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To improve the management (prevention and treatment) of mid-life and early old age MLTCs this project hosts a a series of scoping reviews to inform the COMPuTE program.

The research will be to undertake a narrative systematic review of SW-CRTs published after November 2018. We will describe the problems encountered whilst undertaking this design and critically appraise any reported solutions to these problems.

This protocol outlines a planned meta-epidemiological study to determine the quality of evidence underpinning diagnostic test recommendations in paediatric clinical practice guidelines.

This is a protocol for a retrospective observational study exploring trends in diagnostic tests ordered for children in Oxfordshire, UK from 2005 – 2020.

The prescribing of opioids has increased [1], but it is not known whether codeine-containing medicines sold over-the-counter (OTC) are following similar trends to prescribed opioids. Products containing codeine, an opioid related to morphine, have been associated with dependence, death, and collateral toxicity from combinations with paracetamol and ibuprofen [2,3]. However, access to granular data on OTC sales is limited. The full picture of the growing opioid problem will not be known until both prescription and OTC data on opioid sales are evaluated. Regulation of codeine-containing products varies across the world. In the UK, combination products called co-codamol, containing 8 mg of codeine (a low dose) and 500 mg of paracetamol, can be purchased without a prescription from pharmacies. However, 15 of the 28 European Union member countries do not allow codeine to be sold OTC [4]. More recently, Australia and Manitoba, Canada, changed the status of codeine-containing medicines to prescription-only [5,6]. Thus, there is building pressure to upregulate and restrict access to OTC codeine products. To the best of our knowledge, data on sales of OTC codeine medicines have not been described before. Thus, the aim of our repeat cross-sectional observational study is to describe national sales of over-the-counter (OTC) codeine-containing products purchased from pharmacies across 31 countries between 2013 and 2019. Our objectives are: 1. to determine the total volume (e.g. number of tablets) of OTC codeine-containing products purchased nationally each year, adjusted for population; 2. to determine the total public expenditure (converted to GBP, £ sterling as of 20/09/3019) of OTC codeine-containing products purchased nationally each year; and 3. to assess trends in volume and public expenditure nationally from 2013 to 2019.

This project contains the study protocol for a planned meta-epidemiological study to determine the quality of evidence underpinning diagnostic test recommendations in paediatric clinical practice guidelines.

Definition of conditions being present; flow chart describing study cohort selection; additional figures S2-S18. (DOCX 4106 kb)

Supplementary results. This file contains additional tables presenting results from the analyses which could not be included in the main manuscript. (DOCX 29 kb)

Appendix 2. Logistic regression analysis. Description: Logistic regression analysis to determine the best fitting explanatory variables for the attractiveness of a career in general practice. (DOCX 15 kb)

Appendix 1. Questionnaire. Description: 19-item questionnaire, combining dichotomous, multiple choice, demographic and Likert response scale questions with free text questions (DOCX 15 kb)

Objectives Gastrointestinal (GI) infections are common. Most infections are self-limiting, with some people developing long-term sequelae following their GI infection. Currently, the surveillance of GI infections such as Campylobacter and Salmonella is primarily based on laboratory data held by Public Health England (PHE). Information on symptoms severity, treatment of infection and subsequent complications is not captured by this data source. Electronic Health Records (EHR) provide a platform to assemble cohorts for long-term follow-up at relatively low costs. Record linkage of existing EHR provides a powerful resource to estimate the burden of complications following gastrointestinal Infections (GI) and the associated risk factors such as treatment of the primary GI infection. A range of ethical and data governance approvals processes, motivated to protect patients and patient data, are required to allow use of routine and linked data for research. The aim of this project is to establish a bespoke linkage of PHE laboratory data on Campylobacter, non-typhoidal Salmonella (NTS) and verocytotoxin producing Escherichia coli (VTEC) to the Clinical Practice Research Datalink (CPRD, primary care records), hospital records and other secondary datasets in order to estimate the burden of complications following GI infections. Approach Linkage of laboratory data, primary care data, hospital records, deaths and deprivation index were proposed following an initial data completeness check of laboratory data on Campylobacter spp., NTS and VTEC over a ten year (2004-2014) period. Linkage plans were discussed with all relevant organisations. Finalised study protocols were completed and application for approval for linkage was submitted to the Independent Scientific Advisory Committee (ISAC) and the NHS Research Ethics Committee. An additional application was sent to the Confidential Advisory Group (CAG) to comply with section 251 of the UK NHS Act 2006 on accessing patient identifiable information. Results ISAC approval for CPRD linkage is dependent on CAG approval. Completion of data linkage will allow the measurement of complications following GI infections to be estimated more accurately than is possible using routine, unlinked population-level data. It allows the implementation of designs such as the case-crossover design for the investigation of patient-level risk factors such as use of antibiotics and their association with complications. Conclusions Bespoke record linkage to CPRD can allow the measurement of risk of long-term sequelae following acute infections. Considerable time should be built into research timelines to allow completion of all ethical, governance and data access procedures.

BACKGROUND: Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. METHODS/DESIGN: This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. TRIAL REGISTRATION: ISRCTN 83571366 . Registered 17 July 2014.