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In recent years, a variety of efforts have been made in political science to enable, encourage, or require scholars to be more open and explicit about the bases of their empirical claims and, in turn, make those claims more readily evaluable by others. While qualitative scholars have long taken an interest in making their research open, reflexive, and systematic, the recent push for overarching transparency norms and requirements has provoked serious concern within qualitative research communities and raised fundamental questions about the meaning, value, costs, and intellectual relevance of transparency for qualitative inquiry. In this Perspectives Reflection, we crystallize the central findings of a three-year deliberative process—the Qualitative Transparency Deliberations (QTD)—involving hundreds of political scientists in a broad discussion of these issues. Following an overview of the process and the key insights that emerged, we present summaries of the QTD Working Groups’ final reports. Drawing on a series of public, online conversations that unfolded at www.qualtd.net, the reports unpack transparency’s promise, practicalities, risks, and limitations in relation to different qualitative methodologies, forms of evidence, and research contexts. Taken as a whole, these reports—the full versions of which can be found in the Supplementary Materials—offer practical guidance to scholars designing and implementing qualitative research, and to editors, reviewers, and funders seeking to develop criteria of evaluation that are appropriate—as understood by relevant research communities—to the forms of inquiry being assessed. We dedicate this Reflection to the memory of our coauthor and QTD working group leader Kendra Koivu.1
During the last fifteen years there has been a paradigm shift in the continuum modelling of granular materials; most notably with the development of rheological models, such as the $\mu (I)$-rheology (where $\mu$ is the friction and I is the inertial number), but also with significant advances in theories for particle segregation. This paper details theoretical and numerical frameworks (based on OpenFOAM) which unify these currently disconnected endeavours. Coupling the segregation with the flow, and vice versa, is not only vital for a complete theory of granular materials, but is also beneficial for developing numerical methods to handle evolving free surfaces. This general approach is based on the partially regularized incompressible $\mu (I)$-rheology, which is coupled to the gravity-driven segregation theory of Gray & Ancey (J. Fluid Mech., vol. 678, 2011, pp. 353–588). These advection–diffusion–segregation equations describe the evolving concentrations of the constituents, which then couple back to the variable viscosity in the incompressible Navier–Stokes equations. A novel feature of this approach is that any number of differently sized phases may be included, which may have disparate frictional properties. Further inclusion of an excess air phase, which segregates away from the granular material, then allows the complex evolution of the free surface to be captured simultaneously. Three primary coupling mechanisms are identified: (i) advection of the particle concentrations by the bulk velocity, (ii) feedback of the particle-size and/or frictional properties on the bulk flow field and (iii) influence of the shear rate, pressure, gravity, particle size and particle-size ratio on the locally evolving segregation and diffusion rates. The numerical method is extensively tested in one-way coupled computations, before the fully coupled model is compared with the discrete element method simulations of Tripathi & Khakhar (Phys. Fluids, vol. 23, 2011, 113302) and used to compute the petal-like segregation pattern that spontaneously develops in a square rotating drum.
An intermediate-depth (1751 m) ice core was drilled at the South Pole between 2014 and 2016 using the newly designed US Intermediate Depth Drill. The South Pole ice core is the highest-resolution interior East Antarctic ice core record that extends into the glacial period. The methods used at the South Pole to handle and log the drilled ice, the procedures used to safely retrograde the ice back to the National Science Foundation Ice Core Facility (NSF-ICF), and the methods used to process and sample the ice at the NSF-ICF are described. The South Pole ice core exhibited minimal brittle ice, which was likely due to site characteristics and, to a lesser extent, to drill technology and core handling procedures.
To conduct a pilot study implementing combined genomic and epidemiologic surveillance for hospital-acquired multidrug-resistant organisms (MDROs) to predict transmission between patients and to estimate the local burden of MDRO transmission.
Pilot prospective multicenter surveillance study.
The study was conducted in 8 university hospitals (2,800 beds total) in Melbourne, Australia (population 4.8 million), including 4 acute-care, 1 specialist cancer care, and 3 subacute-care hospitals.
All clinical and screening isolates from hospital inpatients (April 24 to June 18, 2017) were collected for 6 MDROs: vanA VRE, MRSA, ESBL Escherichia coli (ESBL-Ec) and Klebsiella pneumoniae (ESBL-Kp), and carbapenem-resistant Pseudomonas aeruginosa (CRPa) and Acinetobacter baumannii (CRAb). Isolates were analyzed and reported as routine by hospital laboratories, underwent whole-genome sequencing at the central laboratory, and were analyzed using open-source bioinformatic tools. MDRO burden and transmission were assessed using combined genomic and epidemiologic data.
In total, 408 isolates were collected from 358 patients; 47.5% were screening isolates. ESBL-Ec was most common (52.5%), then MRSA (21.6%), vanA VRE (15.7%), and ESBL-Kp (7.6%). Most MDROs (88.3%) were isolated from patients with recent healthcare exposure.
Combining genomics and epidemiology identified that at least 27.1% of MDROs were likely acquired in a hospital; most of these transmission events would not have been detected without genomics. The highest proportion of transmission occurred with vanA VRE (88.4% of patients).
Genomic and epidemiologic data from multiple institutions can feasibly be combined prospectively, providing substantial insights into the burden and distribution of MDROs, including in-hospital transmission. This analysis enables infection control teams to target interventions more effectively.
OBJECTIVES/GOALS: 1. Understand the association between patient perceptions of care measured by the Interpersonal Processes of Care (IPC) Survey and glycemic control, appointment no-shows/cancellations and medication adherence in patients with type II diabetes. 2. Determine how these relationships differ by race for non-Hispanic White and Black patients. METHODS/STUDY POPULATION: This is a cross-sectional study of a random sample of 100 White and 100 Black Type II diabetic patients followed in Duke primary care clinics and prescribed antihyperglycemic medication. We will recruit through email and phone calls. Enrolled patients will complete the Interpersonal Processes of Care Short Form and Extent of Medication Adherence survey to measure patient perceptions of care (predictor) and medication adherence (secondary outcome). No show appointments and cancellations (secondary outcomes) and most recent hemoglobin A1c (primary outcome) will be collected from the Electronic Medical Record. We will also collect basic demographic information, insurance status, financial security, significant co-morbidities, and number and type (subcutaneous vs oral) of antihyperglycemic medications. RESULTS/ANTICIPATED RESULTS: -The study is powered to detect a 0.6% difference in HbA1c, our primary outcome, between high and low scorers on the Interpersonal Processes of Care subdomains. -We expect that higher patient scores in the positive domains of the IPC survey and lower DISCUSSION/SIGNIFICANCE OF IMPACT: This study will provide information to develop and implement targeted interventions to reduce racial and ethnic disparities in patients with Type II diabetes. We hope to gain information on potentially modifiable factors in patient-provider interactions that can be intervened upon to improve prevention and long-term outcomes in these populations.
To examine the efficacy and tolerability of quetiapine SR in patients with schizophrenia switched from quetiapine IR.
Randomised, double-blind study (D1444C00146) using dual-matched placebo. Patients clinically stable on fixed doses of quetiapine IR received twice-daily quetiapine IR 400, 600 or 800 mg/day for 4 weeks. Stable patients were then randomised (1:2) to continue taking quetiapine IR or switch to the same total dose of quetiapine SR (active dose once-daily in the evening) for 6 weeks. Primary analysis: % of patients (modified ITT population) discontinuing due to lack of efficacy or with PANSS total increase ≥20% at any visit, using a 6% non-inferiority margin for the upper 95% CI of the treatment difference. Per-protocol (PP) analysis was also performed.
497 patients were randomised (quetiapine SR 331, IR 166); completion rates were 91.5% and 94.0%, respectively. Few patients discontinued due to lack of efficacy or had a PANSS increase ≥20% in both the MITT (n=496) and PP populations (n=393): 9.1% and 5.3% for quetiapine SR and 7.2% and 6.2% for quetiapine IR, respectively. Quetiapine SR was non-inferior to quetiapine IR in the PP population (treatment difference: -0.83% [95% CI -6.75, 3.71]; p=0017) but not in the MITT population (treatment difference: 1.86% [95% CI -3.78, 6.57]; p=0.0431). The incidence (quetiapine SR 38.7%; IR 35.5%) and profile of AEs were similar in both groups.
Clinically-stable patients receiving quetiapine IR can be switched, without titration, to an equivalent once-daily dose of quetiapine SR without any clinical deterioration or compromise in tolerability.
Optimal management of schizophrenia in adolescents is limited by the lack of available therapies. The efficacy and tolerability of aripiprazole was investigated in this patient population.
This 6-week, randomized, double-blind, placebo controlled trial was conducted at 101 international centers, with a safety monitoring board. 13-17 year-olds with a DSM-IV diagnosis of schizophrenia were randomized to placebo, or a fixed dose of aripiprazole 10 mg or 30 mg reached after a 5 or 11 day titration, respectively. The primary endpoint was mean change from baseline on the PANSS Total score at week 6. Secondary endpoints included the PANSS Positive and Negative subscales, and CGI Improvement score. Tolerabilility assessements included frequency and severity of adverse events, as well as blood chemistries, metabolic parameters and weight gain.
Over 85% of 302 patients completed this study. Both 10 mg and 30 mg doses were superior to placebo on the primary endpoint (PANSS total), with significant differences observed as early as Week 1 (30mg). Both doses showed significant improvement on the PANSS Positive and CGI-I scales; and the 10 mg dose group was superior on PANSS Negative score. Approximately 5% of aripiprazole patients discontinued due to AEs. Weight gain and changes in prolactin were minimal.
10mg and 30mg doses of aripiprazole were superior to placebo in the treatment of adolescents with schizophrenia. Aripiprazole was well tolerated, in general, with few discontinuations due to AEs. EPS was the most common AE. Change in body weight was similar to placebo.
Improving the quality of care on psychiatric inpatient wards has been a major focus in recent mental health policy, a recurrent criticism being that contact between staff and patients is limited in time and therapeutic value. Change is unlikely to be achieved without recruitment and retention of a high quality and well-motivated work force.
The NHS commissioned national inpatient mental health staff morale study is intended to inform service planning and policy by delivering evidence on the morale of the inpatient mental health workforce and the clinical, organisational, architectural and human resources factors that influence it.
100 wards in 17 area ‘Trusts’ are participating in the study, in addition to 40 community teams. The study will take place over two years, and has 6 modules:
1. A quantitative questionnaire for all staff in participating wards and
2. A comparison group in 20 community mental health teams and 20 crisis teams.
3. Case studies of 10 wards scoring in the top and bottom quartile for indicators of morale.
4. Repeated questionnaires for 20 wards in the second year to investigate how morale changes over time.
5. Staff who leave the wards in the course of the first year will be asked their reasons for leaving.
6. Links between rates of staff sickness and morale will be investigated.
Questionnaires have been distributed to 3,500 staff with a response rate of 65%, results from which will be presented in 2009.
Adequate pathways to care are a prerequisite for early detection and intervention in First Episode Psychosis (FEP). Two systematic reviews examined the influence of ethnicity, social and clinical factors on psychosis care pathways. Accessibility to health services differs for under 18s, yet differences in care pathways between age groups and the impact of family factors have not been investigated.
To investigate the influence of family factors in help-seeking pathways for adolescents with FEP.
Naturalistic crossectional study of 1351 FEP (14-35 years) referred to Early Intervention Psychosis teams (London, UK; 2003-2009). Care pathways included accounts on who initiated help-seeking process, initial contact points (GP, emergency services, education, social services, police and court/prison), and family factors (social support, living arrangements and family load of mental illness).
For the majority of adolescents (n=118) and adults (n=1232), first and second contact points were GP (30% vs 42%) and emergency services (18% vs 23%). However, these two services accounted for less than half of the adolescents’ sample. Adolescents made higher use of education (p<0.001). Family factors, such as good social support (p=0.036), living with carers (p<0.001) and family load of mental illness (p=0.018), were associated with family taking a leading role in problem recognition.
Adolescents with psychosis differ from adults in their contact points when seeking help. Problem recognition is a complex process which involves identifying and legitimizing mental health concerns. Parental awareness and perception of problems revealed as a key step in seeking help for adolescents.
Cannabis use has demonstrated an association with earlier onset of psychosis. Investigation of sociodemographic and clinical characteristics in association with cannabis use in adults with first-episode psychosis (FEP) has resulted in inconsistent findings. The clinical profile of cannabis users amongst adolescents with FEP remain widely understudied.
To investigate the frequency of cannabis use, and its association with sociodemographic and clinical characteristics in adolescent-versus adult-onset FEP.
Naturalistic cross-sectional study of 1363 FEP cases aged 14-35 (136 with adolescent-onset psychosis) referred to Early Intervention Services for psychosis in London (UK) (2003-2009). Sociodemographic and clinical data (age of psychosis onset, symptom domains, substance misuse, insight, violence, global functioning, and duration of untreated psychosis [DUP]) were collected at entry to EIS.
Cannabis users were more likely to be male (78.2%), White (43.0%) and unemployed (72.0%). No significant difference was found in cannabis abuse/dependence frequencies between adolescents (28.4%) and adults (24.7%). Cannabis abuse/dependence was associated with an earlier onset of psychosis by 2 years (p<0.001), greater manic and positive symptoms (p<0.001), increased violence (p=0.011), and poorer functioning (p=0.013) and insight (p=0.003). For adolescents, cannabis abuse/dependence was associated with greater positive symptoms, poorer functioning and longer DUP.
Cannabis use shapes the clinical presentation of FEP individuals. Similar frequencies of cannabis use between age groups suggest that substance misuse services should be provided to all, aiming to reducing consumption. Greater vigilance amongst clinicians would enable earlier detection of psychosis in substance misusing adolescents, to reduce DUP and minimise associated poor outcomes.
GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children).
To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD.
To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490).
Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure is change from baseline in ADHD-Rating Scale-version IV (ADHD-RS-IV). Key secondary measures were defined as Clinical Global Impressions-Improvement (CGI-I) and the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P). Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms, and vital signs.
Of 338 patients randomized, 272 (80.5%) completed the study. Placebo-adjusted differences in least squares (LS) mean in ADHD-RS-IV total score, percent improvement versus placebo for CGI-I, placebo-adjusted differences in LS mean change from baseline in WFIRS-P score (family and learning and school domains) are shown in the Table. The most common TEAEs for GXR were somnolence, headache, and fatigue; 8 (7%) TEAEs were severe.
GXR was effective and well tolerated in children and adolescents with ADHD.
Placebo-adjusted difference in LS mean change from baseline in ADHD-RS-IV total score (95% Cl, p-value; effect size)
−8.9 (−11.9, −5.8, p<0.001; 0.76)
−3.8 (−6.8, −0.7, p<0.05; 0.32)
Difference in improvement from placebo for CGI-I (95% Cl, p-value)
23.7% (11.1, 36.4; p<0.001)
12.1% (−0.9, 25.1; p<0.05)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; learning and school domain score (95%CI, p-value; effect size)
−0.22 (−0.36, −0.08, p<0.01; 0.42)
−0.16 (−0.31, −0.02, p<0.05; 0.32)
Placebo-adjusted difference in LS mean change from baseline in WFIRS-P; family domain score (95%CI, p-value; effect size)
GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children.
To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial.
To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145).
Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimization and 6-week maintenance periods on open-label GXR (1–7 mg/day), eligible patients entered a 26-week, double-blind, RWP with GXR or placebo. The primary endpoint was rate of treatment failure (≥50% increase in ADHD-RS-IV total score and ≥2-point increase in CGI-S at two consecutive visits, compared to the RWP baseline). The key secondary endpoint was time-to-treatment failure. Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs.
Of 528 patients enrolled, 316 (60.0%) entered the RWP. At study end, 49.3% (GXR) and 64.9% (placebo) (95%CI; −26.6, −4.5, p<0.01) of patients had relapsed (Figure). Time-to-treatment failure was 56 days (placebo) versus 218 days (GXR), p=0.003. During the RWP, the most common GXR TEAEs (≥5% patients) were headache, somnolence and nasopharyngitis.
GXR demonstrated long-term maintenance of efficacy versus placebo in children and adolescents with ADHD.
Studies suggest that alcohol consumption and alcohol use disorders have distinct genetic backgrounds.
We examined whether polygenic risk scores (PRS) for consumption and problem subscales of the Alcohol Use Disorders Identification Test (AUDIT-C, AUDIT-P) in the UK Biobank (UKB; N = 121 630) correlate with alcohol outcomes in four independent samples: an ascertained cohort, the Collaborative Study on the Genetics of Alcoholism (COGA; N = 6850), and population-based cohorts: Avon Longitudinal Study of Parents and Children (ALSPAC; N = 5911), Generation Scotland (GS; N = 17 461), and an independent subset of UKB (N = 245 947). Regression models and survival analyses tested whether the PRS were associated with the alcohol-related outcomes.
In COGA, AUDIT-P PRS was associated with alcohol dependence, AUD symptom count, maximum drinks (R2 = 0.47–0.68%, p = 2.0 × 10−8–1.0 × 10−10), and increased likelihood of onset of alcohol dependence (hazard ratio = 1.15, p = 4.7 × 10−8); AUDIT-C PRS was not an independent predictor of any phenotype. In ALSPAC, the AUDIT-C PRS was associated with alcohol dependence (R2 = 0.96%, p = 4.8 × 10−6). In GS, AUDIT-C PRS was a better predictor of weekly alcohol use (R2 = 0.27%, p = 5.5 × 10−11), while AUDIT-P PRS was more associated with problem drinking (R2 = 0.40%, p = 9.0 × 10−7). Lastly, AUDIT-P PRS was associated with ICD-based alcohol-related disorders in the UKB subset (R2 = 0.18%, p < 2.0 × 10−16).
AUDIT-P PRS was associated with a range of alcohol-related phenotypes across population-based and ascertained cohorts, while AUDIT-C PRS showed less utility in the ascertained cohort. We show that AUDIT-P is genetically correlated with both use and misuse and demonstrate the influence of ascertainment schemes on PRS analyses.
For life insurers in the United Kingdom (UK), the risk margin is one of the most controversial aspects of the Solvency II regime which came into force in 2016.
The risk margin is the difference between the technical provisions and the best estimate liabilities. The technical provisions are intended to be market-consistent, and so are defined as the amount required to be paid to transfer the business to another undertaking. In practice, the technical provisions cannot be directly calculated, and so the risk margin must be determined using a proxy method; the method chosen for Solvency II is known as the cost-of-capital method.
Following the implementation of Solvency II, the risk margin came under considerable criticism for being too large and too sensitive to interest rate movements. These criticisms are particularly valid for annuity business in the UK – such business is of great significance to the system for retirement provision. A further criticism is that mitigation of the impact of the risk margin has led to an increase in reinsurance of longevity risks, particularly to overseas reinsurers.
This criticism has led to political interest, and the risk margin was a major element of the Treasury Committee inquiry into EU Insurance Regulation.
The working party was set up in response to this criticism. Our brief is to consider both the overall purpose of the risk margin for life insurers and solutions to the current problems, having regard to the possibility of post-Brexit flexibility.
We have concluded that a risk margin in some form is necessary, although its size depends on the level of security desired, and so is primarily a political question.
We have reviewed possible alternatives to the current risk margin, both within the existing cost-of-capital methodology and considering a wide range of alternatives.
We believe that requirements for the risk margin will depend on future circumstances, in particular relating to Brexit, and we have identified a number of possible changes to methodology which should be considered, depending on circumstances.
Multispectral imaging – the acquisition of spatially contiguous imaging data in a modest number (~3–16) of spectral bandpasses – has proven to be a powerful technique for augmenting panchromatic imaging observations on Mars focused on geologic and/or atmospheric context. Specifically, multispectral imaging using modern digital CCD photodetectors and narrowband filters in the 400–1100 nm wavelength region on the Mars Pathfinder, Mars Exploration Rover, Phoenix, and Mars Science Laboratory missions has provided new information on the composition and mineralogy of fine-grained regolith components (dust, soils, sand, spherules, coatings), rocky surface regions (cobbles, pebbles, boulders, outcrops, and fracture-filling veins), meteorites, and airborne dust and other aerosols. Here we review recent scientific results from Mars surface-based multispectral imaging investigations, including the ways that these observations have been used in concert with other kinds of measurements to enhance the overall scientific return from Mars surface missions.
Translocation and rehabilitation programmes are critical tools for wildlife conservation. These methods achieve greater impact when integrated in a combined strategy for enhancing population or ecosystem restoration. During 2002–2016 we reared 37 orphaned southern sea otter Enhydra lutris nereis pups, using captive sea otters as surrogate mothers, then released them into a degraded coastal estuary. As a keystone species, observed increases in the local sea otter population unsurprisingly brought many ecosystem benefits. The role that surrogate-reared otters played in this success story, however, remained uncertain. To resolve this, we developed an individual-based model of the local population using surveyed individual fates (survival and reproduction) of surrogate-reared and wild-captured otters, and modelled estimates of immigration. Estimates derived from a decade of population monitoring indicated that surrogate-reared and wild sea otters had similar reproductive and survival rates. This was true for males and females, across all ages (1–13 years) and locations evaluated. The model simulations indicated that reconstructed counts of the wild population are best explained by surrogate-reared otters combined with low levels of unassisted immigration. In addition, the model shows that 55% of observed population growth over this period is attributable to surrogate-reared otters and their wild progeny. Together, our results indicate that the integration of surrogacy methods and reintroduction of juvenile sea otters helped establish a biologically successful population and restore a once-impaired ecosystem.
Moral reasoning and decision making help guide behavior and facilitate interpersonal relationships. Accounts of morality that position commonsense psychology as the foundation of moral development, (i.e., rationalist theories) have dominated research in morality in autism spectrum disorder (ASD). Given the well-documented differences in commonsense psychology among autistic individuals, researchers have investigated whether the development and execution of moral judgement and reasoning differs in this population compared with neurotypical individuals. In light of the diverse findings of investigations of moral development and reasoning in ASD, a summation and critical evaluation of the literature could help make sense of what is known about this important social-cognitive skill in ASD. To that end, we conducted a systematic review of the literature investigating moral decision making among autistic children and adults. Our search identified 29 studies. In this review, we synthesize the research in the area and provide suggestions for future research. Such research could include the application of an alternative theoretical framework to studying morality in autism spectrum disorder that does not assume a deficits-based perspective.
The rocky shores of the north-east Atlantic have been long studied. Our focus is from Gibraltar to Norway plus the Azores and Iceland. Phylogeographic processes shape biogeographic patterns of biodiversity. Long-term and broadscale studies have shown the responses of biota to past climate fluctuations and more recent anthropogenic climate change. Inter- and intra-specific species interactions along sharp local environmental gradients shape distributions and community structure and hence ecosystem functioning. Shifts in domination by fucoids in shelter to barnacles/mussels in exposure are mediated by grazing by patellid limpets. Further south fucoids become increasingly rare, with species disappearing or restricted to estuarine refuges, caused by greater desiccation and grazing pressure. Mesoscale processes influence bottom-up nutrient forcing and larval supply, hence affecting species abundance and distribution, and can be proximate factors setting range edges (e.g., the English Channel, the Iberian Peninsula). Impacts of invasive non-native species are reviewed. Knowledge gaps such as the work on rockpools and host–parasite dynamics are also outlined.