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Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E): the ALIC4 E protocol.

ABSTRACT: INTRODUCTION:Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies. METHODS AND ANALYSIS:Antivirals for influenza-Like Illness? An rCt of Clinical and Cost effectiveness in primary CarE is a European multinational, multicentre, open-labelled, non-industry funded, pragmatic, adaptive-platform, randomised controlled trial. Initial trial arms will be best usual primary care and best usual primary care plus treatment with oseltamivir for 5?days. We aim to recruit at least 2500 participants ?1?year presenting with influenza-like illness (ILI), with symptom duration ?72?hours in primary care over three consecutive periods of confirmed high influenza incidence. Participant outcomes will be followed up to 28 days by diary and telephone. The primary objective is to determine whether adding antiviral treatment to best usual primary care is effective in reducing time to return to usual daily activity with fever, headache and muscle ache reduced to minor severity or less. Secondary objectives include estimating cost-effectiveness, benefits in subgroups according to age (<12, 12-64 and >64 years), severity of symptoms at presentation (low, medium and high), comorbidity (yes/no), duration of symptoms (?48?hours/>48-72?hours), complications (hospital admission and pneumonia), use of additional prescribed medication including antibiotics, use of over-the-counter medicines and self-management of ILI symptoms. ETHICS AND DISSEMINATION:Research ethics committee (REC) approval was granted by the NRES Committee South Central (Oxford B) and Clinical Trial Authority (CTA) approval by The Medicines and Healthcare products Regulatory Agency. All participating countries gained national REC and CTA approval as required. Dissemination of results will be through peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER:ISRCTN27908921; Pre-results.

SUBMITTER: Bongard E

PROVIDER: S-EPMC6089276 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC<sup>4</sup> E): the ALIC<sup>4</sup> E protocol.

Bongard Emily E van der Velden Alike W AW Cook Johanna J Saville Ben B Beutels Philippe P Munck Aabenhus Rune R Brugman Curt C Chlabicz Slawomir S Coenen Samuel S Colliers Annelies A Davies Melanie M De Paor Muireann M De Sutter An A Francis Nick A NA Glinz Dominik D Godycki-Ćwirko Maciek M Goossens Herman H Holmes Jane J Ieven Margareta M de Jong Menno M Lindbaek Morten M Little Paul P Martinón-Torres Frederico F Moragas Ana A Pauer József J Pfeiferová Markéta M Radzeviciene-Jurgute Ruta R Sundvall Pär-Daniel PD Torres Antoni A Touboul Pia P Varthalis Dionyssios D Verheij Theo T Butler Christopher C CC

BMJ open 20180712 7

<h4>Introduction</h4>Effective management of seasonal and pandemic influenza is a high priority internationally. Guidelines in many countries recommend antiviral treatment for older people and individuals with comorbidity at increased risk of complications. However, antivirals are not often prescribed in primary care in Europe, partly because its clinical and cost effectiveness has been insufficiently demonstrated by non-industry funded and pragmatic studies.<h4>Methods and analysis</h4>Antivira ...[more]

PMID: 30002007

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Project description:ObjectivesTo evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective.DesignCost-effectiveness analysis of a double-blinded randomised controlled trial.SettingGeneral practice in the Netherlands.Participants116 participants with PHP for at least 2 weeks, aged 18-65 years and presenting to the GP.InterventionsParticipants were randomised to GP-led usual care (n=46) or referral to a podiatrist for treatment with a custom-made insole (n=70). Participant randomised to a sham insole (n=69) were excluded from this analysis.Primary and secondary outcomesOutcomes comprised pain during rest and activity, and quality of life. Costs included healthcare and lost productivity costs. Statistical uncertainty was estimated using bootstrapping and presented using cost-effectiveness acceptability curves.ResultsParticipants in the custom-made insole group experienced statistically significant more pain during activity at 26 weeks than participants in the usual care group (overall effect 1.06; 95% CI 0.36 to 1.75). There were no significant differences between groups in other outcomes. Total societal costs in the custom-made insole group were non-significantly higher than in the usual care group (mean difference €376; 95% CI -€1775 to €2038). The intervention with custom-made insoles was dominated by usual care by the GP (ie, more expensive and less effective) for pain during activity and quality of life outcomes. For the outcome pain at rest, the intervention was more expensive and more effective than usual care. However, the maximum probability of cost-effectiveness was only 0.59 at very high ceiling ratios.ConclusionsThese findings show that that custom-made insoles are not cost-effective in comparison with GP-led usual care. Clinicians should be reserved in prescribing custom-made insoles for PHP as a primary intervention.Trial registration numberNTR5346.

Project description:IntroductionThe UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care.Methods and analysisThis cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationThis study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices.Trial registration numberThis study is registered at controlled-trials.com ISRCTN48840025, July 2013.

Project description:BackgroundGeneral practitioners are usually the first health professionals to be contacted by people with early signs of psychosis. We aimed to assess whether increased liaison between primary and secondary care improves the clinical effectiveness and cost-effectiveness of detection of people with, or at high risk of developing, a first psychotic illness.MethodsOur Liaison and Education in General Practices (LEGs) study was a cluster-randomised controlled trial of primary care practices (clusters) in Cambridgeshire and Peterborough, UK. Consenting practices were randomly allocated (1:1) to a 2 year low-intensity intervention (a postal campaign, consisting of biannual guidelines to help identify and refer individuals with early signs of psychosis) or a high-intensity intervention, which additionally included a specialist mental health professional who liaised with every practice and a theory-based educational package. Practices were not masked to group allocation. Practices that did not consent to be randomly assigned comprised a practice-as-usual (PAU) group. The primary outcome was number of referrals of patients at high risk of developing psychosis to the early intervention service per practice site. New referrals were assessed clinically and stratified into those who met criteria for high risk or first-episode psychotic illness (FEP; together: psychosis true positives), and those who did not fulfil such criteria for psychosis (false positives). Referrals from PAU practices were also analysed. We assessed cost-effectiveness with decision analytic modelling in terms of the incremental cost per additional true positive identified. The trial is registered at the ISRCTN registry, number ISRCTN70185866.FindingsBetween Dec 22, 2009, and Sept 7, 2010, 54 of 104 eligible practices provided consent and between Feb 16, 2010, and Feb 11, 2011, these practices were randomly allocated to interventions (28 to low intensity and 26 to high intensity); the remaining 50 practices comprised the PAU group. Two high-intensity practices were excluded from the analysis. In the 2 year intervention period, high-intensity practices referred more FEP cases than did low-intensity practices (mean 1.25 [SD 1.2] for high intensity vs 0.7 [0.9] for low intensity; incidence rate ratio [IRR] 1.9, 95% CI 1.05-3.4, p=0.04), although the difference was not statistically significant for individuals at high risk of psychosis (0.9 [1.0] vs 0.5 [1.0]; 2.2, 0.9-5.1, p=0.08). For high risk and FEP combined, high-intensity practices referred both more true-positive (2.2 [1.7] vs 1.1 [1.7]; 2.0, 1.1-3.6, p=0.02) and false-positive (2.3 [2.4] vs 0.9 [1.2]; 2.6, 1.3-5.0, p=0.005) cases. Referral patterns did not differ between low-intensity and PAU practices. Total cost per true-positive referral in the 2 year follow-up was £26,785 in high-intensity practices, £27,840 in low-intensity practices, and £30,007 in PAU practices.InterpretationThis intensive intervention to improve liaison between primary and secondary care for people with early signs of psychosis was clinically and cost effective.FundingUK National Institute for Health Research.

Project description:IntroductionThe virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.Methods and analysisA consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.DiscussionThe results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.Trial registration numberChiCTR1800016101; Pre-results.

Project description:BACKGROUND:Although evidence is accumulating that lifestyle modification may be cost-effective in patients with prediabetes, information is limited on the cost-effectiveness of interventions implemented in public health and primary health care settings. Evidence from well-conducted pragmatic trials is needed to gain insight into the realistic cost-effectiveness of diabetes prevention interventions in real-world settings. The aim of this study is to assess the cost-effectiveness of the SLIMMER lifestyle intervention targeted at patients at high risk of developing type 2 diabetes compared with usual health care in a primary care setting in the Netherlands. METHODS:Three hundred and sixteen high-risk subjects were randomly assigned to the SLIMMER lifestyle intervention or to usual health care. Costs and outcome assessments were performed at the end of the intervention (12?months) and six months thereafter (18?months). Costs were assessed from a societal perspective. Patients completed questionnaires to assess health care utilisation, participant out-of-pocket costs, and productivity losses. Quality Adjusted Life Years (QALY) were calculated based on the SF-36 questionnaire. Cost-effectiveness planes and acceptability curves were generated using bootstrap analyses. RESULTS:The cost-effectiveness analysis showed that the incremental costs of the SLIMMER lifestyle intervention were €547 and that the incremental effect was 0.02 QALY, resulting in an incremental cost-effectiveness ratio (ICER) of €28,094/QALY. When cost-effectiveness was calculated from a health care perspective, the ICER decreased to €13,605/QALY, with a moderate probability of being cost-effective (56% at a willingness to pay, WTP, of €20,000/QALY and 81% at a WTP of €80,000/QALY). CONCLUSIONS:The SLIMMER lifestyle intervention to prevent type 2 diabetes had a low to moderate probability of being cost-effective, depending on the perspective taken. TRIAL REGISTRATION:The SLIMMER study is retrospectively registered with ClinicalTrials.gov (Identifier NCT02094911) since March 19, 2014.

Project description:BackgroundA recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint.MethodThis economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise referral scheme (NERS) delivered by qualified exercise professionals in local leisure centres in Wales, UK. Health-related quality of life, health care services use, costs per participant in NERS, and willingness to pay for NERS were measured at 6 and 12 months.ResultsThe base case analysis assumed a participation cost of £385 per person per year, with a mean difference in QALYs between the two groups of 0.027. The incremental cost-effectiveness ratio was £12,111 per QALY gained. Probabilistic sensitivity analysis demonstrated an 89% probability of NERS being cost-effective at a payer threshold of £30,000 per QALY. When participant payments of £1 and £2 per session were considered, the cost per QALY fell from £12,111 (base case) to £10,926 and £9,741, respectively. Participants with a mental health risk factor alone or in combination with a risk of chronic heart disease generated a lower ICER (£10,276) compared to participants at risk of chronic heart disease only (£13,060).ConclusionsResults of cost-effectiveness analyses suggest that NERS is cost saving in fully adherent participants. Though full adherence to NERS (62%) was higher for the economics sample than the main sample (44%), results still suggest that NERS can be cost-effective in Wales with respect to existing payer thresholds particularly for participants with mental health and CHD risk factors.Trial registrationCurrent Controlled Trials ISRCTN47680448.

Dataset Information

Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC4 E): the ALIC4 E protocol.

Publications

Antivirals for influenza-Like Illness? A randomised Controlled trial of Clinical and Cost effectiveness in primary CarE (ALIC<sup>4</sup> E): the ALIC<sup>4</sup> E protocol.

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