cancer patients and survivors embark upon changes in lifestyle behaviors, and it calls for the development of partnerships between oncology providers, primary care providers, and experts in nutrition, exercise science, and behavior change to help positively orient cancer patients toward longer and healthier lives.

Background The current literature supports the effectiveness of exercise, education, and self-management interventions for the long-term management of persistent low back pain. However, there is significant uncertainty about the implementation of interventions related to barriers, facilitators, and patient’s preferences. This study will evaluate the Back to Living Well program implementation from a participant and organizational perspective. More specifically we address the following objectives: 1) identify program barriers and facilitators from participants’ perspectives, 2) identify factors related to program, personal and contextual factors that contribute to negative and positive outcomes, and outcome trajectories, 3) identify factors influencing participants’ selection of an in-person or e-health program, and 4) evaluate program specific barriers and facilitators from the organization and care delivery perspectives. Methods This study will utilize a mixed-method convergent design including a longitudinal cohort strand and a longitudinal qualitative interview strand. The RE-AIM framework will be used to assess program implementation. Participants ( n  = 90, 1:1: in person or virtual) who choose to register in the program as well as staff ( n  = 10 to 15) involved in the delivery of the program will be invited to participate. Participants will participate in a 12-week physical activity, education, and self-management program. Implementation outcomes will be measured at 3-, 6-, 12-months, and six months after the end of the follow-ups. Interview scripts and directed content analysis will be constructed based on the Theoretical Domains Framework and the Neuromatrix Model of Pain, Theoretical Domains Framework. Staff interviews will be constructed and analyzed using the Consolidated Framework for Implementation Research. Participants will also complete pain, disability, quality of life and psychological questionnaires, wear an activity tracker at all time points, and complete weekly pain and activity limitation questions using a mobile application. Discussion The study results will provide evidence to inform potential future implementation of the program. An effective, appropriately targeted, and well implemented exercise program for the long-term management (i.e., tertiary prevention) of LBP could minimize the burden of the condition on patients, the health care system and society. Trial registration ClinicalTrials.gov NCT05929846. This (Registration Date: July 3 2023) study has been approved by the Hamilton Integrated Research Ethics Board Project ID#15,354.

Background Epidemiological studies and cardiovascular prevention trials have shown that low-dose aspirin can reduce colorectal cancer (CRC) incidence and mortality, including inhibition of distant metastases. Metformin has also been associated with decreased colon adenoma recurrence in clinical trials and lower CRC incidence and mortality in epidemiological studies in diabetics. While both drugs have been tested as single agents, their combination has not been tested in cancer prevention trials. Methods/design This is a randomized, placebo-controlled, double-blind, 2 × 2 biomarker trial of aspirin and metformin to test the activity of either agent alone and the potential synergism of their combination on a set of surrogate biomarkers of colorectal carcinogenesis. After surgery, 160 patients with stage I-III CRC are randomly assigned in a four-arm trial to either aspirin (100 mg day), metformin (850 mg bis in die) , their combination, or placebo for one year. The primary endpoint biomarker is the change of IHC expression of nuclear factor kappa-B (NFκB) in the unaffected mucosa of proximal and distal colon obtained by multiple biopsies in two paired colonoscopies one year apart. Additional biomarkers will include: 1) the measurement of circulating IL-6, CRP and VEGF; 2) the IHC expression of tissue pS6K, p53, beta-catenin, PI3K; 3) the associations of genetic markers with treatment response as assessed by next generation sequencing of primary tumors; 4) the genomic profile of candidate genes, pathways, and overall genomic patterns in tissue biopsies by genome wide gene expression arrays; and 5) the evaluation of adenoma occurrence at 1 year. Discussion A favorable biomarker modulation by aspirin and metformin may provide important clues for a subsequent phase III adjuvant trial aimed at preventing second primary cancer, delaying recurrence and improving prognosis in patients with CRC. Trial registration EudraCT Number: 2015–004824-77; ClinicalTrial.gov Identifier: NCT03047837 . Registered on February 1, 2017.

The Relapse Prevention (RP) model has been a mainstay of addictions theory and treatment since its introduction three decades ago. This paper provides an overview and update of RP for addictive behaviors with a focus on developments over the last decade (2000-2010). Major treatment outcome studies and meta-analyses are summarized, as are selected empirical findings relevant to the tenets of the RP model. Notable advances in RP in the last decade include the introduction of a reformulated cognitive-behavioral model of relapse, the application of advanced statistical methods to model relapse in large randomized trials, and the development of mindfulness-based relapse prevention. We also review the emergent literature on genetic correlates of relapse following pharmacological and behavioral treatments. The continued influence of RP is evidenced by its integration in most cognitive-behavioral substance use interventions. However, the tendency to subsume RP within other treatment modalities has posed a barrier to systematic evaluation of the RP model. Overall, RP remains an influential cognitive-behavioral framework that can inform both theoretical and clinical approaches to understanding and facilitating behavior change.

ObjectivesTo summarise the best available evidence on tertiary prevention interventions for patients with stroke conducted in African countries, identify the gaps in stroke prevention research and augment efforts to establish stroke rehabilitation guidelines in African countries.DesignWe performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement on the basis of a published protocol.Data sourcesWe conducted a systematic search of nine electronic databases, including PubMed, the Cochrane Library and African Index Medicus, published until August 2023 and additionally contacted authors and screened reference lists.Eligibility criteriaWe included randomised controlled trials (RCTs) and prospective cohort studies on African adult patients with a clinical diagnosis of stroke. The primary outcome was global disability, and secondary outcomes were neurologic function scales.Data extraction and synthesisTwo authors independently screened the search results, with data extracted by one author and verified by a second author. The data were narratively synthesised. A meta-analysis was done using a random-effects model for metric data using standardised mean differences. Risk of bias was assessed using the Cochrane Risk of Bias tool.ResultsOf 3305 publications, 25 studies met the inclusion criteria involving cumulatively 973 patients with subacute and chronic stroke. Two-thirds of the trials were conducted in Nigeria and Egypt. The interventions covered physiotherapeutic, electrophysiologic, psychotherapeutic and transitional care domains with mostly beneficial outcomes. All included studies were RCTs with some concerns about methodologic quality.ConclusionThis systematic review comprises heterogeneous effective interventions for tertiary stroke prevention mostly conducted in small productive research clusters. There is a growing body of research from African countries covering important fields of stroke rehabilitation, including local adaptations of the rehabilitation process and new knowledge concerning transcranial magnetic stimulation. There remains an urgent need to implement interventions aimed at overcoming barriers to stroke rehabilitation.PROSPERO registration numberCRD42020159125.

Tertiary Individual Prevention is an interprofessional inpatient rehabilitation programme offered to workers affected by work-related skin diseases. Health educational interventions aiming at changing skin protection behaviour are a pivotal component of the programme. This paper aims at characterizing the content of the educational interventions of the interprofessional inpatient rehabilitation programme and at reporting the mechanisms and functions for behaviour change. We retrospectively analysed existing health educational interventions with document analyses and field observations. The intervention was described using the Template of Intervention Description and Replication (TIDieR). For the intervention content, the Behaviour Change Technique (BCT) Taxonomy (v1) was applied. To characterize the intervention in detail, the BCTs were then mapped to the intervention functions, the COM-B model (Capability, Opportunity, Motivation) and the Theoretical Domains Framework (TDF) from the Behaviour Change Wheel (BCW). The health educational interventions consist of seven components. Five are delivered in a group and two as tailored face-to-face counselling. We identified 23 BCTs in 10 groups. The most common used BCTs are “instruction on how to perform skin protection behaviour,” “salience of consequences,” “information about skin health,” and “demonstration of skin protection behaviour.” To initiate the process of behaviour change in skin protection behaviour by the individuals, changes are required in all three behavioural sources (Capability, Opportunity, Motivation) and primarily in the theoretical constructs “behavioural regulation,” “skills,” and “beliefs about consequences.” For this purpose, the five intervention functions “enablement,” “training,” “education,” “modelling,” and “persuasion” are used. Health educational interventions to change skin protection behaviour consists of different BCTs, mechanisms of change and intervention functions. This work helps to better understand the mechanisms and means of behaviour change and enables replication in other settings. In the future, the intervention programme should be extended to include BCTs addressing domains for behaviour changes which have not yet been included to maintain the new behaviour in the long-term. Finally, we recommend to report more elements of the rehabilitation programme (e.g. psychological interventions) in a standardized manner by frameworks used in this paper. Well-established tools for transparently reporting behaviour change interventions have been applied in an intervention for patients with work-related skin diseases. The results show which strategies can be used to change skin protection behaviour. Our methodological approach in this paper is adaptable and can be used exemplarily for other fields of health empowerment interventions. Lay Summary In the treatment of work-related skin diseases (WRSD), skin protection behaviour has an important influence in the course of the disease. Health educational interventions as part of an inpatient rehabilitation programme support patients in the process of behaviour change. However, these educational interventions have not been reported in a standardized manner until now. Accurate reporting may contribute to disseminating evidence-based practices because practitioners can better identify strategies for behaviour change, compare the effectiveness in studies and implement an intervention in another contexts. Against this background, it is the aim of this paper to report this intervention using theory-based tools. The educational intervention consists of seven components which are delivered in a group or as tailored face-to-face counselling. The overall aims are to enable, train, and educate patients in changing and improving their skin protection behaviour. Health educators and occupational therapists inform patients about their skin disease, demonstrate, and practice new behaviours and prepare the implementation of new behaviours. Our findings help to better understand the mechanisms and means of behaviour change in the field of WRSD. We also conclude that patients may not receive sufficient educational support in health psychological determinants of behaviour change to implement the new behaviour in the long-term, e.g. to cope with relapses. Graphical Abstract Graphical Abstract

Objective To evaluate the efficacy of cerclage in preventing preterm birth according to indication. Study design Retrospective analysis of all women who underwent cerclage to prevent preterm birth in a university-affiliated medical-center (2007–2017). Multiple gestations were excluded. Cohort was divided to three subgroups according to cerclage indication: group A—primary prevention cerclage, performed during the first trimester, based on a history of cervical insufficiency; group B—secondary prevention cerclage, performed after sonographic visualization of asymptomatic cervical length shortening and previous preterm birth; and group C—tertiary prevention cerclage, performed at mid-trimester in women presenting with asymptomatic cervical dilatation. Primary outcome was gestational age at delivery. Secondary outcomes were maternal and neonatal complications. Results During the study period 273 women underwent cervical cerclage: group A–215 (79%), group B–25 (9%), and group C–33 (12%). Patients in group C had significantly lower gravidity and parity. Gestational age at cerclage was highest in group C and lowest in group A (22 vs. 13 weeks p  < 0.001). Median gestational age at delivery was 37 + 3 weeks in groups A and B and 34 + 3 in group C. This difference persisted after controlling for potential confounders ( p  < 0.0001). Preterm birth prior to 34 weeks of gestation were 10.7% in group A, 16% in group B, and 33.33% in group C ( p  = 0.0021). Neonatal complications including: respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis, were clmore prevalent in group C. Conclusion Cerclage was shown to be an acceptable measure in cases of an anticipated increased risk of preterm birth with a low rate of procedure associated complications. However, the number-needed-to-treat cannot be determined from our data, because a control group was lacking.

To evaluate the pneumonia specific case fatality rate over time following the implementation of a Child Lung Health Programme (CLHP) within the existing government health services in Malawi to improve delivery of pneumonia case management. A prospective, nationwide public health intervention was studied to evaluate the impact on pneumonia specific case fatality rate (CFR) in infants and young children (0 to 59 months of age) following the implementation of the CLHP. The implementation was step-wise from October 1st 2000 until 31st December 2005 within paediatric inpatient wards in 24 of 25 district hospitals in Malawi. Data analysis compared recorded outcomes in the first three months of the intervention (the control period) to the period after that, looking at trend over time and variation by calendar month, age group, severity of disease and region of the country. The analysis was repeated standardizing the follow-up period by using only the first 15 months after implementation at each district hospital. Following implementation, 47,228 children were admitted to hospital for severe/very severe pneumonia with an overall CFR of 9.8%. In both analyses, the highest CFR was in the children 2 to 11 months, and those with very severe pneumonia. The majority (64%) of cases, 2-59 months, had severe pneumonia. In this group there was a significant effect of the intervention Odds Ratio (OR) 0.70 (95%CI: 0.50-0.98); p = 0.036), while in the same age group children treated for very severe pneumonia there was no interventional benefit (OR 0.97 (95%CI: 0.72-1.30); p = 0.8). No benefit was observed for neonates (OR 0.83 (95%CI: 0.56-1.22); p = 0.335). The nationwide implementation of the CLHP significantly reduced CFR in Malawian infants and children (2-59 months) treated for severe pneumonia. Reasons for the lack of benefit for neonates, infants and children with very severe pneumonia requires further research.