Background: The combination of four protective lifestyle behaviours (being physically active, a n... more Background: The combination of four protective lifestyle behaviours (being physically active, a nonsmoker, a moderate alcohol consumer and having adequate fruit and vegetable intake) has been estimated to increase life expectancy by 14 years. However, the effect of adopting these lifestyle behaviours on general health, obesity and mental health is less defined. We examined the combined effect of these behaviours on self-rated health, overweight/obesity and depression. Methods: Using data from the Survey of Lifestyle Attitudes and Nutrition (SLÁ N) 2007 (), a protective lifestyle behaviour (PLB) score was constructed for 10 364 men and women (>18 years), and representative of the Republic of Ireland adult population (response rate 62%). Respondents scored a maximum of four points, one point each for being physically active, consuming five or more fruit and vegetable servings daily, a nonsmoker and a moderate drinker. Results: One-fifth of respondents (20%) adopted four PLBs, 35% adopted three, 29% two, 13% one and 2% adopted none. Compared to those with zero PLBs, those with four were seven times more likely to rate their general health as excellent/very good [OR 6.8 95% CI (3.64-12.82)] and four times more likely to have better mental health [OR 4.4 95% CI (2.34-8.22)]. Conclusions: Adoption of core protective lifestyle factors known to increase life expectancy is associated with positive self-rated health, healthier weight and better mental health. These lifestyles have the potential to add quality and quantity to life.
Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes ... more Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes are particularly at risk of testicular trauma and diseases. Experiencing negative testicular symptoms does not necessarily imply that men seek help. Men’s awareness of testicular diseases is often lacking and their intention to seek help for testicular symptoms is sub-optimal. The use of virtual reality (VR) may be effective in promoting men’s awareness of testicular diseases. The Enhancing Men's Awareness of Testicular diseases (E-MAT) feasibility trial aims to test the effect of E-MATVR (intervention; interactive experience using virtual reality [VR]) compared to information delivered Electronically E-MATE (control; same information as E-MATVR delivered as plain text and images) on testicular knowledge, and testicular self-examination among male athletes affiliated with a national sports organisation. The overall aim of this mixed method process evaluation will be to describe (i) t...
Background Retention to trials is important to ensure the results of the trial are valid and reli... more Background Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols” be included in trial protocols. The evidence for inclusion of this retention information in protocols is absent. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial. Methods A scoping review with searches in key databases (MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014-2019 inclusive) to identify randomised controlled trial protocols. Quantitative and qualitative methods were used to synthesise results. Results Eight-hundred and twenty-four protocols met our inclusion criteria. Definitive RCTs (n=722) and pilot and feasibility trial protocols (n=1...
Background: Registry-based Randomized Controlled Trials (rRCTs) have been described as pragmatic ... more Background: Registry-based Randomized Controlled Trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures including recruitment, randomization and the collection of outcome data. While the practice of utilising registries to support the conduct of randomized trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data and to discuss their advantages and challenges. Methods: A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus, and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two re...
Background Evidence to support the use of many retention strategies in clinical trials is lacking... more Background Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. Methods We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. Results Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention st...
BackgroundAt the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed ... more BackgroundAt the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things?Main textWe focus on randomised trials and look at scale, participants and cost. We randomly selected up to two quantitative intervention reviews published by all clinical Cochrane Review Groups between May 2020 and April 2021. Data including risk of bias, number of participants, intervention type and country were extracted for all trials included in selected reviews. High risk of bias trials were classed as bad. The cost of high risk of bias trials was estimated using published estimates of trial cost per-participant.We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1,659 trials done in 84 countries. Of the 1,640 trials providing risk of b...
Randomised trials, especially those intended to directly inform clinical practice and policy, sho... more Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities. This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are: 1. Ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend; 2. Make sure your trial materials are developed with inclusion in mind; 3. Ensure staff are culturally competent; 4. Build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion probl...
Research Methods in Medicine & Health Sciences, 2021
Background Accurately measuring BMI in large epidemiological studies is problematic as objective ... more Background Accurately measuring BMI in large epidemiological studies is problematic as objective measurements are expensive, so subjective methodologies must usually suffice. The purpose of this study is to explore a new subjective method of BMI measurement: BMI self-selection. Methods A cross-sectional analysis of the Mitchelstown Cohort Rescreen study, a random sample of 1,354 men and women aged 51–77 years recruited from a single primary care centre. BMI self-selection was measured by asking patients to select their BMI category: underweight, normal weight, overweight, obese. Weight and height were also objectively measured. Results 79% were overweight or obese: 86% of males, 69% of females (P < 0.001) and 59% of these underestimated their BMI. The sensitivity for correct BMI self-selection for normal weight, overweight and obese was 77%, 61% and 11% respectively. In multivariable analysis, gender, higher education levels, being told by a health professional to lose weight, an...
Background: It is challenging to measure BMI accurately in population studies because it is an ex... more Background: It is challenging to measure BMI accurately in population studies because it is an expensive and time-consuming task. As a result, subjectively measured BMI, calculated from selfreported height and weight, which we know to be inaccurate, is often used. The purpose of this study is to determine whether using a different, subjective method of measuring BMI, BMI self-selection, would be more accurate. BMI self-selection is determined by asking participants to place themselves in one of the BMI categories, underweight, normal weight, overweight or obese. Methods: A quantitative survey conducted in the outpatient departments of two hospitals in the South West of Ireland. Participants >18 years were included. Pregnant women were excluded. The final sample included 70 participants. Survey completion, including self-reported height and weight and BMI selfselection, preceded the objectively measured weight and height. Demographic and lifestyle factors were also recorded. Resul...
Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies ... more Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures such as case report completion, randomisation and follow up data. While the practice of utilising registries to support the conduct of randomised trials is increasing, the reporting of how a registry is used within a trial can vary, causing difficulty in identifying registry based randomised trials and interpreting their exact definition. Methods: The databases PubMed, Embase, Cinahl Plus, Scopus and the Cochrane Central Register of Controlled Trials will be searched using a combination of subject headings, MeSH and free text terms. Search terms will be adapted accordingly for each database, with English language articles included and no other filters applied. Also, grey literature and reference lists will be searched, contacting trial authors for clarification when necessary. Two indep...
Background Accurately measuring BMI in large epidemiological studies is problematic as objective ... more Background Accurately measuring BMI in large epidemiological studies is problematic as objective measurements are expensive, so subjective methodologies must usually suffice. A number of subjective methodologies have been shown to be inaccurate, resulting in misclassification to a lower BMI category and a subsequent underestimation of obesity prevalence. The purpose of this study is to explore a new subjective method of measuring BMI, BMI perception. Methods A cross-sectional analysis of the Mitchelstown Cohort Rescreen study, a random sample of 1 354 men and women aged 51–77 years recruited from a single primary care centre. Data were collected using self-administered questionnaires. BMI perception was measured by asking “Do you think you are underweight, normal weight, overweight or obese?” Weight and height were also objectively measured. Results 79% of the cohort were overweight or obese: 86% of males, 69% of females, P<0.001. The sensitivity for correct BMI perception for no...
ObjectiveTo describe public health nurses’ (PHN) experiences of referring to, and families’ exper... more ObjectiveTo describe public health nurses’ (PHN) experiences of referring to, and families’ experiences of being referred to, a multicomponent, community-based, childhood weight management programme and to provide insight into families’ motivation to participate in and complete treatment.DesignQualitative study using semi-structured interviews and the draw-and-write technique.SettingTwo geographical regions in the south and west of Ireland.ParticipantsNine PHN involved in the referral process, as well as ten parents and nine children who were referred to and completed the programme, participated in the present study.ResultsPHN were afraid of misclassifying children as obese and of approaching the subject of excess weight with parents. Peer support from other PHN as well as training in how best to talk about weight with parents were potential strategies suggested to alleviate these fears. Parents recalled the anxiety provoked by the ‘medical terminology’ used during referral and thei...
BACKGROUND: There is virtually no evidence for the effectiveness of interventions to promote earl... more BACKGROUND: There is virtually no evidence for the effectiveness of interventions to promote early presentation in breast cancer. We aimed to test the efficacy of an intervention to equip older women with the knowledge, skills, confidence and motivation to detect symptoms and seek help promptly, with the aim of promoting early presentation with breast cancer symptoms. METHODS: We randomised 867 women aged 67 -70 years attending for their final routine appointment on the UK NHS Breast Screening Programme to receive: a scripted 10-min interaction with a radiographer plus a booklet, a booklet alone or usual care. The primary outcome was whether or not a woman was breast cancer aware based on knowledge of breast cancer symptoms and agerelated risk, and reported breast checking. RESULTS: At 1 month, the intervention increased the proportion who were breast cancer aware compared with usual care (interaction arm: 32.8% vs 4.1%; odds ratio (OR): 24.0, 95% confidence interval (CI): 7.7 -73.7; booklet arm: 12.7% vs 4.1%; OR: 4.4, 95% CI: 1.6 -12.0). At 1 year, the effects of the interaction plus booklet, and the booklet, on breast cancer awareness were largely sustained, although the interaction plus booklet remained much more effective. CONCLUSION: An intervention to equip older women with the knowledge, skills, confidence and motivation to detect breast cancer symptoms and seek help promptly increases breast cancer awareness at 1 year. Future research will evaluate whether the intervention promotes early presentation and reduces breast cancer mortality.
Objective: To assess the association between weight perception and BMI among a large, diverse sam... more Objective: To assess the association between weight perception and BMI among a large, diverse sample of adolescents. This study used both measured and self‐reported height and weight to calculate BMI.Research Methods and Procedures: A convenience sample of students (n = 2032) in grades 9 through 12 completed a questionnaire assessing demographic characteristics, self‐reported height and weight, and body weight perception. These students were then weighed and had their height measured using a standard protocol.Results: Using BMI calculated from measured height and weight, 1.5% of students were classified as underweight or at risk for underweight, 51.2% of students were normal weight, and 47.4% were overweight or at risk for overweight. Among this same sample of students, however, 34.8% perceived themselves as underweight, 42.9% perceived themselves as about the right weight, and 22.3% perceived themselves as overweight. Even when using BMI calculated from self‐reported height and wei...
Background: The combination of four protective lifestyle behaviours (being physically active, a n... more Background: The combination of four protective lifestyle behaviours (being physically active, a nonsmoker, a moderate alcohol consumer and having adequate fruit and vegetable intake) has been estimated to increase life expectancy by 14 years. However, the effect of adopting these lifestyle behaviours on general health, obesity and mental health is less defined. We examined the combined effect of these behaviours on self-rated health, overweight/obesity and depression. Methods: Using data from the Survey of Lifestyle Attitudes and Nutrition (SLÁ N) 2007 (), a protective lifestyle behaviour (PLB) score was constructed for 10 364 men and women (>18 years), and representative of the Republic of Ireland adult population (response rate 62%). Respondents scored a maximum of four points, one point each for being physically active, consuming five or more fruit and vegetable servings daily, a nonsmoker and a moderate drinker. Results: One-fifth of respondents (20%) adopted four PLBs, 35% adopted three, 29% two, 13% one and 2% adopted none. Compared to those with zero PLBs, those with four were seven times more likely to rate their general health as excellent/very good [OR 6.8 95% CI (3.64-12.82)] and four times more likely to have better mental health [OR 4.4 95% CI (2.34-8.22)]. Conclusions: Adoption of core protective lifestyle factors known to increase life expectancy is associated with positive self-rated health, healthier weight and better mental health. These lifestyles have the potential to add quality and quantity to life.
Objectives Fever is a common symptom of mostly benign illness in young children, yet concerning f... more Objectives Fever is a common symptom of mostly benign illness in young children, yet concerning for parents. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding fever in children aged ≤5 years of age. Design A cross-sectional study using a previously validated questionnaire. Results were analysed using descriptive statistics and multivariable logistic regression. Setting Purposively selected primary schools (n=8) in Cork, Ireland, using a paper-based questionnaire. Data were collected from a cross-sectional internet-based questionnaire with a convenience sample of parents via websites and web pages (n=10) previously identified in an interview study. Participants Parents with at least one child aged ≤5 years were invited to participate in the study. Main outcome measures Parental knowledge, attitudes and beliefs when managing fever in children. Results One thousand one hundred and four parents contributed to this research (121 parents from schools and 983 parents through an online questionnaire). Almost two-thirds of parents (63.1%) identified temperatures at which they define fever that were either below or above the recognised definition of temperature (38°C). Nearly two of every three parents (64.6%) alternate between two fever-reducing medications when managing a child's fever. Among parents, years of parenting experience, age, sex, educational status or marital status did not predict being able to correctly identify a fever, neither did they predict if the parent alternated between fever-reducing medications. Conclusions Parental knowledge of fever and fever management was found to be deficient which concurs with existing literature. Parental experience and other sociodemographic factors were generally not helpful in identifying parents with high or low levels of knowledge. Resources to help parents when managing a febrile illness need to be introduced to help all parents provide effective care.
Background: We know that parents require resources which can assist them to improve fever knowled... more Background: We know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition. Methods: A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C). Results: A total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified "higher than ≥38°C" as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3-19.9: p < 0.01; T2: OR 10.5; CI 95% 3.4-32.0: p < 0.01). Conclusions: Our RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children. Trial registration: ClinicalTrials.gov NCT02903342, September 16, 2016, Retrospectively registered.
Background: Fever is one of the most common childhood symptoms. It causes significant worry and c... more Background: Fever is one of the most common childhood symptoms. It causes significant worry and concern for parents. Every year there are numerous cases of over-and under-dosing with antipyretics. Caregivers seek reassurance from a variety of sources including healthcare practitioners. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding management of childhood fever in children aged 5 years and under. Method: Semi-structured interviews were conducted with 23 parents at six antenatal clinics in the south west of Ireland during March and April 2015. The Francis method was used to detect data saturation and thereby identify sample size. Thematic analysis was used to analyse the data. Results: Twenty-three parents participated in the study. Five themes emerged from the data: assessing and managing the fever; parental knowledge and beliefs regarding fever; knowledge source; pharmaceutical products; initiatives. Parents illustrated a good knowledge of fever as a symptom. However, management practices varied between participants. Parents revealed a reluctance to use medication in the form of suppositories. There was a desire for more accessible, consistent information to be made available for use by parents when their child had a fever or febrile illness. Conclusion: Parents indicated that further initiatives are required to provide trustworthy information on the management of fever and febrile illness in children. Healthcare professionals should play a significant role in educating parents in how to manage fever and febrile illnesses in their children. The accessible nature and location of pharmacies could provide useful support for both parents and General Practitioners.
Aims Despite the existence of guidelines from national organisations, parental knowledge of fever... more Aims Despite the existence of guidelines from national organisations, parental knowledge of fever and management of fever in children is incomplete. The aim of this study was to assess the effectiveness of an educational intervention to increase parental knowledge of fever. Methods A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. A convenience sample of parents presenting at purposively selected GP practices, urgent and emergency care treatment centres and pharmacies in Cork, Ireland were invited to participate. An information leaflet for use in the trial was designed based on two previous studies with parents. Parents in the control arm were asked to complete a short questionnaire at randomisation (time-point 1) and again two weeks after randomisation (time-point 2). Parents in the intervention arm were asked to read an information leaflet on fever and management of fever in children, complete a short questionnaire at randomisation (timepoint 1) and again two weeks after randomisation (time-point 2). Results A total of 100 parents participated at time-point 1 of the study, with 50 participants in each arm. After time-point 2, 39 parents from the control group and 34 parents from the intervention group had been successfully contacted. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature to recognise fever (38OC) at time-point 1. At time-point 2, 82.4% of the intervention group and 30.8% of the control group selected the correct temperature. When answers from the intervention and control groups were compared at both time points using simple logistic regression, participants in the intervention group were more likely to give the correct answer at both time points (initial questionnaire OR 8.143 CI 95% 3.325–19.943; after two weeks OR 10.5, CI 95% 3.448–31.972). Management practices were also positively influenced by the information leaflet (reduction in alternating between antipyretics and use of tepid sponging). Conclusions An educational intervention can improve parental knowledge of fever and correct management strategies. The effect of the intervention was sustained over-time. This study highlights the need for public health authorities to consider incorporating this leaflet into resources for parents.
Background: The combination of four protective lifestyle behaviours (being physically active, a n... more Background: The combination of four protective lifestyle behaviours (being physically active, a nonsmoker, a moderate alcohol consumer and having adequate fruit and vegetable intake) has been estimated to increase life expectancy by 14 years. However, the effect of adopting these lifestyle behaviours on general health, obesity and mental health is less defined. We examined the combined effect of these behaviours on self-rated health, overweight/obesity and depression. Methods: Using data from the Survey of Lifestyle Attitudes and Nutrition (SLÁ N) 2007 (), a protective lifestyle behaviour (PLB) score was constructed for 10 364 men and women (>18 years), and representative of the Republic of Ireland adult population (response rate 62%). Respondents scored a maximum of four points, one point each for being physically active, consuming five or more fruit and vegetable servings daily, a nonsmoker and a moderate drinker. Results: One-fifth of respondents (20%) adopted four PLBs, 35% adopted three, 29% two, 13% one and 2% adopted none. Compared to those with zero PLBs, those with four were seven times more likely to rate their general health as excellent/very good [OR 6.8 95% CI (3.64-12.82)] and four times more likely to have better mental health [OR 4.4 95% CI (2.34-8.22)]. Conclusions: Adoption of core protective lifestyle factors known to increase life expectancy is associated with positive self-rated health, healthier weight and better mental health. These lifestyles have the potential to add quality and quantity to life.
Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes ... more Background: Testicular cancer (TC) is the most common malignancy in men under 50 years. Athletes are particularly at risk of testicular trauma and diseases. Experiencing negative testicular symptoms does not necessarily imply that men seek help. Men’s awareness of testicular diseases is often lacking and their intention to seek help for testicular symptoms is sub-optimal. The use of virtual reality (VR) may be effective in promoting men’s awareness of testicular diseases. The Enhancing Men's Awareness of Testicular diseases (E-MAT) feasibility trial aims to test the effect of E-MATVR (intervention; interactive experience using virtual reality [VR]) compared to information delivered Electronically E-MATE (control; same information as E-MATVR delivered as plain text and images) on testicular knowledge, and testicular self-examination among male athletes affiliated with a national sports organisation. The overall aim of this mixed method process evaluation will be to describe (i) t...
Background Retention to trials is important to ensure the results of the trial are valid and reli... more Background Retention to trials is important to ensure the results of the trial are valid and reliable. The SPIRIT guidelines (18b) require “plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols” be included in trial protocols. The evidence for inclusion of this retention information in protocols is absent. The purpose of our scoping review is to establish if, and how, trial teams report plans for retention during the design stage of the trial. Methods A scoping review with searches in key databases (MEDLINE/PubMed, Scopus, EMBASE, CINAHL (EBSCO), and Web of Science from 2014-2019 inclusive) to identify randomised controlled trial protocols. Quantitative and qualitative methods were used to synthesise results. Results Eight-hundred and twenty-four protocols met our inclusion criteria. Definitive RCTs (n=722) and pilot and feasibility trial protocols (n=1...
Background: Registry-based Randomized Controlled Trials (rRCTs) have been described as pragmatic ... more Background: Registry-based Randomized Controlled Trials (rRCTs) have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures including recruitment, randomization and the collection of outcome data. While the practice of utilising registries to support the conduct of randomized trials is increasing, the use of the registries within rRCTs is inconsistent. The purpose of this systematic review is to explore the conduct of rRCTs using a patient registry to facilitate trial recruitment and the collection of outcome data and to discuss their advantages and challenges. Methods: A systematic search of the literature was conducted using five databases from inception to June 2020: PubMed, Embase (through Ovid), CINAHL, Scopus, and the Cochrane Controlled Register of Trials (CENTRAL). The search strategy comprised of MESH terms and key words related to rRCTs. Study selection was performed independently by two re...
Background Evidence to support the use of many retention strategies in clinical trials is lacking... more Background Evidence to support the use of many retention strategies in clinical trials is lacking. Despite this, trial teams still need to have some form of retention strategy in their trials to try and avoid high attrition rates. This study aimed to estimate how much this lack of retention evidence might be costing trials in Ireland and the UK. Methods We selected the top ten most routinely used retention strategies by Clinical Trial Units in the UK and made assumptions as to how each of these strategies was most likely to be implemented and the costs involved in doing this. We applied our costing model to a hypothetical trial scenario in both Ireland and the UK as well as to three published trial protocols. We developed the costing model and calculated the costs in Microsoft Excel. Results Retention strategies were often poorly specified, meaning we had to make assumptions about implementation and in some cases about the strategy itself. Based on our assumptions, some retention st...
BackgroundAt the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed ... more BackgroundAt the 2015 REWARD/EQUATOR conference on research waste, the late Doug Altman revealed that his only regret about his 1994 BMJ paper ‘The scandal of poor medical research’ was that he used the word ‘poor’ rather than ‘bad’. But how much research is bad? And what would improve things?Main textWe focus on randomised trials and look at scale, participants and cost. We randomly selected up to two quantitative intervention reviews published by all clinical Cochrane Review Groups between May 2020 and April 2021. Data including risk of bias, number of participants, intervention type and country were extracted for all trials included in selected reviews. High risk of bias trials were classed as bad. The cost of high risk of bias trials was estimated using published estimates of trial cost per-participant.We identified 96 reviews authored by 546 reviewers from 49 clinical Cochrane Review Groups that included 1,659 trials done in 84 countries. Of the 1,640 trials providing risk of b...
Randomised trials, especially those intended to directly inform clinical practice and policy, sho... more Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health Research (NIHR) INCLUDE project identified many groups in the UK that are under-served by trials, including ethnic minorities. This guidance document presents four key recommendations for designing and running trials that include the ethnic groups needed by the trial. These are: 1. Ensure eligibility criteria and recruitment pathway do not limit participation in ways you do not intend; 2. Make sure your trial materials are developed with inclusion in mind; 3. Ensure staff are culturally competent; 4. Build trusting partnerships with community organisations that work with ethnic minority groups. Each recommendation comes with best practice advice, public contributor testimonials, examples of the inclusion probl...
Research Methods in Medicine & Health Sciences, 2021
Background Accurately measuring BMI in large epidemiological studies is problematic as objective ... more Background Accurately measuring BMI in large epidemiological studies is problematic as objective measurements are expensive, so subjective methodologies must usually suffice. The purpose of this study is to explore a new subjective method of BMI measurement: BMI self-selection. Methods A cross-sectional analysis of the Mitchelstown Cohort Rescreen study, a random sample of 1,354 men and women aged 51–77 years recruited from a single primary care centre. BMI self-selection was measured by asking patients to select their BMI category: underweight, normal weight, overweight, obese. Weight and height were also objectively measured. Results 79% were overweight or obese: 86% of males, 69% of females (P < 0.001) and 59% of these underestimated their BMI. The sensitivity for correct BMI self-selection for normal weight, overweight and obese was 77%, 61% and 11% respectively. In multivariable analysis, gender, higher education levels, being told by a health professional to lose weight, an...
Background: It is challenging to measure BMI accurately in population studies because it is an ex... more Background: It is challenging to measure BMI accurately in population studies because it is an expensive and time-consuming task. As a result, subjectively measured BMI, calculated from selfreported height and weight, which we know to be inaccurate, is often used. The purpose of this study is to determine whether using a different, subjective method of measuring BMI, BMI self-selection, would be more accurate. BMI self-selection is determined by asking participants to place themselves in one of the BMI categories, underweight, normal weight, overweight or obese. Methods: A quantitative survey conducted in the outpatient departments of two hospitals in the South West of Ireland. Participants >18 years were included. Pregnant women were excluded. The final sample included 70 participants. Survey completion, including self-reported height and weight and BMI selfselection, preceded the objectively measured weight and height. Demographic and lifestyle factors were also recorded. Resul...
Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies ... more Background: Registry Based Randomised Controlled Trials have been described as pragmatic studies utilising patient data embedded in large scale registries, to facilitate key clinical trial procedures such as case report completion, randomisation and follow up data. While the practice of utilising registries to support the conduct of randomised trials is increasing, the reporting of how a registry is used within a trial can vary, causing difficulty in identifying registry based randomised trials and interpreting their exact definition. Methods: The databases PubMed, Embase, Cinahl Plus, Scopus and the Cochrane Central Register of Controlled Trials will be searched using a combination of subject headings, MeSH and free text terms. Search terms will be adapted accordingly for each database, with English language articles included and no other filters applied. Also, grey literature and reference lists will be searched, contacting trial authors for clarification when necessary. Two indep...
Background Accurately measuring BMI in large epidemiological studies is problematic as objective ... more Background Accurately measuring BMI in large epidemiological studies is problematic as objective measurements are expensive, so subjective methodologies must usually suffice. A number of subjective methodologies have been shown to be inaccurate, resulting in misclassification to a lower BMI category and a subsequent underestimation of obesity prevalence. The purpose of this study is to explore a new subjective method of measuring BMI, BMI perception. Methods A cross-sectional analysis of the Mitchelstown Cohort Rescreen study, a random sample of 1 354 men and women aged 51–77 years recruited from a single primary care centre. Data were collected using self-administered questionnaires. BMI perception was measured by asking “Do you think you are underweight, normal weight, overweight or obese?” Weight and height were also objectively measured. Results 79% of the cohort were overweight or obese: 86% of males, 69% of females, P<0.001. The sensitivity for correct BMI perception for no...
ObjectiveTo describe public health nurses’ (PHN) experiences of referring to, and families’ exper... more ObjectiveTo describe public health nurses’ (PHN) experiences of referring to, and families’ experiences of being referred to, a multicomponent, community-based, childhood weight management programme and to provide insight into families’ motivation to participate in and complete treatment.DesignQualitative study using semi-structured interviews and the draw-and-write technique.SettingTwo geographical regions in the south and west of Ireland.ParticipantsNine PHN involved in the referral process, as well as ten parents and nine children who were referred to and completed the programme, participated in the present study.ResultsPHN were afraid of misclassifying children as obese and of approaching the subject of excess weight with parents. Peer support from other PHN as well as training in how best to talk about weight with parents were potential strategies suggested to alleviate these fears. Parents recalled the anxiety provoked by the ‘medical terminology’ used during referral and thei...
BACKGROUND: There is virtually no evidence for the effectiveness of interventions to promote earl... more BACKGROUND: There is virtually no evidence for the effectiveness of interventions to promote early presentation in breast cancer. We aimed to test the efficacy of an intervention to equip older women with the knowledge, skills, confidence and motivation to detect symptoms and seek help promptly, with the aim of promoting early presentation with breast cancer symptoms. METHODS: We randomised 867 women aged 67 -70 years attending for their final routine appointment on the UK NHS Breast Screening Programme to receive: a scripted 10-min interaction with a radiographer plus a booklet, a booklet alone or usual care. The primary outcome was whether or not a woman was breast cancer aware based on knowledge of breast cancer symptoms and agerelated risk, and reported breast checking. RESULTS: At 1 month, the intervention increased the proportion who were breast cancer aware compared with usual care (interaction arm: 32.8% vs 4.1%; odds ratio (OR): 24.0, 95% confidence interval (CI): 7.7 -73.7; booklet arm: 12.7% vs 4.1%; OR: 4.4, 95% CI: 1.6 -12.0). At 1 year, the effects of the interaction plus booklet, and the booklet, on breast cancer awareness were largely sustained, although the interaction plus booklet remained much more effective. CONCLUSION: An intervention to equip older women with the knowledge, skills, confidence and motivation to detect breast cancer symptoms and seek help promptly increases breast cancer awareness at 1 year. Future research will evaluate whether the intervention promotes early presentation and reduces breast cancer mortality.
Objective: To assess the association between weight perception and BMI among a large, diverse sam... more Objective: To assess the association between weight perception and BMI among a large, diverse sample of adolescents. This study used both measured and self‐reported height and weight to calculate BMI.Research Methods and Procedures: A convenience sample of students (n = 2032) in grades 9 through 12 completed a questionnaire assessing demographic characteristics, self‐reported height and weight, and body weight perception. These students were then weighed and had their height measured using a standard protocol.Results: Using BMI calculated from measured height and weight, 1.5% of students were classified as underweight or at risk for underweight, 51.2% of students were normal weight, and 47.4% were overweight or at risk for overweight. Among this same sample of students, however, 34.8% perceived themselves as underweight, 42.9% perceived themselves as about the right weight, and 22.3% perceived themselves as overweight. Even when using BMI calculated from self‐reported height and wei...
Background: The combination of four protective lifestyle behaviours (being physically active, a n... more Background: The combination of four protective lifestyle behaviours (being physically active, a nonsmoker, a moderate alcohol consumer and having adequate fruit and vegetable intake) has been estimated to increase life expectancy by 14 years. However, the effect of adopting these lifestyle behaviours on general health, obesity and mental health is less defined. We examined the combined effect of these behaviours on self-rated health, overweight/obesity and depression. Methods: Using data from the Survey of Lifestyle Attitudes and Nutrition (SLÁ N) 2007 (), a protective lifestyle behaviour (PLB) score was constructed for 10 364 men and women (>18 years), and representative of the Republic of Ireland adult population (response rate 62%). Respondents scored a maximum of four points, one point each for being physically active, consuming five or more fruit and vegetable servings daily, a nonsmoker and a moderate drinker. Results: One-fifth of respondents (20%) adopted four PLBs, 35% adopted three, 29% two, 13% one and 2% adopted none. Compared to those with zero PLBs, those with four were seven times more likely to rate their general health as excellent/very good [OR 6.8 95% CI (3.64-12.82)] and four times more likely to have better mental health [OR 4.4 95% CI (2.34-8.22)]. Conclusions: Adoption of core protective lifestyle factors known to increase life expectancy is associated with positive self-rated health, healthier weight and better mental health. These lifestyles have the potential to add quality and quantity to life.
Objectives Fever is a common symptom of mostly benign illness in young children, yet concerning f... more Objectives Fever is a common symptom of mostly benign illness in young children, yet concerning for parents. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding fever in children aged ≤5 years of age. Design A cross-sectional study using a previously validated questionnaire. Results were analysed using descriptive statistics and multivariable logistic regression. Setting Purposively selected primary schools (n=8) in Cork, Ireland, using a paper-based questionnaire. Data were collected from a cross-sectional internet-based questionnaire with a convenience sample of parents via websites and web pages (n=10) previously identified in an interview study. Participants Parents with at least one child aged ≤5 years were invited to participate in the study. Main outcome measures Parental knowledge, attitudes and beliefs when managing fever in children. Results One thousand one hundred and four parents contributed to this research (121 parents from schools and 983 parents through an online questionnaire). Almost two-thirds of parents (63.1%) identified temperatures at which they define fever that were either below or above the recognised definition of temperature (38°C). Nearly two of every three parents (64.6%) alternate between two fever-reducing medications when managing a child's fever. Among parents, years of parenting experience, age, sex, educational status or marital status did not predict being able to correctly identify a fever, neither did they predict if the parent alternated between fever-reducing medications. Conclusions Parental knowledge of fever and fever management was found to be deficient which concurs with existing literature. Parental experience and other sociodemographic factors were generally not helpful in identifying parents with high or low levels of knowledge. Resources to help parents when managing a febrile illness need to be introduced to help all parents provide effective care.
Background: We know that parents require resources which can assist them to improve fever knowled... more Background: We know that parents require resources which can assist them to improve fever knowledge and management practices. The purpose of this study, using an RCT, was to examine the effectiveness of an information leaflet at increasing parental knowledge of fever, specifically temperature definition. Methods: A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. Parents presenting at purposively selected healthcare facilities who had a child aged ≤5 years of age were invited to participate. An information leaflet for use in the trial was designed based on previous studies with parents. Parents in the intervention arm read an information leaflet on fever and management of fever in children, completed a short questionnaire at Time 1 (T1) and again 2 weeks after randomisation at Time 2 (T2). Parents in the control arm did not receive the fever information leaflet but completed the same questionnaire as the intervention arm at T1 and againat T2. The primary outcome was the correct definition of fever (higher than ≥38 °C). Results: A total of 100 parents participated in the study at T1. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature (≥38 °C) at T1. 76% of the intervention arm correctly identified "higher than ≥38°C" as the temperature at which a fever is said to be present compared to 28% of the control arm. After 2 weeks, there was an increase of 6% of parents in the intervention arm (increase to 82.4%) who gave the correct temperature compared to just a 2.8% increase in the control arm (increase to 30.8%). Univariate logistic regression showed that parents in the intervention arm were significantly more likely to give the correct answer at both time-points (T1: OR 8.1; CI 95% 3.3-19.9: p < 0.01; T2: OR 10.5; CI 95% 3.4-32.0: p < 0.01). Conclusions: Our RCT of this simple educational intervention has been shown to improve parental understanding of fever knowledge and correct management strategies. Education interventions providing simple, clear information is a key step to decreasing parental mismanagement of fever and febrile illness in children. Trial registration: ClinicalTrials.gov NCT02903342, September 16, 2016, Retrospectively registered.
Background: Fever is one of the most common childhood symptoms. It causes significant worry and c... more Background: Fever is one of the most common childhood symptoms. It causes significant worry and concern for parents. Every year there are numerous cases of over-and under-dosing with antipyretics. Caregivers seek reassurance from a variety of sources including healthcare practitioners. The aim of this study was to describe parental knowledge, attitudes and beliefs regarding management of childhood fever in children aged 5 years and under. Method: Semi-structured interviews were conducted with 23 parents at six antenatal clinics in the south west of Ireland during March and April 2015. The Francis method was used to detect data saturation and thereby identify sample size. Thematic analysis was used to analyse the data. Results: Twenty-three parents participated in the study. Five themes emerged from the data: assessing and managing the fever; parental knowledge and beliefs regarding fever; knowledge source; pharmaceutical products; initiatives. Parents illustrated a good knowledge of fever as a symptom. However, management practices varied between participants. Parents revealed a reluctance to use medication in the form of suppositories. There was a desire for more accessible, consistent information to be made available for use by parents when their child had a fever or febrile illness. Conclusion: Parents indicated that further initiatives are required to provide trustworthy information on the management of fever and febrile illness in children. Healthcare professionals should play a significant role in educating parents in how to manage fever and febrile illnesses in their children. The accessible nature and location of pharmacies could provide useful support for both parents and General Practitioners.
Aims Despite the existence of guidelines from national organisations, parental knowledge of fever... more Aims Despite the existence of guidelines from national organisations, parental knowledge of fever and management of fever in children is incomplete. The aim of this study was to assess the effectiveness of an educational intervention to increase parental knowledge of fever. Methods A prospective, multi-centre, randomised, two-parallel arm, controlled trial with blinded outcome ascertainment was conducted. A convenience sample of parents presenting at purposively selected GP practices, urgent and emergency care treatment centres and pharmacies in Cork, Ireland were invited to participate. An information leaflet for use in the trial was designed based on two previous studies with parents. Parents in the control arm were asked to complete a short questionnaire at randomisation (time-point 1) and again two weeks after randomisation (time-point 2). Parents in the intervention arm were asked to read an information leaflet on fever and management of fever in children, complete a short questionnaire at randomisation (timepoint 1) and again two weeks after randomisation (time-point 2). Results A total of 100 parents participated at time-point 1 of the study, with 50 participants in each arm. After time-point 2, 39 parents from the control group and 34 parents from the intervention group had been successfully contacted. A greater proportion of the intervention group (76%) than the control group (28%) selected the correct temperature to recognise fever (38OC) at time-point 1. At time-point 2, 82.4% of the intervention group and 30.8% of the control group selected the correct temperature. When answers from the intervention and control groups were compared at both time points using simple logistic regression, participants in the intervention group were more likely to give the correct answer at both time points (initial questionnaire OR 8.143 CI 95% 3.325–19.943; after two weeks OR 10.5, CI 95% 3.448–31.972). Management practices were also positively influenced by the information leaflet (reduction in alternating between antipyretics and use of tepid sponging). Conclusions An educational intervention can improve parental knowledge of fever and correct management strategies. The effect of the intervention was sustained over-time. This study highlights the need for public health authorities to consider incorporating this leaflet into resources for parents.
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Papers by Frances Shiely