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Abstract Background The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. Methods A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. Results The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60–80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. Conclusion The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. Trial registration ISCTRN ISRCTN13404264. Registered on 10 October 2018.

Abstract Background Acceptability is recognised as a key concept in the development of health interventions, but there has been a lack of consensus about how acceptability should be conceptualised. The theoretical framework of acceptability (TFA) provides a potential tool for understanding acceptability. It has been proposed that acceptability measured before use of an intervention (anticipated acceptability) may differ from measures taken during and after use (experienced acceptability), but thus far this distinction has not been tested for a specific intervention. This paper 1) directly compares ratings of anticipated and experienced acceptability of a text message-based intervention, 2) explores the applicability of the TFA in a technology-based intervention, and 3) uses these findings to inform suggestions for measuring acceptability over the lifespan of technology-based health interventions. Methods Data were obtained from a quantitative online survey assessing anticipated acceptability of the proposed text messages (n = 59) and a 12-week proof-of-concept mixed methods study assessing experienced acceptability while receiving the text messages (n = 48). Both quantitative ratings by return text message, and qualitative data from participant interviews were collected during the proof-of-concept study. Results The quantitative analysis showed anticipated and experienced acceptability were significantly positively correlated (rs > .4). The qualitative analysis identified four of the seven constructs of the TFA as themes (burden, intervention coherence, affective attitude and perceived effectiveness). An additional two themes were identified as having an important impact on the TFA constructs (perceptions of appropriateness and participants’ role). Three suggestions are given related to the importance of appropriateness, what may affect ratings of acceptability and what to consider when measuring acceptability. Conclusions The high correlation between anticipated and experienced acceptability was a surprising finding and could indicate that, in some cases, acceptability of an intervention can be gauged adequately from an anticipated acceptability study, prior to an expensive pilot or feasibility study. Directly exploring perceptions of appropriateness and understanding whether the acceptability described by participants is related to the intervention or the research - and is for themselves or others - is important in interpreting the results and using them to further develop interventions and predict future use.

Abstract Background Hip fracture is common, affecting 20% of women and 10% of men during their lifetime. The trajectory of patients’ recovery as they transition from the acute hospital setting to their usual residence is poorly understood. Recently, the use of activity trackers to monitor physical activity during recovery has been investigated as a way to explore this trajectory. Methods This prospective observational cohort study followed patients from hospital to home as they recovered from a hip fracture. Participants were recruited from a single centre and provided with a 3-axis logging accelerometer worn as a pendant, for 16 weeks from recruitment. Participants received monthly follow-up visits which included questions about wearing the monitor. Monthly activity monitor data were also downloaded. Participant activity was estimated from the monitor data using the calibrated “Euclidean Norm Minus One” (ENMO) metric. Polynomial mixed-effects modelling was used to evaluate the difference between the weekly activity trends of 2 groups of participants: those with and without independent mobility at 16 weeks (defined by whether aids or personal assistance were required to mobilise). Results Twenty-nine participants from 125 eligible patients were recruited. Of these, 19 (66%) reported being aware of wearing the monitor at least some of the time. Fourteen (48%) participants withdrew before study completion. Data for thirteen (45%) participants were of sufficient quantity to be included in the activity modelling procedure. Of these, 8 reported independent mobility at 16 weeks post-surgery, and 5 did not. By week 7, the weekly predicted mean ENMO ( ENMO ¯ W $$ {\overline{ENMO}}_W $$ ) values were significantly different between the two participant groups, demonstrating feasibility of the model’s ability to predict which patients will report independent mobility at 16 weeks. Conclusions This is the first study to our knowledge to investigate acceptability and feasibility of a pendant-worn activity monitor in this patient cohort. Acceptability of wearing the monitor and feasibility of recruitment and retention of participants were limited. Future research into the use of activity monitors in this population should use minimally intrusive devices which are acceptable to this population. Study registration MoHIP is a sub-study of the World Hip Trauma Evaluation (WHiTE) Study (ISRCTN 63982700).

Aim: The COVID-19 pandemic has necessitated less resource-intensive testing guidelines to identify gestational diabetes mellitus (GDM). We performed a scoping review of the international evidence reporting the ability of diagnostic tests recommended during the pandemic to accurately identify patients with GDM, compared to pre-pandemic reference standards, and associated test and clinical outcomes. Methods: A comprehensive search of the literature was carried out in Embase, LitCovid, Cochrane Covid-19 study register, and medRxiv on 14th June 2021. Results: 145 unique citations were returned; after screening according to pre-specified inclusion criteria by title and abstract and then full text, 13 studies involving 40,836 pregnant people and an additional 52,884 instances of OGTT were included. Thresholds defined in the Australian pandemic guideline appear adequate to identify most GDM cases; false negative cases appeared at lower risk of hyperglycaemia-in-pregnancy(HIP)-related events. For UK and Canadian guidelines, a larger proportion would be misdiagnosed as non-GDM; these false negative cases had broadly equivalent HIP-related event rates as true positives. Conclusions: The OGTT remains the most effective test to identify abnormal glucose processing in pregnancy, supporting the prompt return to standard guidelines post-pandemic. Cohort studies investigating the impact of the change in guidelines on GDM pregnancies and associated outcomes are needed.

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data (RCHD) for at least one outcome were included. RCHD sources and outcome information were extracted. Of 216 RCTs, 102 (47%) planned to use RCHD. A RCHD source was the sole source of outcome data for at least one outcome in 46 (45%) of those 102 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort (NIHR HTA funded trials that had a protocol available) plan to collect outcome data from routinely collected data sources.

Women with past gestational diabetes mellitus (GDM) are at risk of subsequent type 2 diabetes and adverse cardiovascular events. Digital and telemedicine interventions targeting weight loss and reductions in body mass index (BMI) may help reduce risk for women with GDM. The aim was to compare the effectiveness of digital or telemedicine intervention with usual care. Randomized controlled trials (RCTs) were identified in Embase, Medline, CINAHL, PsycINFO and the Cochrane Library. Included trials recruited women with prior GDM but without pre-existing diabetes, and tested a digital or telemedicine intervention with or without an in-person component. Data extraction was carried out independently by two authors. The search yielded 898 citations. Eighteen articles reporting 15 trials were included, of which 8 tested digital interventions. Reported outcomes included weight, BMI, fasting plasma glucose and waist circumference. None of the included trials reported type 2 diabetes incidence or cardiovascular risk. Data were pooled using a random-effects model. The point estimate favored the intervention but was non-significant for both BMI (−0.90 kg/m2, 95% CI −1.89 to 0.09; p=0.08) and weight (−1.83 kg, 95% CI −4.08 to 0.42, p=0.11). Trials evaluating digital and telemedicine interventions identified clinically relevant, but non-significant improvements in BMI and weight compared with control. No trials assessed type 2 diabetes occurrence as an outcome. More well-designed RCTs with adequate power and long-term follow-up are needed to identify the impact of these interventions on type 2 diabetes occurrence.

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data (RCHD) for at least one outcome were included. RCHD sources and outcome information were extracted. Of 216 RCTs, 102 (47%) planned to use RCHD. A RCHD source was the sole source of outcome data for at least one outcome in 46 (45%) of those 102 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort (NIHR HTA funded trials that had a protocol available) plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of which were carried out in North America (McCord et al., 2019).

Routinely collected data about health in medical records, registries and hospital activity statistics is now routinely collected in an electronic form. The extent to which such sources of data are now being routinely accessed to deliver efficient clinical trials, is unclear. The aim of this study was to ascertain current practice amongst a United Kingdom (UK) cohort of recently funded and ongoing randomised controlled trials (RCTs) in relation to sources and use of routinely collected outcome data. Recently funded and ongoing RCTs were identified for inclusion by searching the National Institute for Health Research journals library. Trials that have a protocol available were assessed for inclusion and those that use or plan to use routinely collected health data for at least one outcome were included. Routinely collected data sources and outcome information were extracted. A total of 279 studies were identified with 102 eligible for data extraction. An Electronic Health Record (EHR) was the sole source of outcome data for at least one outcome in 46 trials. The most frequent sources are Hospital Episode Statistics (HES) and Office for National Statistics (ONS), with the most common outcome data to be extracted being on mortality, hospital admission, and health service resource use. Our study has found that around half of publicly funded trials in a UK cohort plan to collect outcome data from routinely collected data sources. This is much higher than the figure of 8% found in a cohort of 189 RCTs published since 2000, the majority of were carried out in North America (McCord et al., 2019).

Abstract Background Competing risks occur when populations may experience outcomes that either preclude or alter the probability of experiencing the main study outcome(s). Many standard survival analysis methods do not account for competing risks. We used mortality risk in people with diabetes with and without albuminuria as a case study to investigate the impact of competing risks on measures of absolute and relative risk. Methods A population with type 2 diabetes was identified in Clinical Practice Research Datalink as part of a historical cohort study. Patients were followed for up to 9 years. To quantify differences in absolute risk estimates of cardiovascular and cancer, mortality standard (Kaplan-Meier) estimates were compared to competing-risks-adjusted (cumulative incidence competing risk) estimates. To quantify differences in measures of association, regression coefficients for the effect of albuminuria on the relative hazard of each outcome were compared between standard cause-specific hazard (CSH) models (Cox proportional hazards regression) and two competing risk models: the unstratified Lunn-McNeil model, which estimates CSH, and the Fine-Gray model, which estimates subdistribution hazard (SDH). Results In patients with normoalbuminuria, standard and competing-risks-adjusted estimates for cardiovascular mortality were 11.1% (95% confidence interval (CI) 10.8–11.5%) and 10.2% (95% CI 9.9–10.5%), respectively. For cancer mortality, these figures were 8.0% (95% CI 7.7–8.3%) and 7.2% (95% CI 6.9–7.5%). In patients with albuminuria, standard and competing-risks-adjusted estimates for cardiovascular mortality were 21.8% (95% CI 20.9–22.7%) and 18.5% (95% CI 17.8–19.3%), respectively. For cancer mortality, these figures were 10.7% (95% CI 10.0–11.5%) and 8.6% (8.1–9.2%). For the effect of albuminuria on cardiovascular mortality, regression coefficient values from multivariable standard CSH, competing risks CSH, and competing risks SDH models were 0.557 (95% CI 0.491–0.623), 0.561 (95% CI 0.494–0.628), and 0.456 (95% CI 0.389–0.523), respectively. For the effect of albuminuria on cancer mortality, these values were 0.237 (95% CI 0.148–0.326), 0.244 (95% CI 0.154–0.333), and 0.102 (95% CI 0.012–0.192), respectively. Conclusions Studies of absolute risk should use methods that adjust for competing risks to avoid over-stating risk, such as the CICR estimator. Studies of relative risk should consider carefully which measure of association is most appropriate for the research question.

Introduction A significant percentage of patients admitted to hospital have undiagnosed hypertension. However, present hypertension guidelines in the UK, Europe and USA do not define a blood pressure threshold at which hospital inpatients should be considered at risk of hypertension, outside of the emergency setting. The objective of this study is to identify the optimal in-hospital mean blood pressure threshold, above which patients should receive postdischarge blood pressure assessment in the community.Methods and analysis Screening for Hypertension in the INpatient Environment is a prospective diagnostic accuracy study. Patients admitted to hospital whose mean average daytime blood pressure after 24 hours or longer meets the study eligibility threshold for mean daytime blood pressure (≥120/70 mm Hg) and who have no prior diagnosis of, or medication for hypertension will be eligible. At 8 weeks postdischarge, recruited participants will wear an ambulatory blood pressure monitor for 24 hours. Mean daytime ambulatory blood pressure will be calculated to assess for the presence or absence of hypertension. Diagnostic performance of in-hospital blood pressure will be assessed by constructing receiver operator characteristic curves from participants’ in-hospital mean systolic and mean diastolic blood pressure (index test) versus diagnosis of hypertension determined by mean daytime ambulatory blood pressure (reference test).Ethics and dissemination Ethical approval has been provided by the National Health Service Health Research Authority South Central—Oxford B Research Ethics Committee (19/SC/0026). Findings will be disseminated through national and international conferences, peer-reviewed journals and social media.

INTRODUCTION:Sexual dysfunction is a common complication for men with diabetes, yet little is known about the lived experiences of sexual difficulties within the context of diabetes, particularly in low-and-middle-income countries. This study explores how men with type 2 diabetes in three sub-Saharan African settings (Cape Town and Johannesburg, South Africa; Lilongwe, Malawi) perceive and experience sexual functioning and sexual well-being, and the biopsychosocial contexts in which these occur and are shaped. METHODS:We used a qualitative research design, including individual interviews (n = 15) and focus group discussions (n = 4). Forty-seven men were included in the study. We used an inductive thematic analysis approach to develop our findings. A biopsychosocial conceptual model on the relationship between chronic illness and sexuality informed the interpretation of findings. RESULTS:Men across the study settings identified sexual difficulties as a central concern of living with diabetes. These difficulties went beyond biomedical issues of erectile dysfunction, comprising complex psychological and relational effects. Low self-esteem, related to a sense of loss of masculinity and reduced sexual and emotional intimacy in partner relationships were common experiences. Specific negative relational effects included suspicion of infidelity, mutual mistrust, general unhappiness, and fear of losing support from partners. These effects may impact on men's ability to cope with their diabetes. Further stressors were a lack of information about the reasons for their sexual difficulties, perceived lack of support from healthcare providers and an inability to communicate with partners about sexual difficulties. CONCLUSION:More in-depth research is needed to better understand sexual functioning and well-being within the context of diabetes, and its potential impact on diabetes self-management. Holistic and patient-centered care should include raising awareness of sexual problems as a potential complication of diabetes amongst patients, their partners and care providers, and incorporating sexual well-being as part of routine clinical care.

Background: Annual screening for adults with type 2 diabetes to detect the early onset of kidney disease is widely recommended, but the recommendations are based on a limited methodological approach. In addition, there are continuing uncertainties about underlying rates of progression of the condition and the benefits of treatments with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers. Objectives: We aimed to estimate the clinical value and cost-effectiveness of different screening intervals to diagnose early diabetic kidney disease. Data sources: We used the following databases for the literature review (searched January 2005 to August 2010): MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews. Individual patient data were obtained from the Oxford Regional Prospective Diabetes Study and the Collaborative Atorvastatin Diabetes Study. Methods: Data from systematically identified randomised trials reporting the impact on renal outcomes of angiotensin-converting enzyme inhibitors and angiotensin 2 receptor blockers for type 1 and type 2 diabetes patients with normoalbuminuria and microalbuminuria were pooled to derive estimates of effect. Individual patient data for type 1 and type 2 diabetes patients were used to obtain parameters describing progression and variability of measurement over time for the albumin-to-creatinine ratio (ACR) and estimated glomerular filtration rate. Based on accepted diagnostic thresholds, we modelled whether these tests accurately identified patients who were developing early diabetic kidney disease and required intensification of treatment. Cost-effectiveness analyses were carried out using simulation outcome models to estimate the incremental costs per quality-adjusted life-year (QALY) for different screening intervals. Results: In total, 49 trials (n = 34,082 patients) were eligible for inclusion in the systematic review. For type 1 diabetes, pooled estimates of urinary albumin excretion (UAE) for treated patients with microalbuminuria were on average 67% [95% confidence interval (CI) 54% to 77%] lower at the end of the trial than for untreated patients. There was no significant treatment effect for patients with normoalbuminuria (p interaction = 0.006). For treated patients with type 2 diabetes and normoalbuminuria or microalbuminuria, UAE was lower by, on average, 21% (95% CI 97% to 32%) or 27% (95% CI 15% to 38%), respectively. The proportion (95% CI) of men and women with type 1 diabetes screened annually for microalbuminuria over 6 years and inaccurately identified as having microalbuminuria would be 48% (43% to 53%) and 55% (48% to 61%), respectively. The corresponding proportions for type 2 diabetes are 36% (32% to 42%) and 48% (41% to 55%). Decreasing the screening interval to 3-yearly would reduce this for men with type 1 diabetes to 38% (33% to 44%), with an increase in those not identified over 6 years from 1.5% (95% CI 1% to 2%) to 4% (95% CI 3% to 5%). For type 1 diabetes, incremental cost per QALY [standard deviation (SD)] of a 5-yearly compared with a 4-yearly screening interval was £3612 (£6586), increasing to £9601 (£34,112) for annual compared with 2-yearly screening. The probability that the intervention is cost saving is around 25%, and it has around an 80% chance of being below a cost-effectiveness threshold of £30,000. For type 2 diabetes, incremental cost per QALY (SD) of a yearly compared with a 2-yearly screening interval was £606 (£1782). The intervention is almost certainly below a cost-effectiveness threshold of £5000. Conclusions: These results support current UK guidance, which recommends annual screening with ACR to identify early kidney disease in patients with diabetes, despite a high false-positive rate leading to, at worst, unnecessary or, at best, early therapeutic intervention. For type 1 diabetes, screening costs for annual compared with 2-yearly screening are well within the bounds of accepted cost-effectiveness. Annual screening is even more cost-effective in type 2 diabetes than in type 1 diabetes. Identification of alternative markers for developing diabetic nephropathy may improve targeting of treatment for those at high risk. Funding: The National Institute for Health Research Health Technology Assessment programme.

BackgroundCurrent guidance about the interval needed before retesting HbA1c when monitoring for glycaemic control is based on expert opinion rather than well-powered studies. The aim of our work was to explore how fast HbA1c changes after a change in glucose-lowering medication. This has implications for whether routine HbA1c testing intervals before 12 weeks could inform diabetes medication adjustments.MethodsThis 12-week cohort study recruited patients from 18 general practices in the United Kingdom with non-insulin treated diabetes who were initiating or changing dose of oral glucose-lowering medication. HbA1c was measured at baseline and 2, 4, 8 and 12 weeks after recruitment. HbA1c levels at earlier time intervals were correlated with 12-week HbA1c. A ROC curve analysis was used to identify the 8-week threshold above which medication adjustment may be clinically appropriate.ResultsNinety-three patients were recruited to the study. Seventy-nine patients with no change in medication and full 12-week follow-up had the following baseline characteristics: mean ± standard deviation age of 61.3 ± 10.8 years, 34% were female and diabetes duration of 6.0 ± 4.3 years. Mean HbA1c at baseline, 2, 4, 8 and 12 weeks was 8.7 ± 1.5%, (72.0 ± 16.8 mmol/mol) 8.6 ± 1.6% (70.7 ± 17.0 mmol/mol), 8.4 ± 1.5% (68.7 ± 15.9 mmol/mol), 8.2 ± 1.4% (66.3 ± 15.8 mmol/mol) and 8.1 ± 1.4% (64.8 ± 15.7 mmol/mol) respectively. At the end of the study 61% of patients had sub-optimal glycaemic control (HbA1c>7.5% or 59 mmol/mol). The 8-week change correlated significantly with the 12-week change in HbA1c and an HbA1c above 8.2% (66 mmol/mol) at 8 weeks correctly classified all 28 patients who had not achieved glycaemic control by 12 weeks.Conclusions/interpretationThis is the first study designed with sufficient power to examine short-term changes in HbA1c. The 12-week change in HbA1c can be predicted 8 weeks after a medication change. Many participants who had not achieved glycaemic control after 12 weeks may have benefitted from an earlier review of their HbA1c and medication.