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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.
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Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative studyBackground: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. Aim: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. Design & setting: Primary care multi-method qualitative study. Method: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n=15, 73% female) and an online discussion forum (n=31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within-domains to generate subthemes, and subtheme comparison to form across-domain overarching themes. The behaviour change technique taxonomy v.1 and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. Results: 32 facilitator and barrier subthemes for patients reducing opioids were identified across 13 TDF domains. These combined into six overarching themes: learning to live with pain, opioid reduction expectations, assuming a medical model, pharmacist-delivered reviews, pharmacist-patient relationship and patient engagement. Subthemes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. Conclusion: This study generated theoretically-informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.
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Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility studyDepression is the leading cause of disability globally and has serious consequences for the individual, their family and for society. Effective, accessible and affordable treatments are urgently needed. In-person group-based mindfulness-based interventions are an effective treatment for depression, but are not widely available and can be costly. Clinician supported use of mindfulness self-help resources such as mindfulness smartphone applications could widen access at a reduced cost, but there are key feasibility questions that need answering. This is a mixed-methods feasibility study of a blended intervention involving the mindfulness smartphone app Headspace alongside six clinician support sessions with mental health treatment seeking adults experiencing moderate to moderately severe symptoms of depression. In line with recommendations for feasibility studies, we examine whether: (1) it is possible to recruit participants to this novel intervention, (2) participants engage with the intervention, (3) participants and clinicians find the intervention acceptable, and (4) pre-post outcomes on measures of depression (primary outcome), anxiety, wellbeing, mindfulness, self-compassion, rumination and worry indicate effectiveness. Findings show that recruitment is feasible with 54 participants enrolled in the intervention within a 6-month window. In terms of engagement, 44.4% completed at least 80% of recommended Headspace sessions and 72.2% of participants attended at least three clinician support sessions. Clinician-supported Headspace was deemed acceptable by participants and clinicians. Pre-post effect sizes were statistically significant and in the small-medium or medium-large range on all outcomes, with an effect size of d = 0.69 (95% CI: 0.34-1.04) for the primary outcome of depression symptom severity. The number of Headspace sessions engaged with was associated with greater reduction in depression symptom severity. Findings suggest that a blended intervention combining Headspace with clinician support has potential as a first-line treatment for moderate/moderately severe depression, but findings are too preliminary to recommend the intervention outside of a research trial. Important caveats are noted including the need for future research to examine predictors of engagement with Headspace sessions so that engagement can be enhanced, to measure the longer term effects of such interventions and to better understand the potential for lasting negative effects of the intervention so that these can be minimised.
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Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platformBackground: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. Methods: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. Results: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. Conclusions: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment.
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Mapping and characterising electronic palliative care coordination systems and their intended impact: A national survey of end-of-life care commissionersObjectives: In England, Electronic Palliative Care Coordination Systems (EPaCCS) were introduced in 2008 to support care coordination and delivery in accordance with patient preferences. Despite policy supporting their implementation, there has been a lack of rigorous evaluation of EPaCCS and it is not clear how they have been translated into practice. This study sought to examine the current national implementation of EPaCCS, including their intended impact on patient and service outcomes, and barriers and facilitators for implementation. Methods: We conducted a national cross-sectional online survey of end-of-life care commissioning leads for Clinical Commissioning Groups (CCGs) in England. We enquired about the current implementation status of EPaCCS, their role in information sharing and intended impact, and requested routine patient-level data relating to EPaCCS. Results: Out of 135 CCGs, 85 (63.0%) responded, with 57 (67.1%) having operational EPaCCS. Use of EPaCCS were confined to healthcare providers with most systems (67%) not supporting information sharing with care homes and social care providers. Most systems (68%) sought to facilitate goal concordant care, although there was inconsonance between intended impacts and monitoring measures used. Common challenges to implementation included healthcare professionals' limited engagement. Only one-third of patients had an EPaCCS record at death with limited recording of patient preferences. Conclusions: Critical gaps exist in engagement with EPaCCS and their ability to facilitate information sharing across care providers. The limited alignment between stated goals of EPaCCS and their monitoring impedes efforts to understand which characteristics of systems can best support care delivery.
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Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic studyBackground: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. Conclusions: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted.
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A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivorsBackground: Many cancer survivors following primary treatment have prolonged poor quality of life. Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. Design: Pragmatic parallel open randomised trial. Setting: UK general practices. Methods: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.
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A Community and Hospital cAre Bundle to improve the medical treatment of severe cLaudIcation and critical limb iSchaemia (CHABLIS)Background: Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. Methods: This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Results: Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. Conclusions: The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.
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Nottinghamshire GP Phoenix Programme trainee transition scheme: an innovative education programme supporting GP trainees transition to independent practiceIt is well-established that GP trainees do not feel confident when transitioning to independent practice. In 2019, the Nottinghamshire GP Phoenix Programme Trainee Transition Scheme (TTS) was established to improve this transition and encourage local retention of newly qualified GPs. The TTS has been evaluated by surveying a total of 344 trainees from August 2022 to August 2023 using an electronic Google Form. Two-thirds of the trainees surveyed felt the mix of TTS-led non-clinical topics and trainee-led clinical topics taught during their locality time were useful for their learning. 72% felt that the TTS would influence their decision to remain working locally after qualification. Based on these positive findings, it is proposed that the TTS should be adopted in other areas to improve both transition and retention of newly qualified GPs.
