-
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 -
Medical & Biological Engineering &... Jun 2024According to the available studies, mobile applications have provided significant support in improving the diverse skills of special individuals with social pragmatic...
According to the available studies, mobile applications have provided significant support in improving the diverse skills of special individuals with social pragmatic communication disorder (SPCD). Over the last decade, SPCD has affected 8 to 11% of individuals, and therapy sessions cost between $50 and $150 per hour. This preliminary study aims to develop an interactive, user-friendly intervention to enhance social and emotional interaction skills in individuals with SPCD. The proposed intervention is an Android application that enhances social and emotional interaction skills. This pilot study involved 29 human subjects aged 7-13 years with pragmatic communication deficits. In a randomized controlled trial, the intervention was developed and implemented with consideration of caregiver and professional requirements. The improvement was analyzed using standard scales, including the Social Communication Questionnaire (SCQ) and the Social Communication Disorder Scale (SCDS). Moreover, the outcomes were examined through statistical parameters (mean, standard deviation) and tests (t-test). The intervention significantly improved the social and emotional skills of individuals with deficits. Before using the intervention, the identified statistical values for SCQ (mean = 6.48 and standard deviation = 3.37) and SCDS (mean = 8.17 and standard deviation = 4.79). However, after using the intervention, values for SCQ (mean = 8.24 and standard deviation = 3.95) and SCDS (mean = 9.48 and standard deviation = 4.72) were improved in comparison to the before-intervention outcome. The evaluation of the t-scores and p-values indicates that there has been significant improvement in the performance of individuals after the successful completion of the intervention. The proposed and applied intervention resulted in a significant impact in terms of improvement in social and emotional skills. The study concluded that it allows individuals to practice social and emotional interaction skills in a structured, controlled, and interactive environment. The proposed intervention has been found acceptable as per the reviews of caregivers and professionals, based on essential criteria including user experience, usability, interactive nature, reliability, and creditability.
PubMed: 38890200
DOI: 10.1007/s11517-024-03151-7 -
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 -
Diabetes, Obesity & Metabolism Jun 2024To evaluate the real-world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D).
AIM
To evaluate the real-world effectiveness of automated insulin delivery (AID) systems in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS
PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov were searched for studies published up until 2 March 2024. We included pragmatic randomized controlled trials (RCTs), cohort studies, and before-after studies that compared AID systems with conventional insulin therapy in real-world settings and reported continuous glucose monitoring outcomes. Percent time in range (TIR; 3.9-10 mmol/L), time below range (TBR; <3.9 mmol/L), time above range (TAR; >10 mmol/L), and glycated haemoglobin (HbA1c) level were extracted. Data were summarized as mean differences (MDs) with 95% confidence interval.
RESULTS
A total of 23 before-after studies (101 704 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR (11.61%, 10.47 to 12.76; p < 0.001). The favourable effect of AID systems was consistently observed when used continuously for 6 (11.76%) or 12 months (11.33%), and in both children (12.16%) and adults (11.04%). AID systems also showed favourable effects on TBR (-0.53%, -0.63 to -0.42), TAR (-9.65%, -10.63 to -8.67) and HbA1c level (-0.42%, -0.47 to -0.37) when compared with previous treatments.
CONCLUSIONS
Similar improvements in glycaemic parameters were observed in real-world settings in RCTs using AID systems in T1D. AID systems benefit both children and adults by increasing TIR for both short- and long-term interventions.
PubMed: 38888056
DOI: 10.1111/dom.15718 -
Circulation. Cardiovascular Quality and... Jun 2024Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique...
BACKGROUND
Cardiogenic shock is a morbid complication of heart disease that claims the lives of more than 1 in 3 patients presenting with this syndrome. Supporting a unique collaboration across clinical specialties, federal regulators, payors, and industry, the American Heart Association volunteers and staff have launched a quality improvement registry to better understand the clinical manifestations of shock phenotypes, and to benchmark the management patterns, and outcomes of patients presenting with cardiogenic shock to hospitals across the United States.
METHODS
Participating hospitals will enroll consecutive hospitalized patients with cardiogenic shock, regardless of etiology or severity. Data are collected through individual reviews of medical records of sequential adult patients with cardiogenic shock. The electronic case record form was collaboratively designed with a core minimum data structure and aligned with Shock Academic Research Consortium definitions. This registry will allow participating health systems to evaluate patient-level data including diagnostic approaches, therapeutics, use of advanced monitoring and circulatory support, processes of care, complications, and in-hospital survival. Participating sites can leverage these data for onsite monitoring of outcomes and benchmarking versus other institutions. The registry was concomitantly designed to provide a high-quality longitudinal research infrastructure for pragmatic randomized trials as well as translational, clinical, and implementation research. An aggregate deidentified data set will be made available to the research community on the American Heart Association's Precision Medicine Platform. On March 31, 2022, the American Heart Association Cardiogenic Shock Registry received its first clinical records. At the time of this submission, 100 centers are participating.
CONCLUSIONS
The American Heart Association Cardiogenic Shock Registry will serve as a resource using consistent data structure and definitions for the medical and research community to accelerate scientific advancement through shared learning and research resulting in improved quality of care and outcomes of shock patients.
PubMed: 38887950
DOI: 10.1161/CIRCOUTCOMES.123.010637 -
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