scholarly journals Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitoring study

2020 ◽  
pp. 174077452097265
Author(s):  
William J Cragg ◽  
Caroline Hurley ◽  
Victoria Yorke-Edwards ◽  
Sally P Stenning
Keyword(s):  
Time To Event ◽  
Case Scenario ◽  
Monitoring Method ◽  
Central Monitoring ◽  
Stakeholder Groups ◽  
Site Monitoring ◽  
Independent Review ◽  
Compromise Patient Safety ◽  
Randomised Controlled ◽  
The Cost

Background/Aims: Clinical trials should be designed and managed to minimise important errors with potential to compromise patient safety or data integrity, employ monitoring practices that detect and correct important errors quickly, and take robust action to prevent repetition. Regulators highlight the use of risk-based monitoring, making greater use of centralised monitoring and reducing reliance on centre visits. The TEMPER study was a prospective evaluation of triggered monitoring (a risk-based monitoring method), whereby centres are prioritised for visits based on central monitoring results. Conducted in three UK-based randomised cancer treatment trials of investigational medicine products with time-to-event outcomes, it found high levels of serious findings at triggered centre visits but also at visits to matched control centres that, based on central monitoring, were not of concern. Here, we report a detailed review of the serious findings from TEMPER centre visits. We sought to identify feasible, centralised processes which might detect or prevent these findings without a centre visit. Methods: The primary outcome of this study was the proportion of all ‘major’ and ‘critical’ TEMPER centre visit findings theoretically detectable or preventable through a feasible, centralised process. To devise processes, we considered a representative example of each finding type through an internal consensus exercise. This involved (a) agreeing the potential, by some described process, for each finding type to be centrally detected or prevented and (b) agreeing a proposed feasibility score for each proposed process. To further assess feasibility, we ran a consultation exercise, whereby the proposed processes were reviewed and rated for feasibility by invited external trialists. Results: In TEMPER, 312 major or critical findings were identified at 94 visits. These findings comprised 120 distinct issues, for which we proposed 56 different centralised processes. Following independent review of the feasibility of the proposed processes by 87 consultation respondents across eight different trial stakeholder groups, we conclude that 306/312 (98%) findings could theoretically be prevented or identified centrally. Of the processes deemed feasible, those relating to informed consent could have the most impact. Of processes not currently deemed feasible, those involving use of electronic health records are among those with the largest potential benefit. Conclusions: This work presents a best-case scenario, where a large majority of monitoring findings were deemed theoretically preventable or detectable by central processes. Caveats include the cost of applying all necessary methods, and the resource implications of enhanced central monitoring for both centre and trials unit staff. Our results will inform future monitoring plans and emphasise the importance of continued critical review of monitoring processes and outcomes to ensure they remain appropriate.

scholarly journals Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: further analyses of findings from the prospective TEMPER triggered monitoring study

2020 ◽  
Author(s):  
William J Cragg ◽  
Caroline Hurley ◽  
Victoria Yorke-Edwards ◽  
Sally P Stenning
Keyword(s):  
Time To Event ◽  
Case Scenario ◽  
Monitoring Method ◽  
Central Monitoring ◽  
Stakeholder Groups ◽  
Site Monitoring ◽  
Independent Review ◽  
Compromise Patient Safety ◽  
Randomised Controlled ◽  
The Cost

AbstractBackground/AimsClinical trials should be designed and managed to minimise important errors with potential to compromise patient safety or data integrity, employ monitoring practices that detect and correct important errors quickly, and take robust action to prevent repetition. Regulators highlight the use of risk-based monitoring, making greater use of centralised monitoring and reducing reliance on centre visits. The TEMPER study was a prospective evaluation of triggered monitoring (a risk-based monitoring method), whereby centres are prioritised for visits based on central monitoring results. Conducted in three UK-based randomised cancer treatment trials of investigational medicine products with time-to-event outcomes, it found high levels of serious findings at triggered centre visits but also at visits to matched control centres that, based on central monitoring, were not of concern. Here, we report a detailed review of the serious findings from TEMPER centre visits. We sought to identify feasible, centralised processes which might detect or prevent these findings without a centre visit.MethodsWe considered a representative example of each finding type through a three-staged consensus exercise. 1: Three trialists independently reviewed the issues and graded their potential for detection by central monitoring or prevention by some described process, each on a five-point scale. 2. Results of round 1 were shared anonymously and each trialist re-reviewed the list choosing whether or not to change their grading. 3. The three trialists discussed and agreed grades for any issues without consensus, and proposed a feasibility score for each proposed process. In a consultation exercise, the proposed processes were reviewed and rated for feasibility by an invited external trialist group. The primary outcome was the proportion of all major and critical findings theoretically detectable or preventable through a feasible, centralised process.ResultsIn TEMPER, 312 major or critical findings were identified at 94 visits. These findings comprised 120 distinct issues, for which we proposed 56 different centralised processes. Following independent review of the feasibility of the proposed processes by 87 consultation respondents across different stakeholder groups, we conclude that 306/312 (98%) findings could theoretically be prevented or identified centrally.ConclusionsThis work presents a best-case scenario, where a large majority of monitoring findings were deemed theoretically preventable or detectable by central processes. Caveats include the cost of applying all necessary methods, and the resource implications of enhanced central monitoring for both centre and trials unit staff. Of processes not currently deemed feasible, use of electronic health records has the largest potential benefit.Our results will inform future monitoring plans and emphasise the importance of continued critical review of monitoring processes and outcomes to ensure they remain appropriate.

Structural displacement and strain monitoring based on the edge detection operator

2016 ◽  
Vol 20 (2) ◽  
pp. 191-201 ◽  
Author(s):  
Wei Lu ◽  
Yan Cui ◽  
Jun Teng
Keyword(s):  
Edge Detection ◽  
Image Features ◽  
Image Feature ◽  
Monitoring Method ◽  
Strain Monitoring ◽  
Morphological Operator ◽  
Filtering Effect ◽  
Circular Target ◽  
Plane Displacement ◽  
The Cost

To decrease the cost of instrumentation for the strain and displacement monitoring method that uses sensors as well as considers the structural health monitoring challenges in sensor installation, it is necessary to develop a machine vision-based monitoring method. For this method, the most important step is the accurate extraction of the image feature. In this article, the edge detection operator based on multi-scale structure elements and the compound mathematical morphological operator is proposed to provide improved image feature extraction. The proposed method can not only achieve an improved filtering effect and anti-noise ability but can also detect the edge more accurately. Furthermore, the required image features (vertex of a square calibration board and centroid of a circular target) can be accurately extracted using the extracted image edge information. For validation, the monitoring tests for the structural local mean strain and in-plane displacement were designed accordingly. Through analysis of the error between the measured and calculated values of the structural strain and displacement, the feasibility and effectiveness of the proposed edge detection operator are verified.

scholarly journals Cost-efficiency assessments of marine monitoring methods lack rigor—a systematic mapping of literature and an end-user view on optimal cost-efficiency analysis

2021 ◽  
Vol 193 (7) ◽  
Author(s):  
Heini Hyvärinen ◽  
Annaliina Skyttä ◽  
Susanna Jernberg ◽  
Kristian Meissner ◽  
Harri Kuosa ◽  
...  
Keyword(s):  
Comparative Studies ◽  
Cost Efficiency ◽  
Cost Benefit ◽  
Marine Ecosystems ◽  
Actual Cost ◽  
Monitoring Methods ◽  
Monitoring Method ◽  
Marine Monitoring ◽  
The Status ◽  
The Cost

AbstractGlobal deterioration of marine ecosystems, together with increasing pressure to use them, has created a demand for new, more efficient and cost-efficient monitoring tools that enable assessing changes in the status of marine ecosystems. However, demonstrating the cost-efficiency of a monitoring method is not straightforward as there are no generally applicable guidelines. Our study provides a systematic literature mapping of methods and criteria that have been proposed or used since the year 2000 to evaluate the cost-efficiency of marine monitoring methods. We aimed to investigate these methods but discovered that examples of actual cost-efficiency assessments in literature were rare, contradicting the prevalent use of the term “cost-efficiency.” We identified five different ways to compare the cost-efficiency of a marine monitoring method: (1) the cost–benefit ratio, (2) comparative studies based on an experiment, (3) comparative studies based on a literature review, (4) comparisons with other methods based on literature, and (5) subjective comparisons with other methods based on experience or intuition. Because of the observed high frequency of insufficient cost–benefit assessments, we strongly advise that more attention is paid to the coverage of both cost and efficiency parameters when evaluating the actual cost-efficiency of novel methods. Our results emphasize the need to improve the reliability and comparability of cost-efficiency assessments. We provide guidelines for future initiatives to develop a cost-efficiency assessment framework and suggestions for more unified cost-efficiency criteria.

On-site monitoring of bearing failure in composite bolted joints using built-in eddy current sensing film

2020 ◽  
pp. 002199832097973
Author(s):  
Qijian Liu ◽  
Hu Sun ◽  
Yuan Chai ◽  
Jianjian Zhu ◽  
Tao Wang ◽  
...  
Keyword(s):  
Numerical Simulations ◽  
Eddy Current ◽  
Failure Modes ◽  
Bolted Joints ◽  
Bearing Failure ◽  
Monitoring Method ◽  
Current Sensing ◽  
Site Monitoring ◽  
Array Sensing ◽  
Bearing Damage

Bearing damage is one of the common failure modes in composite bolted joints. This paper describes the development of an on-site monitoring method based on eddy current (EC) sensing film to monitor the bearing damage in carbon fiber reinforced plastic (CFRP) single-lap bolted joints under tensile testing. Configuration design and operating principles of EC array sensing film are demonstrated. A series of numerical simulations are conducted to analyze the variation of EC when the bearing failure occurs around the bolt hole. The results of damage detection in the horizontal direction and through the thickness direction in the bolt hole with different exciting current directions are presented by the finite element method (FEM). Experiments are performed to prove the feasibility of the proposed EC array sensing film when the bearing failure occurs in CFRP single-lap bolted joints. The results of numerical simulations and experiments indicate that bearing failure can be detected according to the variation of EC in the test specimen.

scholarly journals Cost-effectiveness analysis of an intimate partner violence prevention intervention targeting men, women and couples in rural Ethiopia: evidence from the Unite for a Better Life randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma
Keyword(s):  
Intimate Partner Violence ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Partner Violence ◽  
Controlled Trial ◽  
Intimate Partner ◽  
Community Level ◽  
Secondary Outcome ◽  
Randomised Controlled ◽  
The Cost

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)

A Systematic Review of Cost-Effectiveness Analyses Alongside Randomised Controlled Trials of Acupuncture

2012 ◽  
Vol 30 (4) ◽  
pp. 273-285 ◽  
Author(s):  
Song-Yi Kim ◽  
Hyangsook Lee ◽  
Younbyoung Chae ◽  
Hi-Joon Park ◽  
Hyejung Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Economic Evaluations ◽  
Controlled Trials ◽  
German Studies ◽  
Life Years ◽  
Randomised Controlled ◽  
The Cost

Objective To summarise the evidence on the cost-effectiveness of acupuncture. Methods We identified full economic evaluations such as cost-effectiveness analysis (CEA), cost-utility analysis (CUA) and cost-benefit analysis (CBA) alongside randomised controlled trials (RCTs) that assessed the consequences and costs of acupuncture for any medical condition. Eleven electronic databases were searched up to March 2011 without language restrictions. Eligible RCTs were assessed using the Cochrane criteria for risk of bias and a modified version of the checklist for economic evaluation. The general characteristics and the results of each economic analysis such as incremental cost-effectiveness ratios (ICERs) were extracted. Results Of 17 included studies, nine were CUAs that measured quality-adjusted life years (QALYs) and eight were CEAs that assessed effectiveness of acupuncture based on improvements in clinical symptoms. All CUAs showed that acupuncture with or without usual care was cost-effective compared with waiting list control or usual care alone, with ICERs ranging from ¢3011/QALY (dysmenorrhoea) to ¢22 298/QALY (allergic rhinitis) in German studies, and from £3855/QALY (osteoarthritis) to £9951/QALY (headache) in UK studies. In the CEAs, acupuncture was beneficial at a relatively low cost in six European and Asian studies. All CUAs were well-designed with a low risk of bias, but this was not the case for CEAs. Conclusions Overall, this review demonstrates the cost-effectiveness of acupuncture. Despite such promising results, any generalisation of these results needs to be made with caution given the diversity of diseases and the different status of acupuncture in the various countries.

scholarly journals The Evaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: a randomised controlled trial

2021 ◽  
Vol 19 (3) ◽  
pp. 2397
Author(s):  
M. Rozaini Rosli ◽  
Chin F. Neoh ◽  
David B. Wu ◽  
Nazariah W. Hassan ◽  
Mahani Mahmud ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Community Pharmacists ◽  
Anthropometric Data ◽  
Anthropometric Parameters ◽  
Home Medication ◽  
Medication Wastage ◽  
Randomised Controlled ◽  
The Cost

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients. Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage. Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively. Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted. Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted. 

scholarly journals Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review

2020 ◽  
Author(s):  
William J Cragg ◽  
Caroline Hurley ◽  
Victoria Yorke-Edwards ◽  
Sally P Stenning
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Research Question ◽  
Trial Data ◽  
Monitoring Methods ◽  
Central Monitoring ◽  
Statistical Monitoring ◽  
Site Monitoring ◽  
Central Statistical ◽  
Monitoring Activity

AbstractBackground/AimsIt is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have in recent years encouraged more risk-based monitoring. Risk assessment should take place before a trial begins in order to define the overarching monitoring strategy. It can also be done on an ongoing basis, in order to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like ‘central statistical monitoring’, ‘triggered monitoring’ or, as in ICH Good Clinical Practice guidance, ‘targeted on-site monitoring’. We conducted a scoping review to identify such methods, to establish if any published methods were supported by adequate evidence to allow wider implementation, and to point the way to future developments in this field of research.MethodsWe used 7 publication databases, 2 sets of methodological conference abstracts and an internet search engine to look for methods for using centrally held trial data to assess site conduct during a trial. We included only reports in English, and excluded reports published before 1996 and reports not directly relevant to our research question. We used reference and citation searches to find additional relevant reports. We extracted data using a pre- defined template. We contacted authors to request additional information about included reports and to check whether reports might be eligible.ResultsWe included 30 reports in our final dataset, of which 21 were peer-reviewed publications. 20 reports described central statistical monitoring methods (of which 7 focussed on detection of fraud or misconduct) and 9 described triggered monitoring methods. 21 reports included some assessment of their methods’ effectiveness. Most commonly this involved exploring the methods’ characteristics using real trial data with no known integrity issues. Of the 21 with some effectiveness assessment, most presented limited or no information about whether or not concerns identified through central monitoring constituted meaningful problems. Some reports commented on cost savings from reduced on-site monitoring, but none gave detailed costings for the development and maintenance of central monitoring methods themselves.ConclusionsOur review identified various proposed methods, some of which could be combined within the same trial. The apparent emphasis on fraud detection may not be proportionate in all trial settings. Although some methods have self-justifying benefits for data cleaning activity, many have limitations that may currently prevent their routine use for targeting trial monitoring activity. The implementation costs, or uncertainty about these, may also be a barrier. We make recommendations for how the evidence-base supporting these methods could be improved.

scholarly journals No gender-related bias in COPD diagnosis and treatment in Sweden: a randomised, controlled, case-based trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00342-2020
Author(s):  
Hamid Akbarshahi ◽  
Zainab Ahmadi ◽  
David C. Currow ◽  
Jacob Sandberg ◽  
Zac Vandersman ◽  
...  
Keyword(s):  
Gender Bias ◽  
Diagnostic Procedures ◽  
Morbidity And Mortality ◽  
Case Scenario ◽  
Double Blind ◽  
Diagnosis And Management ◽  
Hypothetical Patient ◽  
Parallel Group ◽  
Randomised Controlled ◽  
Study Participants

IntroductionCOPD is a major cause of morbidity and mortality. The prevalence, morbidity and mortality of COPD among females have increased. Previous studies indicate a possible gender bias in the diagnosis and management of COPD. The present study aims to determine if there is gender bias in the management of COPD in Sweden.MethodsThis was a double-blind, randomised (1:1), controlled, parallel-group, web-based trial using the hypothetical case scenario of a former smoker (40 pack-years and quit smoking 3 years ago) who was male or female. The participants were blind to the randomisation and the purpose of the trial. The case progressively revealed more information with associated questions on how the physician would manage the patient. Study participants chose from a list of tests and treatments at each step of the case scenario.ResultsIn total, 134 physicians were randomised to a male (n=62) or a female (n=72) case. There was no difference in initial diagnosis (61 (98%) male cases and 70 (97%) female cases diagnosed with COPD) and planned diagnostic procedures between the male and female cases. Spirometry was chosen by all the physicians as one of the requested diagnostic tests. The management of the hypothetical COPD case did not differ by sex of the responding physician.ConclusionIn Sweden, diagnosis and management of a hypothetical patient with COPD did not differ by the gender of the patient or physician.

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