OverviewWe found it helpful to consider phases 0, 1, and 2 of the stepwise approach as part of one larger iterative activity rather than as sequential stages (box 2). We found we needed data to clarify our understanding of the context of the research, the problem we sought to tackle, the intervention, and the evaluation (figure⇓).1 Research on all these areas can be conducted simultaneously. In the following sections, we outline the important contextual considerations, describe the aim of each of three main components (problem definition, intervention, and evaluation), the key tasks necessary to meet each aim, and the conceptual and research approaches helpful in achieving the key tasks.View larger version: In this window In a new window Relation between context, problem definition, intervention, and evaluation for complex interventions

Persistent insomnia, although very common in general practice, often proves problematic to manage. This study investigates the clinical effectiveness and the feasibility of applying cognitive behavior therapy (CBT) methods for insomnia in primary care. Pragmatic randomized controlled trial of CBT versus treatment as usual. General medical practice. Two hundred one adults (mean age, 54 years) randomly assigned to receive CBT (n = 107; 72 women) or treatment as usual (n = 94; 65 women). CBT comprised 5 sessions delivered in small groups by primary care nurses. Treatment as usual comprised usual care from general practitioners. Assessments were completed at baseline, after treatment, and at 6-month follow-up visits. Sleep outcomes were appraised by sleep diary, actigraphy, and clinical endpoint. CBT was associated with improvements in self-reported sleep latency, wakefulness after sleep onset, and sleep efficiency. Improvements were partly sustained at follow-up. Effect sizes were moderate for the index variable of sleep efficiency. Participants receiving treatment as usual did not improve. Actigraphically estimated sleep improved modestly after CBT, relative to no change in treatment as usual. CBT was also associated with significant positive changes in mental health and energy/vitality. Comorbid physical and mental health difficulties did not impair sleep improvement following CBT. This study suggests that trained and supervised nurses can effectively deliver CBT for insomnia in routine general medical practice. Treatment response to small-group service delivery was encouraging, although effect sizes were smaller than those obtained in efficacy studies. Further research is required to consider the possibility that CBT could become the treatment of first choice for persistent insomnia in primary healthcare.

Addressing the causes of low engagement in health care is a prerequisite for reducing health inequalities. People who miss multiple appointments are an under-researched group who might have substantial unmet health needs. Individual-level patterns of missed general practice appointments might thus provide a risk marker for vulnerability and poor health outcomes. We sought to ascertain the contributions of patient and practice factors to the likelihood of missing general practice appointments. For this national retrospective cohort analysis, we extracted UK National Health Service general practice data that were routinely collected across Scotland between Sept 5, 2013, and Sept 5, 2016. We calculated the per-patient number of missed appointments from individual appointments and investigated the risk of missing a general practice appointment using a negative binomial model offset by number of appointments made. We then analysed the effect of patient-level factors (including age, sex, and socioeconomic status) and practice-level factors (including appointment availability and geographical location) on the risk of missing appointments. The full dataset included information from 909 073 patients, of whom 550 083 were included in the analysis after processing. We observed that 104 461 (19·0%) patients missed more than two appointments in the 3 year study period. After controlling for the number of appointments made, patterns of non-attendance could be differentiated, with patients who were aged 16-30 years (relative risk ratio [RRR] 1·21, 95% CI 1·19-1·23) or older than 90 years (2·20, 2·09-2·29), and of low socioeconomic status (Scottish Index of Multiple Deprivation decile 1: RRR 2·27, 2·22-2·31) significantly more likely to miss multiple appointments. Men missed fewer appointments overall than women, but were somewhat more likely to miss appointments in the adjusted model (1·05, 1·04-1·06). Practice factors also substantially affected attendance patterns, with urban practices in affluent areas that typically have appointment waiting times of 2-3 days the most likely to have patients who serially miss appointments. The combination of both patient and practice factors to predict appointments missed gave a higher pseudo R2 value (0·66) than models using either group of factors separately (patients only R2=0·54; practice only R2=0·63). The findings that both patient and practice characteristics contribute to non-attendance of general practice appointments raise important questions for both the management of patients who miss multiple appointments and the effectiveness of existing strategies that aim to increase attendance. Addressing these issues should lead to improvements in provision of services and public health. Scottish Government Chief Scientist Office and Data Sharing and Linkage Service of the Scottish Government.

Recently, studies have examined the underlying patient and practice factors for missed appointments, but less is known about the impact on patient health. People with one or more long-term conditions who fail to attend appointments may be at risk of premature death. This is the first study to examine the effect of missed primary healthcare appointments on all-cause mortality in those with long-term mental and physical health conditions. We used a large, nationwide retrospective cohort (n = 824,374) extracted from routinely collected general practice data across Scotland over a 3-year period from September 2013 until September 2016. This data encompasses appointment history for approximately 15% of the Scottish population, and was linked to Scottish deaths records for patients who had died within a 16-month follow-up period. We generated appointment attendance history, number of long-term conditions and prescriptions data for patients. These factors were used in negative binomial and Cox’s proportional hazards modelling to examine the risk of missing appointments and all-cause mortality. Patients with a greater number of long-term conditions had an increased risk of missing general practice appointments despite controlling for number of appointments made, particularly among patients with mental health conditions. These patients were at significantly greater risk of all-cause mortality, and showed a dose-based response with increasing number of missed appointments. Patients with long-term mental health conditions who missed more than two appointments per year had a greater than 8-fold increase in risk of all-cause mortality compared with those who missed no appointments. These patients died prematurely, commonly from non-natural external factors such as suicide. Missed appointments represent a significant risk marker for all-cause mortality, particularly in patients with mental health conditions. For these patients, existing primary healthcare appointment systems are ineffective. Future interventions should be developed with a particular focus on increasing attendance by these patients.

Objectives To explore how general practitioners operate the sickness certification system, their views on the system, and suggestions for change. Design Qualitative focus group study consisting of 11 focus groups with 67 participants. Setting General practitioners in practices in Glasgow, Tayside, and Highland regions, Scotland. Sample Purposive sample of general practitioners, with further theoretical sampling of key informant general practitioners to examine emerging themes. Results General practitioners believed that the sickness certification system failed to address complex, chronic, or doubtful cases. They seemed to develop various operational strategies for its implementation. There appeared to be important deliberate misuse of the system by general practitioners, possibly related to conflicts about roles and incongruities in the system. The doctor-patient relationship was perceived to conflict with the current role of general practitioners in sickness certification. When making decisions about certification, the general practitioners considered a wide variety of factors. They experienced contradictory demands from other system stakeholders and felt blamed for failing to make impossible reconciliations. They clearly identified the difficulties of operating the system when there was no continuity of patient care. Many wished either to relinquish their gatekeeper role or to continue only with major changes. Conclusions Policy makers need to recognise and accommodate the range and complexity of factors that influence the behaviour of general practitioners operating as gatekeepers to the sickness certification system, before making changes. Such changes are otherwise unlikely to result in improvement. Models other than the primary care gatekeeper model should be considered.

Pathological stress responses are implicated in numerous disorders. Hypothalamic–pituitary–adrenal axis function is influenced by gene–environment interaction, with early-life environmental adversity having long-lasting effects. We examine the evidence that, in humans, these effects are apparent from infancy. We systematically reviewed published findings on cortisol response to a stressor, in 0–5-year-olds already exposed to adversity. Adversity was defined as a negative environmental influence present post-conception. We searched Ovid MEDLINE (1950–May 2010), EMBASE (1980–May 2010) and PsychINFO (1806–May 2010). We included peer-reviewed, English language studies that analysed salivary cortisol before and after a standardised stressor. We identified 30 studies, of which 27 reported a significant effect of adversity on the cortisol response to stress. Six of these demonstrated an effect of prenatal substance exposure. Thirteen studies found that psychosocial adversity increased cortisol reactivity. Three studies reported that cortisol reactivity could be normalised by intervention programmes. The studies were heterogeneous, both in nature of adversity studied and in stressor used, precluding meta-analysis and assessment of publication bias. Our review presents evidence that adversity disrupts the stress response from an early age. Longitudinal studies are required to determine whether effects persist, alter with time, or are reversible with intervention.