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BMJ Open Jun 2024Smoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with...
Assessing the feasibility and acceptability of a diabetes-specific nurse-led multicomponent smoking cessation intervention in diabetes education: study protocol for an open-label pragmatic randomised controlled trial.
INTRODUCTION
Smoking cessation is an essential, but often overlooked aspect of diabetes management. Despite the need for tailored smoking cessation support for individuals with diabetes, evidence of effective interventions for this cohort is limited. Additionally, individuals with diabetes do not easily adopt such interventions, resulting in low uptake and abstinence rates. This protocol describes a study that aims to assess the feasibility and acceptability of a unique smoking cessation intervention, based on the best evidence, theory and the needs of individuals with diabetes, among patients and service providers, the diabetes nurse educators.
METHODS AND ANALYSIS
This is an open-label pragmatic randomised controlled trial. Between 80 and 100 individuals with type 1 or type 2 diabetes who smoke will be recruited from the diabetes outpatients at the main acute public hospital in Malta, starting in August 2023. Participants will be randomly assigned (1:1 ratio) to the intervention or control arm for 12 weeks. The experimental intervention will consist of three to four smoking cessation behavioural support sessions based on the 5As (Ask, Advise, Assess, Assist and Arrange) algorithm, and a 6-week supply of nicotine replacement therapy. The control intervention will consist of an active referral to the Maltese National Health Service's one-to-one smoking cessation support service, which is based on motivational interviewing. The primary feasibility and acceptability outcomes include the recruitment and participation rates, resources used, problems identified by the nurses, the nurses' perceived challenges and facilitators to implementation and the nurses' and patients' acceptability of the study intervention. Data analyses will be descriptive, with quantitative feasibility and acceptability outcomes reported with 95% confidence intervals.
ETHICS AND DISSEMINATION
Ethical clearance was obtained from the Faculty of Health Sciences Research Ethics Committee, University of Malta. The study results will be disseminated through conference presentations and a publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
NCT05920096.
Topics: Humans; Smoking Cessation; Feasibility Studies; Pragmatic Clinical Trials as Topic; Diabetes Mellitus, Type 2; Patient Education as Topic; Diabetes Mellitus, Type 1; Patient Acceptance of Health Care
PubMed: 38904126
DOI: 10.1136/bmjopen-2023-083235 -
Frontiers in Neurology 2024Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant...
BACKGROUND
Painful diabetic neuropathy (PDN) is a common chronic neurological complication of diabetes mellitus. Medications are often used to relieve pain, but with significant side effects. Acupuncture is now a component of pragmatic and integrative treatment for PDN. An increasing number of relevant randomized controlled trials have been published in recent years, but a comprehensive meta-analysis has not yet been performed. The aim of this paper is to verify the effectiveness and safety of acupuncture for PDN by meta-analysis and trial sequential analysis (TSA).
METHODS
All participants in this study should have had a PDN diagnosis and the trial group was treated with acupuncture. Eight databases, including EMbase, PubMed, Web of science, Cochrane Library, China Biology Medicine disc (CBM), China National Knowledge Infrastructure (CNKI), Wanfang and Chongqing VIP (CQVIP) were retrieved from inception to 5 April 2023. Meta-analysis was conducted utilizing RevMan 5.3 and Stata 15.0. TSA was performed to assess the adequacy of sample size for the outcomes.
RESULTS
A total of 36 studies, comprising 2,739 PDN patients, were included. Among them, 1,393 patients were assigned to the trial group and 1,346 patients were treated in the control group. Outcomes covers the primary indicator Total effective rate (RR = 1.42, 95%CI [1.34, 1.52], < 0.00001), with 21 studies reported, Pain intensity (SMD = -1.27, 95%CI [-1.58, -0.95], p < 0.00001), with 23 studies reported, and other outcomes, including motor nerve conduction velocity (MCV; MD = 3.58, 95%CI [2.77, 4.38], < 0.00001), sensory nerve conduction velocity (SCV; MD = 3.62, 95%CI [2.75, 4.49], < 0.00001), Depression score (SMD = -1.02, 95%CI [1.58, 0.46]), Toronto clinical scoring system (TCSS; MD = -2.41, 95%CI [-3.37, -1.45], < 0.00001), Quality of life (SMD = 1.06, 95%CI [0.66, 1.46]), traditional Chinese medicine (TCM) syndrome score (MD = -4.99, 95%CI [-6.79, -3.18], < 0.00001), suggesting that acupuncture have an ameliorating effect on PDN in various respect. Egger's test revealed publication bias for four outcomes. TSA showed that as for Total effective rate, Pain Intensity, MCV and SCV, the number of included studies was sufficient to support the conclusions.
CONCLUSION
Acupuncture demonstrates significant effectiveness in improving PDN outcomes, including Total effective rate, Pain intensity, MCV, SCV, Depression score, TCSS, Quality of life, TCM syndrome score. But the Adverse events rate is no different in trail group and control group. The publication bias presented in Total effective rate, Pain intensity, MCV and SCV can be remedied by Trim and filling method.
SYSTEMATIC REVIEW REGISTRATION
Prospero, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=477295.
PubMed: 38903165
DOI: 10.3389/fneur.2024.1402458 -
British Dental Journal Jun 2024Introduction The International Caries Classification and Management System (ICCMS) was developed to standardise caries diagnosis, risk assessment and treatment decisions...
Introduction The International Caries Classification and Management System (ICCMS) was developed to standardise caries diagnosis, risk assessment and treatment decisions based on overall evidence. To evaluate its criteria in practice, a clinical trial assessed professionals' perceptions of two caries management systems.Methods A perception questionnaire was administered to two groups: one using ICCMS criteria and the other based on professional experience criteria (non-ICCMS group). The online questionnaire included quantitative scale questions to measure effort and satisfaction and two open-ended questions to collect the positive and negative perceptions of dentists by using either criteria system. The questionnaires were administered six months after the study's implementation.Results Both groups showed high levels of effort and satisfaction. Professionals using ICCMS reported more positive perceptions by citing improved diagnosis (71.4%) and standardised patient care (43%). However, they also noted negative aspects, such as increased number of questionnaires and records (58%), longer clinical sessions (43%) and higher rates of patient absenteeism (29%).Conclusion Professionals who used the ICCMS had a positive outlook on the system, with benefits seen in diagnosis and patient monitoring. However, there is room for improvement in terms of automation and simplification to enhance the professional use of the system in the clinical setting.
PubMed: 38902437
DOI: 10.1038/s41415-024-7510-9 -
International Journal of Medical... Jun 2024The surge in emergency head CT imaging and artificial intelligence (AI) advancements, especially deep learning (DL) and convolutional neural networks (CNN), have... (Review)
Review
BACKGROUND
The surge in emergency head CT imaging and artificial intelligence (AI) advancements, especially deep learning (DL) and convolutional neural networks (CNN), have accelerated the development of computer-aided diagnosis (CADx) for emergency imaging. External validation assesses model generalizability, providing preliminary evidence of clinical potential.
OBJECTIVES
This study systematically reviews externally validated CNN-CADx models for emergency head CT scans, critically appraises diagnostic test accuracy (DTA), and assesses adherence to reporting guidelines.
METHODS
Studies comparing CNN-CADx model performance to reference standard were eligible. The review was registered in PROSPERO (CRD42023411641) and conducted on Medline, Embase, EBM-Reviews and Web of Science following PRISMA-DTA guideline. DTA reporting were systematically extracted and appraised using standardised checklists (STARD, CHARMS, CLAIM, TRIPOD, PROBAST, QUADAS-2).
RESULTS
Six of 5636 identified studies were eligible. The common target condition was intracranial haemorrhage (ICH), and intended workflow roles auxiliary to experts. Due to methodological and clinical between-study variation, meta-analysis was inappropriate. The scan-level sensitivity exceeded 90 % in 5/6 studies, while specificities ranged from 58,0-97,7 %. The SROC 95 % predictive region was markedly broader than the confidence region, ranging above 50 % sensitivity and 20 % specificity. All studies had unclear or high risk of bias and concern for applicability (QUADAS-2, PROBAST), and reporting adherence was below 50 % in 20 of 32 TRIPOD items.
CONCLUSION
0.01 % of identified studies met the eligibility criteria. The evidence on the DTA of CNN-CADx models for emergency head CT scans remains limited in the scope of this review, as the reviewed studies were scarce, inapt for meta-analysis and undermined by inadequate methodological conduct and reporting. Properly conducted, external validation remains preliminary for evaluating the clinical potential of AI-CADx models, but prospective and pragmatic clinical validation in comparative trials remains most crucial. In conclusion, future AI-CADx research processes should be methodologically standardized and reported in a clinically meaningful way to avoid research waste.
PubMed: 38901270
DOI: 10.1016/j.ijmedinf.2024.105523 -
Movement Disorders Clinical Practice Jun 2024Parkinson's Disease (PD) is a progressive neurological disorder that results in potentially debilitating mobility deficits. Recently, spinal cord stimulation (SCS) has... (Review)
Review
BACKGROUND
Parkinson's Disease (PD) is a progressive neurological disorder that results in potentially debilitating mobility deficits. Recently, spinal cord stimulation (SCS) has been proposed as a novel therapy for PD gait disorders. The highest levels of evidence remain limited for SCS.
OBJECTIVES
In this systematic review and narrative synthesis, the literature was searched using combinations of key phrases indicating spinal cord stimulation and PD.
METHODS
We included pre-clinical studies and all published clinical trials, case reports, conference abstracts as well as protocols for ongoing clinical trials. Additionally, we included trials of SCS applied to atypical parkinsonism.
RESULTS
A total of 45 human studies and trials met the inclusion criteria. Based on the narrative synthesis, a number of knowledge gaps and future avenues of potential research were identified. This review demonstrated that evidence for SCS is currently not sufficient to recommend it as an evidence-based therapy for PD related gait disorders. There remain challenges and significant barriers to widespread implementation, including issues regarding patient selection, effective outcome selection, stimulation location and mode, and in programming parameter optimization. Results of early randomized controlled trials are currently pending. SCS is prone to placebo, lessebo and nocebo as well as blinding effects which may impact interpretation of outcomes, particularly when studies are underpowered.
CONCLUSION
Therapies such as SCS may build on current evidence and be shown to improve specific gait features in PD. Early negative trials should be interpreted with caution, as more evidence will be required to develop effective methodologies in order to drive clinical outcomes.
PubMed: 38899557
DOI: 10.1002/mdc3.14143 -
Clinical Trials (London, England) Jun 2024Performing large randomized trials in anesthesiology is often challenging and costly. The clinically integrated randomized trial is characterized by simplified logistics...
BACKGROUND
Performing large randomized trials in anesthesiology is often challenging and costly. The clinically integrated randomized trial is characterized by simplified logistics embedded into routine clinical practice, enabling ease and efficiency of recruitment, offering an opportunity for clinicians to conduct large, high-quality randomized trials under low cost. Our aims were to (1) demonstrate the feasibility of the clinically integrated trial design in a high-volume anesthesiology practice and (2) assess whether trial quality improvement interventions led to more balanced accrual among study arms and improved trial compliance over time.
METHODS
This is an interim analysis of recruitment to a cluster-randomized trial investigating three nerve block approaches for mastectomy with immediate implant-based reconstruction: paravertebral block (arm 1), paravertebral plus interpectoral plane blocks (arm 2), and serratus anterior plane plus interpectoral plane blocks (arm 3). We monitored accrual and consent rates, clinician compliance with the randomized treatment, and availability of outcome data. Assessment after the initial year of implementation showed a slight imbalance in study arms suggesting areas for improvement in trial compliance. Specific improvement interventions included increasing the frequency of communication with the consenting staff and providing direct feedback to clinician investigators about their individual recruitment patterns. We assessed overall accrual rates and tested for differences in accrual, consent, and compliance rates pre- and post-improvement interventions.
RESULTS
Overall recruitment was extremely high, accruing close to 90% of the eligible population. In the pre-intervention period, there was evidence of bias in the proportion of patients being accrued and receiving the monthly block, with higher rates in arm 3 (90%) compared to arms 1 (81%) and 2 (79%, p = 0.021). In contrast, in the post-intervention period, there was no statistically significant difference between groups (p = 0.8). Eligible for randomization rate increased from 89% in the pre-intervention period to 95% in the post-intervention period (difference 5.7%; 95% confidence interval = 2.2%-9.4%, p = 0.002). Consent rate increased from 95% to 98% (difference of 3.7%; 95% confidence interval = 1.1%-6.3%; p = 0.004). Compliance with the randomized nerve block approach was maintained at close to 100% and availability of primary outcome data was 100%.
CONCLUSION
The clinically integrated randomized trial design enables rapid trial accrual with a high participant compliance rate in a high-volume anesthesiology practice. Continuous monitoring of accrual, consent, and compliance rates is necessary to maintain and improve trial conduct and reduce potential biases. This trial methodology serves as a template for the implementation of other large, low-cost randomized trials in anesthesiology.
PubMed: 38895970
DOI: 10.1177/17407745241255087 -
BMJ Surgery, Interventions, & Health... 2024Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced...
Clinical effectiveness of a modified muscle sparing posterior technique compared with a standard lateral approach in hip hemiarthroplasty for displaced intracapsular fractures (HemiSPAIRE): a multicenter, parallel-group, randomized controlled trial.
OBJECTIVES
Assess the effect of a modified muscle sparing posterior approach; SPAIRE (Save Piriformis and Internus, Repairing Externus), in hip hemiarthroplasty for displaced intracapsular fractures on postoperative mobility and function compared with a standard lateral approach.
DESIGN
Pragmatic, superiority, multicenter, parallel-group, randomized controlled trial (with internal pilot). Participants, ward staff, and research staff conducting postoperative assessments were blinded to allocation. A CTU allocated treatments centrally using computer-generated lists.
SETTING
Six hospitals in Southwest England, recruiting November 25, 2019-April 25, 2022.
PARTICIPANTS
244 adults (≥60 years) requiring hip hemiarthroplasty (122 allocated to each approach). 90 and 85 participants allocated to SPAIRE and lateral, respectively, had primary outcome data within the prespecified data collection window.
INTERVENTIONS
Surgery using SPAIRE or standard lateral approach. Follow-up 3 days and 120 days postoperation.
MAIN OUTCOME MEASURE
Oxford Hip Score (OHS), via telephone at 120 days. Secondary outcomes: function and mobility (3 days), pain (3 days, 120 days), discharge destination, length of hospital stay, complications and mortality (within 120 days), quality of life and place of residence (120 days).
RESULTS
Participants' mean age was 84.6 years (SD 7.2); 168 (69%) were women. Primary outcome: little evidence of a difference in OHS at 120 days; adjusted mean difference (SPAIRE-lateral) -1.23 (95% CI -3.96 to 1.49, p=0.37). Secondary outcomes: indication of lower participant-reported pain at 3 days in SPAIRE arm; no differences between arms for remaining outcomes.
CONCLUSIONS
Participants' mobility and function are similar in the short term (3 days) and longer term (120 days), whether receiving the SPAIRE or lateral approach. Neither approach confers benefit over the other in terms of length of hospital stay, return to prefracture residence, survival within 120 days, or quality of life at 120 days. Participants receiving SPAIRE approach may experience less pain in the early postoperative period. Modifying the posterior approach in hip hemiarthroplasty to the SPAIRE approach gives equivalent patient outcomes to the lateral approach within 120 days.
TRIAL REGISTRATION NUMBER
NCT04095611.
PubMed: 38895600
DOI: 10.1136/bmjsit-2023-000251 -
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