Impact of adverse childhood experiences on analgesia-related outcomes: a systematic review.

BACKGROUND: There is well-established evidence linking adverse childhood experiences (ACEs) and chronic pain in adulthood. It is less clear how ACE exposure might influence the response to chronic pain treatment. In this systematic review, we synthesise the literature assessing the impact of ACE exposure on outcomes relating to the use, benefits, and harms of analgesic medications (analgesia-related outcomes). METHODS: We searched seven databases from inception to September 26, 2023, for studies investigating adverse events in childhood (<18 yr) and any analgesia-related outcome during adulthood (≥18 yr). Title/abstract screening, full-text review, data extraction, and risk of bias assessment were performed independently by two authors. Given the high degree of study heterogeneity, a narrative synthesis was performed. RESULTS: From 7531 records, 66 studies met inclusion criteria, involving 137 395 participants. Analgesia-related outcomes were classed into six categories: use of analgesics (n=12), analgesic side-effects (n=4), substance misuse (n=45), lifetime drug overdose (n=2), endogenous pain signalling (n=4), and other outcomes (n=2). No studies assessed the effect of ACE exposure on the potential benefits of analgesics. ACE exposure was associated with greater use of analgesic medication, higher incidence of analgesic medication side-effects, greater risk and severity of substance misuse, greater risk of drug overdose, and greater risk of attempted suicide in opioid dependency. CONCLUSIONS: Adverse childhood experience exposure is associated with poor analgesia-related outcomes, so individual assessment adverse childhood experiences is important when considering the treatment of chronic pain. However, significant gaps in the literature remain, especially relating to the use and harms of non opioid analgesics. SYSTEMATIC REVIEW PROTOCOL: CRD42023389870 (PROSPERO).

Patient and GP experiences of pathways to diagnosis of a second primary cancer: a qualitative study.

BACKGROUND: More people are surviving a first primary cancer and experiencing a second, different cancer. However, little is known about the diagnostic journeys of patients with second primary cancer (SPC). This study explores the views of patients and general practitioners (GPs) on their experiences of pathways to diagnosis of SPC, including the influence of a previous diagnosis of cancer on symptom appraisal, help-seeking and referral decisions. METHODS: Qualitative interviews with patients with a SPC diagnosis and case-linked GP interviews in a Scottish primary care setting. In-depth face to face or telephone interviews were conducted, underpinned by a social constructionist approach. Interviews were transcribed and Braun and Clarke's thematic analysis undertaken. Three analysts from the research team read transcripts and developed the coding framework using QSR NVivo version 10, with input from a fourth researcher. Themes were developed from refined codes and interpreted in the context of existing literature and theory. RESULTS: Interviews were conducted with 23 patients (aged 43-84 years) with a SPC diagnosis, and 7 GPs. Five patient themes were identified: Awareness of SPC, symptom appraisal and help-seeking, pathways to diagnosis, navigating the healthcare system, and impact of SPC. GPs interviews identified: experience and knowledge of SPC and referrals and decision-making. CONCLUSIONS: Insights into the pathway to diagnosis of SPC highlights the need for increased awareness of and vigilance for SPC among patients and healthcare providers (HCPs), and emotional support to manage the psychosocial burden.

A qualitative evaluation of the impact of a training programme on colorectal cancer risk reduction for Specialist Screening Practitioners on health promotion, knowledge and practice.

OBJECTIVE: Colorectal cancer (CRC) is the fourth most common cancer in the UK. It is estimated that around 50% of the disease burden is caused by lifestyle factors. This paper evaluates the impact of a training programme for Specialist Screening Practitioners (SSPs) on knowledge of CRC risk reduction and subsequent health promotion activities. METHOD: Attendees (n = 21) were invited to participate in semi-structured qualitative telephone interviews developed in conjunction with programme organisers. An independent researcher undertook the interviews on the perceived impact of the training on knowledge about risk reduction, communicating health promotion messages and working practices. RESULTS: Ten interviews were conducted. The programme was perceived to be successful in increasing knowledge about CRC risk and methods to promote behavioural change. Participants questioned the suitability of the endoscopy setting to communicate health promotion messages given patient anxiety pre-investigation and post-investigation elation after negative results. Key barriers to health promotion activities were time, hesitancy over raising issues that could not be easily discussed and scepticism about the ability of older adults to change their lifestyle. CONCLUSIONS: Training on CRC risk reduction increased knowledge and behaviour change skills among SSPs. Further work is needed to explore opportunities to optimise the screening environment for health promotion activities.

The contribution of a negative colorectal screening test result to symptom appraisal and help-seeking behaviour among patients subsequently diagnosed with an interval colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) screening programmes using a guaiac faecal occult blood test (gFOBt) reduce CRC mortality. Interval cancers are diagnosed between screening rounds: reassurance from a negative gFOBt has the potential to influence the pathway to diagnosis of an interval colorectal cancer. METHODS: Twenty-six semi-structured face-to-face interviews were carried out in Scotland and England, with individuals diagnosed with an interval colorectal cancer following a negative gFOBt result. RESULTS: Participants reported they were reassured by a negative gFOBt, interpreting their result as an "all clear". Therefore, most did not suspect cancer as a possible cause of symptoms and many did not recall their screening result during symptom appraisal. Among those who did consider cancer, and did think about their screening test result, reassurance from a negative gFOBt led some to "downplay" the seriousness of their symptoms with some interviewees explicitly stating that their negative test result contributed to a delayed decision to seek help. CONCLUSION: Screening participants need to be informed of the limitations of screening and the ongoing risk of developing colorectal cancer even when in receipt of a negative result: the importance of minimizing delay in seeking medical advice for colorectal symptoms should be emphasized.

Understanding of a negative bowel screening result and potential impact on future symptom appraisal and help-seeking behaviour: a focus group study.

BACKGROUND: Colorectal cancer (CRC) screening using a faecal occult blood test (FOBt) has the potential to reduce cancer-related mortality. Symptom vigilance remains crucial as a proportion of cancers will be diagnosed between screening rounds. A negative FOBt has the potential to influence how participants respond to future symptoms of CRC. OBJECTIVE: To explore (i) understanding of a negative FOBt and (ii) the potential impact of a negative FOBt upon future symptom appraisal and help-seeking behaviour. DESIGN: Qualitative methodology utilizing focus groups with participants who received a negative FOBt within the National Bowel Cancer Screening Programme in Coventry and Lothian. Topics explored included: experience of screening participation, interpretation and understanding of a negative result, symptom awareness and attitudes towards help-seeking. RESULTS: Four broad themes were identified: (i) emotional response to a negative FOBt, (ii) understanding the limitations of FOBt screening, (iii) symptom knowledge and interpretation and (iv) over-reassurance from a negative FOBt. Participants were reassured by a negative FOBt, but there was variability in the extent to which the result was interpreted as an "all clear". Some participants acknowledged the residual risk of cancer and the temporal characteristic of the result, while others were surprised that the result was not a guarantee that they did not have cancer. DISCUSSION AND CONCLUSIONS: Participants recognized that reassurance from a negative FOBt could lead to a short-term delay in help-seeking if symptoms developed. Screening programmes should seek to emphasize the importance of the temporal nature of FOBt results with key messages about symptom recognition and prompt help-seeking behaviour.

Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study.

BACKGROUND: Long-term disorders are the main challenge facing health-care systems worldwide, but health systems are largely configured for individual diseases rather than multimorbidity. We examined the distribution of multimorbidity, and of comorbidity of physical and mental health disorders, in relation to age and socioeconomic deprivation. METHODS: In a cross-sectional study we extracted data on 40 morbidities from a database of 1,751,841 people registered with 314 medical practices in Scotland as of March, 2007. We analysed the data according to the number of morbidities, disorder type (physical or mental), sex, age, and socioeconomic status. We defined multimorbidity as the presence of two or more disorders. FINDINGS: 42·2% (95% CI 42·1-42·3) of all patients had one or more morbidities, and 23·2% (23·08-23·21) were multimorbid. Although the prevalence of multimorbidity increased substantially with age and was present in most people aged 65 years and older, the absolute number of people with multimorbidity was higher in those younger than 65 years (210,500 vs 194,996). Onset of multimorbidity occurred 10-15 years earlier in people living in the most deprived areas compared with the most affluent, with socioeconomic deprivation particularly associated with multimorbidity that included mental health disorders (prevalence of both physical and mental health disorder 11·0%, 95% CI 10·9-11·2% in most deprived area vs 5·9%, 5·8%-6·0% in least deprived). The presence of a mental health disorder increased as the number of physical morbidities increased (adjusted odds ratio 6·74, 95% CI 6·59-6·90 for five or more disorders vs 1·95, 1·93-1·98 for one disorder), and was much greater in more deprived than in less deprived people (2·28, 2·21-2·32 vs 1·08, 1·05-1·11). INTERPRETATION: Our findings challenge the single-disease framework by which most health care, medical research, and medical education is configured. A complementary strategy is needed, supporting generalist clinicians to provide personalised, comprehensive continuity of care, especially in socioeconomically deprived areas. FUNDING: Scottish Government Chief Scientist Office.

Engagement of people with lived experience of dementia advisory group and cross-cutting program: reflections on the first year.

BACKGROUND: The objective of this paper is to describe the activities, challenges and mitigation strategies, lessons learned and reflections on the importance of engagement from the first year of the Canadian Consortium on Neurodegeneration in Aging (CCNA) Engagement of People with Lived Experience of Dementia (EPLED) Advisory Group and cross-cutting program. EPLED was created to support persons with dementia and care partners to be actively involved in the CCNA research process. MAIN BODY: The Advisory Group was formed to work with CCNA researchers and programs to develop new ways to further collaborate and advance the methods of patient engagement in research on dementia. A role profile and recruitment poster were developed and, after interviews, 17 people were invited to join the Advisory Group. We planned three online EPLED meetings to take place between July-August of 2020, with one in-person meeting to be held in Canada. Due to COVID-19, we moved all of these meetings online. In the first year, EPLED and the Advisory Group met seven times formally, four times informally, developed a website, engaged with CCNA research projects, participated in CCNA "Central" activities and formulated an evaluation plan. For researchers and people with lived experience of dementia, motivations for patient engagement included challenging stigma, making meaning from their experience (such as building relationships and having their voices heard) and contributing to research. Common challenges to engagement were related to navigating the impact of COVID-19, such as difficulty in getting to know each other and technical issues with video-conference software. We learned that developing trusting relationships, providing education, offering support, being flexible and acknowledging tensions between research, practice and lived experience, were vital to the success of the Advisory Group. CONCLUSION: The first year of the EPLED Advisory Group demonstrated the potential contributions of people with lived experience of dementia as partners in research. Building these collaborations with individuals and communities-people living with dementia, care partners, researchers and research institutions-has the potential for positive impact across these groups and, ultimately, improve the lives of people living with dementia and their care partners.

In this paper, we describe the development of the Canadian Consortium of Neurodegeneration in Aging (CCNA) Engagement of People with Lived Experience of Dementia (EPLED) cross-cutting program and the first year of the EPLED Advisory Group. EPLED was created to build opportunities for patient engagement in the CCNA's research on dementia. People living with dementia and current/former friends, family and care partners were recruited from across Canada to join the Advisory Group. In the first year, the Advisory Group met seven times formally, four times informally, developed a website, engaged with CCNA research projects, participated in CCNA "Central" activities and formulated an evaluation plan. Challenges included the impacts of the COVID-19 pandemic, online meetings, and differing expectations and priorities. Lessons learned and reflections on the importance of engagement are discussed in the context of research on dementia and from the perspectives of researchers and Advisory Group members.

Duplication within the SEPT9 gene associated with a founder effect in North American families with hereditary neuralgic amyotrophy.

Hereditary neuralgic amyotrophy (HNA) is an autosomal dominant disorder associated with recurrent episodes of focal neuropathy primarily affecting the brachial plexus. Point mutations in the SEPT9 gene have been previously identified as the molecular basis of HNA in some pedigrees. However in many families, including those from North America demonstrating a genetic founder haplotype, no sequence mutations have been detected. We report an intragenic 38 Kb SEPT9 duplication that is linked to HNA in 12 North American families that share the common founder haplotype. Analysis of the breakpoints showed that the duplication is identical in all pedigrees, and molecular analysis revealed that the duplication includes the 645 bp exon in which previous HNA mutations were found. The SEPT9 transcript variants that span this duplication contain two in-frame repeats of this exon, and immunoblotting demonstrates larger molecular weight SEPT9 protein isoforms. This exon also encodes for a majority of the SEPT9 N-terminal proline rich region suggesting that this region plays a role in the pathogenesis of HNA.

Nursing student perceptions of required online educational programs utilized outside the classroom.

BACKGROUND: The use of online educational programs (OEPs) such as ATI™, Kaplan™, and Course Point™, to facilitate learning is generally thought to be an innovative and complementary approach to supplement learning across many nursing programs. The rapid transition to an online learning environment, dominated by Zoom, as a result of the COVID-19 pandemic has further increased faculty and student reliance on OEPs both in and out of the classroom. The aim of this study is to examine student perceptions of faculty assigned OEPs utilized outside the classroom. METHOD: Cross-sectional, correlational survey design was used to explore the relationships between student perceptions and the use of OEPs among nursing students enrolled in a traditional baccalaureate nursing program. RESULTS: Nursing students (n = 221) spent an average of 7.85 h on OEPs and an additional 6.4 h on the Zoom platform. Sophomore students spent significantly more hours engaging in the OEPs (F(3,191) = 10.09, p = .00) and Zoom (F(3,193) = 8.89, p = .00) than the other academic levels. On average, sophomores spent a total of 20 h per week engaging in OEPs (M = 10.9, SD = 11.5) and Zoom (M = 9.18, SD = 4.3). Freshmen students had a significantly more favorable view of OEPs than senior students did (p = .02). Qualitative data analysis from open ended responses revealed four themes: Too many programs, Cost, Technological challenges, and Benefits. CONCLUSIONS: The cost, ease of use, and the number of OEPs assigned influence student perception of OEP. Faculty should be mindful of student burden related to number of OEPs assigned, time required to complete the OEPs, and cost. Furthermore, faculty should consider collaborating with other faculty to streamline the use of OEPs, enhance relevancy, and eliminate redundancy.

Faecal Haemoglobin Estimated by Faecal Immunochemical Tests-An Indicator of Systemic Inflammation with Real Clinical Potential.

Multimorbidity is the major cause of ill-health and premature death in developed countries. The ability to identify individuals at risk of developing chronic disease, particularly multimorbidity, reliably, and simply, and to identify undiagnosed disorders, is vital to reducing the global burden of disease. This narrative review, the first of recent studies, demonstrates that raised faecal haemoglobin concentration (f-Hb) is associated with increased all-cause and cause-specific mortality and with longer-term conditions including diabetes, hypertension, cardiovascular disease, and psoriasis, and with probable intake of particulate matter. We and others have hypothesized that elevated f-Hb (measured using a faecal immunochemical test) has considerable potential to identify individuals at risk of, or who already have, early stage, undiagnosed chronic disease. If f-Hb does prove to be an effective biomarker for chronic disease and multimorbidity, individuals with detectable f-Hb, but without an obvious source of gastrointestinal blood loss, could benefit from further assessment and early intervention. To test this hypothesis rigorously, longitudinal data-linkage methodology is required linking colorectal cancer screening data, and data on patients presenting with lower gastrointestinal symptoms, with routinely collected health information.

Association between faecal occult bleeding and medicines prescribed for chronic disease: a data linkage study.

AIMS: The presence of detectable faecal haemoglobin (f-Hb) has been shown to be associated with all-cause mortality and with death from a number of chronic diseases not known to cause gastrointestinal blood loss. This effect is independent of taking medicines that increase the risk of bleeding. To further investigate the association of f-Hb with chronic disease, the relationship between f-Hb and prescription of medicines for a variety of conditions was studied. METHODS: All subjects (134 192) who participated in guaiac faecal occult blood test (gFOBT) screening in Tayside, Scotland, between March 2000 and March 2016, were studied in a cross-sectional manner by linking their gFOBT result (abnormal or normal) with prescribing data at the time of the test. RESULTS: The screening participants with an abnormal gFOBT result were more likely to have been being prescribed medicines for heart disease, hypertension, diabetes and depression than those with a normal test result. This association persisted after adjustment for sex, age and deprivation (OR 1.35 (95%CI 1.23 to 1.48), 1.39 (1.27 to 1.52), 1.35 (1.15 to 1.58), 1.36 (1.16 to 1.59), all p<0.0001, for the four medicine categories, respectively). CONCLUSIONS: The results of this study confer further substantial weight to the concept that detectable f-Hb is associated with a range of common chronic conditions that have a systemic inflammatory component; we speculate that f-Hb might have potential in identifying individuals who are high risk of developing chronic conditions or are at an early stage of disease.

Pathways to diagnosis of a second primary cancer: protocol for a mixed-methods systematic review.

INTRODUCTION: As cancer survivors continue to live longer, the incidence of second primary cancers (SPCs) will also rise. Relatively little is understood about the diagnostic pathway for SPCs, how people appraise, interpret symptoms and seek help for a second different cancer and the experiences (including challenges) of healthcare providers relating to SPCs. This study aims to systematically appraise and synthesise the literature on the pathways to diagnosis of an SPC and the associated patient and healthcare provider experiences. METHODS: The approach taken includes systematic searches of published and unpublished literature without any date or language restrictions. MEDLINE, Embase, CAB Abstracts, MEDLINE In-Process and non-indexed citations, PsycINFO, Epub Ahead of Print, In-Process and other non-indexed citations, Ovid MEDLINE Daily, CINAHL, ASSIA, Sociological Abstracts, Web of Science, PROSPERO and grey literature will be searched to identify observational, systematic reviews, mixed methods and qualitative studies of interest. Titles, abstracts and full texts will be screened against the inclusion-exclusion criteria by at least two reviewers independently. Relevant outcomes of interest and study and population characteristics will be extracted. Synthesis will be used guided by the Pathways to Treatment model and the Olesen model of time intervals. ETHICS AND DISSEMINATION: Ethical approval is not required. This systematic review will provide a deeper understanding of the complex and heterogeneous diagnostic pathways of SPCs, while identifying common themes across the diagnostic interval, routes to diagnosis and patient and healthcare provider experiences. These findings will help provide a nuanced picture of the diagnostic pathway for SPCs that may inform policy and consistent practice. In particular, approaches to early diagnosis for an SPC; including the timing and reasons behind the decision by the patient to seek care,the challenges faced by healthcare providers, and in the development of future interventions to reduce the delay in patient time-to-presentation. PROSPERO REGISTRATION NUMBER: CRD42016051692.

Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial.

OBJECTIVE:  To evaluate the effectiveness of feedback on safety of prescribing compared with moderately enhanced usual care. DESIGN:  Three arm, highly pragmatic cluster randomised trial. SETTING AND PARTICIPANTS:  262/278 (94%) primary care practices in three Scottish health boards. INTERVENTIONS:  Practices were randomised to: "usual care," consisting of emailed educational material with support for searching to identify patients (88 practices at baseline, 86 analysed); usual care plus feedback on practice's high risk prescribing sent quarterly on five occasions (87 practices, 86 analysed); or usual care plus the same feedback incorporating a behavioural change component (87 practices, 86 analysed). MAIN OUTCOME MEASURES:  The primary outcome was a patient level composite of six prescribing measures relating to high risk use of antipsychotics, non-steroidal anti-inflammatories, and antiplatelets. Secondary outcomes were the six individual measures. The primary analysis compared high risk prescribing in the two feedback arms against usual care at 15 months. Secondary analyses examined immediate change and change in trend of high risk prescribing associated with implementation of the intervention within each arm. RESULTS:  In the primary analysis, high risk prescribing as measured by the primary outcome fell from 6.0% (3332/55 896) to 5.1% (2845/55 872) in the usual care arm, compared with 5.9% (3341/56 194) to 4.6% (2587/56 478) in the feedback only arm (odds ratio 0.88 (95% confidence interval 0.80 to 0.96) compared with usual care; P=0.007) and 6.2% (3634/58 569) to 4.6% (2686/58 582) in the feedback plus behavioural change component arm (0.86 (0.78 to 0.95); P=0.002). In the pre-specified secondary analysis of change in trend within each arm, the usual care educational intervention had no effect on the existing declining trend in high risk prescribing. Both types of feedback were associated with significantly more rapid decline in high risk prescribing after the intervention compared with before. CONCLUSIONS:  Feedback of prescribing safety data was effective at reducing high risk prescribing. The intervention would be feasible to implement at scale in contexts where electronic health records are in general use.Trial registration Clinical trials NCT01602705.

A primary care Web-based Intervention Modeling Experiment replicated behavior changes seen in earlier paper-based experiment.

OBJECTIVES: Intervention Modeling Experiments (IMEs) are a way of developing and testing behavior change interventions before a trial. We aimed to test this methodology in a Web-based IME that replicated the trial component of an earlier, paper-based IME. STUDY DESIGN AND SETTING: Three-arm, Web-based randomized evaluation of two interventions (persuasive communication and action plan) and a "no intervention" comparator. The interventions were designed to reduce the number of antibiotic prescriptions in the management of uncomplicated upper respiratory tract infection. General practitioners (GPs) were invited to complete an online questionnaire and eight clinical scenarios where an antibiotic might be considered. RESULTS: One hundred twenty-nine GPs completed the questionnaire. GPs receiving the persuasive communication did not prescribe an antibiotic in 0.70 more scenarios (95% confidence interval [CI] = 0.17-1.24) than those in the control arm. For the action plan, GPs did not prescribe an antibiotic in 0.63 (95% CI = 0.11-1.15) more scenarios than those in the control arm. Unlike the earlier IME, behavioral intention was unaffected by the interventions; this may be due to a smaller sample size than intended. CONCLUSIONS: A Web-based IME largely replicated the findings of an earlier paper-based study, providing some grounds for confidence in the IME methodology.

Use of oral anticoagulants in atrial fibrillation is highly variable and only weakly associated with estimated stroke risk: cross-sectional population database study.

BACKGROUND: Current international guidelines promote the use of stroke risk stratification tools to inform decision making about oral anticoagulant (OAC) use in atrial fibrillation (AF). OBJECTIVES: To examine (a) differences between CHADS2 and CHA2DS2VASc in classifying stroke risk in a primary care population of AF patients; (b) patterns of use of antithrombotics by stroke risk; and (c) patient and practice characteristics associated with use of oral anticoagulants in patients with AF. METHODS: Cross-sectional multilevel modelling study of all patients with AF and without rheumatic heart disease or valve replacement (n = 21 564) from 315 Scottish General Practices. RESULTS: (a) CHADS2 characterized 30.3% in the intermediate and 53.8% in the high-risk category, compared to CHA2DS2VASC only 9.7% intermediate and 85.1% high-risk. (b) Of included patients, 17.8% were currently not prescribed any antithrombotic and 43.3% were on OAC. OAC use was only weakly related to stroke risk. (c) Patients with paroxysmal AF and those with dementia and previous peptic ulcer (adjusted ORs 0.26, 0.25 and 0.79) were less likely to be prescribed OAC. OAC use varied over five-fold between practices after adjustment for patient case mix, with remote and non-training practices and those with high levels of high-risk prescribing being more likely to prescribe OAC. CONCLUSION: Evidence was found of both underuse and overuse of OAC in patients with AF. Promoting instruments for stroke risk assessment in AF is a plausible but untested strategy to improve decision making in AF, and its impact on OAC prescribing and patient outcomes should be evaluated in pragmatic trials.

Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705).

BACKGROUND: High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. METHODS: The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. RESULTS: Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×). CONCLUSIONS: The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01602705.

Paper-based and web-based intervention modeling experiments identified the same predictors of general practitioners' antibiotic-prescribing behavior.

OBJECTIVES: To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. STUDY DESIGN AND SETTING: Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. RESULTS: Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. CONCLUSION: A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial.

Protocol for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study: a cluster randomised controlled trial using ePrescribing data.

INTRODUCTION: High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions to improve care are attractive because they are relatively cheap to widely implement. There is good evidence that feedback has small to moderate effects, but the most recent Cochrane review called for more high-quality, large trials that explicitly test different forms of feedback. METHODS AND ANALYSIS: The study is a three-arm cluster-randomised trial with general practices being randomised and outcomes measured at patient level. 262 practices in three Scottish Health Board areas have been randomised (94% of all possible practices). The two active arms receive different forms of prescribing safety data feedback, with rates of high-risk prescribing compared with a 'usual care' arm. Sample size estimation used baseline data from participating practices. With 85 practices randomised to each arm, then there is 93% power to detect a 25% difference in the percentage of high-risk prescribing (from 6.1% to 4.5%) between the usual care arm and each intervention arm. The primary outcome is a composite of six high-risk prescribing measures (antipsychotic prescribing to people aged ≥75 years; non-steroidal anti-inflammatory drug (NSAID) prescribing to people aged ≥75 without gastroprotection; NSAID prescribing to people prescribed aspirin/clopidogrel without gastroprotection; NSAID prescribing to people prescribed an ACE inhibitor/angiotensin receptor blocker and a diuretic; NSAID prescription to people prescribed an oral anticoagulant without gastroprotection; aspirin/clopidogrel prescription to people prescribed an oral anticoagulant without gastroprotection). The primary analysis will use multilevel modelling to account for repeated measurement of outcomes in patients clustered within practices. ETHICS AND DISSEMINATION: The study was reviewed and approved by the NHS Tayside Committee on Medical Research Ethics B (11/ES/0001). The study will be disseminated via a final report to the funder with a publicly available research summary, and peer reviewed publications. TRIAL REGISTRATION: ClinicalTrials.gov, dossier number NCT01602705.

E-mail invitations to general practitioners were as effective as postal invitations and were more efficient.

OBJECTIVE: To evaluate which of two invitation methods, e-mail or post, was most effective at recruiting general practitioners (GPs) to an online trial. STUDY DESIGN AND SETTING: Randomized controlled trial. Participants were GPs in Scotland, United Kingdom. RESULTS: Two hundred and seventy GPs were recruited. Using e-mail did not improve recruitment (risk difference=0.7% [95% confidence interval -2.7% to 4.1%]). E-mail was, however, simpler to use and cheaper, costing £3.20 per recruit compared with £15.69 for postal invitations. Reminders increased recruitment by around 4% for each reminder sent for both invitation methods. CONCLUSIONS: In the Scottish context, inviting GPs to take part in an online trial by e-mail does not adversely affect recruitment and is logistically easier and cheaper than using postal invitations.

High risk prescribing in primary care patients particularly vulnerable to adverse drug events: cross sectional population database analysis in Scottish general practice.

OBJECTIVE: To examine the prevalence and patterns of high risk prescribing, defined as potentially inappropriate prescribing of drugs to primary care patients particularly vulnerable to adverse drug events. DESIGN: Cross sectional population database analysis. SETTING: General practices in Scotland. PARTICIPANTS: 315 Scottish general practices with 1.76 million registered patients, 139 404 (7.9%) of whom were defined as particularly vulnerable to adverse drug events because of age, comorbidity, or co-prescription. MAIN OUTCOME MEASURES: How reliably each of 15 indicators-four each for non-steroidal anti-inflammatory drugs, co-prescription with warfarin, and prescribing in heart failure, two for dose instructions for methotrexate, and one for antipsychotic prescribing in dementia-and a composite of all 15 could distinguish practices in terms of their rates of high risk prescribing; and characteristics of patients and practices associated with high risk prescribing in a multilevel model. RESULTS: 19 308 of 139 404 (13.9%, 95% confidence interval 13.7% to 14.0%) patients had received at least one high risk prescription in the past year. This composite indicator was a reasonably reliable measure of practice rates of high risk prescribing (reliability >0.7 for 95.6% of practices, >0.8 for 88.2%). The patient characteristic most strongly associated with high risk prescribing was the number of drugs prescribed (>11 long term prescribed drugs v 0; odds ratio 7.90, 95% confidence interval 7.19 to 8.68). After adjustment for patient characteristics, rates of high risk prescribing varied by fourfold between practices, which was not explained by structural characteristics of the practices. CONCLUSIONS: Almost 14% of patients defined as particularly vulnerable to adverse drug events were prescribed one or more high risk drugs. The composite indicator of high risk prescribing used could identify practices as having above average or below average high risk prescribing rates with reasonable confidence. After adjustment, only the number of drugs prescribed long term to patients was strongly associated with high risk prescribing, and considerable unexplained variation existed between practices. High risk prescribing will often be appropriate, but the large variation between practices suggests opportunities for improvement.