scholarly journals Medisinsk kunnskap før og nå:Fra teori til systematiske oversikter

2013 ◽  
Vol 23 (2) ◽  
Author(s):  
Atle Fretheim
Keyword(s):  
Health Services ◽  
Medical Research ◽  
Systematic Reviews ◽  
Controlled Trial ◽  
Current Evidence ◽  
Randomised Trials ◽  
Starting Point ◽  
Effectiveness And Efficiency ◽  
Randomised Controlled ◽  
Random Reflections

<p>Teorien om balansen mellom de fire kroppsvæskene – humoralpatologien – dominerte sykdomsforståelse og dermed også medisinsk behandling i 2000 år. Brekkmidler, årelating og avføringsmidler var hyppig brukte virkemidler for å rette opp i ”ubalanse” mellom kroppsvæskene, som var regnet som årsak til sykdom.</p><p>Det var ikke før på 1700-tallet at faktisk empirisk kunnskap ble etterspurt som begrunnelse for valg av behandlingsmetoder. Det å telle opp hvordan det gikk med pasienter som fikk en behandling, og sammenlikne med pasienter som ikke fikk behandlingen, var en ny måte å presentere behandlingseffekter på. Fra 1800-tallet av er det mange eksempler på at behandlingsmetoder ble prøvet ut ved å la annenhver pasient motta behandlingen.</p><p>Streptomycinstudien til UK Medical Research Council (1946) regnes for å være det første randomiserte kontrollerte forsøket innen medisinsk forskning, og for å ha satt standarden for hvordan kliniske utprøvninger bør utføres.</p><p>I boka ”Effectiveness and Efficiency. Random Reflections on Health Services” (1972) kritiserte Archie Cochrane mangelen på dokumentasjon for mange av tiltakene som utføres i helsetjenesten. Han ønsket seg langt flere randomiserte studier. Dessuten tok han til orde for at alle randomiserte studier burde samles, og at resultatene burde oppsummeres jevnlig. Iain Chalmers tok utfordringen og påbegynte et omfattende arbeid med å utarbeide en database over randomiserte kontrollerte forsøk. Med utgangspunkt i denne databasen ble det så utarbeidet systematiske oversikter over gjeldende kunnskap om effekt av tiltak i helsetjenesten. Dette ble starten på Cochrane-samarbeidet.</p><p>Fretheim A. <strong>Medical knowledge then and now: From theory to systematic reviews.</strong> <em>Nor J Epidemiol</em> 2013; <strong>23</strong> (2): 113-118.</p><p><strong>ENGLISH SUMMARY</strong></p><p>The humoral medicine-theory dominated the understanding of diseases and thus also medical treatments over 2,000 years. Purgatives, bloodletting and laxatives were frequently used to correct ”imbalances” between body fluids, which were seen as the cause of disease.</p><p>It was not until the 18th century that actual empirical knowledge was seen as important as a basis for making decisions about choice of treatment. At this time, the idea of counting the outcomes among patients receiving a treatment and compare with patients who did not, was a new approach for presenting treatment effects. As of the 19th century there are many examples of treatments being tested by the use of alternation, i.e. allocating every other patient to the treatment under evaluation.</p><p>The UK Medical Research Council’s streptomycin-trial (1946) is regarded as the first randomised controlled trial in medicine, and for having set the standard for clinical trials.</p><p>In his book, ”Effectiveness and Efficiency. Random Reflections on Health Services” (1972), Archie Cochrane criticised the lack of evidence for many of the interventions being performed in the health services. He called for far more randomised trials. He also proposed that findings from randomised trials should be collated, and that the results should be summarised on a regular basis. Iain Chalmers took the challenge and engaged in the huge task of developing a database of randomised controlled trials. With the database as a starting point, several systematic reviews of current evidence on the effects of interventions in the health services were produced. This was the start of the Cochrane Collaboration.</p>

scholarly journals How important is the relative balance of fat and carbohydrate as sources of energy in relation to health?

2015 ◽  
Vol 75 (2) ◽  
pp. 147-153 ◽  
Author(s):  
Thomas A. B. Sanders
Keyword(s):  
Controlled Trial ◽  
Dietary Guidelines ◽  
Partial Replacement ◽  
Current Evidence ◽  
Added Sugar ◽  
Increased Risk ◽  
Total Fat ◽  
Randomised Controlled ◽  
Refined Carbohydrates ◽  
The Impact

Both the intake of fat, especially saturated trans fatty acids, and refined carbohydrates, particularly sugar, have been linked to increased risk of obesity, diabetes and CVD. Dietary guidelines are generally similar throughout the world, restrict both intake of SFA and added sugar to no more than 10 and 35 % energy for total fat and recommend 50 % energy from carbohydrates being derived from unrefined cereals, tubers, fruit and vegetables. Current evidence favours partial replacement of SFA with PUFA with regard to risk of CVD. The translation of these macronutrient targets into food-based dietary guidelines is more complex because some high-fat foods play an important part in meeting nutrient requirements as well as influencing the risk of chronic disease. Some of the recent controversies surrounding the significance of sugar and the type of fat in the diet are discussed. Finally, data from a recently published randomised controlled trial are presented to show the impact of following current dietary guidelines on cardiovascular risk and nutrient intake compared with a traditional UK diet.

scholarly journals Incentives in Diabetic Eye Assessment by Screening (IDEAS) trial: a three-armed randomised controlled trial of financial incentives

2017 ◽  
Vol 5 (15) ◽  
pp. 1-60 ◽  
Author(s):  
Gaby Judah ◽  
Ara Darzi ◽  
Ivo Vlaev ◽  
Laura Gunn ◽  
Derek King ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health Services ◽  
Financial Incentives ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Fixed Group ◽  
Screening Uptake ◽  
Invitation Letter ◽  
Screening Attendance ◽  
Randomised Controlled

BackgroundThe UK national diabetic eye screening (DES) programme invites diabetic patients aged > 12 years annually. Simple and cost-effective methods are needed to increase screening uptake. This trial tests the impact on uptake of two financial incentive schemes, based on behavioural economic principles.ObjectivesTo test whether or not financial incentives encourage screening attendance. Secondarily to understand if the type of financial incentive scheme used affects screening uptake or attracts patients with a different sociodemographic status to regular attenders. If financial incentives were found to improve attendance, then a final objective was to test cost-effectiveness.DesignThree-armed randomised controlled trial.SettingDES clinic within St Mary’s Hospital, London, covering patients from the areas of Kensington, Chelsea and Westminster.ParticipantsPatients aged ≥ 16 years, who had not attended their DES appointment for ≥ 2 years.Interventions(1) Fixed incentive – invitation letter and £10 for attending screening; (2) probabilistic (lottery) incentive – invitation letter and 1% chance of winning £1000 for attending screening; and (3) control – invitation letter only.Main outcome measuresThe primary outcome was screening attendance. Rates for control versus fixed and lottery incentive groups were compared using relative risk (RR) and risk difference with corresponding 95% confidence intervals (CIs).ResultsA total of 1274 patients were eligible and randomised; 223 patients became ineligible before invite and 1051 participants were invited (control,n = 435; fixed group,n = 312; lottery group,n = 304). Thirty-four (7.8%, 95% CI 5.29% to 10.34%) control, 17 (5.5%, 95% CI 2.93% to 7.97%) fixed group and 10 (3.3%, 95% CI 1.28% to 5.29%) lottery group participants attended. Participants offered incentives were 44% less likely to attend screening than controls (RR 0.56, 95% CI 0.34 to 0.92). Examining incentive groups separately, the lottery group were 58% less likely to attend screening than controls (RR 0.42, 95% CI 0.18 to 0.98). No significant differences were found between fixed incentive and control groups (RR 0.70, 95% CI 0.35 to 1.39) or between fixed and lottery incentive groups (RR 1.66, 95% CI 0.65 to 4.21). Subgroup analyses showed no significant associations between attendance and sociodemographic factors, including gender (female vs. male, RR 1.25, 95% CI 0.77 to 2.03), age (≤ 65 years vs. > 65 years, RR 1.26, 95% CI 0.77 to 2.08), deprivation [0–20 Index of Multiple Deprivation (IMD) decile vs. 30–100 IMD decile, RR 1.12, 95% CI 0.69 to 1.83], years registered [mean difference (MD) –0.13, 95% CI –0.69 to 0.43], and distance from screening location (MD –0.18, 95% CI –0.65 to 0.29).LimitationsDespite verification, some address details may have been outdated, and high ethnic diversity may have resulted in language barriers for participants.ConclusionsThose receiving incentives were not more likely to attend a DES than those receiving a usual invitation letter in patients who are regular non-attenders. Both fixed and lottery incentives appeared to reduce attendance. Overall, there is no evidence to support the use of financial incentives to promote diabetic retinopathy screening. Testing interventions in context, even if they appear to be supported by theory, is important.Future workFuture research, specifically in this area, should focus on identifying barriers to screening and other non-financial methods to overcome them.Trial registrationCurrent Controlled Trials ISRCTN14896403.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 5, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Effectiveness and cost-effectiveness of a progressive, individualised walking and education programme for prevention of low back pain recurrence in adults: study protocol for the WalkBack randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037149
Author(s):  
Natasha Celeste Pocovi ◽  
Chung-Wei C Lin ◽  
Jane Latimer ◽  
Dafna Merom ◽  
Anne Tiedemann ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Education Programme ◽  
Current Evidence ◽  
Low Back ◽  
Treatment Control ◽  
Randomised Controlled

IntroductionLow back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).Methods and analysisA pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.Ethics and disseminationApproved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberACTRN12619001134112.

scholarly journals Randomised controlled trial of effect of Baby Check on use of health services in first 6 months of life

BMJ ◽  
1999 ◽  
Vol 318 (7200) ◽  
pp. 1740-1744 ◽  
Author(s):  
H. Thomson ◽  
S. Ross ◽  
P. Wilson ◽  
A. McConnachie ◽  
R. Watson
Keyword(s):  
Randomised Controlled Trial ◽  
Health Services ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
Use Of Health Services

scholarly journals Community treatment orders: Current evidence and the implications

2013 ◽  
Vol 203 (6) ◽  
pp. 406-408 ◽  
Author(s):  
Jorun Rugkåsa ◽  
John Dawson
Keyword(s):  
Controlled Trial ◽  
Revolving Door ◽  
Community Treatment ◽  
Current Evidence ◽  
Case Control Studies ◽  
Community Treatment Orders ◽  
Evaluation Trial ◽  
Randomised Controlled ◽  
Treatment Order ◽  
Community Treatment Order

SummaryCommunity treatment orders (CTOs) have been widely introduced to address the problems faced by ‘revolving door’ patients. A number of case–control studies have been conducted but show conflicting results concerning the effectiveness of CTOs. The Oxford Community Treatment Order Evaluation Trial (OCTET) is the third randomised controlled trial (RCT) to show that CTOs do not reduce rates of readmission over 12 months, despite restricting patients' autonomy. This evidence gives pause for thought about current CTO practice. Further high-quality RCTs may settle the contentious debate about effectiveness.

scholarly journals When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015815 ◽  
Author(s):  
J Jull ◽  
M Whitehead ◽  
M Petticrew ◽  
E Kristjansson ◽  
D Gough ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Health Equity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Evidence Base ◽  
Social Disadvantage ◽  
Randomised Trials ◽  
Individual Level ◽  
International Research Team ◽  
Randomised Controlled

BackgroundRandomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.MethodsAn interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.ResultsA randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies.ConclusionThe conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

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