Prioritising Informed Health Choices Key Concepts for those impacted by cancer: a protocol.

Background: Few areas of health have been as insidiously influenced by misinformation as cancer. Thus, interventions that can help people impacted by cancer reduce the extent to which they are victims of misinformation are necessary. The Informed Health Choices (IHC) initiative has developed Key Concepts that can be used in the development of interventions for evaluating the trustworthiness of claims about the effects of health treatments. We are developing an online education programme called Informed Health Choices-Cancer (IHC-C) based on the IHC Key Concepts. We will provide those impacted by cancer with the knowledge and skills necessary to think critically about the reliability of health information and claims and make informed choices. Methods: We will establish a steering group (SG) of 12 key stakeholders, including oncology specialists and academics. In addition, we will establish a patient and public involvement (PPI) panel of 20 people impacted by cancer. After training the members on the Key Concepts and the prioritisation process, we will conduct a two-round prioritisation process. In the first round, 12 SG members and four PPI panel members will prioritise Key Concepts for inclusion. In the second round, the remaining 16 PPI members will undertake the prioritisation based on the prioritised Key Concepts from the first round. Participants in both rounds will use a structured judgement form to rate the importance of the Key Concepts for inclusion in the online IHC-C programme. A consensus meeting will be held, where members will reach a consensus on the Key Concepts to be included and rank the order in which the prioritised Key Concepts will be addressed in the IHC-C programme. Conclusions: At the end of this process, we will identify which Key Concepts should be included and the order in which they should be addressed in the IHC-C programme.

The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).

Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting.   Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017).

GPs' attitudes towards the diagnosis and treatment of male urinary tract infections: a qualitative interview study in Ireland.

BACKGROUND: In general practice, males represent around 20% of the total number of urinary tract infection (UTI) consultations. The majority of UTI research focuses on the diagnosis and treatment of women with UTIs but there is little evidence on how male UTIs are treated. AIM: To better understand GPs' attitudes towards the diagnosis and treatment of male UTIs. This research aimed to support future investigations to determine best practice in diagnosis and treatment of male UTI. DESIGN AND SETTING: A qualitative interview study was carried out with 15 GPs across Ireland. METHOD: A topic guide was created to ensure consistency in interviews. The interviews were audiorecorded and transcribed verbatim. Transcripts were analysed using thematic analysis. RESULTS: Fifteen interviews with GPs were completed. Analysis indicated that GPs' knowledge of guidelines and implementation of them varied widely when deciding a treatment plan for a male presenting with UTI symptoms. There was clear consensus that male UTIs were uncommon and complicated to diagnose. Three GPs reported never treating a male UTI, while others reported treating <5 patients in their careers. There was an assumption that sexually transmitted infections (STI) take precedence in young males when presenting with similar symptoms. The use of antimicrobial treatment guidelines varied widely, in line with the interpretation of the origin and severity of symptoms. CONCLUSION: Male UTIs are perceived by GPs as rare and complicated. GPs expressed that patient age, resources, and guidelines available limited their confidence in diagnosing and treating male UTIs.

Correction to: Sleep and physical activity: a cross-sectional objective profile of people with rheumatoid arthritis.

The original article can be found online.

Sleep and physical activity: a cross-sectional objective profile of people with rheumatoid arthritis.

Regular physical activity (PA) is important for people with rheumatoid arthritis (RA). Poor sleep is a common complaint among people with RA, which may have an influence on their PA levels. There is a lack of objective information regarding total sleep time (TST) and PA duration in this population. A cross-sectional study design was used. SenseWear Pro3 Armband(R)TM is used to measure TST and total PA duration. Four valid days, with 95% wear time necessary for inclusion in final results. Disease activity and function were measured using the DAS-28, HAQ and VAS. Data analysis carried out using SPSS v22. Seventy-five (75) participants completed monitoring period, with 51 (68%) meeting modified PA duration guidelines. Data with 95% wear time over a minimum of 4 days were available for 32 recorded participants, with a mean TST of 5.7 (SD_1.11) hours per night and a median 1.25 (IQR_1.88) hours of daily PA. TST had a positive significant relationship with PA (p = 0.018); PA demonstrated a negative significant relationship with functional limitations (p = 0.009) and correlated with lower CRP levels; CRP levels had in turn a significant relationship to global health (p = 0.034). Total sleep time was low for people with RA. People with RA who are more physically active have longer TST. These findings provide an objective profile of TST and PA duration in people with RA and suggest a relationship between increased PA duration and longer TST. Further research is needed to confirm these novel findings.

Screening for gestational diabetes mellitus in primary versus secondary care: The clinical outcomes of a randomised controlled trial.

AIMS: To examine the clinical outcomes of screening for gestational diabetes mellitus (GDM) in primary care versus secondary care, in the Irish healthcare system. DESIGN AND METHODS: A parallel group randomised controlled trial (RCT) of screening for GDM in primary versus secondary care was used to examine (i) prevalence, (ii) gestational week of screen, (iii) time to access specialist care, and (iv) maternal and neonatal outcomes. In total 781 women were recruited for screening in primary care (n=391) or secondary care (n=390). RESULTS: The prevalence of GDM and gestational week of screen were similar in both locations. There was a trend towards a longer time to access diabetes care in primary care (24days) versus secondary care (19days), a difference of 5days (p=0.09). Women screened in primary care also showed a trend towards a higher rate of large for gestational age (LGA) infants (20%) than those screened in secondary care (14.7%), (p=0.09). There were no differences between groups in maternal outcomes. CONCLUSIONS: This RCT suggests that screening for GDM in secondary care may be associated with potentially faster time to access specialist antenatal diabetes care and possibly lower LGA rates. Further research is needed to clarify these findings and to improve the delay in accessing specialist care requires an urgent focus. Further research is needed to test these findings in other health systems.

Perspectives on the provision of GDM screening in general practice versus the hospital setting: a qualitative study of providers and patients.

OBJECTIVE: A novel gestational diabetes mellitus (GDM) screening programme which involved offering screening at the patient's general practitioner (GP) compared with the traditional hospital setting was trialled. This study investigates perspectives of involved stakeholders on the provision of GDM screening at both settings. DESIGN: Thematic analysis of the perspectives of stakeholders involved in the receiving and provision of GDM screening in both the GP and hospital settings drawn from focus groups and interviews. PARTICIPANTS: 3 groups of participants are included in this research--patient participants, GP screening providers and hospital screening providers. All were recruited from a larger sample who participated in a randomised controlled screening trial. Purposeful sampling was utilised to select participants with a wide variety of perspectives on the provision of GDM screening. SETTING: Participants were recruited from a geographical area covered by 3 hospitals in Ireland. RESULTS: 4 themes emerged from thematic analysis--namely (1) travel distance, (2) best care provision, (3) sense of ease created and (4) optimal screening. CONCLUSIONS: The influence of travel distance from the screening site is the most important factor influencing willingness to attend for GDM screening among women who live a considerable distance from the hospital setting. For patients who live equidistance from both settings, other factors are important; namely the waiting facilities including parking, perceived expertise of screening provider personnel, access to emergency treatment if necessary, accuracy of tests and access to timely results and treatment. Optimal screening for GDM should be specialist led, incorporate expert advice of GDM screening, treatment and management, should be provided locally, offer adequate parking and comfort levels, provide accurate tests, and timely access to results and treatment. Such a service should result in improved rates of GDM screening uptake. TRIAL REGISTRATION NUMBER: ISRCTN41202110.

The cost-effectiveness of screening for gestational diabetes mellitus in primary and secondary care in the Republic of Ireland.

AIMS/HYPOTHESIS: The aim of the study was to assess the cost-effectiveness of screening for gestational diabetes mellitus (GDM) in primary and secondary care settings, compared with a no-screening option, in the Republic of Ireland. METHODS: The analysis was based on a decision-tree model of alternative screening strategies in primary and secondary care settings. It synthesised data generated from a randomised controlled trial (screening uptake) and from the literature. Costs included those relating to GDM screening and treatment, and the care of adverse outcomes. Effects were assessed in terms of quality-adjusted life years (QALYs). The impact of the parameter uncertainty was assessed in a range of sensitivity analyses. RESULTS: Screening in either setting was found to be superior to no screening, i.e. it provided for QALY gains and cost savings. Screening in secondary care was found to be superior to screening in primary care, providing for modest QALY gains of 0.0006 and a saving of €21.43 per screened case. The conclusion held with high certainty across the range of ceiling ratios from zero to €100,000 per QALY and across a plausible range of input parameters. CONCLUSIONS/INTERPRETATION: The results of this study demonstrate that implementation of universal screening is cost-effective. This is an argument in favour of introducing a properly designed and funded national programme of screening for GDM, although affordability remains to be assessed. In the current environment, screening for GDM in secondary care settings appears to be the better solution in consideration of cost-effectiveness.

Health related quality of life two to five years after gestational diabetes mellitus: cross-sectional comparative study in the ATLANTIC DIP cohort.

BACKGROUND: There is no consensus on the effect of gestational diabetes mellitus (GDM) on health-related quality of life (HRQOL) for the mother in the short or long term. In this study we examined HRQOL in a group of women who had GDM in the index pregnancy 2 to 5 years previously and compared it to a group of women with normal glucose tolerance (NGT) in the index pregnancy during the same time period. METHODS: The sample included 234 women who met International Association of Diabetes Study Groups (IADPSG) criteria for GDM in the index pregnancy and 108 who had NGT. The sample was drawn from the ATLATIC-DIP (Diabetes In Pregnancy) cohort - a network of antenatal centers along the Irish Atlantic seaboard serving a population of approximately 500,000 people. HRQOL was measured using the visual analogue component of the EQ-5D-3 L instrument in a cross-sectional survey. RESULTS: The difference in HRQOL between GDM and NGT groups was not significant when adjusted for the effects of the covariates. HRQOL was negatively affected by increased BMI and abnormal glucose tolerance post-partum in the NGT group. Moderate alcohol consumption was positively associated with HRQOL in the NGT group only. The negative association with smoking on HRQOL was substantially higher in the GDM group. CONCLUSIONS: A diagnosis of GDM does not appear to have an adverse effect on HRQOL, 2 to 5 years after the index pregnancy. On the contrary, its diagnosis might lead to the development of coping strategies, which, consequently attenuates the adverse effect of the subsequent acquisition of abnormal glucose tolerance post-partum on HRQOL. Women whose pregnancy was affected by GDM are more susceptible to the adverse effects on HRQOL of alcohol use and tobacco smoking.

Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM)? Findings from a Randomized Control Mixed Methods Trial.

OBJECTIVE: To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM). DESIGN: A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n = 24) or wait control (n = 26) and postintervention qualitative interviews with participants. MAIN OUTCOME MEASURES: Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG) from study entry to one-year follow-up. RESULTS: At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. CONCLUSIONS: Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

Feasibility, acceptability and uptake rates of gestational diabetes mellitus screening in primary care vs secondary care: findings from a randomised controlled mixed methods trial.

AIMS/HYPOTHESIS: It is postulated that uptake rates for gestational diabetes mellitus (GDM) screening would be improved if offered in a setting more accessible to the patient. The aim of this study was to evaluate the proportion of uptake of GDM screening in the primary vs secondary care setting, and to qualitatively explore the providers' experiences of primary care screening provision. METHODS: This mixed methods study was composed of a quantitative unblinded parallel group randomised controlled trial and qualitative interview trial. The primary outcome was the proportion of uptake of screening in both the primary and secondary care settings. All pregnant women aged 18 years or over, with sufficient English and without a diagnosis or diabetes or GDM, who attended for their first antenatal appointment at one of three hospital sites along the Irish Atlantic seaboard were eligible for inclusion in this study. Seven hundred and eighty-one pregnant women were randomised using random permutated blocks to receive a 2 h 75 g OGTT in either a primary (n = 391) or secondary care (n = 390) setting. Semi-structured interviews were conducted with 13 primary care providers. Primary care providers who provided care to the population covered by the three hospital sites involved were eligible for inclusion. RESULTS: Statistically significant differences were found between the primary care (n = 391) and secondary care (n = 390) arms for uptake (52.7% vs 89.2%, respectively; effect size 36.5 percentage points, 95% CI 30.7, 42.4; p < 0.001), crossover (32.5% vs 2.3%, respectively; p < 0.001) and non-uptake (14.8% vs 8.5%, respectively; p = 0.005). There were no significant differences in uptake based on the presence of a practice nurse or the presence of multiple general practitioners in the primary care setting. There was evidence of significant relationship between probability of uptake of screening and age (p < 0.001). Primary care providers reported difficulties with the conduct of GDM screening, despite recognising that the community was the most appropriate location for screening. CONCLUSIONS/INTERPRETATION: Currently, provision of GDM screening in primary care in Ireland, despite its acknowledged benefits, is unfeasible due to poor uptake rates, poor rates of primary care provider engagement and primary care provider concerns. TRIAL REGISTRATION: http://isrctn.org ISRCTN02232125 FUNDING: This study was funded by the Health Research Board (ICE2011/03).

Profile of energy expenditure in people with rheumatoid arthritis.

BACKGROUND: No definitive conclusions have been made on the levels of physical activity in the rheumatoid arthritis (RA) population. Similarly no clear consensus has been reached on the correlates and predictors of physical activity in the population. OBJECTIVE: To profile total energy expenditure (TEE), resting energy expenditure (REE) and physical activity related energy expenditure (PAEE) levels using a validated objective measurement tool and to determine demographic and health related factors which influence and predict TEE and PAEE levels in individuals with RA. METHODS: Fifty nine (41 female, 18 male) individuals with RA were recruited to this cross sectional study. Energy expenditure was measured over seven days using SenseWear Armband. Correlational analysis and logistic regression were used to examine the relationship between demographic and health related factors and TEE, REE and PAEE. RESULTS: A profile of energy expenditure in RA individuals was developed in terms of levels, differences between genders and differences between weekdays and weekend days. Median TEE, PAEE and REE were 2204.0, 409.5 and 1506.2 kcal/day respectively. Energy expenditure was associated with factors such as gender, age, body mass index, employment status, disease severity and smoking. CONCLUSION: The findings add to the growing research assessing energy expenditure in the RA population and strengthen the position due to the use of an objective validated tool. Some recommendations on what factors are associated with energy expenditure in the RA population are made, thus unveiling ways to tailor physical activity type interventions in this group.

Users' experience of physical activity monitoring technology in rheumatoid arthritis.

OBJECTIVES: The aim of the present study was to qualitatively explore users' experiences of home monitoring of health with specific regard to physical activity monitors. METHODS: Fourteen participants were randomly selected from a larger sample of individuals with rheumatoid arthritis (RA) who had taken part in a physical activity monitoring study and had worn two physical activity monitors for seven days in their homes. These individuals were assigned to one of two focus groups. Each focus group lasted for between 40 minutes and an hour and was audio-recorded. A semi-structured questioning route was used, followed by subsequent theoretical thematic analysis. RESULTS: No statistically significant differences were noted in the demographic factors between those who took part in the focus groups and the entire RA sample. Three distinct themes were identified: i) Experiences of having health monitored in the home, which was found to be largely positive; ii) Experiences of use of specific technology to monitor physical activity, which was generally reported as unobtrusive and not to impact significantly negatively on their daily life; iii) Perceptions and experiences of physical activity and exercise, which monitoring was reported to facilitate focusing on physical activity choices. CONCLUSIONS: These focus groups were the first to highlight the perceptions held by individuals with RA regarding home monitoring and, in particular, physical activity monitoring. This has implications for those planning interventions for this group which involve home monitoring. Interesting findings were also highlighted regarding the perceptions and understanding of physical activity and exercise among people with RA.

Study to determine the criterion validity of the SenseWear Armband as a measure of physical activity in people with rheumatoid arthritis.

OBJECTIVE: Measuring physical activity in people with rheumatoid arthritis (RA) is of great importance in light of the increased mortality in this population due to cardiovascular disease. Validation of activity monitors in specific populations is recommended to ensure the accuracy of physical activity measurement. Thus, the purpose of this study was to determine the validity of the SenseWear Pro3 Armband (SWA) as a measure of physical activity during activities of daily living (ADL) in people with RA. METHODS: Fourteen subjects (8 men and 6 women) with a diagnosis of RA were recruited from rheumatology clinics at the Mid-Western Regional Hospitals, Limerick, Ireland. Participants undertook a series of ADL of varying intensities. The SWA was compared to the criterion measures of the Oxycon Mobile indirect calorimetry system (energy expenditure in kJ) and of manual video observation (step count). Bland and Altman, intraclass correlation coefficient (ICC), and correlation analyses were done using SPSS, version 19.0. RESULTS: The SWA showed substantial agreement (ICC 0.717, P < 0.001) and a strong relationship (Pearson's correlation coefficient = 0.852) compared with the criterion measure when estimating energy expenditure during ADL. However, it was found that the SWA overestimated energy expenditure, particularly at higher intensity levels. The ability of the SWA to estimate step counts during ADL was poor (ICC 0.304, P = 0.038). CONCLUSION: The SWA can be considered a valid tool to estimate energy expenditure during ADL in the RA population; however, attention should be paid to its tendency to overestimate energy expenditure.

Physical activity in rheumatoid arthritis: a systematic review.

BACKGROUND: Physical activity is associated with improved health outcomes in many populations. It is assumed that physical activity levels in the rheumatoid arthritis (RA) population may be reduced as a result of symptoms of the disease. The objective of this review is to establish the current evidence base for levels of physical activity in the RA population. METHODS: A systematic review was performed of 7 databases (Emabase, MEDLINE, AMED, Biomedical Reference Collection Expanded, CINAHL, Nursing and Allied Health Collection, and SportsDiscus) up to February 2011 to examine the evidence in the area. RESULTS: One hundred and thirty-six studies were identified through electronic searching. One hundred and six were excluded based on title and/or abstract analysis and a further 14 were excluded based on full text analysis. Sixteen studies meeting the criteria were deemed suitable for inclusion. The results of the included studies indicate that the level of physical activity may be lower among individuals with RA when compared with healthy controls or normative data. CONCLUSIONS: There are a number of methodological considerations at play within the studies reviewed which prohibits definitive conclusion on the physical activity levels of this population group. Given the known health benefits of physical activity, further research in this area appears indicated.

Activity level classification algorithm using SHIMMER™ wearable sensors for individuals with rheumatoid arthritis.

In rheumatoid arthritis (RA) it is believed that symptoms associated with the progression of the disease result in a reduction in the physical activity level of the patient. One of the key flaws of the research surrounding this hypothesis to date is the use of non-validated physical activity outcomes measures. In this study, an algorithm to estimate physical activity levels in patients as they perform a simulated protocol of typical activities of daily living using SHIMMER kinematic sensors, incorporating tri-axial gyroscopes and accelerometers, is proposed. The results are validated against simultaneously recorded energy expenditure data and the defined activity protocol and demonstrate that SHIMMER can be used to accurately estimate physical activity levels in RA populations.