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Trials Jun 2024Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of...
Trial participants' self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck.
BACKGROUND
Evidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.
METHODS
We collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase.
RESULTS
Two hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases.
CONCLUSIONS
Potential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.
Topics: Humans; Gambling; Comprehension; Pamphlets; Ireland; Research Subjects; Patient Education as Topic; Health Knowledge, Attitudes, Practice; Self Report; United Kingdom; Female; Health Literacy; Male; Informed Consent; Clinical Trials as Topic; Middle Aged; Adult; Randomized Controlled Trials as Topic
PubMed: 38890748
DOI: 10.1186/s13063-024-08217-3 -
BMJ Open Jun 2024
Correction: Effectiveness of the med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.
PubMed: 38890145
DOI: 10.1136/bmjopen-2022-061725corr1 -
BMJ Open Jun 2024There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of...
INTRODUCTION AND OBJECTIVES
There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan.
METHODS
We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers.
TRIAL REGISTRATION NUMBER
ISRCTN10761003.
Topics: Humans; Cognitive Behavioral Therapy; Pilot Projects; Pakistan; Depression; Pragmatic Clinical Trials as Topic; Tuberculosis; Multicenter Studies as Topic; Cost-Benefit Analysis; Antitubercular Agents; Adult
PubMed: 38889941
DOI: 10.1136/bmjopen-2023-083483 -
BMJ Open Jun 2024Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although...
Conservative management versus invasive management of significant traumatic pneumothoraces in the emergency department (the CoMiTED trial): a study protocol for a randomised non-inferiority trial.
INTRODUCTION
Traumatic pneumothoraces are present in one of five victims of severe trauma. Current guidelines advise chest drain insertion for most traumatic pneumothoraces, although very small pneumothoraces can be managed with observation at the treating clinician's discretion. There remains a large proportion of patients in whom there is clinical uncertainty as to whether an immediate chest drain is required, with no robust evidence to inform practice. Chest drains carry a high risk of complications such as bleeding and infection. The default to invasive treatment may be causing potentially avoidable pain, distress and complications. We are evaluating the clinical and cost-effectiveness of an initial conservative approach to the management of patients with traumatic pneumothoraces.
METHODS AND ANALYSIS
The CoMiTED (Conservative Management in Traumatic Pneumothoraces in the Emergency Department) trial is a multicentre, pragmatic parallel group, individually randomised controlled non-inferiority trial to establish whether initial conservative management of significant traumatic pneumothoraces is non-inferior to invasive management in terms of subsequent emergency pleural interventions, complications, pain, breathlessness and quality of life. We aim to recruit 750 patients from at least 40 UK National Health Service hospitals. Patients allocated to the control (invasive management) group will have a chest drain inserted in the emergency department. For those in the intervention (initial conservative management) group, the treating clinician will be advised to manage the participant without chest drain insertion and undertake observation. The primary outcome is a binary measure of the need for one or more subsequent emergency pleural interventions within 30 days of randomisation. Secondary outcomes include complications, cost-effectiveness, patient-reported quality of life and patient and clinician views of the two treatment options; participants are followed up for 6 months.
ETHICS AND DISSEMINATION
This trial received approval from the Wales Research Ethics Committee 4 (reference: 22/WA/0118) and the Health Research Authority. Results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ISRCTN35574247.
Topics: Humans; Conservative Treatment; Pneumothorax; Chest Tubes; Emergency Service, Hospital; Drainage; Quality of Life; Cost-Benefit Analysis; Equivalence Trials as Topic; United Kingdom; Thoracic Injuries; Multicenter Studies as Topic
PubMed: 38889939
DOI: 10.1136/bmjopen-2024-087464 -
Acta Orthopaedica Jun 2024Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND AND PURPOSE
Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences.
METHODS AND ANALYSES
A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.
Topics: Humans; Scoliosis; Adolescent; Radiography; Child; Follow-Up Studies; Female; Male
PubMed: 38888063
DOI: 10.2340/17453674.2024.40904 -
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