General population screening for paediatric type 1 diabetes-A qualitative study of UK professional stakeholders.

AIMS: Identifying children at risk of type 1 diabetes allows education for symptom recognition and monitoring to reduce the risk of diabetic ketoacidosis at presentation. We aimed to explore stakeholder views towards paediatric general population screening for type 1 diabetes in the United Kingdom (UK). METHODS: Qualitative interviews were undertaken with 25 stakeholders, including diabetes specialists, policymakers and community stakeholders who could be involved in a future type 1 diabetes screening programme in the UK. A thematic framework analysis was performed using the National Screening Committee's evaluative criteria as the overarching framework. RESULTS: Diabetic ketoacidosis prevention was felt to be a priority and proposed benefits of screening included education, monitoring and helping the family to better prepare for a future with type 1 diabetes. However, diabetes specialists were cautious about general population screening because of lack of evidence for public acceptability. Concerns were raised about the harms of living with risk, provoking health anxiety and threatening the child's right to an 'open future'. Support systems that met the clinical and psychological needs of the family living with risk were considered essential. Stakeholders were supportive of research into general population screening and acknowledged this would be a priority if an immunoprevention agent were licensed in the UK. CONCLUSIONS: Although stakeholders suggested the harms of UK paediatric general population screening currently outweigh the benefits, this view would potentially be altered if prevention therapies were licensed. In this case, an evidence-based screening strategy would need to be formulated and public acceptability explored.

Views of children with diabetes from underserved communities, and their families on diabetes, glycaemic control and healthcare provision: A qualitative evidence synthesis.

AIMS: Children and young people with diabetes (CYPD) from socio-economically deprived and/or ethnic minority groups tend to have poorer glucose control and greater risk of diabetes-related complications. In this systematic review of qualitative evidence (qualitative evidence synthesis, QES), we aimed to explore the experiences and views of clinical encounters in diabetes care from the perspectives of CYPD and their family/carers from underserved communities and healthcare professionals in diabetes care. METHODS: We searched 6 databases to March 2022 with extensive search terms, and used a thematic synthesis following methods of Thomas and Harden. RESULTS: We identified 7 studies and described 11 descriptive themes based on primary and secondary constructs. From these, three "analytical themes" were developed. (1) "Alienation of CYPD" relates to their social identity and interaction with peers, family and health service practitioners in the context of diabetes self- and family/carer management and is impacted by communication in the clinical encounter. (2) "Empowerment of CYPD and family/carers" explores families' understanding of risks and consequences of diabetes and taking responsibility for self- and family/carer management in the context of their socio-cultural background. (3) "Integration of diabetes (into self and family)" focuses on the ability to integrate diabetes self-management into the daily lives of CYPD and family/carers beyond the clinical consultation. CONCLUSIONS: The analytical themes are interdependent and provide a conceptual framework from which to explore and strengthen the therapeutic alliance in clinical encounters and to foster greater concordance with treatment plans. Communicating the biomedical aspects of managing diabetes in the clinical encounter is important, but should be balanced with addressing socio-emotional factors important to CYPD and family/carers.

Cooking outdoors or with cleaner fuels does not increase malarial risk in children under 5 years: a cross-sectional study of 17 sub-Saharan African countries.

BACKGROUND: Smoke from solid biomass cooking is often stated to reduce household mosquito levels and, therefore, malarial transmission. However, household air pollution (HAP) from solid biomass cooking is estimated to be responsible for 1.67 times more deaths in children aged under 5 years compared to malaria globally. This cross-sectional study investigates the association between malaria and (i) cleaner fuel usage; (ii) wood compared to charcoal fuel; and, (iii) household cooking location, among children aged under 5 years in sub-Saharan Africa (SSA). METHODS: Population-based data was obtained from Demographic and Health Surveys (DHS) for 85,263 children within 17 malaria-endemic sub-Saharan countries who were who were tested for malaria with a malarial rapid diagnostic test (RDT) or microscopy. To assess the independent association between malarial diagnosis (positive, negative), fuel type and cooking location (outdoor, indoor, attached to house), multivariable logistic regression was used, controlling for individual, household and contextual confounding factors. RESULTS: Household use of solid biomass fuels and kerosene cooking fuels was associated with a 57% increase in the odds ratio of malarial infection after adjusting for confounding factors (RDT adjusted odds ratio (AOR):1.57 [1.30-1.91]; Microscopy AOR: 1.58 [1.23-2.04]) compared to cooking with cleaner fuels. A similar effect was observed when comparing wood to charcoal among solid biomass fuel users (RDT AOR: 1.77 [1.54-2.04]; Microscopy AOR: 1.21 [1.08-1.37]). Cooking in a separate building was associated with a 26% reduction in the odds of malarial infection (RDT AOR: 0.74 [0.66-0.83]; Microscopy AOR: 0.75 [0.67-0.84]) compared to indoor cooking; however no association was observed with outdoor cooking. Similar effects were observed within a sub-analysis of malarial mesoendemic areas only. CONCLUSION: Cleaner fuels and outdoor cooking practices associated with reduced smoke exposure were not observed to have an adverse effect upon malarial infection among children under 5 years in SSA. Further mixed-methods research will be required to further strengthen the evidence base concerning this risk paradigm and to support appropriate public health messaging in this context.

Effectiveness of interventions to reduce household air pollution from solid biomass fuels and improve maternal and child health outcomes in low- and middle-income countries: A systematic review and meta-analysis.

Interventions to reduce household air pollution (HAP) are key to reducing associated morbidity and mortality in low- and middle- income countries (LMICs); especially among pregnant women and young children. This systematic review aims to determine the effectiveness of interventions aimed to reduce HAP exposure associated with domestic solid biomass fuel combustion, compared to usual cooking practices, for improving health outcomes in pregnant women and children under five in LMIC settings. A systematic review and meta-analysis was undertaken with searches undertaken in MEDLINE, EMBASE, CENTRAL, GIM, ClinicalTrials.gov, and Greenfile in August 2020. Inclusion criteria were experimental, non-experimental, or quasi-experimental studies investigating the impact of interventions to reduce HAP exposure and improve associated health outcomes among pregnant women or children under 5 years. Study selection, data extraction, and quality assessment using the Effective Public Health Practice Project tool were undertaken independently by two reviewers. Seventeen out of 7293 retrieved articles (seven pregnancy, nine child health outcome; 13 studies) met the inclusion criteria. These assessed improved cookstoves (ICS; n = 10 studies), ethanol stoves (n = 1 study), and Liquefied Petroleum Gas (LPG; n = 2 studies) stoves interventions. Meta-analysis showed no significant effect of ICS interventions compared to traditional cooking for risk of preterm birth (n = 2 studies), small for gestational age (n = 2 studies), and incidence of acute respiratory infections (n = 6 studies). Although an observed increase in mean birthweight was observed, this was not statistically significant (n = 4). However, ICS interventions reduced the incidence of childhood burns (n = 3; observations = 41 723; Rate Ratio: 0.66 [95% CI: 0.45-0.96]; I2 : 46.7%) and risk of low birth weight (LBW; n = 4; observations = 3456; Odds Ratio: 0.73 [95% CI: 0.61-0.87]; I2 : 21.1%). Although few studies reported health outcomes, the data indicate that ICS interventions were associated with reduced risk of childhood burns and LBW. The data highlight the need for the development and implementation of robust, well-reported and monitored, community-driven intervention trials with longer-term participant follow-up.

Snacktivity™ to Promote Physical Activity: a Qualitative Study.

BACKGROUND: Adults should achieve a minimum of 150 min of moderate-to-vigorous intensity physical activity per week, but many people do not achieve this. Changes to international guidance have removed the requirement to complete physical activity in bouts of at least 10 min. Snacktivity is a novel and complementary approach that could motivate people to be physically active. It focuses on promoting shorter (2-5 min) and more frequent bouts, or 'snacks' of physical activity throughout the day. It is not known whether promoting physical activity in shorter bouts is acceptable to the public, or whether it likely to translate into health behaviour change. METHODS: As part of a larger research programme, this study explored the merits of using small bouts of physical activity to help the public become physically active (the Snacktivity™ programme). Thirty-one inactive adults used the approach for five days then participated in semi- structured interviews about their experiences. The data were analysed using the Framework approach. RESULTS: Whilst participants highlighted some potential barriers to implementation, they expressed the ease with which Snacktivity could be achieved, which gave them a new awareness of opportunities to do more physical activity throughout the day. Participants raised the importance of habit formation to achieve regular small bouts of physical activity. CONCLUSIONS: Findings demonstrated that participants liked the Snacktivity concept and viewed it as a motivating approach. Guidance about physical activity must lead to advice that has the best chance of preserving and promoting health and Snacktivity has potential to meet this ambition.

Global prevalence and types of complementary and alternative medicines use amongst adults with diabetes: systematic review and meta-analysis.

AIM: This study aimed to undertake a systematic review and meta-analysis of global prevalence and types of complementary and alternative medicine (CAM) use amongst adults with diabetes. METHODS: Nine databases, including MEDLINE and EMBASE, were searched for studies published between 2009 and 2019 which included extractable data for CAM use in adult patients with diabetes. Study characteristics, types of CAM, and overall and subgroup prevalence data in relation to CAM use were extracted. Meta-analysis of aggregate level data on prevalence and prevalence ratios (PRs) was performed using a random effects model. RESULTS: From the 38 studies included in the review, a total of 37 types of CAM and 223 types of herbs were identified. Pooled prevalence of CAM use was 51%. A wide variation in prevalence rates (predictive interval 8-93%) was observed. In the context of high heterogeneity, we found no evidence that CAM use was associated with gender, chronicity or type of diabetes. Approximately one third of patients did not disclose their use of CAM to healthcare professionals (95% PrI 25%, 97%). Herbal medicines, acupuncture, homoeopathy and spiritual healing were the common CAM types reported. CONCLUSIONS: A wide variation in prevalence of CAM use by patients with diabetes was identified. Healthcare professionals should be aware of their patients' use of CAM to ensure treatment optimization, avoid herb-drug interactions and promote medication adherence in diabetes. Diabetic reviews and clinical guidelines should incorporate exploration of patient use of CAM as many patients do not proactively disclose the use of CAM to their healthcare professionals. REGISTRATION: The protocol for this study was registered with the Centre for Review and Dissemination (CRD). Protocol registration number CRD42019125036.

The experiences of postnatal women and healthcare professionals of a brief weight management intervention embedded within the national child immunisation programme.

BACKGROUND: After childbirth, most women do not lose the extra weight gained during pregnancy. This is important because postnatal weight retention contributes to the development of obesity in later life. Research shows that postnatal women living with overweight would prefer to weigh less, are interested in implementing weight loss strategies, and would like support. Without evidence for the benefit of weight management interventions during pregnancy, postnatal interventions are increasingly important. Research has focused on intensive weight loss programmes, which cannot be offered to all postnatal women. Instead, we investigated the feasibility of a brief intervention delivered to postnatal women at child immunisation appointments. This qualitative study explored the views of women who received the intervention and healthcare professionals who delivered it. METHODS: The intervention was delivered within the context of the national child immunisation programme. The intervention group were offered brief support encouraging self-management of weight when attending general practices to have their child immunised at two, three and four months of age. The intervention involved motivation and support from practice nurses to encourage women to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. Nurses provided external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a weight record card. Nested within this trial, semi-structured interviews explored the experiences of postnatal women who received the intervention and nurses who delivered it. RESULTS: The intervention was generally acceptable to participants and child immunisation appointments considered a suitable intervention setting. Nurses were hesitant to discuss maternal weight, viewing the postnatal period as a vulnerable time. Whilst some caveats to implementation were discussed by nurses, they felt the intervention was easy to deliver and would motivate postnatal women to lose weight. CONCLUSIONS: Participants were keen to lose weight after childbirth. Overall, they reported that the intervention was acceptable, convenient, and, appreciated support to lose weight after childbirth. Although nurses, expressed concerns about raising the topic of weight in the early postnatal period, they felt the intervention was easy to deliver and would help to motivate women to lose weight.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.

BACKGROUND: Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. METHODS: This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. FINDINGS: 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. INTERPRETATION: Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. FUNDING: National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.

Measurement of blood pressure for the diagnosis and management of hypertension in different ethnic groups: one size fits all.

BACKGROUND: Hypertension is a major risk factor for cardiovascular disease and prevalence varies by ethnic group. The diagnosis and management of blood pressure are informed by guidelines largely based on data from white populations. This study addressed whether accuracy of blood pressure measurement in terms of diagnosis of hypertension varies by ethnicity by comparing two measurement modalities (clinic blood pressure and home monitoring) with a reference standard of ambulatory BP monitoring in three ethnic groups. METHODS: Cross-sectional population study (June 2010 - December 2012) with patients (40-75 years) of white British, South Asian and African Caribbean background with and without a previous diagnosis of hypertension recruited from 28 primary care practices. The study compared the test performance of clinic BP (using various protocols) and home-monitoring (1 week) with a reference standard of mean daytime ambulatory measurements using a threshold of 140/90 mmHg for clinic and 135/85 mmHg for out of office measurement. RESULTS: A total of 551 participants had complete data of whom 246 were white British, 147 South Asian and 158 African Caribbean. No consistent difference in accuracy of methods of blood pressure measurement was observed between ethnic groups with or without a prior diagnosis of hypertension: for people without hypertension, clinic measurement using three different methodologies had high specificity (75-97%) but variable sensitivity (33-65%) whereas home monitoring had sensitivity of 68-88% and specificity of 64-80%. For people with hypertension, detection of a raised blood pressure using clinic measurements had sensitivities of 34-69% with specificity of 73-92% and home monitoring had sensitivity (81-88%) and specificity (55-65%). CONCLUSIONS: For people without hypertension, ABPM remains the choice for diagnosing hypertension compared to the other modes of BP measurement regardless of ethnicity. Differences in accuracy of home monitoring and clinic monitoring (higher sensitivity of the former; higher specificity of the latter) were also not affected by ethnicity.

Parental experiences of prenatal whole exome sequencing (WES) in cases of ultrasound diagnosed fetal structural anomaly.

OBJECTIVE: To explore parental experiences of whole exome sequencing (WES) for prenatal diagnosis and ascertain what influenced their decision-making to undergo testing. METHOD: Twelve women comprised a purposeful sample in a series of semistructured interviews. All had received a fetal anomaly diagnosis on ultrasound. A topic guide was used, and transcripts were thematically analyzed to elicit key themes. RESULTS: Five main themes (parental experiences of prenatal WES, need for information, consent/reasons for prenatal WES, sources of support for prenatal WES, and return of WES findings to families) emerged, some with multiple subthemes. CONCLUSIONS: Parents desired as much information as possible and appreciated information being repeated and provided in various formats. Many struggled with clinical uncertainty relating to the cause and prognosis following a fetal anomaly diagnosis and found it difficult to balance the risks of invasive testing against their need for more definitive information. Parents trusted their clinicians and valued their support with decisions in pregnancy. Testing was sometimes pursued to reassure parents that their baby was "normal" rather than to confirm an underlying genetic problem. Parents were motivated to undergo WES for personal and altruistic reasons but disliked waiting times for results and were uncertain about what findings might be returned.

Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study.

BACKGROUND: Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. METHODS: This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. RESULTS: Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. CONCLUSIONS: Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

Blood pressure self-monitoring in pregnancy (BuMP) feasibility study; a qualitative analysis of women's experiences of self-monitoring.

BACKGROUND: Hypertensive disorders in pregnancy are a leading cause of maternal and fetal morbidity worldwide. Raised blood pressure (BP) affects 10% of pregnancies worldwide, of which almost half develop pre-eclampsia. The proportion of pregnant women who have risk factors for pre-eclampsia (such as pre-existing hypertension, obesity and advanced maternal age) is increasing. Pre-eclampsia can manifest itself before women experience symptoms and can develop between antenatal visits. Incentives to improve early detection of gestational hypertensive disorders are therefore strong and self-monitoring of blood pressure (SMBP) in pregnancy might be one means to achieve this, whilst improving women's involvement in antenatal care. The Blood Pressure Self-Monitoring in Pregnancy (BuMP) study aimed to evaluate the feasibility and acceptability of SMBP in pregnancy. METHODS: To understand women's experiences of SMBP during pregnancy, we undertook a qualitative study embedded within the BuMP observational feasibility study. Women who were at higher risk of developing hypertension and/or pre-eclampsia were invited to take part in a study using SMBP and also invited to take part in an interview. Semi-structured interviews were conducted at the women's homes in Oxfordshire and Birmingham with women who were self-monitoring their BP as part of the BuMP feasibility study in 2014. Interviews were conducted by a qualitative researcher and transcribed verbatim. A framework approach was used for analysis. RESULTS: Fifteen women agreed to be interviewed. Respondents reported general willingness to engage with monitoring their own BP, feeling that it could reduce anxiety around their health during pregnancy, particularly if they had previous experience of raised BP or pre-eclampsia. They felt able to incorporate self-monitoring into their weekly routines, although this was harder post-partum. Self-monitoring of BP made them more aware of the risks of hypertension and pre-eclampsia in pregnancy. Feelings of reassurance and empowerment were commonly reported by the women in our sample. CONCLUSIONS: SMBP in pregnancy was both acceptable and feasible to women in this small pilot study.

How Do People With COPD Value Different Activities? An Adapted Meta-Ethnography of Qualitative Research.

Chronic Obstructive Pulmonary Disease (COPD) is a long-term condition where activities of daily living (ADLs) may be very restricted; people with COPD need to prioritize what is important to them. We conducted a meta-ethnography to understand which ADLs are valued and why, systematically searching for articles including experiences of ADLs and organizing themes from the articles into five linked concepts: (a) caring for the body, (b) caring for the personal environment, (c) moving between spaces, (d) interacting with others, and (e) selfhood across time. In addition, we identified three key aspects of personal integrity: effectiveness, connectedness, and control. We found that ADLs were valued if they increased integrity; however, this process was also informed by gendered roles and social values. People whose sense of control depended on effectiveness often found accepting help very difficult to bear; therefore, redefining control as situational and relational may help enjoyment of activities that are possible.

Test result communication in primary care: clinical and office staff perspectives.

OBJECTIVE: To understand how the results of laboratory tests are communicated to patients in primary care and perceptions on how the process may be improved. DESIGN: Qualitative study employing staff focus groups. SETTING: Four UK primary care practices. PARTICIPANTS: Staff involved in the communication of test results. FINDINGS: Five main themes emerged from the data: (i) the default method for communicating results differed between practices; (ii) clinical impact of results and patient characteristics such as anxiety level or health literacy influenced methods by which patients received their test result; (iii) which staff member had responsibility for the task was frequently unclear; (iv) barriers to communicating results existed, including there being no system or failsafe in place to determine whether results were returned to a practice or patient; (v) staff envisaged problems with a variety of test result communication methods discussed, including use of modern technologies, such as SMS messaging or online access. CONCLUSIONS: Communication of test results is a complex yet core primary care activity necessitating flexibility by both patients and staff. Dealing with the results from increasing numbers of tests is resource intensive and pressure on practice staff can be eased by greater utilization of electronic communication. Current systems appear vulnerable with no routine method of tracing delayed or missing results. Instead, practices only become aware of missing results following queries from patients. The creation of a test communication protocol for dissemination among patients and staff would help ensure both groups are aware of their roles and responsibilities.

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial.

IMPORTANCE: Self-monitoring of blood pressure with self-titration of antihypertensives (self-management) results in lower blood pressure in patients with hypertension, but there are no data about patients in high-risk groups. OBJECTIVE: To determine the effect of self-monitoring with self-titration of antihypertensive medication compared with usual care on systolic blood pressure among patients with cardiovascular disease, diabetes, or chronic kidney disease. DESIGN, SETTING, AND PATIENTS: A primary care, unblinded, randomized clinical trial involving 552 patients who were aged at least 35 years with a history of stroke, coronary heart disease, diabetes, or chronic kidney disease and with baseline blood pressure of at least 130/80 mm Hg being treated at 59 UK primary care practices was conducted between March 2011 and January 2013. INTERVENTIONS: Self-monitoring of blood pressure combined with an individualized self-titration algorithm. During the study period, the office visit blood pressure measurement target was 130/80 mm Hg and the home measurement target was 120/75 mm Hg. Control patients received usual care consisting of seeing their health care clinician for routine blood pressure measurement and adjustment of medication if necessary. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in systolic blood pressure between intervention and control groups at the 12-month office visit. RESULTS: Primary outcome data were available from 450 patients (81%). The mean baseline blood pressure was 143.1/80.5 mm Hg in the intervention group and 143.6/79.5 mm Hg in the control group. After 12 months, the mean blood pressure had decreased to 128.2/73.8 mm Hg in the intervention group and to 137.8/76.3 mm Hg in the control group, a difference of 9.2 mm Hg (95% CI, 5.7-12.7) in systolic and 3.4 mm Hg (95% CI, 1.8-5.0) in diastolic blood pressure following correction for baseline blood pressure. Multiple imputation for missing values gave similar results: the mean baseline was 143.5/80.2 mm Hg in the intervention group vs 144.2/79.9 mm Hg in the control group, and at 12 months, the mean was 128.6/73.6 mm Hg in the intervention group vs 138.2/76.4 mm Hg in the control group, with a difference of 8.8 mm Hg (95% CI, 4.9-12.7) for systolic and 3.1 mm Hg (95% CI, 0.7-5.5) for diastolic blood pressure between groups. These results were comparable in all subgroups, without excessive adverse events. CONCLUSIONS AND RELEVANCE: Among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN87171227.

Views of healthcare professionals on complementary and alternative medicine use by patients with diabetes: a qualitative study.

BACKGROUND: Recent estimates indicate that a significant proportion of diabetic patients globally, up to 51%, are utilizing complementary and alternative medicine (CAM). To improve patient-provider communication and optimize prescribed treatments, healthcare professionals (HCPs) must understand the factors associated with CAM use among diabetic patients. There is a dearth of literature on HCPs perspectives on CAM use by diabetic patients. This study explored HCPs knowledge, perspective, and views on their diabetic patients' use of CAM. METHODS: Qualitative study using one-to-one semi-structured interviews conducted with 22 HCPs involved in the care of diabetic patients (6 endocrinologists, 4 general practitioners, 4 nurses and 8 pharmacists). Participants were recruited through general practices, community pharmacies and a diabetic centre in Saudi Arabia. Data were analyzed using thematic analysis. RESULTS: Five key themes resulted from the analysis. HCPs generally demonstrated negative perceptions toward CAM, particularly regarding their evidence-based effectiveness and safety. Participants described having limited interactions with diabetic patients regarding CAM use due to HCPs' lack of knowledge about CAM, limited consultation time and strict consultation protocols. Participants perceived convenience as the reason why patients use CAM. They believed many users lacked patience with prescribed medications to deliver favourable clinical outcomes and resorted to CAM use. CONCLUSIONS: HCPs have noted inadequate engagement with diabetic patients regarding CAM due to a lack of knowledge and resources. To ensure the safe use of CAM in diabetes and optimize prescribed treatment outcomes, one must address the communication gap by implementing a flexible consultation protocol and duration. Additionally, culturally sensitive, and evidence-based information should be available to HCPs and diabetic patients.

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

BACKGROUND: Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. METHODS/DESIGN: The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. TRIAL REGISTRATION: ISRCTN87171227.

Promoting participation in physical activity through Snacktivity: A qualitative mixed methods study.

BACKGROUND: Public health guidance acknowledges the benefits of physical activity of any duration. We have proposed a whole-day approach to promoting physical activity called Snacktivity™, which encourages frequent 2-5 minute 'activity snacks' of moderate-to-vigorous intensity. METHODS: Using repeated semi-structured interviews and a think aloud protocol, this study aimed to understand participants' experiences of integrating Snacktivity™ into daily life, to provide insights to refine the delivery of Snacktivity™ interventions. Physically inactive adults recruited via primary care and a community health service engaged with an intervention to encourage Snacktivity™ over three weeks, which included using a Fitbit and linked mobile phone app (SnackApp). Participants took part in semi-structured interviews on two occasions during the intervention, with a sub-group participating in a think aloud study. Three study data sets were generated and independently explored using inductive thematic analysis, with findings combined into a single set of themes. RESULTS: Eleven adults participated in the interview study who were interviewed twice (total interviews completed n = 21, 1 participant declined the second interview), of whom six completed the think aloud study (total voice recordings n = 103). Three main themes emerged from the combined data; lived experience of participating in Snacktivity™, motivation for Snacktivity™ and experiences with the Snacktivity™ technology. Participants undertook a variety of activity snacks, utilising their environment, which they believed improved their psychological wellbeing. Participants were enthusiastic about Snacktivity™, with some stating that activity snacks were more accessible than traditional exercise, but perceived they were often prevented from doing so in the presence of others. Participants were mostly enthusiastic about using the Snacktivity™ technology. CONCLUSION: Participants were able to incorporate Snacktivity™ into their lives, particularly at home, and found this approach acceptable. Participants felt they experienced health benefits from Snacktivity™ although barriers to participation were reported. This study offers insights for translating guidance into practice and supporting people to become more physically active.

Snacktivity™ to promote physical activity and reduce future risk of disease in the population: protocol for a feasibility randomised controlled trial and nested qualitative study.

BACKGROUND: Many people do not regularly participate in physical activity, which may negatively impact their health. Current physical activity guidelines are focused on promoting weekly accumulation of at least 150 min of moderate to vigorous intensity physical activity (MVPA). Whilst revised guidance now recognises the importance of making small changes to physical activity behaviour, guidance still focuses on adults needing to achieve at least 150 min of MVPA per week. An alternative 'whole day' approach that could motivate the public to be more physically active, is a concept called Snacktivity™. Instead of focusing on achieving 150 min per week of physical activity, for example 30 min of MVPA over 5 days, Snacktivity™ encourages the public to achieve this through small, but frequent, 2-5 min 'snacks' of MVPA throughout the whole day. METHODS: The primary aim is to undertake a feasibility trial with nested qualitative interviews to assess the feasibility and acceptability of the Snacktivity™ intervention to inform the design of a subsequent phase III randomised trial. A two-arm randomised controlled feasibility trial aiming to recruit 80 inactive adults will be conducted. Recruitment will be from health and community settings and social media. Participants will be individually randomised (1:1 ratio) to receive either the Snacktivity™ intervention or usual care. The intervention will last 12 weeks with assessment of outcomes completed before and after the intervention in all participants. We are interested in whether the Snacktivity™ trial is appealing to participants (assessed by the recruitment rate) and if the Snacktivity™ intervention and trial methods are acceptable to participants (assessed by Snacktivity™/physical activity adherence and retention rates). The intervention will be delivered by health care providers within health care consultations or by researchers. Participants' experiences of the trial and intervention, and health care providers' views of delivering the intervention within health consultations will be explored. DISCUSSION: The development of physical activity interventions that can be delivered at scale are needed. The findings from this study will inform the viability and design of a phase III trial to assess the effectiveness and cost-effectiveness of Snacktivity™ to increase physical activity. TRIAL REGISTRATION: ISRCTN: 64851242.

Factors affecting complementary and alternative medicine (CAM) use by adult diabetic patients: A systematic review using the theoretical domains framework (TDF).

BACKGROUND: It is estimated that approximately 50% of patients with diabetes use some form of complementary and alternative medicine (CAM) to manage their condition. OBJECTIVES: The objective of this study was to undertake a systematic review to explore factors that influence the use of CAM by diabetic patients. METHODS: A systematic review of literature was conducted using Cochrane and PRISMA guidelines. Nine databases including MEDLINE and EMBASE were searched from 2010 to March 2021 using medical subject headings and natural language keywords. Data in relation to factors associated with use of CAM in diabetic patients 18 years of age and older were extracted and further categorised as per the theoretical domains framework (TDF). RESULTS: Forty-three studies from 28 countries were included. A total of 84 factors were identified. Key factors related to the 'intentions (to treat and relieve symptoms) and goals' domain of the TDF. Accessibility and affordability compared to physician visits and modern medicines (TDF- environmental context and resources), 'Social influences' from family members, friends, religious and spiritual scholars were amongst other factors reported to be important. Users also reported lack of trust in modern medicines and perceived CAMs to be safer and free from adverse effects. CONCLUSIONS: Decisions to use CAM in diabetes are multifactorial. Healthcare professionals' awareness of patients' CAM use and associated factors can inform counselling practices and promote treatment optimisation, adherence and patient safety through avoidance of drug-CAM interactions. Alleviating patients' concerns and reluctance to use prescribed treatments are imperative to achieve therapeutic goals. Improving access and affordability is imperative where high costs prevent use of prescribed medicines leading to many patients using CAM as a standalone therapy. [Systematic review registration: PROSPERO CRD42019125036].