Knowledge, attitudes, and behaviors related to dietary salt intake and the acceptability of salt substitute among the Australian culturally and linguistically diverse community: An online survey.

The Australian culturally and linguistically diverse (CALD) communities may be at higher risk of salt intake than recommended given the use of a combination of discretionary sources and exposure to processed foods within a western country. This survey aimed to understand the knowledge, attitudes, and behaviors toward dietary salt and the acceptability of salt substitutes in the CALD communities. An online cross-sectional survey was conducted among adults who self-reported being a part of a CALD community, which was defined as non-Indigenous cultural groups in Australia having cultural or linguistic connections with their overseas place of birth, ancestry or ethnic origin, religion, preferred language or language spoken at home. A total of 218 respondents opened the survey link. A total of 196 completed the entire survey. The majority of respondents (162, 83%) were aware that high salt intake causes serious health problems. Altogether 134 (69%) respondents were aware that there is a recommended amount for daily salt consumption although only 59 (44%) knew precise recommendations as <5 g salt per day. Around one quarter of the respondents rarely or never looked for ?low in salt'' or ?reduced salt'' messages on food labels when shopping. Over half specified they always or often added salt during cooking or preparing foods in the household. Almost 4 in 5 CALD respondents were willing to reduce their salt intake for health and 3 in 4 were open to trying a salt substitute. Further research into the utility of a salt substitute intervention in the Australian CALD community is warranted.

The Effect of Weight Loss Through Lifestyle Interventions in Patients With Heart Failure With Preserved Ejection Fraction-A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) accounts for >50% of heart failure cases and is associated with significant morbidity and health system burden. To date, there have been limited treatment options proven to improve outcomes in these patients, with sodium glucose co-transporter 2 (SGLT2) inhibitors the first class of drug to demonstrate significant clinical benefits, including reductions in heart failure hospitalisation. Obesity is associated with all forms of heart failure and has been linked with worse clinical outcomes. Numerous reviews support the benefits of weight loss in heart failure, more specifically in patients with heart failure with reduced ejection fraction. However, the evidence in HFpEF patients is less clear. With limited pharmacotherapy options and growing support for weight loss in patients with HFpEF, this systematic review and meta-analysis aims to examine the effects of lifestyle interventions on weight loss and other health outcomes in patients with HFpEF. METHODS: Web of Science, Embase, Scopus, and PubMed databases were searched to identify relevant studies up to February 2023. Included studies were randomised controlled trials (with a duration of four weeks or more) of lifestyle interventions conducted in adults with HFpEF that reported weight loss. Outcomes of interest were body weight, body mass index (BMI), blood pressure (systolic and diastolic), aerobic capacity (6-minute walk distance), New York Heart Association (NYHA) Functional Classification, self-reported health quality of life (Minnesota Living with Heart Failure Questionnaire; MLHFQ), and N-terminal pro B-Type Natriuretic Peptide (NT-proBNP) levels. Review Manager software was used to conduct random effect meta-analyses, forest plots were generated for each outcome, and between-study heterogeneity was estimated using the I2 test statistic. Risk-of-bias assessment used the Cochrane risk-of-bias tool, and the certainty of the evidence was assessed using GRADE. RESULTS: From 2,282 records identified, six studies with a total of 375 participants, between three to six months in duration, were included in this systematic review and meta-analysis. Lifestyle interventions consisted of diet only, exercise only, combination of diet and exercise, and education and exercise. Over a mean follow-up of 4.5 months, pooled effects of the interventions were associated with a reduction in body weight of >5kg (weight mean difference (WMD): -5.30 kg; 95% CI: -8.72 to -1.87; p=0.002), and a reduction in resting systolic (WMD: -2.98 mmHg; 95% CI: -4.20 to -1.76; p<0.001) and diastolic blood pressure (WMD: -4.51 mmHg; 95% CI: -8.39 to -0.64; p=0.02) compared with those who received usual care. Interventions also improved 6-minute walk distance (WMD: 43.63 m; 95% CI: 22.28 to 64.97; p<0.001), NYHA class (WMD: -0.54; 95% CI: -0.75 to -0.33; p<0.001), and MLHFQ score (WMD: -17.77; 95% CL: -19.00 to -16.53; p<0.001). CONCLUSION: In patients with HFpEF, lifestyle intervention was associated with a significant reduction in body weight and had favourable effects on blood pressure, aerobic capacity, NYHA class, and health-related quality of life. Further research is needed in this population to examine the feasibility and durability of weight loss interventions and to examine the potential impact on hard clinical endpoints.

Exploring factors to interpretation of targeted nutrition messages for people living with multiple sclerosis.

OBJECTIVES: Current dietary recommendations for MS suggest following national dietary guidelines developed for the general population. The aim of this study was to explore the interpretation of MS-targeted nutrition messages. METHODS: Using the Elaboration Likelihood Model of persuasion, three nutrition messages were developed targeting the strongest evidence for MS: vitamin D, dietary fat, and dietary diversity. Semi-structured interviews including the cognitive 'thinking-aloud' technique were used to test the messages with adults living with MS. Data were transcribed and coded thematically. RESULTS: Theoretical saturation was reached by 15 interviews. The data corpus indicated three themes and seven subthemes. The data revealed that people living with MS changed their diet after MS diagnosis. Dietary change was due to uncertainty, fear of disease progression and risk of relapse. The admiration and scepticism of extremist MS diets depended on personal vulnerability and support from health care professionals. The unique MS journey appeared influential to message interpretation; driven by engagement, practicality, and credibility. CONCLUSION: The interpretation of targeted nutrition messages revealed that dietary changes made after diagnosis are a coping mechanism to improve sense of control and self-management. PRACTICAL IMPLICATIONS: The potential psychological benefit of dietary change for MS management must be prioritised using person-centred care.

Recruitment, retention, and experiences of Australian male dietitians: A cross-sectional online survey.

AIM: Male dietitians are under-represented in the global dietetics workforce, including in Australia. This study explores Australian males' experiences as dietitians in the Australian workforce, with the aim to identify influences that initially attracted them to dietetics, as well as barriers that may affect their decision to stay in or leave the profession. METHODS: A cross-sectional, semi-quantitative web-based survey was distributed to male dietitians using purposive, snowball sampling. Closed and open-ended questions were included. Descriptive statistics were generated, and content analysis of free-text responses identified major themes. RESULTS: Seventy-one respondents opened the survey link, of which 65 respondents attempted the survey. Fifty-four (83.1%) respondents agreed that dietetics is female-dominated. An interest in food and nutrition was the most reported reason for studying dietetics (73.8%). Of the 55 respondents who were not intending to retire in the next 5 years, 15 (27.3%) stated they were somewhat or extremely likely to leave the profession of dietetics. Respondents identified issues that impacted their experiences as a male dietitian, including gender differences, a lack of male role models, barriers to career progression/employment, and perceptions of a lack of respect and impact within healthcare. CONCLUSIONS: Australian male dietitians perceive systemic, social, and personal factors that have influenced their career experiences. Greater exposure to prominent male role models may be self-perpetuating in improving male dietitian recruitment and eventually, retention. A multi-pronged approach is needed to improve the rate of recruitment of male dietitians, with a role for tertiary education providers and peak dietetics bodies.

The effects of canagliflozin in type 2 diabetes in subgroups defined by population-specific body mass index: Insights from the CANVAS Program and CREDENCE trial.

AIM: To assess the effects of canagliflozin on clinical outcomes and intermediate markers across population-specific body mass index (BMI) categories in the CANVAS Program and CREDENCE trial. METHODS: Individual participant data were pooled and analysed in subgroups according to population-specific BMI. The main outcomes of interest were: major adverse cardiovascular events (MACE, a composite of nonfatal myocardial infarction, nonfatal stroke or cardiovascular death); composite renal outcome; and changes in systolic blood pressure (SBP), body weight, albuminuria and estimated glomerular filtration rate (eGFR) slope. Cox proportional hazards models and mixed-effect models were used. RESULTS: A total of 14 520 participants were included, of whom 9378 (65%) had obesity. Overall, canagliflozin reduced the risk of MACE (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.75 to 0.93) with no heterogeneity of treatment effect across BMI subgroups (Pheterogeneity = 0.76). Similarly, canagliflozin reduced composite renal outcomes (HR 0.75, 95% CI 0.66 to 0.84) with no heterogeneity across subgroups observed (Pheterogeneity = 0.72). The effects of canagliflozin on body weight and SBP differed across BMI subgroups (Pheterogeneity <0.01 and 0.04, respectively) but were consistent for albuminuria (Pheterogeneity = 0.60). Chronic eGFR slope with canagliflozin treatment was consistent across subgroups (Pheterogeneity >0.95). CONCLUSIONS: The cardiovascular and renal benefits of canagliflozin and its safety profile were consistent across population-specific BMI subgroups for adults in the CANVAS Program and CREDENCE trial.

Tree Nut and Peanut Consumption and Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Cardiovascular disease (CVD) is the leading cause of death globally. Habitual consumption of tree nuts and peanuts is associated with cardioprotective benefits. Food-based dietary guidelines globally recommend nuts as a key component of a healthy diet. This systematic review and meta-analysis were conducted to examine the relationship between tree nut and peanut consumption and risk factors for CVD in randomized controlled trials (RCTs) (PROSPERO: CRD42022309156). MEDLINE, PubMed, CINAHL, and Cochrane Central databases were searched up to 26 September, 2021. All RCT studies that assessed the effects of tree nut or peanut consumption of any dose on CVD risk factors were included. Review Manager software was used to conduct a random effect meta-analysis for CVD outcomes from RCTs. Forest plots were generated for each outcome, between-study heterogeneity was estimated using the I2 test statistic and funnel plots and Egger's test for outcomes with ≥10 strata. The quality assessment used the Health Canada Quality Appraisal Tool, and the certainty of the evidence was assessed using grading of recommendations assessment, development, and evaluation (GRADE). A total of 153 articles describing 139 studies (81 parallel design and 58 cross-over design) were included in the systematic review, with 129 studies in the meta-analysis. The meta-analysis showed a significant decrease for low-density lipoprotein (LDL) cholesterol, total cholesterol (TC), triglycerides (TG), TC:high-density lipoprotein (HDL) cholesterol, LDL cholesterol:HDL cholesterol, and apolipoprotein B (apoB) following nut consumption. However, the quality of evidence was "low" for only 18 intervention studies. The certainty of the body of evidence for TC:HDL cholesterol, LDL cholesterol:HDL cholesterol, and apoB were "moderate" because of inconsistency, for TG were "low," and for LDL cholesterol and TC were "very low" because of inconsistency and the likelihood of publication bias. The findings of this review provide evidence of a combined effect of tree nuts and peanuts on a range of biomarkers to create an overall CVD risk reduction.

Supports and Barriers to Lifestyle Interventions in Women with Gestational Diabetes Mellitus in Australia: A National Online Survey.

BACKGROUND: Gestational diabetes mellitus (GDM) affects approximately one in six pregnancies, causing a significant burden on maternal and infant health. Lifestyle interventions are first-line therapies to manage blood glucose levels (BGLs) and prevent future cardiometabolic complications. However, women with GDM experience considerable barriers to lifestyle interventions; thus, the aim of this study was to determine how women with GDM manage their condition and to identify the primary supports and barriers to lifestyle intervention participation. METHODS: An online cross-sectional survey of women in Australia with a history of GDM was conducted. Questions included participant demographics, strategies used to manage BGLs, physical activity and dietary habits, and barriers and supports to lifestyle interventions. RESULTS: A total of 665 individuals consented and responded to the advertisement, of which 564 were eligible and provided partial or complete responses to the survey questions. Most respondents were between 35 and 39 years of age (35.5%), not pregnant (75.4%), working part-time (26.7%), university-educated (58.0%), and had only one child (40.1%). Most respondents managed their BGLs through diet (88.3%), with "low-carbohydrate" diets being the most popular (72.3%), and 46.2% of respondents were undertaking insulin therapy. Only 42.2% and 19.8% of respondents reported meeting the aerobic and strengthening exercise recommendations, respectively. Women with one child or currently pregnant expecting their first child were 1.51 times more likely (95% CI, 1.02, 2.25) to meet the aerobic exercise recommendations than those with two or more children. The most common reported barriers to lifestyle intervention participation were "lack of time" (71.4%) and "childcare" commitments (57.7%). Lifestyle interventions delivered between 6 and 12 months postpartum (59.0%), involving an exercise program (82.6%), and delivered one-on-one were the most popular (64.9%). CONCLUSION: Most women report managing their GDM with lifestyle strategies. The most common strategies reported involve approaches not currently included in the clinical practice guidelines such as reducing carbohydrate consumption. Furthermore, despite being willing to participate in lifestyle interventions, respondents report significant barriers, including lack of time and childcare commitments, whereas mentioned supports included having an online format. Lifestyle interventions for women with a history of GDM should be designed in a manner that is both tailored to the individual and considerate of existing barriers and supports to participation.

Canagliflozin and atrial fibrillation in type 2 diabetes mellitus: A secondary analysis from the CANVAS Program and CREDENCE trial and meta-analysis.

AIM: To assess the effects of canagliflozin on the incidence of atrial fibrillation/atrial flutter (AF/AFL) and other key cardiorenal outcomes in a pooled analysis of the CANVAS and CREDENCE trials. MATERIALS AND METHODS: Participants with type 2 diabetes and high risk of cardiovascular disease or chronic kidney disease were included and randomly assigned to canagliflozin or placebo. We explored the effects of canagliflozin on the incidence of first AF/AFL events and AF/AFL-related complications (ischaemic stroke/transient ischaemic attack/hospitalization for heart failure). Major adverse cardiovascular events and a renal-specific outcome by baseline AF/AFL status were analysed using Cox regression models. RESULTS: Overall, 354 participants experienced a first AF/AFL event. Canagliflozin had no detectable effect on AF/AFL (hazard ratio [HR] 0.82, 95% confidence interval [CI] 0.67-1.02) compared with placebo. Subgroup analysis, however, suggested a possible reduction in AF/AFL in those with no AF/AFL history (HR 0.78, 95% CI 0.62-0.99). Canagliflozin was also associated with a reduction in AF/AFL-related complications (HR 0.74, 95% CI 0.65-0.86). There was no evidence of treatment heterogeneity by baseline AF/AFL history for other key cardiorenal outcomes (all Pinteraction > 0.14). Meta-analysis of five sodium-glucose cotransporter-2 (SGLT2) inhibitor trials demonstrated a 19% reduction in AF/AFL events with active treatment (HR 0.81, 95% CI 0.72-0.92). CONCLUSIONS: Overall, a significant effect of canagliflozin on the incidence of AF/AFL events could not be shown, however, a possible reduction in AF/AFL events in those with no prior history requires further investigation. Meta-analysis suggests SGLT2 inhibition reduces AF/AFL incidence.

Clinical researchers' lived experiences with data quality monitoring in clinical trials: a qualitative study.

BACKGROUND: Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials. METHODS: We conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships. RESULTS: Data saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme 'education and training' influenced the other four primary themes. While 'working with technology' influenced the 'way of working'. All other themes had reciprocal relationships. There was no relationship reported between 'working within regulatory requirements' and 'working with technology'. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring. CONCLUSION: Clinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

A Clinician-Led, Experience-Based Co-Design Approach for Developing mHealth Services to Support the Patient Self-management of Chronic Conditions: Development Study and Design Case.

BACKGROUND: Despite the increasing use of mobile health (mHealth) services, such as mHealth apps or SMS text messaging services, that support the patient self-management of chronic conditions, many existing mHealth services lack theoretical guidance. In addition, although often the target audience for requirement acquisition at the initial mHealth app design stage, it is a common challenge for them to fully conceptualize their needs for mHealth services that help self-manage chronic conditions. OBJECTIVE: This study proposes a novel co-design approach with the initial requirements for mHealth services proposed by clinicians based on their experiences in guiding patients to self-manage chronic conditions. A design case is presented to illustrate our innovative approach to designing an mHealth app that supports the self-management of patients with obesity in their preparation for elective surgery. METHODS: We adopted a clinician-led co-design approach. The co-design approach consisted of the following four cyclic phases: understanding user needs, identifying an applicable underlying theory, integrating the theory into the prototype design, and evaluating and refining the prototype mHealth services with patients. Expert panel discussions, a literature review, intervention mapping, and patient focus group discussions were conducted in these four phases. RESULTS: In stage 1, the expert panel proposed the following three common user needs: motivational, educational, and supportive needs. In stage 2, the team selected the Social Cognitive Theory to guide the app design. In stage 3, the team designed and developed the key functions of the mHealth app, including automatic push notifications; web-based resources; goal setting and monitoring; and interactive health-related exchanges that encourage physical activity, healthy eating, psychological preparation, and a positive outlook for elective surgery. Push notifications were designed in response to a patient's risk level, as informed by the person's response to a baseline health survey. In stage 4, the prototype mHealth app was used to capture further requirements from patients in the two focus group discussions. Focus group participants affirmed the potential benefits of the app and suggested more requirements for the function, presentation, and personalization needs. The app was improved based on these suggestions. CONCLUSIONS: This study reports an innovative co-design approach that was used to leverage the clinical experiences of clinicians to produce the initial prototype app and the approach taken to allow patients to effectively voice their needs and expectations for the mHealth app in a focus group discussion. This approach can be generalized to the design of any mHealth service that aims to support the patient self-management of chronic conditions.

Time-consuming and expensive data quality monitoring procedures persist in clinical trials: A national survey.

INTRODUCTION: The Good Clinical Practice guideline identifies that data monitoring is an essential research activity. However, limited evidence exists on how to perform monitoring including the amount or frequency that is needed to ensure data quality. This study aims to explore the monitoring procedures that are implemented to ensure data quality in Australian clinical research studies. MATERIAL AND METHODS: Clinical studies listed on the Australian and New Zealand Clinical Trials Registry were invited to participate in a national cross-sectional, mixed-mode, multi-contact (postal letter and e-mail) web-based survey. Information was gathered about the types of data quality monitoring procedures being implemented. RESULTS: Of the 3689 clinical studies contacted, 589 (16.0%) responded, of which 441 (77.4%) completed the survey. Over half (55%) of the studies applied source data verification (SDV) compared to risk-based targeted and triggered monitoring (10-11%). Conducting 100% on-site monitoring was most common for those who implemented the traditional approach. Respondents who did not conduct 100% monitoring, included 1-25% of data points for SDV, centralized or on-site monitoring. The incidence of adverse events and protocol deviations were the most likely factors to trigger a site visit for risk-based triggered (63% and 44%) and centralized monitoring (48% and 44%), respectively. CONCLUSION: Instead of using more optimal risk-based approaches, small single-site clinical studies are conducting traditional monitoring procedures which are time consuming and expensive. Formal guidelines need to be improved and provided to all researchers for 'new' risk-based monitoring approaches.

Heterogeneity in clinical research data quality monitoring: A national survey.

INTRODUCTION: Clinical research is vital in the discovery of new medical knowledge and reducing disease risk in humans. In clinical research poor data quality is one of the major problems, affecting data integrity and the generalisability of the research findings. To achieve high quality data, guidance needs to be provided to clinical studies on the collection, processing and handling of data. However, clinical trials are implementing ad hoc, pragmatic approaches to ensure data quality. This study aims to explore the procedures for ensuring data quality in Australian clinical research studies. MATERIAL AND METHODS: We conducted a national cross-sectional, mixed-mode multi-contact (postal letter and e-mail) web-based survey of clinical researchers associated with clinical studies listed on the Australian and New Zealand Clinical Trials Registry. RESULTS: Of the 3689 clinical studies contacted, 589 (16%) responded, 570 (97%) consented and 441 (77%) completed the survey. 67% clinical studies reported following national and/or international guidelines for data monitoring, with the National Statement (86%) and Good Clinical Practice Guidelines (55%) most common. Source data were most likely to be recorded on one instrument (46%), of which paper (77%) being most common. 46.4% studies did not use data management software and 55% monitored data via traditional approaches (e.g. source data verification). Training on data quality was only provided to less than half of the staff responsible for data entry (43.9%) and data monitoring (37.5%). Regression analysis on 179 (33%) respondents found a borderline significant association between intervention trials and a definition for protocol deviation and/or violation (odds 3.065, p = 0.096). This may suggest when clinical trials are provided with additional guidance and resources, they are more likely to implement required procedures. Statistical strength of the full regression model was not significant χ2 (13, 179) = 15.827, p = 0.259. CONCLUSION: Small single-site academic clinical studies implemented ad hoc procedures to ensure data quality. Education and training are required to promote standardised practices to ensure data quality in small scale clinical trials.

Exploring perceptions, barriers and use of systematic reviews amongst nutrition professionals and nutrition students.

AIM: Systematic reviews (SRs) are a core component of evidence-based practice and are widely used in developing nutrition policy. This study aimed to examine nutrition professionals and students' perceptions, barriers and use of SRs. A secondary aim was to examine confidence using and conducting SRs. METHODS: A self-administered online survey was developed, pilot-tested and implemented via SurveyMonkey. The survey consisted of 29 items separated into demographics, perceptions, use, and knowledge of SRs, confidence in using and conducting SRs, and barriers to use and conduct of SRs. The survey was disseminated via professional newsletters and social media. RESULTS: Ninety-four nutrition professionals/students completed the survey. Survey results indicated respondents valued SRs, with SRs used most commonly to update knowledge. While most respondents (67%) were confident in using SRs, many (59%) expressed a lack of confidence in conducting a SR. In particular, few respondents (12%) reported confidence in conducting meta-analyses. The majority of respondents were aware that SRs underpinned guidelines and nutrition resources, however, few (21%) respondents identified that self-substantiation of health claims were based on SRs. Time, access to scientific database, lack of workplace support and confidence were the main barriers to SRs use. CONCLUSIONS: SRs were reported as being valued by nutrition professionals and students, though time constraints, a lack of confidence and organisations which did not prioritise research were barriers to conducting SRs. The findings of this survey highlight a need for training and education as potential strategies to promote SR engagement in nutrition professionals and students.

Assessing data quality and the variability of source data verification auditing methods in clinical research settings.

INTRODUCTION: Data audits within clinical settings are extensively used as a major strategy to identify errors, monitor study operations and ensure high-quality data. However, clinical trial guidelines are non-specific in regards to recommended frequency, timing and nature of data audits. The absence of a well-defined data quality definition and method to measure error undermines the reliability of data quality assessment. This review aimed to assess the variability of source data verification (SDV) auditing methods to monitor data quality in a clinical research setting. MATERIAL AND METHODS: The scientific databases MEDLINE, Scopus and Science Direct were searched for English language publications, with no date limits applied. Studies were considered if they included data from a clinical trial or clinical research setting and measured and/or reported data quality using a SDV auditing method. RESULTS: In total 15 publications were included. The nature and extent of SDV audit methods in the articles varied widely, depending upon the complexity of the source document, type of study, variables measured (primary or secondary), data audit proportion (3-100%) and collection frequency (6-24 months). Methods for coding, classifying and calculating error were also inconsistent. Transcription errors and inexperienced personnel were the main source of reported error. Repeated SDV audits using the same dataset demonstrated ∼ 40% improvement in data accuracy and completeness over time. No description was given in regards to what determines poor data quality in clinical trials. CONCLUSIONS: A wide range of SDV auditing methods are reported in the published literature though no uniform SDV auditing method could be determined for "best practice" in clinical trials. Published audit methodology articles are warranted for the development of a standardised SDV auditing method to monitor data quality in clinical research settings.

Exploring Data Quality Management within Clinical Trials.

BACKGROUND: Clinical trials are an important research method for improving medical knowledge and patient care. Multiple international and national guidelines stipulate the need for data quality and assurance. Many strategies and interventions are developed to reduce error in trials, including standard operating procedures, personnel training, data monitoring, and design of case report forms. However, guidelines are nonspecific in the nature and extent of necessary methods. OBJECTIVE: This article gathers information about current data quality tools and procedures used within Australian clinical trial sites, with the aim to develop standard data quality monitoring procedures to ensure data integrity. METHODS: Relevant information about data quality management methods and procedures, error levels, data monitoring, staff training, and development were collected. Staff members from 142 clinical trials listed on the National Health and Medical Research Council (NHMRC) clinical trials Web site were invited to complete a short self-reported semiquantitative anonymous online survey. RESULTS: Twenty (14%) clinical trials completed the survey. Results from the survey indicate that procedures to ensure data quality varies among clinical trial sites. Centralized monitoring (65%) was the most common procedure to ensure high-quality data. Ten (50%) trials reported having a data management plan in place and two sites utilized an error acceptance level to minimize discrepancy, set at <5% and 5 to 10%, respectively. The quantity of data variables checked (10-100%), the frequency of visits (once-a-month to annually), and types of variables (100%, critical data or critical and noncritical data audits) for data monitoring varied among respondents. The average time spent on staff training per person was 11.58 hours over a 12-month period and the type of training was diverse. CONCLUSION: Clinical trial sites are implementing ad hoc methods pragmatically to ensure data quality. Findings highlight the necessity for further research into "standard practice" focusing on developing and implementing publically available data quality monitoring procedures.

Measuring Data Quality Through a Source Data Verification Audit in a Clinical Research Setting.

Health data has long been scrutinised in relation to data quality and integrity problems. Currently, no internationally accepted or "gold standard" method exists measuring data quality and error rates within datasets. We conducted a source data verification (SDV) audit on a prospective clinical trial dataset. An audit plan was applied to conduct 100% manual verification checks on a 10% random sample of participant files. A quality assurance rule was developed, whereby if >5% of data variables were incorrect a second 10% random sample would be extracted from the trial data set. Error was coded: correct, incorrect (valid or invalid), not recorded or not entered. Audit-1 had a total error of 33% and audit-2 36%. The physiological section was the only audit section to have <5% error. Data not recorded to case report forms had the greatest impact on error calculations. A significant association (p=0.00) was found between audit-1 and audit-2 and whether or not data was deemed correct or incorrect. Our study developed a straightforward method to perform a SDV audit. An audit rule was identified and error coding was implemented. Findings demonstrate that monitoring data quality by a SDV audit can identify data quality and integrity issues within clinical research settings allowing quality improvement to be made. The authors suggest this approach be implemented for future research.