In a systematic review of qualitative research, Katie Gallacher and colleagues examine the evidence related to treatment burden after stroke from the patient perspective. Please see later in the article for the Editors' Summary

Review questionWhat is known about the evidence that web-based/online/computerised tools for self management of asthma can improve indices of asthma control, lung function, health care utilisation, patient quality of life, and patient satisfaction, and what helps or hinders the use of such interventions by patients, carers and health professionals. Objectives• To undertake a systematic review of all published reviews (quanti tative and qualitative) of web-based/online/computerised self-management asthma interventions.• To establish if the use of web-based/online/computerised self care interventions have been found to have a positive effect on asthma symptom scores, lung function, medication use, health care utilisation, or asthma quality of life scores.• To identify the presence of techniques in these interventions known to promote behavioural change e.g. educational information, self monitoring, attitudinal arguments, and the use of prompts.• To examine what factors, if any, have been identified as promoting or inhibiting the uptake and utilisation of online tools by patients, carers and practitioners? Searches• Databases to be searched: MEDL I NE, EMBASE, CINAH L, PsycINFO, ERIC, Cochrane Library (including CDSR, DARE, Central, and HTA databases), DoPHER and TROPHI (both produced by the EPPI Centre), Social Science Citation Index and Science Citation Index. These databases will be searched using a combination of subject headings where available (such as MeSH) and words in the t i tle and abstracts.The search strategy combines 3 facets of search terms:1. Online technology 2. Asthma 3. Self management/behavior change/patient experience Searches employing more general terms, such as respiratory t ract diseases, will be explored as they may identify records where in the full document i t becomes clear that patients with asthma are included.

Anti-disialoside antibodies (Abs) that bind NeuAc(alpha2-8) NeuAc epitopes on GQ1b and related gangliosides are found in human autoimmune neuropathy sera and are considered to be pathogenic. In a model system in mice, one mechanism by which anti-disialoside Abs have been demonstrated to induce paralysis is through a complement dependent blocking effect on transmitter release at the neuromuscular junction, similar to the effects of alpha-latrotoxin. Although direct targeting of presynaptic neuronal membranes occurs in this model, concomitant injury to perisynaptic Schwann cells (pSC) could indirectly contribute to this paralytic effect by influencing nerve terminal function and survival. To examine this possibility and the specific complement components that might mediate these effects, we exposed neuromuscular junctions in vivo and in vitro to an anti-disialoside Ab in conjunction with intact and selectively deficient complement sources. Using immuno-electron microscopy, we observed Ab deposits equally distributed on both neuronal and pSC membranes, and ultrastructural evidence of injury at both sites. Presynaptic neuronal injury was demonstrated functionally with microelectrode recordings and histologically as neurofilament loss. As hypothesized, concomitant pSC injury occurred, as indicated by abnormal uptake of ethidium dimer into pSC nuclei. The pSC and nerve terminal damage indicators correlated well with deposition of the pore-forming terminal complement component, membrane attack complex (MAC) in pSC and nerve terminal membranes. Furthermore, both neuronal and pSC injury were exacerbated in tissues from mice lacking the inhibitory complement regulator, CD59, where MAC formation is increased. These data demonstrate that both presynaptic neuronal membranes and pSCs are targets for anti-disialoside Abs, and that the injury to both sites is mediated by MAC and further regulated by CD59. This is the first demonstration that complement mediated pSC injury occurs in a model of autoimmune neuropathy and provides a rationale for investigating the possibility of pSC injury in equivalent conditions in man.

BackgroundTreatment burden can be defined as the self-care practices that patients with chronic illness must perform to respond to the requirements of their healthcare providers, as well as the impact that these practices have on patient functioning and well being. Increasing levels of treatment burden may lead to suboptimal adherence and negative outcomes. Systematic review of the qualitative literature is a useful method for exploring the patient experience of care, in this case the experience of treatment burden. There is no consensus on methods for qualitative systematic review. This paper describes the methodology used for qualitative systematic reviews of the treatment burdens identified in three different common chronic conditions, using stroke as our exemplar.MethodsQualitative studies in peer reviewed journals seeking to understand the patient experience of stroke management were sought. Limitations of English language and year of publication 2000 onwards were set. An exhaustive search strategy was employed, consisting of a scoping search, database searches (Scopus, CINAHL, Embase, Medline & PsycINFO) and reference, footnote and citation searching. Papers were screened, data extracted, quality appraised and analysed by two individuals, with a third party for disagreements. Data analysis was carried out using a coding framework underpinned by Normalization Process Theory (NPT).ResultsA total of 4364 papers were identified, 54 were included in the review. Of these, 51 (94%) were retrieved from our database search. Methodological issues included: creating an appropriate search strategy; investigating a topic not previously conceptualised; sorting through irrelevant data within papers; the quality appraisal of qualitative research; and the use of NPT as a novel method of data analysis, shown to be a useful method for the purposes of this review.ConclusionThe creation of our search strategy may be of particular interest to other researchers carrying out synthesis of qualitative studies. Importantly, the successful use of NPT to inform a coding frame for data analysis involving qualitative data that describes processes relating to self management highlights the potential of a new method for analyses of qualitative data within systematic reviews.

Patient preference studies could provide valuable insights to a National Institute for Health and Care Excellence committee into the preferences patients have for different treatment options, especially if the study sample is representative of the broader patient population. We identify three main uses of patient preference studies along a technology's pathway from drug development to clinical use: in early clinical development to guide the selection of appropriate endpoints, to inform benefitrisk assessments carried out by regulators and to inform reimbursement decisions made by health technology assessment bodies. In the context of the National Institute for Health and Care Excellence's methods and processes, we do not see a role for quantitative patient preference data to be directly incorporated into health economic modelling. Rather, we see a role for patient preference studies to be submitted alongside other types of evidence. Examples where patient preference studies might have added value in health technology assessments include cases where two distinctly different treatment options are being compared, when patients have to decide between multiple treatment options, when technologies have important nonhealth benefits or when a treatment is indicated for a heterogenous population.

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The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision‐making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.

BackgroundChronic obstructive pulmonary disease (COPD) is common, and a major cause of morbidity and mortality worldwide. Recent studies suggest that comorbidities of COPD increase the risk of hospitalisation, polypharmacy, and mortality, but their estimated prevalence varies widely in the literature. AimTo evaluate the prevalence of 38 physical and mental health comorbidities in people with COPD, and compare findings with those for people without COPD in a large nationally representative dataset. Design and settingA cross-sectional data analysis on 1 272 685 adults in Scotland from 314 primary care practices. MethodData on COPD, along with 31 physical and seven mental health comorbidities, were extracted. The prevalence of comorbidities was compared between people who did, and did not, have COPD, standardised by age, sex, and socioeconomic deprivation. ResultsFrom the total sample, 51 928 patients had COPD (4.1%). Of these, 86.0% had at least one comorbidity, compared with 48.9% of people without COPD. Of those with COPD, 22.3% had ≥5 comorbid conditions compared with 4.9% of those who did not have COPD (adjusted odds ratio 2.63, 95% confidence interval = 2.56 to 2.70). In total, 29 of the 31 physical conditions and six of the seven mental health conditions were statistically significantly more prevalent in people who had COPD than those who did not. ConclusionPatients with COPD have extensive associated comorbidities. There is a real need for guidelines and health care to reflect this complexity, including how to detect those common comorbidities that relate to both physical and mental health, and how best to manage them. Primary care, which is unique in terms of offering expert generalist care, is best placed to provide this integrated approach.