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Trials Jun 2024
Correction: Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study.
PubMed: 38886820
DOI: 10.1186/s13063-024-08176-9 -
Trials Jun 2024Untreated hepatitis C virus (HCV) infection can result in cirrhosis and hepatocellular cancer. Direct-acting antiviral (DAA) therapies are highly effective and have few...
Financial incentives to motivate treatment for hepatitis C with direct acting antivirals among Australian adults (The Methodical evaluation and Optimisation of Targeted IncentiVes for Accessing Treatment of Early-stage hepatitis C: MOTIVATE-C): protocol for a dose-response randomised controlled...
BACKGROUND
Untreated hepatitis C virus (HCV) infection can result in cirrhosis and hepatocellular cancer. Direct-acting antiviral (DAA) therapies are highly effective and have few side effects compared to older interferon-based therapy. Despite the Australian government providing subsidised and unrestricted access to DAA therapy for chronic HCV infection, uptake has not been sufficient to meet the global target of eliminating HCV as a public health threat by 2030. This study will offer people with HCV financial incentives of varying values in order to evaluate its effect on initiation of DAA therapy in primary care.
METHODS
Australian adults (18 years or older) who self-report as having current untreated HCV infection can register to participate via an automated SMS-based system. Following self-screening for eligibility, registrants are offered a financial incentive of randomised value (AUD 0 to 1000) to initiate DAA therapy. Study treatment navigators contact registrants who have consented to be contacted, to complete eligibility assessment, outline the study procedures (including the requirement for participants to consult a primary care provider), obtain consent, and finalise enrolment. Enrolled participants receive their offered incentive on provision of evidence of DAA therapy initiation within 12 weeks of registration (primary endpoint). Balanced randomisation is used across the incentive range until the first analysis, after which response-adaptive randomisation will be used to update the assignment probabilities. For the primary analysis, a Bayesian 4-parameter EMAX model will be used to estimate the dose-response curve and contrast treatment initiation at each incentive value against the control arm (AUD 0). Specified secondary statistical and economic analyses will evaluate the effect of incentives on adherence to DAA therapy, virological response, and cost-effectiveness.
DISCUSSION
This project seeks to gain an understanding of the dose-response relationship between incentive value and DAA treatment initiation, while maximising the number of people treated for HCV within fixed budget and time constraints. In doing so, we hope to offer policy-relevant recommendation(s) for the use of financial incentives as a pragmatic, efficient, and cost-effective approach to achieving elimination of HCV from Australia.
TRIAL REGISTRATION
ANZCTR (anzctr.org.au), Identifier ACTRN12623000024640, Registered 11 January 2023 ( https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384923&isReview=true ).
Topics: Humans; Antiviral Agents; Motivation; Australia; Randomized Controlled Trials as Topic; Hepatitis C, Chronic; Treatment Outcome; Adult; Drug Costs; Cost-Benefit Analysis; Primary Health Care; Time Factors
PubMed: 38886819
DOI: 10.1186/s13063-024-08212-8 -
Pilot and Feasibility Studies Jun 2024Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive...
BACKGROUND
Long COVID is a serious public health concern due to its high prevalence and potentially debilitating symptoms. Symptoms may include fatigue, dyspnea, cognitive problems, insomnia, anxiety, and depression. There is currently no cure for long COVID, and the average length of recovery and proportion of patients who fully recover are still unknown. Subsequently, there is a critical need to improve function. Research in other chronic conditions suggests that psychosocial self-management interventions reduce symptom severity and interference with functioning. We describe the design of our study to examine the feasibility, acceptability, appropriateness, and preliminary efficacy of an intervention designed to improve symptom management and coping in adults with long COVID.
METHODS
This pilot trial (N = 50) uses a pragmatic, randomized two-group parallel design set within the University of Washington Post-COVID Rehabilitation and Recovery Clinic. The self-management intervention is a 6-week, group-based telemedicine intervention that teaches evidence-based strategies to manage common symptoms and improve stress management as well as communication and self-advocacy. The comparator is a wait-list control. Participants complete self-report measures of the primary and secondary outcomes at baseline and post-treatment/wait-list. Primary outcomes include intervention feasibility, acceptability, and appropriateness. Secondary outcomes include Patient-Reported Outcomes Measurement Information System measures of fatigue, sleep disturbance, cognitive difficulties, self-efficacy, pain interference, depression and anxiety symptoms, and a measure of long COVID symptoms and impression of change. At post-intervention, intervention participants also complete a qualitative interview to inform intervention refinement. Quantitative data will be examined using descriptive and statistical analysis including t-tests and chi-square tests to compare the intervention and wait-list groups on secondary outcomes. Qualitative data will be analyzed using the rigorous and accelerated data reduction technique (RADaR).
DISCUSSION
Results of this pilot randomized controlled trial will characterize the feasibility, acceptability, and appropriateness of the self-management intervention and inform intervention refinement necessary prior to further testing. Long COVID is a public health concern, and rehabilitation approaches that equip patients to manage symptoms may improve patient function and quality of life and reduce burden on the health care system.
TRIAL REGISTRATION
NCT05658536. December 16, 2022.
PubMed: 38886814
DOI: 10.1186/s40814-024-01515-2 -
Journal of Translational Medicine Jun 2024
Correction: move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial.
PubMed: 38886723
DOI: 10.1186/s12967-024-05343-z -
BMC Public Health Jun 2024Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in...
BACKGROUND
Structural and behavioral interventions to manage work-related stress are effective in employees. Nonetheless, they have been implemented insufficiently, particularly in micro- and small-sized enterprises (MSE). Main barriers include a lack of knowledge and limited resources, which could potentially be overcome with simplified web-based alternatives for occupational stress prevention. However, there is a lack of implementation research about web-based prevention in realistic settings of MSE.
OBJECTIVE
The aim of this study is to evaluate the implementation process and success of an integrated web-based platform for occupational stress prevention ("System P") and to identify potential barriers for its uptake and use in MSE in Germany.
METHODS
This study with a mixed-methods approach investigates eight process-related outcomes in a quantitative part I (adoption, reach, penetration, fidelity/dose, costs, acceptability) and a qualitative part II (acceptability, appropriateness and feasibility). Part I has a pre-post design with two measurements (6 months apart) with 98 individual participants and part II consists of 12 semi-structured interviews with managers and intercorporate stakeholders.
RESULTS
Part I revealed shortcomings in the implementation process. Adoption/Reach: Despite extensive marketing efforts, less than 1% of the contacted MSE responded to the offer of System P. A total of 40 MSE registered, 24 of which, characterized by good psychosocial safety climate, adopted System P. Penetration: Within these 24 MSE, 15% of the employees used the system. Fidelity/Dose: 11 MSE started a psychosocial risk-assessment (PRA), and no MSE finished it. The stress-management training (SMT) was started by 25 users and completed by 8.
COSTS
The use of System P was free of charge, but the time required to engage with was an indirect cost. Part II added insights on the perception of the web-based intervention: Acceptance of System P by users and stakeholders was good and it was assessed as appropriate for MSE. Results for feasibility were mixed.
CONCLUSIONS
Although System P was generally perceived as useful and appropriate, only a small number of contacted MSE implemented it as intended. Prior experience and sensitivity for occupational (stress) prevention were mentioned as key facilitators, while (perceived) indirect costs were a key barrier. Enabling MSE to independently manage stress prevention online did not result in successful implementation. Increasing external support could be a solution. ⁺ FULL PROJECT NAME: "PragmatiKK - Pragmatische Lösungen für die Implementation von Maßnahmen zur Stressprävention in Kleinst- und Kleinbetrieben" (= Pragmatic solutions for the implementation of stress prevention interventions in micro and small-sized enterprises).
TRIAL REGISTRATION
German Register of Clinical Studies (DRKS) DRKS00026154, date of registration 2021-09-16.
Topics: Humans; Germany; Occupational Stress; Female; Male; Adult; Middle Aged; Small Business; Internet; Program Evaluation; Internet-Based Intervention; Qualitative Research
PubMed: 38886711
DOI: 10.1186/s12889-024-19102-8 -
BMJ Open Jun 2024To estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH). (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
OBJECTIVE
To estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH).
DESIGN
Economic evaluation undertaken using health resource use and outcome data from the 12-month multicentre, pragmatic, parallel-group, randomised, Randomised Evaluation of Surgery with Craniectomy for Patients Undergoing Evacuation-ASDH trial.
SETTING
UK secondary care.
PARTICIPANTS
248 UK patients undergoing surgery for traumatic ASDH were randomised to craniotomy (N=126) or DC (N=122).
INTERVENTIONS
Surgical evacuation via craniotomy (bone flap replaced) or DC (bone flap left out with a view to replace later: cranioplasty surgery).
MAIN OUTCOME MEASURES
In the base-case analysis, costs were estimated from a National Health Service and Personal Social Services perspective. Outcomes were assessed via the quality-adjusted life-years (QALY) derived from the EuroQoL 5-Dimension 5-Level questionnaire (cost-utility analysis) and the Extended Glasgow Outcome Scale (GOSE) (cost-effectiveness analysis). Multiple imputation and regression analyses were conducted to estimate the mean incremental cost and effect of craniotomy compared with DC. The most cost-effective option was selected, irrespective of the level of statistical significance as is argued by economists.
RESULTS
In the cost-utility analysis, the mean incremental cost of craniotomy compared with DC was estimated to be -£5520 (95% CI -£18 060 to £7020) with a mean QALY gain of 0.093 (95% CI 0.029 to 0.156). In the cost-effectiveness analysis, the mean incremental cost was estimated to be -£4536 (95% CI -£17 374 to £8301) with an OR of 1.682 (95% CI 0.995 to 2.842) for a favourable outcome on the GOSE.
CONCLUSIONS
In a UK population with traumatic ASDH, craniotomy was estimated to be cost-effective compared with DC: craniotomy was estimated to have a lower mean cost, higher mean QALY gain and higher probability of a more favourable outcome on the GOSE (though not all estimated differences between the two approaches were statistically significant).
ETHICS
Ethical approval for the trial was obtained from the North West-Haydock Research Ethics Committee in the UK on 17 July 2014 (14/NW/1076).
TRIAL REGISTRATION NUMBER
ISRCTN87370545.
Topics: Humans; Cost-Benefit Analysis; Decompressive Craniectomy; Craniotomy; United Kingdom; Male; Hematoma, Subdural, Acute; Female; Middle Aged; Quality-Adjusted Life Years; Adult; Aged; Glasgow Outcome Scale; Treatment Outcome
PubMed: 38885989
DOI: 10.1136/bmjopen-2024-085084 -
Learning Health Systems Jun 2024Shared decision-making (SDM) is a method of care by which patients and clinicians work together to co-create a plan of care. Electronic health record (EHR) integration...
INTRODUCTION
Shared decision-making (SDM) is a method of care by which patients and clinicians work together to co-create a plan of care. Electronic health record (EHR) integration of SDM tools may increase adoption of SDM. We conducted a "lightweight" integration of a freely available electronic SDM tool, CV Prevention Choice, within the EHRs of three healthcare systems. Here, we report how the healthcare systems collaborated to achieve integration.
METHODS
This work was conducted as part of a stepped wedge randomized pragmatic trial. CV Prevention Choice was developed using guidelines for HTML5-based web applications. Healthcare systems integrated the tool in their EHR using documentation the study team developed and refined with lessons learned after each system integrated the electronic SDM tool into their EHR. CV Prevention Choice integration populates the tool with individual patient data locally without sending protected health information between the EHR and the web. Data abstraction and secure transfer systems were developed to manage data collection to assess tool implementation and effectiveness outcomes.
RESULTS
Time to integrate CV Prevention Choice in the EHR was 12.1 weeks for the first system, 10.4 weeks for the second, and 9.7 weeks for the third. One system required two 1-hour meetings with study team members and two healthcare systems required a single 1-hour meeting. Healthcare system information technology teams collaborated by sharing information and offering improvements to documentation. Challenges included tracking CV Prevention Choice use for reporting and capture of combination medications. Data abstraction required refinements to address differences in how each healthcare system captured data elements.
CONCLUSION
Targeted documentation on tool features and resource mapping supported collaboration of IT teams across healthcare systems, enabling them to integrate a web-based SDM tool with little additional research team effort or oversight. Their collaboration helped overcome difficulties integrating the web application and address challenges to data harmonization for trial outcome analyses.
PubMed: 38883873
DOI: 10.1002/lrh2.10418 -
MedRxiv : the Preprint Server For... Jun 2024Dental caries is the world's most prevalent noncommunicable disease, disproportionately affecting children from low-income families and rural geographic areas.
BACKGROUND
Dental caries is the world's most prevalent noncommunicable disease, disproportionately affecting children from low-income families and rural geographic areas.
METHODS
The CariedAway 3.0 study was a cluster-randomized pragmatic non-inferiority trial comparing silver diamine fluoride (SDF) to sealants and atraumatic restorations (ART) for the prevention and control of dental caries. All participants also received fluoride varnish. Analysis consisted of mixed-effects logistic regression for caries prevalence and weighted least squares and mixed-effects negative binomial regression for caries incidence. A non-inferiority margin of 10% for the difference between groups was used. Dental caries was defined as an ICDAS score of four or greater.
RESULTS
A total of 3345 children were enrolled across 35 schools; however there was a large proportion of children who were noncompliant and received external dental care over the course of the trial. In adjusted analyses of compliant participants (n=1083; 543 in the SDF group and 540 in the sealant and ART group), there was no difference in the weighted risk difference between treatment groups (B=0.003, 95% CI = -0.0001, 0.0008). The odds of caries prevalence was elevated in the SDF group in longitudinal analyses (OR = 1.35, 95% CI = 0.86, 2.11) but was not significant and was below the non-inferiority margin. There were no significant differences between groups for caries incidence in adjusted models (IRR = 1.19, 95% CI = 0.81, 1.74). Results for intent to treat analyses were similar to that of per-protocol.
DISCUSSION
In this school-based clinical trial, the prevalence of dental caries in children treated with SDF and fluoride varnish was non-inferior compared to those treated with sealants, ART, and fluoride varnish, although the overall risk was slightly higher. Unfortunately, a high rate of dropout and participant noncompliance was observed, likely due to the impacts of COVID-19 on study procedures. As a result, observed effects may be unreliable beyond the short-term. NCT03448107.
PubMed: 38883737
DOI: 10.1101/2024.06.05.24308499 -
MedRxiv : the Preprint Server For... Jun 2024Late predictions of hospitalized patient deterioration, resulting from early warning systems (EWS) with limited data sources and/or a care team's lack of shared...
IMPORTANCE
Late predictions of hospitalized patient deterioration, resulting from early warning systems (EWS) with limited data sources and/or a care team's lack of shared situational awareness, contribute to delays in clinical interventions. The COmmunicating Narrative Concerns Entered by RNs (CONCERN) Early Warning System (EWS) uses real-time nursing surveillance documentation patterns in its machine learning algorithm to identify patients' deterioration risk up to 42 hours earlier than other EWSs.
OBJECTIVE
To test our a priori hypothesis that patients with care teams informed by the CONCERN EWS intervention have a lower mortality rate and shorter length of stay (LOS) than the patients with teams not informed by CONCERN EWS.
DESIGN
One-year multisite, pragmatic controlled clinical trial with cluster-randomization of acute and intensive care units to intervention or usual-care groups.
SETTING
Two large U.S. health systems.
PARTICIPANTS
Adult patients admitted to acute and intensive care units, excluding those on hospice/palliative/comfort care, or with Do Not Resuscitate/Do Not Intubate orders.
INTERVENTION
The CONCERN EWS intervention calculates patient deterioration risk based on nurses' concern levels measured by surveillance documentation patterns, and it displays the categorical risk score (low, increased, high) in the electronic health record (EHR) for care team members.
MAIN OUTCOMES AND MEASURES
Primary outcomes: in-hospital mortality, LOS; survival analysis was used. Secondary outcomes: cardiopulmonary arrest, sepsis, unanticipated ICU transfers, 30-day hospital readmission.
RESULTS
A total of 60 893 hospital encounters (33 024 intervention and 27 869 usual-care) were included. Both groups had similar patient age, race, ethnicity, and illness severity distributions. Patients in the intervention group had a 35.6% decreased risk of death (adjusted hazard ratio [HR], 0.644; 95% confidence interval [CI], 0.532-0.778; P<.0001), 11.2% decreased LOS (adjusted incidence rate ratio, 0.914; 95% CI, 0.902-0.926; P<.0001), 7.5% decreased risk of sepsis (adjusted HR, 0.925; 95% CI, 0.861-0.993; P=.0317), and 24.9% increased risk of unanticipated ICU transfer (adjusted HR, 1.249; 95% CI, 1.093-1.426; P=.0011) compared with patients in the usual-care group.
CONCLUSIONS AND RELEVANCE
A hospital-wide EWS based on nursing surveillance patterns decreased in-hospital mortality, sepsis, and LOS when integrated into the care team's EHR workflow.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03911687.
PubMed: 38883706
DOI: 10.1101/2024.06.04.24308436 -
Acta Oncologica (Stockholm, Sweden) Jun 2024While the prevalence of older breast cancer patients is rapidly increasing, these patients are greatly underrepresented in clinical trials. We discuss barriers to... (Review)
Review
BACKGROUND AND PURPOSE
While the prevalence of older breast cancer patients is rapidly increasing, these patients are greatly underrepresented in clinical trials. We discuss barriers to recruitment of older patients to clinical trials and propose solutions on how to mitigate these challenges and design optimal clinical trials through the paradigm of IMPORTANT trial.
PATIENTS AND METHODS
This is a narrative review of the current literature evaluating barriers to including older breast cancer patients in clinical trials and how mitigating strategies can be implemented in a pragmatic clinical trial.
RESULTS
The recognized barriers can be roughly divided into trial design-related (e.g. the adoption of strict inclusion criteria, the lack of pre-specified age-specific analysis), patient-related (e.g. lack of knowledge, valuation of the quality-of-life instead of survival, transportation issues), or physician-related (e.g. concern for toxicity). Several strategies to mitigate barriers have been identified and should be considered when designing a clinical trial dedicated to older patients with cancer. The pragmatic, de-centralized IMPORTANT trial focusing on dose optimization of CDK4/6 -inhibitors in older breast cancer patients is a paradigm of a study design where different mitigating strategies have been adopted.
INTERPRETATION
Because of the existing barriers, older adults in clinical trials are considerably healthier than the average older patients treated in clinical practice. Thus, the study results cannot be generalized to the older population seen in daily clinical practice. Broader inclusion/exclusion criteria, offering telehealth visits, and inclusion of patient-reported, instead of physician-reported outcomes may increase older patient participation in clinical trials.
Topics: Humans; Breast Neoplasms; Female; Aged; Research Design; Patient Selection; Clinical Trials as Topic; Age Factors; Quality of Life; Aged, 80 and over
PubMed: 38881342
DOI: 10.2340/1651-226X.2023.40365