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Dr Gemma Hughes, Health Services Researcher at the Nuffield Department of Primary Care Health Sciences, blogs about Virtual Presence, an international research collaboration.
A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A feasibility trial
Objective: To assess the feasibility of a blood pressure self-monitoring intervention for managing pregnancy hypertension. Study design: OPTIMUM-BP was an unmasked randomised controlled trial comparing a self-monitoring of blood pressure (SMBP) intervention versus usual care for the management of pregnancy hypertension. Women with chronic (CH) or gestational hypertension (GH) from 4 UK centres were randomised (2:1) intervention to control. Self-monitoring involved daily home blood pressure (BP) measurements, with recording via study diary or telemonitoring. Clinicians were invited to use the home readings in clinical and antihypertensive titration decisions. Main outcomes: The primary outcomes were recruitment, retention, adherence and persistence with the intervention. Results: Women from four UK centres were randomised: 158/222 (71%) of those approached agreed, comprising: 86 women with chronic hypertension (55 SMBP, 31 control) and 72 with gestational hypertension (49 SMBP, 23 control) of whom outcome data were available from 154 (97%) and were included in the analysis. The median (IQR) number of days with home BP readings per week were 5.5 (3.1–6.5) for those with chronic hypertension and 6.1 (4.5–6.7) with gestational hypertension. Participants persisted with the intervention for 80% or more of their time from enrolment until delivery in 86% (43/50) and 76% (38/49) of those with chronic and gestational hypertension respectively. Recorded clinic and study BPs were similar for both groups. Conclusions: This is the first randomised investigation of BP self-monitoring for the management of pregnancy hypertension and indicates that a large RCT would be feasible.
Self-monitoring of blood pressure following a stroke or transient ischaemic attack (TASMIN5S): a randomised controlled trial
Background: Blood pressure (BP) control following stroke is important but currently sub-optimal. This trial aimed to determine whether self-monitoring of hypertension with telemonitoring and a treatment escalation protocol, results in lower BP than usual care in people with previous stroke or transient ischaemic attack (TIA). Methods: Unblinded randomised controlled trial, comparing a BP telemonitoring-based intervention with control (usual care) for hypertension management in 12 primary care practices in England. People with previous stroke or TIA with clinic systolic BP 130–180 mmHg, taking ≤ 3 antihypertensive medications and on stable treatment for at least four weeks were randomised 1:1 using secure online system to intervention or control. The BP:Together intervention comprised self-monitoring of blood pressure with a digital behavioural intervention which supported telemonitoring of self-monitored BP with feedback to clinicians and patients regarding medication titration. The planned primary outcome was difference in clinic measured systolic BP 12 months from randomisation but was not available following early study termination due to withdrawal of funding during the COVID-19 pandemic. Instead, in addition to pre-randomised data, routinely recorded BP was extracted from electronic patient records both pre- and post-randomisation and presented descriptively only. An intention to treat approach was taken. Results: From 650 postal invitations, 129 (20%) responded, of whom 95 people had been screened for eligibility prior to the pandemic (November 2019-March 2020) and 55 (58%) were randomised. Pre-randomisation routinely recorded mean BP was 145/78 mmHg in the control (n = 26) and 145/79 mmHg in the self-monitoring (n = 21) groups. Post-randomisation mean BP was 134/73 mmHg in the control (n = 19) and 130/75 mmHg in the self-monitoring (n = 25) groups. Participants randomised to self-monitoring used the intervention for ≥ 7 months in 25/27 (93%) of cases. Conclusions: Recruitment of people with stroke/TIA to a trial comparing a BP self-monitoring and digital behavioural intervention to usual care was feasible prior to the COVID-19 pandemic and the vast majority of those randomised to intervention used it while the trial was running. Routinely recorded blood pressure control improved in both groups. Digital interventions including self-monitoring are feasible for people with stroke/TIA and should be definitively evaluated in future trials. Trial registration: ISRCTN57946500 06/09/2019 Prospective.
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure
Background: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. Methods: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. Results: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. Conclusion: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.
Effect of antihypertensive deprescribing on hospitalisation and mortality: long-term follow-up of the OPTiMISE randomised controlled trial
Background: Deprescribing of antihypertensive medications is recommended for some older patients with low blood pressure and frailty. The OPTiMISE trial showed that this deprescribing can be achieved with no differences in blood pressure control at 3 months compared with usual care. We aimed to examine effects of deprescribing on longer-term hospitalisation and mortality. Methods: This randomised controlled trial enrolled participants from 69 general practices across central and southern England. Participants aged 80 years or older, with systolic blood pressure less than 150 mm Hg and who were receiving two or more antihypertensive medications, were randomly assigned (1:1) to antihypertensive medication reduction (removal of one antihypertensive) or usual care. General practitioners and participants were aware of the treatment allocation following randomisation but individuals responsible for analysing the data were masked to the treatment allocation throughout the study. Participants were followed up via their primary and secondary care electronic health records at least 3 years after randomisation. The primary outcome was time to all-cause hospitalisation or mortality. Intention-to-treat analyses were done using Cox regression modelling. A per-protocol analysis of the primary outcome was also done, excluding participants from the intervention group who did not reduce treatment or who had medication reinstated during the initial trial 12-week follow-up period. This study is registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT2016-004236-38) and the ISRCTN Registry (ISRCTN97503221). Findings: Between March 20, 2017, and Sept 30, 2018, a total of 569 participants were randomly assigned. Of these, 564 (99%; intervention=280; control=284) were followed up for a median of 4·0 years (IQR 3·7–4·3). Participants had a mean age of 84·8 years (SD 3·4) at baseline and 273 (48%) were women. Medication reduction was sustained in 109 participants at follow-up (51% of the 213 participants alive in the intervention group). Participants in the intervention group had a larger reduction in antihypertensives than the control group (adjusted mean difference –0·35 drugs [95% CI –0·52 to –0·18]). Overall, 202 (72%) participants in the intervention group and 218 (77%) participants in the control group experienced hospitalisation or mortality during follow-up (adjusted hazard ratio [aHR] 0·93 [95% CI 0·76 to 1·12]). There was some evidence that the proportion of participants experiencing the primary outcome in the per-protocol population was lower in the intervention group (aHR 0·80 [0·64 to 1·00]). Interpretation: Half of participants sustained medication reduction with no evidence of an increase in all-cause hospitalisation or mortality. These findings suggest that an antihypertensive deprescribing intervention might be safe for people aged 80 years or older with controlled blood pressure taking two or more antihypertensives. Funding: British Heart Foundation and National Institute for Health and Care Research.
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial
Background: Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented. Methods: We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563). Findings: Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19–88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference –3·05, 95% CI –3·83 to –2·28; p<0·0001; Cohen's d –0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention. Interpretation: Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder. Funding: The National Institute for Health and Care Research Health Technology Assessment Programme.
Evaluating the feasibility and acceptability of the diabetes in primary care improving classification (Depiction) to tool
Aims: Misclassification of diabetes types (type 1, type 2 and MODY) is common, affecting 7%–15% of type 1 and 2 cases and 77% of MODY cases. We developed a decision support tool using validated prediction models to automatically search primary care systems and identify patients with diabetes at high probability of misclassification, and who may benefit from further investigations or referral to secondary care. This study evaluates the feasibility and acceptability of using this tool to improve diabetes classification in adults diagnosed ≤50 years. Methods: A mixed-methods, non-randomised intervention study across 12 primary care practices in the Southwest and East Midlands, UK. Feasibility is assesed through practice uptake, data quality, misclassification rates and practitioner workload. Acceptability is explored via one-to-one qualitative interviews with up to 40 practice staff and patients and thematically analysed. Results: Eleven practices have run the tool (mean practice size: 15,623), identifying a mean of 27 patients with diabetes per practice with potential misclassification: 3 with a high probability of MODY, 12 coded as type 1 but more likely type 2 and 12 coded as type 2 but more likely type 1. Preliminary qualitative data suggest the tool can help to audit miscoding and improve patient care. Practice staff reported that the tool was easy to use, though embedding in primary care systems was preferred. Conclusions: The DePICtion tool shows promise for improving diabetes classification and is potentially acceptable to both practitioners and patients. Further refinement could ensure better diagnosis and management for more patients.
Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users' views.
BACKGROUND: Self-sampling and self-testing have been increasingly used for sexually transmitted infections (STIs) and quickly became widespread during the COVID-19 pandemic. User acceptability, preferences, and experiences are important factors affecting self-sampling/self-testing uptake. Understanding these factors is key to managing infections and planning responses to health emergencies. This review aimed to identify user views and experiences related to the acceptability, usability, motivations and preferences for self-sampling/self-testing for infections. METHODS: We conducted a rapid systematic review. We searched Medline, EMBASE, PsycINFO, CINAHL, and Web of Science, limiting records to those published in English between 2014 and 2023. We also searched manually for additional peer-reviewed and grey literature. We included reports of public users' views on self-sampling/self-testing for any symptomatic and asymptomatic infections (except human papillomavirus) with qualitative, mixed-methods or survey data relevant to the review aim. Data were extracted into tables and qualitative findings were coded in NVivo. We synthesised data narratively. RESULTS: We identified 194 eligible reports, including 64 from Europe (which we prioritised for detailed synthesis) and 130 from outside of Europe. In Europe, the studied infections were respiratory (n = 42, including 37 for COVID-19), STIs/HIV/genital infections (n = 20), and hepatitis C (n = 2). Findings indicate that users found self-sampling/self-testing acceptable across infection/sampling types, populations, settings, and countries. Users wanted self-sampling/self-testing to help determine infection status and protect others. The main benefits were privacy and convenience, helping reduce the potential stigma of STIs/HIV/genital infections, and (for COVID-19) informing behaviour (e.g., socialising, self-isolating) and contributing to research. Easier to perform and less invasive sampling approaches were more acceptable. However, some participants reported challenges to self-sampling/self-testing, such as not understanding instructions, pain/discomfort in collecting samples, and lack of confidence in interpreting results. CONCLUSIONS: This review synthesised evidence on the acceptability of SS/ST and factors affecting it across different infections, sampling approaches, settings, and populations. Evidence shows that most people with experience of self-sampling/self-testing found it acceptable and were willing to accept some discomfort in favour of several perceived benefits. This amenability to self-sampling/self-testing could be leveraged for diagnosing infections and preventing transmission. It can be used to support the viability of new models of clinical care and pandemic preparedness. TRIAL REGISTRATION: The review was pre-registered on PROSPERO (ref. CRD42024507656 ).
Patient and clinician experiences of remote consultation during the SARS-CoV-2 pandemic: A service evaluation
Objectives: During the SARS-CoV-2 pandemic, clinicians were instructed to move all but emergency consultations to remote means to reduce the spread of the virus. The aim of this study was to evaluate patients’ and clinicians’ experiences of moving to remote means of consultation with their health care professionals during the SARS-CoV-2 pandemic. Methods: The study design was a qualitative service evaluation. Twenty-six clinicians and forty-eight patients who met the inclusion criteria consented to be interviewed. Clinician participants were from either medical, nursing, or allied health professional backgrounds. Patients were recruited from diabetes, acute care, and haematology and cancer areas. Data analysis was conducted using a thematic analysis framework. Results: Following coding and thematic analysis of the data collected from clinicians, five themes were identified: personal and professional well-being; providing a safe and high-quality experience; adapting to a new way of working; making remote consultations fit for purpose and an awareness of altered dynamics during consultation. Patient data was coded into 3 themes: remote consultation adds value; remote consultation brings challenges and concerns about remote consultation. Conclusions: Clinician and patient experiences reported here are reflected in the literature. The study indicates that remote consultation is not suitable for all patients and in all contexts. Whilst maintaining the benefits to patients, remote means of consultation needs organisational support and preparation. A way forward that maintains the benefits whilst addressing concerns seems urgent.
A paradigm shift in cystic fibrosis nutritional care: Clinicians' views on the management of patients with overweight and obesity
Background: Overweight and obesity among people with cystic fibrosis (pwCF) has become more prevalent since the widespread adoption of CF transmembrane conductance regulator (CFTR) modulator therapies and presents a new challenge for nutritional care. We aimed to explore how clinicians working in CF care approach the management of adults with overweight and obesity. Methods: We conducted semi-structured interviews with n = 20 clinicians (n = 6 physiotherapists, n = 6 doctors and n = 8 dietitians) working in 15 adult CF centres in the United Kingdom. The interviews explored their perspectives and current practices caring for people with CF and overweight/obesity. Data were analysed using reflexive thematic analysis. Results: Four main themes were identified: 1) challenges of raising the topic of overweight and obesity in the CF clinic (e.g., clinician-patient rapport and concerns around weight stigma); 2) the changing landscape of assessment due to CF-specific causes of weight gain: (e.g., impact of CFTR modulators and CF legacy diet) 3) presence of clinical equipoise for weight management due to the lack of CF-specific evidence on the consequences of obesity and intentional weight loss (e.g., unclear consequences on respiratory outcomes and risk of weight related co-morbidities) and 4) opportunities for a safe, effective, and acceptable weight management treatment for people with CF (e.g., working collaboratively with current multidisciplinary CF care). Conclusions: Approaching weight management in the CF setting is complex. Trials are needed to assess the equipoise of weight management interventions in this group and CF-specific issues should be considered when developing such interventions.