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Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with psychosis experience (NEON Trial): a pragmatic randomised controlled trialBackground: The Narrative Experiences Online (NEON) Intervention provides self-managed web-based access to mental health recovery narratives (n = 659). We evaluated effectiveness and cost-effectiveness in improving quality of life for adults resident in England with mental health problems and recent psychosis experience. Methods: Prospectively registered pragmatic parallel-group randomised trial controlling for usual care, recruiting from statutory mental health services and through community engagement activities, with a 52-week primary endpoint (ISRCTN11152837). All trial procedures and the NEON Intervention were delivered by an integrated web-application. Randomisation was through an independently generated list (no stratification). Allocation was masked for statistical staff and the Chief Investigator but not participants. Intervention arm participants received immediate NEON Intervention access. Control arm participants received access after completing primary endpoint questionnaires. The primary outcome was quality of life through the Manchester Short Assessment (MANSA). Serious Adverse Events (SAEs) were collected through web-based safety report forms and identified from health service usage data. The primary analysis was by a prospectively described Intention To Treat principle excluding participants who had registered multiple times, with multiple imputation for missing data. Findings: Between 9 March 2020 and 1 March 2021, 739 participants were randomised (intervention:370; control: 369), providing more than 90% power to detect a baseline-adjusted difference of 0.25 in the MANSA score. Mean age was 34.8 years (standard deviation (SD) 12.0), 561 (75.9%) were white British, 443 (59.9%) were female, 609 (82.4%) had accessed specialist care mental health services, and 698 (94.5%) had accessed primary care mental health services. Mean baseline MANSA score was 3.7 for control and intervention arms (SD 0.9 and 1.0). 565 (76.5%) participants provided primary endpoint MANSA data with a mean score of 4.1 (SD 1.0) for both arms. We found no significant difference in Quality of Life between the two arms at the primary endpoint (baseline-adjusted difference 0.07, 95% CI -0.07 to 0.21, p = 0.35). The incremental cost-effectiveness ratio (£110,501 per quality-adjusted life-year (QALY)) exceeded the prospectively defined cost-effectiveness threshold (£30,000 per QALY). 158 (42.8%) control arm and 194 (52.4%) intervention arm participants accessed narratives outside of the NEON Intervention. There were no related serious adverse events (SAEs). 116 unrelated SAEs were reported by control arm participants, and 107 by intervention arm participants. Interpretation: Our findings do not indicate NEON Intervention access for all people with psychosis experience. Future research should consider a) evaluation with current mental health services users; b) optimisation to enable users to find hope-promoting narratives.
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Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trialBackground: Up to half of people hospitalised with COVID-19 report diverse and persistent symptoms affecting quality of life for months and sometimes years after discharge (long-COVID). We describe the development of an online group exercise and behavioural support intervention for people who continue to experience such physical and/or emotional health problems more than three months after hospital discharge. Methods: Intervention development was informed by the Medical Research Council framework for complex interventions. Our multidisciplinary team of academics, clinicians, and people with long-COVID, had collective expertise in the development and testing of complex interventions. We integrated a bio-psycho-social model of care drawing on rehabilitation literature for long-term health conditions and experiences from our pre-pilot study. Multiple stakeholder meetings were held to refine the intervention which was designed to be deliverable within the UK National Health Service. We adhere to TIDieR guidance for transparent and explicit reporting of telehealth interventions. Results: The final REGAIN online exercise and behavioural support intervention consisted of an initial 1:1 consultation with a trained practitioner, followed by eight online group exercise, and six group support, sessions delivered over eight weeks. Participants could also access an online library of on-demand exercise and support videos. Conclusions: The final REGAIN intervention, combining exercise and behavioural support, is fully manualised with clear pathways to delivery and implementation. It is currently being tested in a randomised controlled trial. The intervention, developed with extensive patient and stakeholder engagement, could be incorporated into existing NHS rehabilitation programmes, should it prove to be clinically and cost-effective for people with long-COVID.
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Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with non-psychotic mental health problems: a pragmatic randomized controlled trialNarratives describing first-hand experiences of recovery from mental health problems are widely available. Emerging evidence suggests that engaging with mental health recovery narratives can benefit people experiencing mental health problems, but no randomized controlled trial has been conducted as yet. We developed the Narrative Experiences Online (NEON) Intervention, a web application providing self-guided and recommender systems access to a collection of recorded mental health recovery narratives (n=659). We investigated whether NEON Intervention access benefited adults experiencing non-psychotic mental health problems by conducting a pragmatic parallel-group randomized trial, with usual care as control condition. The primary endpoint was quality of life at week 52 assessed by the Manchester Short Assessment (MANSA). Secondary outcomes were psychological distress, hope, self-efficacy, and meaning in life at week 52. Between March 9, 2020 and March 26, 2021, we recruited 1,023 participants from across England (the target based on power analysis was 994), of whom 827 (80.8%) identified as White British, 811 (79.3%) were female, 586 (57.3%) were employed, and 272 (26.6%) were unemployed. Their mean age was 38.4±13.6 years. Mood and/or anxiety disorders (N=626, 61.2%) and stress-related disorders (N=152, 14.9%) were the most common mental health problems. At week 52, our intention-to-treat analysis found a significant baseline-adjusted difference of 0.13 (95% CI: 0.01-0.26, p=0.041) in the MANSA score between the intervention and control groups, corresponding to a mean change of 1.56 scale points per participant, which indicates that the intervention increased quality of life. We also detected a significant baseline-adjusted difference of 0.22 (95% CI: 0.05-0.40, p=0.014) between the groups in the score on the "presence of meaning" subscale of the Meaning in Life Questionnaire, corresponding to a mean change of 1.1 scale points per participant. We found an incremental gain of 0.0142 quality-adjusted life years (QALYs) (95% credible interval: 0.0059 to 0.0226) and a £178 incremental increase in cost (95% credible interval: -£154 to £455) per participant, generating an incremental cost-effectiveness ratio of £12,526 per QALY compared with usual care. This was lower than the £20,000 per QALY threshold used by the National Health Service in England, indicating that the intervention would be a cost-effective use of health service resources. In the subgroup analysis including participants who had used specialist mental health services at baseline, the intervention both reduced cost (-£98, 95% credible interval: -£606 to £309) and improved QALYs (0.0165, 95% credible interval: 0.0057 to 0.0273) per participant as compared to usual care. We conclude that the NEON Intervention is an effective and cost-effective new intervention for people experiencing non-psychotic mental health problems.
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Pragmatic, feasibility randomized controlled trial of a recorded mental health recovery narrative intervention: narrative experiences online intervention for informal carers (NEON-C)Introduction: Informal carers of people with mental health problems often have unmet support needs. Mental health recovery narratives are increasingly accessible, but their relevance to and effect on informal carers have been minimally investigated. The Narrative Experiences Online (NEON) Intervention is a first-in-field intervention that provides informal carers with access to a diverse collection of recorded mental health recovery narratives. This trial aimed to examine the feasibility and acceptability of the NEON Intervention for informal carers. Methods: This study involved a two-arm feasibility randomized controlled trial. Carers were randomly assigned to receiving versus not receiving the NEON Intervention. The feasibility aspects investigated included the acceptability of the intervention and of randomization, trial processes, engagement rates, recruitment procedures, attrition, sample size estimation, identification of candidate primary and secondary outcomes, and the feasibility of conducting a definitive trial. A qualitative process evaluation was conducted. Findings: A total of 121 carers were eligible, of whom 54 were randomized (intervention: 27, control: 27). Twelve-month follow-up data were available for 36 carers. Carers accessed a mean of 25 narratives over a 12-month period, and the intervention group, compared with the control group, reported a small effect on hope and a moderate effect on the presence of meaning in life. Five modifications were recommended to improve the user experience, applicability, and trial processes. Discussion: The NEON Intervention is feasible and acceptable. Significant refinement of the NEON Intervention and trial processes is required to personalize and ensure applicability to carers. Further feasibility testing is recommended prior to a definitive trial.
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Improving the integration of care for trans adults: ICTA a mixed-methods studyBackground: This research concerns improving the National Health Service health services trans adults need. These include the national specialist Gender Identity Clinics that support people making a medical transition. Not all trans people need to make a medical transition, and transition can take many different paths. Waits to be seen by Gender Identity Clinics are, however, several years long, and there may be significant problems of co-ordination between different aspects of transition-related care, and between transition-related care and general health care. Objectives: The main objectives were to understand which factors make services more or less accessible and acceptable to the variety of trans adults and how initiatives for providing more person-centred and integrated care can be successfully implemented and further improved. Design, data sources and participants: An online and paper screening survey was used to gather data on demographics and service use of trans people across the United Kingdom, with 2056 responses. Researchers used survey data to construct five purposive subsamples for individual qualitative interviews, identifying groups of people more likely to experience social exclusion or stigma. There were 65 online interviews. In addition, 23 trans Black people and people of colour attended focus groups. Results: The following undermine person-centred co-ordinated care and can lead to experiences of harm: • lack of respectful treatment of trans people by general practitioner practices; • inadequate funding of services; • lack of support during waiting; • the extended and challenging nature of Gender Identity Clinic diagnostic assessments, sometimes experienced as adversarial; • breakdowns in collaboration between Gender Identity Clinics and general practitioner practices over hormone therapy; • lack of National Health Service psychological support for trans people.
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Exploring listening-related fatigue in children with and without hearing loss using self-report and parent-proxy measuresChildren with hearing loss appear to experience greater fatigue than children with normal hearing (CNH). Listening-related fatigue is often associated with an increase in effortful listening or difficulty in listening situations. This has been observed in children with bilateral hearing loss (CBHL) and, more recently, in children with unilateral hearing loss (CUHL). Available tools for measuring fatigue in children include general fatigue questionnaires such as the child self-report and parent-proxy versions of the PedsQLTM-Multidimensional Fatigue Scale (MFS) and the PROMIS Fatigue Scale. Recently, the Vanderbilt Fatigue Scale (VFS-C: child self-report; VFS-P: parent-proxy report) was introduced with a specific focus on listening-related fatigue. The aims of this study were to compare fatigue levels experienced by CNH, CUHL and CBHL using both generic and listening-specific fatigue measures and compare outcomes from the child self-report and parent-proxy reports. Eighty children aged 6-16 years (32 CNH, 19 CUHL, 29 CBHL), and ninety-nine parents/guardians (39 parents to CNH, 23 parents to CUHL, 37 parents to CBHL), completed the above fatigue questionnaires online. Kruskal-Wallis H tests were performed to compare fatigue levels between the CNH, CUHL and CBHL. To determine the agreement between parent-proxy and child self-report measures, Bland-Altman 95% limits of agreement were performed. All child self-report fatigue measures indicated that CBHL experience greater fatigue than CNH. Only the listening-specific tool (VFS-C) was sufficiently able to show greater fatigue in CUHL than in CNH. Similarly, all parent-proxy measures of fatigue indicated that CBHL experience significantly greater fatigue than CNH. The VFS-P and the PROMIS Fatigue Parent-Proxy also showed greater fatigue in CUHL than in CNH. Agreement between the parent-proxy and child self-report measures were found within the PedsQL-MFS and the PROMIS Fatigue Scale. Our results suggest that CBHL experience greater levels of daily-life fatigue compared to CNH. CUHL also appear to experience more fatigue than CNH, and listening-specific measures of fatigue may be better able to detect this effect. Further research is needed to understand the bases of fatigue in these populations and to clarify whether fatigue experienced by CBHL and CUHL is comparable in nature and degree.
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Influence of sociodemographic characteristics on the preferred format of health education delivery in individuals with type 2 diabetes mellitus and or cardiovascular disease: a questionnaire studyAim: To examine the influence of sociodemographic factors of interest on preference for a particular health education format among people with type 2 diabetes and/or cardiovascular disease. Methods: A questionnaire was used to collect information on the influence of six sociodemographic factors of interest on the preference for health education formats in people with type 2 diabetes and/or cardiovascular disease. Chi-squared tests were used to examine the distribution of preferences between groups. The characteristics of the population preferring the online format were then examined in more detail using logistic regression. Results: Responses were received from 1559 participants. Overall the preferred health education format was one-to-one learning from a doctor or nurse (67%). Age, gender, diagnosis and educational level all affected the preferences expressed. The characteristics showing most consistent and significant influence were age and educational level. Overall, 29% ranked the online format highly (scores 1 or 2). This group were more likely to be aged < 65 years (P < 0.001) and to have a higher level of educational attainment (upper secondary education or higher; P < 0.001). Conclusions: Significant differences between sociodemographic groups exist in preferences for health education formats among people with type 2 diabetes and/or cardiovascular disease. Preferences should be considered when designing educational interventions to ensure they are accessible to the target group and to avoid increases in health inequality.
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Acceptability, tolerability and safety of the BRIGhTMIND trial: Connectivity-guided intermittent theta-burst stimulation versus F3- repetitive transcranial magnetic stimulation for treatment-resistant depressionBackground: The BRIGhTMIND study was a double-blind RCT comparing repetitive transcranial magnetic stimulation at a standard simulation site (the "F3" location given by the International 10-20 system, F3-rTMS) versus connectivity-guided intermittent theta burst stimulation (cgiTBS) for treatment-resistant depression. This present study reports the acceptability, safety, and tolerability of F3-rTMS versus cgiTBS. Methods: The present study used quantitative and qualitative methods. Two hundred fifty-four participants were included in the quantitative BRIGhTMIND acceptability and safety analysis (n = 126 F3-rTMS, n = 128 cgiTBS). Qualitative analysis included interviews for 15 participants (n = 7 F3-rTMS, n = 8 cgiTBS) and 582 written comments made by any participant randomised to the BRIGhTMIND trial regarding their experience of TMS and the study. Statistical analyses were used to explore differences between F3-rTMS and cgiTBS, as well as associations between acceptability, impression of change and safety. Qualitative data was analysed using an inductive thematic framework approach. Outcomes: Acceptability, TMS benefits/negative effects and impression of improvement ratings did not differ across the two treatment protocols, with ratings maintained long-term (71.4 % rated TMS acceptable, 48.8 % indicated benefits of TMS outweighed negative effects and 52.2 % feeling somewhat or much better at 26 week follow-up n = 203). Impression of improvement was positively associated with acceptability and TMS benefits. Qualitative themes included participants' TMS experience, TMS response variability, and lay theories of effectiveness. Safety profiles were comparable between F3-rTMS and cgiTBS, with 74.5 % of participants (n = 190/254) experiencing at least one adverse event possibly, probably, or definitely related to TMS. The majority of adverse events were transient and mild, with a sizeable number requiring simple treatments or small adjustments to TMS intensity and coil positioning. The F3-rTMS group had a significantly greater proportion of participants that required small adjustments to TMS to tolerate treatment compared to the cgiTBS group. Serious adverse events were rare, with one serious event in each treatment arm possibly related to TMS (F3-rTMS- psychotic episode, cgiTBS-manic episode). Conclusion: F3-rTMS and cgiTBS are comparably safe, tolerable and highly acceptable interventions for treatment-resistant depression. BRIGhTMIND systematically collected data from a large sample, providing evidence to meet the information needs of patients, clinicians and policy makers.
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Applications of Grounded Theory Methodology to Investigate Hearing Loss: A Methodological Qualitative Systematic Review With Developed GuidelinesObjectives: Qualitative methodologies are commonly adopted in hearing loss research. Grounded theory methodology is increasingly used to establish novel theories explaining experiences related to hearing loss. Establishing and improving the quality of grounded theory studies has been emphasized as critical to ensuring theoretical trustworthiness. Thus, the primary aim of the present study was to systematically review hearing loss research studies that have applied grounded theory methodology and assess the methodological quality of those grounded theory applications. Secondarily aims were to (i) explore how grounded theory methodology has been applied to investigate hearing loss, and (ii) use the findings of the review to develop a set of guidelines to aid the future high-quality application of grounded theory methodology to hearing loss research. Design: Original peer-reviewed studies applying grounded theory methodology and published in English were identified through systematic searches in 10 databases; Applied Social Sciences Index and Abstracts, British Nursing Index, Cumulative Index to Nursing and Allied Health Literature, EBSCO, Global Health, MEDLINE (OvidSP), PsycINFO, PubMed, Scopus, and Web of Science. The quality of studies was assessed according to 12 grounded theory principles using the Guideline for Reporting, Evaluating, and applying the core principles of Grounded Theory studies (GUREGT) tool. Data were analyzed using qualitative inductive thematic analysis. Results: After the removal of duplicates, 155 articles were retrieved. Of those, 39 met the criteria for inclusion in the systematic review. An increase in the adoption of grounded theory methodology to investigate hearing loss was identified with the number of published studies tripling in the last 5 years. Critical appraisal using the GUREGT tool identified four studies as high-quality. Most included studies were of moderate study quality (n = 25), and 10 were classified as being of low study quality. Using inductive thematic analysis, the included studies investigated one of four areas relating to hearing loss: (a) Living with hearing loss, (b) Identity and hearing loss, (c) Coping strategies for hearing loss, and (d) Audiological counseling and rehabilitation. Analysis also identified four main grounded theory factors frequently overlooked in hearing loss research: the different schools of grounded theory, sampling strategy, sample size, and the depth of grounded theory application. Conclusions: Use of grounded theory methodology is increasing at a rapid rate in hearing loss research. Despite this, studies conducted in the field to date do not meet and apply the full spectrum of grounded theory principles, as outlined by the GUREGT tool. To improve methodological rigor in future studies using grounded theory, we propose a set of guidelines that address the most commonly overlooked methodological considerations in hearing loss studies to date. The guidelines are designed to aid researchers to achieve high methodological quality in any field, improve qualitative rigor, and promote theoretical credibility.
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Glucose Lowering through Weight management (GLoW): a randomised controlled trial of the clinical and cost effectiveness of a diabetes education and behavioural weight management programme vs a diabetes education programme in adults with a recent diagnosis of type 2 diabetesAims/hypothesis: UK standard care for type 2 diabetes is structured diabetes education, with no effects on HbA1c, small, short-term effects on weight and low uptake. We evaluated whether remotely delivered tailored diabetes education combined with commercial behavioural weight management is cost-effective compared with current standard care in helping people with type 2 diabetes to lower their blood glucose, lose weight, achieve remission and improve cardiovascular risk factors. Methods: We conducted a pragmatic, randomised, parallel two-group trial. Participants were adults (≥18 years) with overweight or obesity (BMI≥25 kg/m2) and recently diagnosed with type 2 diabetes (≤3 years), recruited from 159 primary care practices in England. We randomised participants to a tailored diabetes education and behavioural weight management programme (DEW; delivered by Weight Watchers) or to current standard care diabetes education (DE; Diabetes Education and Self Management for Ongoing and Newly Diagnosed [DESMOND] programme), using a computer-generated randomisation sequence in a 1:1 allocation stratified by gender and diabetes duration, unknown to those collecting and analysing the data. Participants could not be blinded due to the nature of the interventions. Participants completed assessments at 0, 6 and 12 months. The primary outcome was 12 month change from baseline in HbA1c. We also assessed bodyweight, blood pressure, cholesterol (total, HDL, LDL), glucose-lowering medication, behavioural measures (physical activity, food intake), psychosocial measures (eating behaviour, diabetes-related quality of life, wellbeing) and within-trial and modelled lifetime cost effectiveness. Results: We randomised 577 participants (DEW: 289, DE: 288); 398 (69%) completed 12 month follow-up. We found no evidence for an intervention effect on change in HbA1c from baseline to 12 months (difference: -0.84 [95% CI -2.99, 1.31] mmol/mol, p=0.44) or 6 months (-1.83 [-4.05, 0.40] mmol/mol). We found an intervention effect on weight at 6 (-1.77 [-2.86, -0.67] kg) and 12 months (-1.38 [-2.56, -0.19] kg). Participants in DEW had a higher likelihood of achieving diabetes remission than participants in DE (6 months: RR 2.10 [95% CI 1.03, 4.47]; 12 months: RR 2.53 [1.30, 5.16]). DEW was cost-effective compared with DE in within-trial and lifetime analyses, in the latter generating an incremental cost effectiveness ratio of £2290 per quality-adjusted life year gained. Conclusions/interpretation: A commercial behavioural weight management programme combined with remote dietary counselling after diagnosis of type 2 diabetes did not improve HbA1c up to 12 months post intervention in this trial. The intervention could help people achieve weight loss and be cost-effective compared with current standard National Health Service care.
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Comparison of cognitive behaviour therapy versus activity management, both delivered remotely, to treat paediatric chronic fatigue syndrome/myalgic encephalomyelitis: the UK FITNET-NHS RCTDesign: Parallel-group randomised controlled trial. Methods: Adolescents aged 11-17 years, diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome and with no local specialist treatment centre, were referred to a specialist service in South West England. Interventions: Fatigue In Teenagers on the interNET in the National Health Service is a web-based myalgic encephalomyelitis/chronic fatigue syndrome-focused cognitive-behavioural therapy programme for adolescents, supported by individualised written, asynchronous electronic consultations with a clinical psychologist/cognitive-behavioural therapy practitioner. The comparator was videocall-delivered activity management with a myalgic encephalomyelitis/chronic fatigue syndrome clinician. Both treatments were intended to last 6 months. Objectives: Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for paediatric myalgic encephalomyelitis/chronic fatigue syndrome. Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for those with mild/moderate comorbid mood disorders. From a National Health Service perspective, estimate the cost-effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management over a 12-month horizon. Primary outcome: 36-item Short Form Health Survey Physical Function subscale at 6 months post randomisation. Randomisation: Web-based, using minimisation with a random component to balance allocated groups by age and gender. Blinding: While the investigators were blinded to group assignment, this was not possible for participants, parents/carers and therapists. Results: The treatment of 314 adolescents was randomly allocated, 155 to Fatigue In Teenagers on the interNET in the National Health Service. Mean age was 14 years old and 63% were female. Primary outcome: At 6 months, participants allocated to Fatigue In Teenagers on the interNET in the National Health Service were more likely to have improved physical function (mean 60.5, standard deviation 29.5, n = 127) compared to Activity Management (mean 50.3, standard deviation 26.5, n = 138). The mean difference was 8.2 (95% confidence interval 2.7 to 13.6, p = 0.003). The result was similar for participants meeting the National Institute for Health and Care Excellence 2021 diagnostic criteria. Secondary outcomes: Fatigue In Teenagers on the interNET in the National Health Service participants attended, on average, half a day more school per week at 6 months than those allocated Activity Management, and this difference was maintained at 12 months. There was no strong evidence that comorbid mood disorder impacted upon the relative effectiveness of the two interventions. Similar improvement was seen in the two groups for pain and the Clinical Global Impression scale, with a mixed picture for fatigue. Both groups continued to improve, and no clear difference in physical function remained at 12 months [difference in means 4.4 (95% confidence interval -1.7 to 10.5)]. One or more of the pre-defined measures of a worsening condition in participants during treatment, combining therapist and patient reports, were met by 39 (25%) participants in the Fatigue In Teenagers on the interNET in the National Health Service group and 42 (26%) participants in the Activity Management group. A small gain was observed for the Fatigue In Teenagers on the interNET in the National Health Service group compared to Activity Management in quality-adjusted life-years (0.002, 95% confidence interval -0.041 to 0.045). From an National Health Service perspective, the costs were £1047.51 greater in the Fatigue In Teenagers on the interNET in the National Health Service group (95% confidence interval £624.61 to £1470.41). At a base cost-effectiveness threshold of £20,000 per quality-adjusted life-year, the incremental cost-effectiveness ratio was £457,721 with incremental net benefit of -£1001 (95% confidence interval -£2041 to £38). Conclusion: At 6 months post randomisation, compared with Activity Management, Fatigue In Teenagers on the interNET in the National Health Service improved physical function and school attendance. The additional cost of Fatigue In Teenagers on the interNET in the National Health Service and limited sustained impact mean it is unlikely to be cost-effective.
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CATHETER II: a randomised controlled trial comparing the clinical effectiveness of various washout policies versus no washout policy in preventing catheter-associated complications in adults living with long-term cathetersObjectives: Do weekly prophylactic saline or acidic catheter washouts in addition to standard long-term catheter (LTC) care improve the outcomes of adults with LTC compared with standard LTC care only. Design: Three-arm superiority open-label randomised controlled trial. Setting: UK community-based study. Participants: 80 adults with LTC (any type/route) ≥28 days in situ with no plans to discontinue and able to self-manage the washouts/study documentation with/without a carer. Interventions: Randomly allocated (26:27:27) to receive standard LTC care with weekly saline or weekly acidic or no prophylactic washouts for up to 24 months. Primary and secondary outcome measures: The primary outcome was catheter blockage requiring intervention (per 1000 catheter days). Secondary outcomes were symptomatic catheter-associated urinary tract infection (S-CAUTI) requiring antibiotics, adverse events, participants' quality of life and day-to-day activities, acceptability and adherence. Results: Outcomes reported for 25 saline, 27 acidic and 26 control participants. LTC blockages (per 1000 catheter days) requiring treatment were 9.96, 10.53 and 20.92 in the saline, acidic and control groups, respectively. The incident rate ratio (IRR) favours the washout groups (saline 0.65 (97.5% CI 0.24 to 1.77); p=0.33 and acidic 0.59 (97.5% CI 0.22 to 1.63); p=0.25), although not statistically significant. The S-CAUTI rate (per 1000 catheter days) was 3.71, 6.72 and 8.05 in the saline, acidic and control groups, respectively. The IRR favours the saline group (saline 0.40 (97.5% CI 0.20 to 0.80); p=0.003 and acidic 0.98 (97.5% CI 0.54 to 1.78); p=0.93). The trial closed before reaching target recruitment due to reduced research capacity during the COVID-19 pandemic. Conclusions: Early closure and small sample size limits our ability to provide a definite answer. However, the observed non-statistically significant differences over control are favourable for lower rates of LTC blockages without a concomitant rise in S-CAUTI. The results support a multinational randomised controlled trial of catheter washouts in patients with LTC to ascertain their clinical and cost-effectiveness.
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Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trialBackground: 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.
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Proactive total diet replacement referral for type 2 diabetes: A service evaluationAims: Type 2 Diabetes Mellitus morbidity disproportionally effects the most socioeconomically deprived 20 % of England. Total Diet Replacement (TDR) is a high impact intervention currently commissioned by Integrated Care Boards (ICB). Finding and referring eligible, motivated patients is a significant challenge. This study evaluates a 12-month population health management, proactive referral intervention commissioned by Nottingham and Nottinghamshire ICB during a 2-year TDR pilot designed to supplement referrals from primary care. Methods: A Diabetes specialist nurse clinically reviewed a list of potentially eligible patients found by searching routinely collected health care data from 16 primary care centres in 3 PCNs. Results: 19.7 % (50/254) of potential patients were referred during the intervention period. 19.3 % (49/254) were uncontactable. 39.8 % (101/254) declined referral. 17.7 % (45/254) were ineligible after clinical review. An interrupted time series analysis suggests monthly referrals increased during the study period due to the intervetion (F (1,22) = 5.19 p=0.0345). Searching for patients from more socioeconomically deprived areas (index of multiple deprivation deciles 1–3) did not meaningfully alter the referral yield (19.6 %, 19/97). Conclusions: Proactive care interventions could be used to facilitate referrals to the TDR or other high impact interventions by healthcare commissioning bodies.
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Evaluating the impact of an incentive scheme to encourage pregnant people to set a quit-smoking datePurpose: This study aims to demonstrate the evaluation of an incentive scheme to encourage pregnant people to set a quit-smoking date. Design/methodology/approach: The paper outlines a collaborative approach, working with pregnant people, clinicians, tobacco dependency practitioners and academics to gain insights into their perspectives and experiences. Quantitative and qualitative data were analysed. Findings: The incentive scheme and appropriate support from clinicians have been shown to encourage pregnant people to set a quit date. The tobacco dependency practitioners helped remove barriers, such as the perception of the stigmatisation of smoking when pregnant. The practitioners also helped pregnant people make informed decisions to support successful behaviour change. The impact of the scheme resulted in improved infant health indicators. The scheme’s evaluation also supported establishing stakeholder knowledge exchange and learning processes. Research limitations/implications: This is a single-site study among a relatively small group of people designed to achieve a specific evaluation objective. Caution in generalising to wider settings should be exercised. Practical implications: This study highlights the efficacy of an incentive scheme, complemented with support from clinicians, and the significance of knowledge exchange and collaboration between stakeholders in health care with significance in similar settings. Originality/value: The paper details the incentive scheme input, actions, output, outcomes and impact involving a wider range of stakeholders, including the emotional consequences for participants, clinicians and academics.
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A retrospective audit of patients with a radiological finding of moderate or severe emphysema. Should we perform spirometry as part of the targeted lung health check?Low dose computer tomography (LDCT) performed in high risk patients in Targeted Lung Health Check programme commonly reports on incidental findings. An audit of patients has found the largest cohort with incidental findings is those with radiological findings of Emphysema. Should we routinely be offering spirometry to this patient group?
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A retrospective audit of patients with a radiological finding of moderate or severe emphysema. Should we perform spirometry as part of the targeted lung health check?Low dose computed tomography (LDCT), screening for lung cancer is being implemented in some European countries. The targeted lung health checks (TLHC) programme is a new and ground-breaking flagship programme of work in England which will contribute to the ambition of the NHS Long Term Plan to improve early diagnosis and survival for those diagnosed with cancer (NHSE, 2022). The Mansfield and Ashfield TLHC commenced in March 2021 and was part of phase one of the NHSE (National Health Service England) pilot programme. Participants invited for the TLHC are those who are, at the date of the first low dose CT scan, aged between 55 and 74 years, 364 days of age, are registered with a GP practice and have ever smoked. Those who are eligible will be assessed to calculate their individual risk of developing lung cancer within the next 5 years using a pre-defined algorithm that automatically calculates both Prostate, Lung, Colorectal and Ovarian (PLCO) (Hocking et al, 2010) risk prediction model and the Liverpool Lung project (LLP) (Cassidy et al, 2008). All identified high risk patients i.e., a risk threshold of ≥1.51% threshold for PLCO and/or ≥2.5 for LLPv2 algorithms, then go on to a face-to-face appointment with trained TLHC nurses to confirm their risk assessment and where it is proven high risk, a low dose computer tomography (LDCT). Incidental findings are detected frequently following a LDCT and have the potential to benefit or harm the participant, and their management adds costs (Morgan et al, 2017). Localised audit of the patients has found the largest cohort of patients with incidental findings within our programme was those with radiological findings of Emphysema. The question is should we routinely be offering spirometry to this patient group either as part of the TLHC programme or making recommendations to primary care to perform one and are there any benefits to the patient?
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Management of Paediatric Chronic Insomnia in Primary CareBehavioural insomnia, a form of chronic insomnia, is highly prevalent in children. Persisting sleep problems can have multiple impacts on the child and family. Behavioural/sleep hygiene interventions are effective management strategies, and primary care provides the potential for early management and prevention. This thesis explores the management of chronic insomnia in children within primary care. A systematic review explored the evidence-base for primary care practitioners’ (PCP) knowledge, beliefs/attitudes, and practice. A systematic narrative synthesis of 26 studies found that PCPs are aware of the impacts of chronic insomnia, perceive management to be within their role, and endorse behavioural management strategies, but have varied knowledge and confidence for management. However, the methodological quality of the studies varied, and they were from limited primary care settings and countries (usually UK health visitors or US paediatricians). Higher quality UK research for both GPs and health visitors was lacking. A qualitative study analysed posts in online discussion forums to explore parental concerns about children’s sleep problems, awareness of management resources, and perception of management within primary care. Results from 93 discussion threads across two forums suggested that: parents have multiple and varied concerns relating to their children’s sleep; that parents often turn to one another online for emotional and practical support; and use resources online, non-PCPs (such as private sleep consultants) and books. It is uncertain how many of these resources are evidence-based. Parents posted about primary care less frequently but had mixed experiences of and attitudes towards health visitors, and limited experiences with GPs. A mixed-methods study (surveys and qualitative interviews) of UK practicing PCPs was conducted to explore their knowledge, training, beliefs and practice for insomnia management in children up to the age of five. Survey findings (n=355, mainly GPs) suggested that PCPs perceive negative impacts of chronic insomnia on children and their families and believe that it should be addressed in healthcare. However, insomnia is infrequently discussed in consultations, PCPs have varied knowledge and confidence regarding management, and limited training and knowledge of resources. Interview findings (n=21) echoed the survey findings, providing greater depth and insight. Health visitors had greater training opportunities and were perceived to be more suited to in-depth management, whereas the general practitioner’s role was perceived as excluding the presence of other conditions, brief advice and signposting to health visitors and other resources. GPs were interested in undertaking brief training. Further health visitor research and support, Increased discussions of insomnia in primary care consultations, improved access to GP training, and greater awareness of available resources has the potential to improve paediatric chronic insomnia management in primary care.
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Community seroprevalence of SARS-CoV-2 in children and adolescents in England, 2019-2021Objective: To understand community seroprevalence of SARS-CoV-2 in children and adolescents. This is vital to understanding the susceptibility of this cohort to COVID-19 and to inform public health policy for disease control such as immunisation. Design: We conducted a community-based cross-sectional seroprevalence study in participants aged 0-18 years old recruiting from seven regions in England between October 2019 and June 2021 and collecting extensive demographic and symptom data. Serum samples were tested for antibodies against SARS-CoV-2 spike and nucleocapsid proteins using Roche assays processed at UK Health Security Agency laboratories. Prevalence estimates were calculated for six time periods and were standardised by age group, ethnicity and National Health Service region. Results: Post-first wave (June-August 2020), the (anti-spike IgG) adjusted seroprevalence was 5.2%, varying from 0.9% (participants 10-14 years old) to 9.5% (participants 5-9 years old). By April-June 2021, this had increased to 19.9%, varying from 13.9% (participants 0-4 years old) to 32.7% (participants 15-18 years old). Minority ethnic groups had higher risk of SARS-CoV-2 seropositivity than white participants (OR 1.4, 95% CI 1.0 to 2.0), after adjusting for sex, age, region, time period, deprivation and urban/rural geography. In children <10 years, there were no symptoms or symptom clusters that reliably predicted seropositivity. Overall, 48% of seropositive participants with complete questionnaire data recalled no symptoms between February 2020 and their study visit. Conclusions: Approximately one-third of participants aged 15-18 years old had evidence of antibodies against SARS-CoV-2 prior to the introduction of widespread vaccination. These data demonstrate that ethnic background is independently associated with risk of SARS-CoV-2 infection in children.
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Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCTBackground: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. Objective: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. Design: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. Setting: A total of 44 English general practices. Participants: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. Interventions: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. Comparator: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. Main outcome measure: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). Methods: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. Results: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. Limitations: The over-riding weakness was the failure to recruit enough children. Conclusions: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again.
