Growing levels of both obesity and chronic disease in the general population pose a major public health problem. In the UK, an innovative 'health and weight' cohort trials facility, the 'South ...Yorkshire Cohort', is being built in order to provide robust evidence to inform policy, commissioning and clinical decisions in this field. This protocol reports the design of the facility and outlines the recruitment phase methods.
The South Yorkshire Cohort health and weight study uses the cohort multiple randomised controlled trial design. This design recruits a large observational cohort of patients with the condition(s) of interest which then provides a facility for multiple randomised controlled trials (with large representative samples of participants, long term outcomes as standard, increased comparability between each trial conducted within the cohort and increased efficiency particularly for trials of expensive interventions) as well as ongoing information as to the natural history of the condition and treatment as usual.This study aims to recruit 20,000 participants to the population based South Yorkshire Cohort health and weight research trials facility. Participants are recruited by invitation letters from their General Practitioners. Data is collected using postal and/or online patient self completed Health Questionnaires. NHS numbers will be used to facilitate record linkage and access to routine data. Participants are eligible if they are: aged 16 - 85 years, registered with one of 40 practices in South Yorkshire, provide consent for further contact from the researchers and to have their information used to look at the benefit of health treatments. The first wave of data is being collected during 2010/12 and further waves are planned at 2 - 5 year intervals for the planned 20 year duration of the facility.
The South Yorkshire Cohort combines the strengths of the standard observational, longitudinal cohort study design with a population based cohort facility for multiple randomised controlled trials in a range of long term health and weight related conditions (including obesity). This infrastructure will allow the rapid and cheap identification and recruitment of patients, and facilitate the provision of robust evidence to inform the management and self-management of health and weight.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
The objective of this study was to compare the response rates, data completeness, and representativeness of survey data produced by online and postal surveys.
A randomized trial nested within a ...cohort study in Yorkshire, United Kingdom. Participants were randomized to receive either an electronic (online) survey questionnaire with paper reminder (N = 2,982) or paper questionnaire with electronic reminder (N = 2,855).
Response rates were similar for electronic contact and postal contacts (50.9% vs. 49.7%, difference = 1.2%, 95% confidence interval: −1.3% to 3.8%). The characteristics of those responding to the two groups were similar. Participants nevertheless demonstrated an overwhelming preference for postal questionnaires, with the majority responding by post in both groups.
Online survey questionnaire systems need to be supplemented with a postal reminder to achieve acceptable uptake, but doing so provides a similar response rate and case mix when compared to postal questionnaires alone. For large surveys, online survey systems may be cost saving.
Systematic reviews have identified a range of brief interventions which increase physical activity in previously sedentary people. A randomised controlled trial is needed to assess whether providing ...motivational interviewing, three months after giving initial advice, sustains physical activity levels in those who recently became physically active. This paper reports the results of an internal pilot study designed to test the feasibility of the study in terms of recruitment, per protocol delivery of the intervention and retention at three months.
Participants were: aged 40-64 years; resident in deprived areas of Sheffield, UK; and, had recently become physically active as a result of using a brief intervention following an invitation from a mass mail out.
Motivational Interviewing 'boosters' aimed at sustaining change in physical activity status delivered face-to-face or over the telephone compared with no further intervention. Outcomes of the feasibility study: recruitment of 60 participants from mail out of 3,300; retention of 45 participants with 3-month follow-up accelerometry measurements; 70% of those randomised to boosters receiving intervention per protocol. Sample size and power were recalculated using the accelerometry data collected.
Forty-seven participants were randomised (78% of the feasibility target); 37 participants were retained at three months, 29 with at least four days of accelerometry data (64% of the feasibility target); 79% of those allocated boosters received them per protocol (surpassing the feasibility target). The proposed sample size of 600 was confirmed as appropriate and power is expected to be sufficient to detect a difference between groups.
The main study will continue with the original recruitment target of 600 participants but to ensure feasibility, it is necessary to increase recruitment and improve the numbers of those followed-up who have evaluable data. Strategies will include increasing the number of initial invitations sent out and improving the training of research assistants and participants in the positioning of the accelerometer.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Accurately estimating the costs of clinical trials is challenging. There is currently no reference class data to allow researchers to understand the potential costs associated with database change ...management in clinical trials.
We used a case-based approach, summarising post-live changes in eleven clinical trial databases managed by Sheffield Clinical Trials Research Unit. We reviewed the database specifications for each trial and summarised the number of changes, change type, change category, and timing of changes. We pooled our experiences and made observations in relation to key themes.
Median total number of changes across the eleven trials was 71 (range 40–155) and median number of changes per study week was 0.48 (range 0.32–1.34). The most common change type was modification (median 39, range 20–90), followed by additions (median 32, range 18–55), then deletions (median 7, range 1–12). In our sample, changes were more common in the first half of the trial's lifespan, regardless of its overall duration. Trials which saw continuous changes seemed more likely to be external pilots or trials in areas where the trial team was either less experienced overall or within the particular therapeutic area.
Researchers should plan trials with the expectation that clinical trial databases will require changes within the life of the trial, particularly in the early stages or with a less experienced trial team. More research is required to understand potential differences between clinical trial units and database types.
•There has been very little literature to date about clinical database change management•Yet database changes are common, particularly in the earlier stages of a trial•The likelihood of unanticipated changes has an effect on costing for a trial•The experience of the trial team and type of trial may affect the frequency of changes•The emergent nature of the trials environment necessitates anticipation of and allowance for database changes
Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, ...but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP.
OPTION-DM was a multicentre, randomised, double-blind, crossover trial in patients with DPNP with mean daily pain numerical rating scale (NRS) of 4 or higher (scale is 0–10) from 13 UK centres. Participants were randomly assigned (1:1:1:1:1:1), with a predetermined randomisation schedule stratified by site using permuted blocks of size six or 12, to receive one of six ordered sequences of the three treatment pathways: amitriptyline supplemented with pregabalin (A-P), pregabalin supplemented with amitriptyline (P-A), and duloxetine supplemented with pregabalin (D-P), each pathway lasting 16 weeks. Monotherapy was given for 6 weeks and was supplemented with the combination medication if there was suboptimal pain relief (NRS >3), reflecting current clinical practice. Both treatments were titrated towards maximum tolerated dose (75 mg per day for amitriptyline, 120 mg per day for duloxetine, and 600 mg per day for pregabalin). The primary outcome was the difference in 7-day average daily pain during the final week of each pathway. This trial is registered with ISRCTN, ISRCTN17545443.
Between Nov 14, 2017, and July 29, 2019, 252 patients were screened, 140 patients were randomly assigned, and 130 started a treatment pathway (with 84 completing at least two pathways) and were analysed for the primary outcome. The 7-day average NRS scores at week 16 decreased from a mean 6·6 (SD 1·5) at baseline to 3·3 (1·8) at week 16 in all three pathways. The mean difference was –0·1 (98·3% CI –0·5 to 0·3) for D-P versus A-P, –0·1 (–0·5 to 0·3) for P-A versus A-P, and 0·0 (–0·4 to 0·4) for P-A versus D-P, and thus not significant. Mean NRS reduction in patients on combination therapy was greater than in those who remained on monotherapy (1·0 SD 1·3 vs 0·2 1·5). Adverse events were predictable for the monotherapies: we observed a significant increase in dizziness in the P-A pathway, nausea in the D-P pathway, and dry mouth in the A-P pathway.
To our knowledge, this was the largest and longest ever, head-to-head, crossover neuropathic pain trial. We showed that all three treatment pathways and monotherapies had similar analgesic efficacy. Combination treatment was well tolerated and led to improved pain relief in patients with suboptimal pain control with a monotherapy.
National Institute for Health Research (NIHR) Health Technology Assessment programme.
Cohort Profile: The Yorkshire Health Study Green, Mark A; Li, Jessica; Relton, Clare ...
International journal of epidemiology,
06/2016, Letnik:
45, Številka:
3
Journal Article
Recenzirano
Odprti dostop
The Yorkshire Health Study is a longitudinal observational regional health study collecting health information on the residents from the Yorkshire and Humberside region in England. The second wave of ...data collection is currently under way. The study aims to inform National Health Service (NHS) and local authority health-related decision making in Yorkshire, with wider implications from findings as well. The first wave contains records for 27 806 individuals (2010-12), aged between 16 and 85, from one part of Yorkshire (South Yorkshire), with the second wave expanding data collection to the whole of the Yorkshire and Humberside region. Data were collected on current and long-standing health, health care usage and health-related behaviours, with a particular focus on weight and weight management. The majority of individuals have also given consent for record linkage with routine clinical data, allowing the linking to disease diagnosis, medication use and health care usage. The study encourages researchers to utilize the sample through the embedding of randomized controlled trials, other controlled trials and qualitative studies. To access the anonymized data or use the sample to recruit participants to studies, researchers should contact Clare Relton (c.relton@sheffield.ac.uk).
The WHO and National Institute for Health and Care Excellence recommend various triage tools to assist decision-making for patients with suspected COVID-19. We aimed to compare the accuracy of triage ...tools for predicting severe illness in adults presenting to the ED with suspected COVID-19.
We undertook a mixed prospective and retrospective observational cohort study in 70 EDs across the UK. We collected data from people attending with suspected COVID-19 and used presenting data to determine the results of assessment with the WHO algorithm, National Early Warning Score version 2 (NEWS2), CURB-65, CRB-65, Pandemic Modified Early Warning Score (PMEWS) and the swine flu adult hospital pathway (SFAHP). We used 30-day outcome data (death or receipt of respiratory, cardiovascular or renal support) to determine prognostic accuracy for adverse outcome.
We analysed data from 20 891 adults, of whom 4611 (22.1%) died or received organ support (primary outcome), with 2058 (9.9%) receiving organ support and 2553 (12.2%) dying without organ support (secondary outcomes). C-statistics for the primary outcome were: CURB-65 0.75; CRB-65 0.70; PMEWS 0.77; NEWS2 (score) 0.77; NEWS2 (rule) 0.69; SFAHP (6-point rule) 0.70; SFAHP (7-point rule) 0.68; WHO algorithm 0.61. All triage tools showed worse prediction for receipt of organ support and better prediction for death without organ support. At the recommended threshold, PMEWS and the WHO criteria showed good sensitivity (0.97 and 0.95, respectively) at the expense of specificity (0.30 and 0.27, respectively). The NEWS2 score showed similar sensitivity (0.96) and specificity (0.28) when a lower threshold than recommended was used.
CURB-65, PMEWS and the NEWS2 score provide good but not excellent prediction for adverse outcome in suspected COVID-19, and predicted death without organ support better than receipt of organ support. PMEWS, the WHO criteria and NEWS2 (using a lower threshold than usually recommended) provide good sensitivity at the expense of specificity.
ISRCTN56149622.
Objective
To identify clinical features associated with pulmonary embolism (PE) diagnosis and determine the accuracy of decision rules and D‐dimer for diagnosing suspected PE in pregnant/postpartum ...women
Design
Observational cohort study augmented with additional cases.
Setting
Emergency departments and maternity units at eleven prospectively recruiting sites and maternity units in the United Kingdom Obstetric Surveillance System (UKOSS)
Population
324 pregnant/postpartum women with suspected PE and 198 pregnant/postpartum women with diagnosed PE
Methods
We recorded clinical features, elements of clinical decision rules, D‐dimer measurements, imaging results, treatments and adverse outcomes up to 30 days
Main outcome measures
Women were classified as having PE on the basis of imaging, treatment and adverse outcomes by assessors blind to clinical features and D‐dimer. Primary analysis was limited to women with conclusive imaging to avoid work‐up bias. Secondary analyses included women with clinically diagnosed or ruled out PE.
Results
The only clinical features associated with PE on multivariate analysis were age (odds ratio 1.06; 95% confidence interval 1.01–1.11), previous thrombosis (3.07; 1.05–8.99), family history of thrombosis (0.35; 0.14–0.90), temperature (2.22; 1.26–3.91), systolic blood pressure (0.96; 0.93–0.99), oxygen saturation (0.87; 0.78–0.97) and PE‐related chest x‐ray abnormality (13.4; 1.39–130.2). Clinical decision rules had areas under the receiver‐operator characteristic curve ranging from 0.577 to 0.732 and no clinically useful threshold for decision‐making. Sensitivities and specificities of D‐dimer were 88.4% and 8.8% using a standard threshold and 69.8% and 32.8% using a pregnancy‐specific threshold.
Conclusions
Clinical decision rules and D‐dimer should not be used to select pregnant or postpartum women with suspected PE for further investigation. Clinical features and chest x‐ray appearances may have counter‐intuitive associations with PE in this context.
Tweetable
Clinical decision rules and D‐dimer are not helpful for diagnosing pregnant/postpartum women with suspected PE
Tweetable
Clinical decision rules and D‐dimer are not helpful for diagnosing pregnant/postpartum women with suspected PE.
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