British Journal of General Practice最新文献

Background: Low-dose amitriptyline and mirtazapine are widely prescribed off-label for insomnia disorder. However, evidence of their effectiveness from placebo-controlled studies is lacking.

Aim: To assess the effectiveness of low-dose mirtazapine and amitriptyline in patients with insomnia disorder.

Design and setting: Pragmatic, double-blind, randomised, placebo-controlled trial undertaken in general practices in the Amsterdam region, the Netherlands.

Method: Patients (aged 18-85 years) with insomnia disorder and sleep maintenance problems for whom non-pharmacological treatment was insufficient were randomised to mirtazapine (7.5-15 mg/day), amitriptyline (10-20 mg/day), or placebo for 16 weeks (optional double-dose regimen in week 2-14). Insomnia Severity Index (ISI) scores (range 0-28) were assessed at baseline and again at 6, 12, 20, and 52 weeks. The primary outcome was an ISI total score at 6 weeks that was clinically relevant and signified either 'improvement' (>7 points lower than baseline) or 'recovery' (total score ≤10 points).

Results: In total, 80 participants were included. At 6 weeks, in the intention-to-treat analyses, mirtazapine and amitriptyline each led to statistically significantly lower ISI scores when compared with placebo: mirtazapine mean difference = -6.0 points (95% confidence interval [CI] = -9.0 to -3.0), amitriptyline mean difference = -3.4 points (95% CI = -6.3 to -0.4). At 6 weeks mirtazapine resulted in statistically significantly higher improvement and recovery rates (52% and 56%, respectively) compared with placebo (both 14%), whereas amitriptyline (with rates of 40% and 36%, respectively) did not. From 12 weeks onwards no statistically significant differences in ISI scores were observed.

Conclusion: Compared with placebo, low-dose mirtazapine provided a statistically significant and clinically relevant reduction of insomnia severity at 6 weeks, but not at later time points. Low-dose amitriptyline resulted in a statistically significant reduction at 6 weeks, but this was not clinically relevant. The results do not support the prescription of low-dose amitriptyline and mirtazapine for several months in patients with insomnia disorder in general practice. Based on the results, GPs may consider prescribing off-label low-dose mirtazapine for a period of about 6 weeks in case non-pharmacological treatment is insufficient.

Background: Engaging patients and families has been promoted as a key strategy for improving patient safety of health systems. However, evidence remains scarce on the effectiveness of this approach in primary care.

Aim: To assess the combined effectiveness of primary care interventions in randomised controlled trials (RCTs) promoting patient and family engagement in patient safety.

Design and setting: A systematic review and meta-analysis.

Method: The review followed PRISMA and Cochrane guidelines. Five electronic databases (Medline, CINAHL, Embase, Web of Science, CENTRAL) were searched from inception to 18 September 2024 with keywords in four blocks (patient and family engagement; patient safety; primary care; randomised controlled trial). Patient and family engagement levels were appraised. Where appropriate, results were combined into meta-analyses.

Results: Of the 19 included records, 12 reported on completed RCTs. Only one intervention integrated patients/families into overall care safety (high engagement); six aimed at enhancing skills and tools (intermediate), and 12 informed patients/families how to engage and prompted them to do it (low). RCTs primarily targeted medication safety, with meta-analyses showing no significant effects on reducing adverse drug events (odds ratio [OR] 0.86, 95% confidence interval [CI] = 0.70 to 1.08) or improving medication appropriateness measured categorically (OR 0.92, 95% CI = 0.76 to 1.13) or continuously (mean difference 0.71, 95% CI = -0.10 to 1.52). Overall risk of bias was low and certainty of evidence very low to moderate.

Conclusion: Existing randomised controlled evidence on patient and family engagement in primary care remains inconclusive and limited in scope. Future interventions should include higher levels of engagement and address more diverse patient safety outcomes relevant for primary care.

Background: Complications arising from uncontrolled type 2 diabetes mellitus (T2DM) pose a significant burden on individuals' wellbeing and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition.

Aim: To assess the impact of DiabeText, a new theory-based, patient-centred, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management.

Design and setting: A pragmatic, phase-three, 12-month, two-arm randomised clinical trial involving primary care patients with T2DM in the Balearic Islands, Spain, including in urban and rural areas.

Method: In total, 742 participants with suboptimal glycaemic control (glycated haemoglobin [HbA1c] level >7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. In addition to usual care, the DiabeText group received 167 messages focused on healthy lifestyle and medication adherence. The primary outcome was HbA1c level. Secondary outcomes were: medication possession ratio; health-related quality of life (measured using the EQ-5D-5L questionnaire); diabetes self-efficacy (measured using the Diabetes Self-Efficacy Scale [DSES]); and self-reported adherence to medication, Mediterranean diet (measured using the 14-Item Mediterranean Diet Adherence Screener [MEDAS-14]), and physical activity (measured using the International Physical Activity Questionnaire [IPAQ]).

Results: Over the 12-month period, no statistically significant differences in HbA1c were observed between the intervention and the control groups (β = -0.025 [95% confidence interval {CI} = -0.198 to 0.147; P = 0.772]). In comparison with the control group, the DiabeText group showed significant (P<0.05) improvements in self-reported medication adherence (odds ratio = 1.4; 95% CI = 1.0 to 1.9), DSES (Cohen's d = 0.35), and EQ-5D-5L (Cohen's d = 0.18) scores, but not for the rest of the secondary outcomes.

Conclusion: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.

Background: Many patients receive repeat prescriptions for routine medications used to treat chronic conditions. Doctors typically issue repeat prescriptions with durations ranging from 28 to 84 days. There is currently no national guidance in England for the optimal prescription duration for routine medications.

Aim: To evaluate current prescription durations for five common routine medications in England; explore and visualise geographical variation; and identify practice factors that are associated with shorter prescribing duration to inform policy making.

Design and setting: A retrospective cohort study of NHS primary care prescribing data in England from December 2018 to November 2019.

Method: The prescription duration was analysed for five common routine medications in England; ramipril, atorvastatin, simvastatin, levothyroxine, and amlodipine. Variation was assessed between regional clinical commissioning groups (CCGs), and practice factors associated with different durations were identified.

Results: Of the common medications included, 28-day prescriptions accounted for 48.5% (2.5 billion) tablets/capsules issued, while 43.6% were issued for 56 days. There was very wide regional variation (7.2%-95.0%) in the proportion of 28-day prescriptions issued by CCGs. Practice dispensing status was the most likely predictor of prescription duration; dispensing practices had a higher 28-day prescribing proportion than non-dispensing practices. The proportion of patients with chronic conditions and the electronic health record system used by a practice were also associated with prescription duration.

Conclusion: This analysis of OpenPrescribing data showed that repeat prescriptions of 28 days are common for patients taking routine medications for chronic conditions, particularly in dispensing practices. This provides data to inform the policy debate on current practice. Configuration of electronic health record systems offer an opportunity to implement and evaluate new policies on repeat prescription duration in England.

Background: People with long-term physical conditions are more likely to experience distress, depression, or anxiety. Physical-mental comorbidity is associated with lower quality of life, poorer clinical outcomes, and increased mortality than physical conditions alone. People of South Asian origin are the largest minority group in the UK, and more likely to have long-term conditions (LTCs) such as diabetes and heart disease.

Aim: To explore how men of South Asian origin with LTCs understand and experience emotional distress as well as the experiences of GPs supporting them.

Design and setting: A UK qualitative study interviewing South Asian men with diabetes or coronary heart disease, and GPs working at practices with higher proportions than average in the UK of people of South Asian origin.

Method: Online semi-structured interviews with South Asian men and GPs were undertaken. Data were analysed via reflexive thematic analysis. Topic guides were modified iteratively as data collection and analysis progressed. An ethnically appropriate patient advisory group of South Asian men was involved in all stages of the research.

Results: Seventeen South Asian men with LTCs and 18 GPs were interviewed. Participants described contextualising distress, including LTCs influencing distress and the intersections of social determinants of distress including ethnicity, poverty, and perceptions of prejudice. Participants understood distress as different from depression with the need to negotiate multiple identities as well as integrative paradigms of health.

Conclusion: This study highlights the influence of social determinants of distress in South Asian men with LTCs. It provides an insight into how primary care has the potential to address health inequalities by considering the intersection of these factors.

Background: The effectiveness of single disease management programmes in general practice may be limited for patients with low socioeconomic status (SES), as these programmes insufficiently take into account the specific problems and needs of this population. A person-centred integrated care (PC-IC) approach focusing on individual patient's needs and concerns could address these problems.

Aim: To explore experiences of patients with (multiple) chronic diseases with regard to the acceptability of a general practice-based PC-IC approach, with a focus on patients with low SES, and to establish which modifications are needed to tailor the approach to this group.

Design and setting: In 2021, a feasibility study in seven general practices in the Netherlands was carried out. The healthcare professionals provided care based on a PC-IC approach for patients with diabetes, chronic respiratory diseases and/or cardiovascular disorders. Patients were followed for 6 months.

Method: This was a qualitative study using focus group discussions, in-depth interviews, and semi-structured telephone interviews in a total of 46 patients with chronic diseases and multimorbidity, including 31 patients with low SES.

Results: An overall positive experience of participants with the PC-IC approach was observed. Discussing their health made patients feel they were being taken more seriously and seen as a unique individual, and it provided the opportunity to discuss their life and health concerns. Recommended adaptations of the PC-IC approach for patients with low SES include creating materials that are clear and easy to understand and offering communication training for healthcare professionals.

Conclusion: The PC-IC approach seems helpful for patients with chronic diseases, provided that it is tailored to their skills and abilities. Several modifications for patients with low SES were suggested.

Background: Irritable bowel syndrome (IBS) can cause troublesome symptoms, which impact patients' quality of life and incur considerable health service resource use. Guidelines suggest low-dose amitriptyline for IBS as second-line treatment, but this is rarely prescribed in primary care.

Aim: To explore patients' and GPs' views and experiences of using low-dose amitriptyline for IBS.

Design and setting: Qualitative interview study with patients and GPs in England, nested within the ATLANTIS trial of low-dose amitriptyline versus placebo (ISRCTN48075063).

Method: Semi-structured telephone interviews were conducted with 42 patients at 6 months post-randomisation, with 19 patients again at 12 months post-randomisation, and with 16 GPs between April 2020 and March 2022. Reflexive thematic analysis was used to analyse patient and GP data separately, then together, to identify unique and cross-cutting themes.

Results: We found concerns about amitriptyline being an antidepressant, medicalising IBS, and side effects. Perceived benefits included the low and flexible dose, ease of treatment, and familiarity of amitriptyline and its potential to offer benefits beyond IBS symptom relief. These concerns and perceived benefits were expressed in the context of desire for a novel approach to IBS: GPs were keen to offer more options for IBS and patients sought a cure for their symptoms.

Conclusion: Patients and GPs felt that the potential benefits of trying low-dose amitriptyline for IBS outweighed their concerns. When offering low-dose amitriptyline for IBS, GPs could address patient concerns about taking an antidepressant for IBS, highlighting the low and flexible dosage, and other potential benefits of amitriptyline such as improved sleep.

Background: Post-inpatient discharge is a risky time for older patients, especially those with polypharmacy and multimorbidity. General practice care at this time, including the processes for managing hospital discharge summaries, lacks standardisation and is of variable quality. Understanding these processes will support the design of interventions and guidance to improve general practice management of the post-discharge period.

Aim: To understand and visualise how ongoing care for older people after discharge from hospital is organised in general practice, including the processes for managing discharge summaries.

Design and setting: Rapid ethnography study in 10 general practices in the West Midlands, England.

Method: We mapped the practices' systems of post-discharge care. Data sources included informal conversations with staff, practice policies, and direct observations of discharge summary handling. Fieldnotes and quotes were subject to an interpretivist framework analysis. A systems modelling technique (the Functional Resonance Analysis Method) was used to present visual representations of the professional roles working in these complex systems.

Results: Three basic typographies of system emerged based on professional roles: GP-led, pharmacist-led, and administrative-led. We report on three themes that weave around the Functional Resonance Analysis Method process maps: comfort with demands of administrative role; general practice team dynamics; and interaction with patients.

Conclusion: General practice systems for inpatient discharge summary processing are complex and varied. New roles in general practices are being used extensively, often requiring significant input in supervision by GPs. Our findings highlight safety features of different systems and should help practices understand the advantages and limitations of models they work within.

Background: A growing literature examines the way two changes in primary care - the shift towards remote working and the diversification of practice teams to incorporate, for instance, physician associates and paramedics - affect patient care within the practice. However, little is known about the effect of these changes on community nurses.

Aim: To explore community nurses' experiences of delivering palliative care in the context of GPs' new ways of working.

Design and setting: Qualitative study using focus groups in the UK.

Method: Focus groups were conducted on Zoom with community nurses. Data were analysed thematically using constant comparison.

Results: Community nurses described extending their roles in palliative care. Alongside pride and satisfaction about this, participants raised several areas of concern and dissatisfaction, some of which they associated with changes in GPs' ways of working. Two reasons for dissatisfaction concerned remote working. First, remote communication with colleagues was seen as creating obstacles to nurses' everyday collaboration with GPs, damaging important working relationships. Second, nurses increased their workload by taking the lead in person-centred care where they saw remote provision by GPs as unsatisfactory. Where workforce diversification led to delegating home visits to paramedics or nurse practitioners, community nurses described feeling a lack of the 'GP back-up' that many identified as essential for community palliative care.

Conclusion: When considering and evaluating interventions that change the way GPs work, policymakers and commissioners should look not only at consequences that affect primary care teams, but also at the effects across the complex ecosystem within which these teams operate.

Background: In England online services in general practice encompass a range of provision from ordering repeat medication to having a consultation. Some groups of individuals may find accessing and/or using such services difficult and may require 'digital facilitation', that is the range of processes, procedures, and personnel which seeks to support NHS patients in their uptake and use of online services.

Aim: To gain insight, from the perspective of general practice staff and patients/carers, into how and why digital facilitation might lead to benefits, and the key processes involved in supporting patients to use online services.

Design and setting: Eight general practices across England with varied geographical and sociodemographic characteristics were included in the study.

Method: This was a focused ethnographic case study of observations and interviews (N = 69).

Results: Typically, digital facilitation was delivered in an ad hoc fashion to individual patients. Online services were delivered via multiple systems each working differently and creating a need for support so that patients could access them. Younger practice staff were expected to deliver support on account of their age, despite there being no evidence of age-related training and experience. It was understood by practice staff that patients with challenging personal circumstances may require specific support to access online services.

Conclusion: At present patient use of online services is supported by digital facilitation that is primarily delivered by reception staff. Supporting patients to use online services requires review of how many services are provided and what for, and consideration for the time and effort needed to support patients to use them.