SummaryBackgroundStudies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care.MethodsThis study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366.Findings1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, −3·5 mm Hg [95% CI −5·8 to −1·2]; telemonitoring, −4·7 mm Hg [–7·0 to −2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference −1·2 mm Hg [95% CI −3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups.InterpretationSelf-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care.FundingNational Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.

BackgroundFor a trial of supportive self-management for people with chronic headache we needed to develop and validate a telephone classification interview that can be used by a non-headache specialist to classify common chronic headache types in primary care. We aimed to specifically: exclude secondary headaches other than medication overuse, exclude primary headache disorders other than migraine and tension type headache (TTH), distinguish between chronic migraine and chronic TTH, and identify medication overuse headache.MethodsWe held a headache classification consensus conference to draw on evidence and expertise to inform the content of a logic model underpinning the classification interview. Nurses trained to use the logic model did telephone classification interviews with participants recruited from primary care. Doctors specialising in headache did a second validation interview.ResultsTwenty-six delegates attended the headache classification conference including headache specialist doctors, nurses and lay representatives (with chronic headache). We trained six nurses to do the classification interviews and completed 107 paired interviews, median days between interviews was 32 days (interquartile range 21–48 days). We measured level of agreement between the nurse and doctor interviews using proportion of concordance, simple kappa and prevalence-adjusted bias-adjusted kappa (PABAK). Proportion of concordance of agreement between nurse and doctor interviews was 0.76, simple kappa coefficient κ 0.31 (95% CI, 0.09 to 0.52), and PABAK 0.51 (95% CI, 0.35 to 0.68), a moderate agreement. In a sensitivity test following review of headache characteristics recorded, concordance was 0.91, κ = 0.53 (95% CI, 0.28 to 0.79), and PABAK = 0.81 (95% CI, 0.70 to 0.92), a very good agreement.ConclusionWe developed and validated a new evidence-based telephone classification interview that can be used by a non-headache specialist to classify common chronic headache types in primary care.Electronic supplementary materialThe online version of this article (10.1186/s10194-018-0954-z) contains supplementary material, which is available to authorized users.

Background The informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research. Methods In order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory. Discussion Findings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.

ObjectiveTo develop and refine a programme theory that explains factors that influence decisions to take part in health research by people of diverse ethnic and cultural backgrounds.DesignRealist review following a sequence of five steps: (a) scoping search and identification of programme theory; (b) evidence searching; (c) critical appraisal and data extraction; (d) organisation of evidence and (e) refinement of programme theory.Eligibility criteriaDocuments (including peer-reviewed articles, grey literature, websites, reports and conference papers) either full text, or a section of relevance to the overarching research question were included.Data sourcesEMBASE, Medline, Web of Science, Psych Info, Google and Google Scholar were searched iteratively between May and August 2020. Search strategy was refined for each database providing a broad enough review for building of programme theory.AnalysisData from eligible documents was extracted to build understanding of the factors that influence decision-making. Data were mapped to create a data matrix according to context (C), mechanism (M), outcome (O), configurations (C) (CMOCs) for the process of informed consent, to aid interpretation and produce final programme theory.Results566 documents were screened and 71 included. Final programme theory was underpinned by CMOCs on processes influencing decisions to take part in research. Key findings indicate the type of infrastructure required, for example, resources, services and policies, to support inclusion in health research, with a greater need to increase the social presence of researchers within communities, improve cultural competency of individuals and organisations, reduce the complexity of participant information, and provide additional resources to support adaptive processes and shared decision making.ConclusionThe review indicates the need for a more inclusive research infrastructure that facilitates diverse participation in health research through incorporating adaptive processes that support shared decision making within the informed consent process and in the conduct of research projects.

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