Project description:BackgroundThe COVID-19 pandemic is characterized by rapid increases in infection burden owing to the emergence of new variants with higher transmissibility and immune escape. To date, monitoring the COVID-19 pandemic has mainly relied on passive surveillance, yielding biased epidemiological measures owing to the disproportionate number of undetected asymptomatic cases. Active surveillance could provide accurate estimates of the true prevalence to forecast the evolution of the pandemic, enabling evidence-based decision-making.ObjectiveThis study compared 4 different approaches of active SARS-CoV-2 surveillance focusing on feasibility and epidemiological outcomes.MethodsA 2-factor factorial randomized controlled trial was conducted in 2020 in a German district with 700,000 inhabitants. The epidemiological outcome comprised SARS-CoV-2 prevalence and its precision. The 4 study arms combined 2 factors: individuals versus households and direct testing versus testing conditioned on symptom prescreening. Individuals aged ≥7 years were eligible. Altogether, 27,908 addresses from 51 municipalities were randomly allocated to the arms and 15 consecutive recruitment weekdays. Data collection and logistics were highly digitized, and a website in 5 languages enabled low-barrier registration and tracking of results. Gargle sample collection kits were sent by post. Participants collected a gargle sample at home and mailed it to the laboratory. Samples were analyzed with reverse transcription loop-mediated isothermal amplification (RT-LAMP); positive and weak results were confirmed with real-time reverse transcription-polymerase chain reaction (RT-PCR).ResultsRecruitment was conducted between November 18 and December 11, 2020. The response rates in the 4 arms varied between 34.31% (2340/6821) and 41.17% (2043/4962). The prescreening classified 16.61% (1207/7266) of the patients as COVID-19 symptomatic. Altogether, 4232 persons without prescreening and 7623 participating in the prescreening provided 5351 gargle samples, of which 5319 (99.4%) could be analyzed. This yielded 17 confirmed SARS-CoV-2 infections and a combined prevalence of 0.36% (95% CI 0.14%-0.59%) in the arms without prescreening and 0.05% (95% CI 0.00%-0.108%) in the arms with prescreening (initial contacts only). Specifically, we found a prevalence of 0.31% (95% CI 0.06%-0.58%) for individuals and 0.35% (95% CI 0.09%-0.61%) for households, and lower estimates with prescreening (0.07%, 95% CI 0.0%-0.15% for individuals and 0.02%, 95% CI 0.0%-0.06% for households). Asymptomatic infections occurred in 27% (3/11) of the positive cases with symptom data. The 2 arms without prescreening performed the best regarding effectiveness and accuracy.ConclusionsThis study showed that postal mailing of gargle sample kits and returning home-based self-collected liquid gargle samples followed by high-sensitivity RT-LAMP analysis is a feasible way to conduct active SARS-CoV-2 population surveillance without burdening routine diagnostic testing. Efforts to improve participation rates and integration into the public health system may increase the potential to monitor the course of the pandemic.Trial registrationDeutsches Register Klinischer Studien (DRKS) DRKS00023271; https://tinyurl.com/3xenz68a.International registered report identifier (irrid)RR2-10.1186/s13063-021-05619-5.

Project description:BackgroundFew patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral.MethodsA cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the softwareResultsFrom 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral.ConclusionThere was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations.

Project description:IntroductionHeavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.Methods and analysisHGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout'). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.Ethics and disseminationEthical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.Trial registration numberISRCTN10483894.

Project description:IntroductionPeople with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education.Methods and analysisA multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2?years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24?months in those participants whose baseline HbA1c is at or above 7.5% (58?mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58?mmol/mol) or less at 24?months.Ethics and disseminationThe protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups.Trial registration numberISRCTN 61215213.

Project description:BACKGROUND: Summary measures of health that combine mortality and morbidity into a single indicator are being estimated in the Canadian context for approximately 200 diseases and conditions. To manage the large amount of data and calculations for this many diseases, we have developed a structured workbook system with easy to use tools. We expect this system will be attractive to researchers from other countries or regions of Canada who are interested in estimating the health-adjusted life years (HALYs) lost to premature mortality and year-equivalents lost to reduced functioning, as well as population attributable fractions (PAFs) associated with risk factors. This paper describes the workbook system using cancers as an example, and includes the entire system as a free, downloadable package. METHODS: The workbook system was developed in Excel and runs on a personal computer. It is a database system that stores data on population structure, mortality, incidence, distributions of cases entering a multitude of health states, durations of time spent in health states, preference scores that weight for severity, life table estimates of life expectancies, and risk factor prevalence and relative risks. The tools are Excel files with embedded macro programs. The main tool generates workbooks that estimate HALY, one per disease, by copying data from the database into a pre-defined template. Other tools summarize the HALY results across diseases for easy analysis. RESULTS: The downloadable zip file contains the database files initialized with Canadian data for cancers, the tools, templates and workbooks that estimate PAF and a user guide. The workbooks that estimate HALY are generated from the system at a rate of approximately one minute per disease. The resulting workbooks are self-contained and can be used directly to explore the details of a particular disease. Results can be discounted at different rates through simple parameter modification. CONCLUSION: The structured workbook approach offers researchers an efficient, easy to use, and easy to understand set of tools for estimating HALY and PAF summary measures for their country or region of interest.

Dataset Information

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial.

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