Showing papers by "Rod S Taylor published in 2011"
TL;DR: Exercise-based cardiac rehabilitation is effective in reducing total and cardiovascular mortality and hospital admissions but not total MI or revascularisation (CABG or PTCA); despite inclusion of more recent trials, the population studied in this review is still predominantly male, middle aged and low risk.
Abstract: BackgroundCoronary heart disease (CHD) is the single most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people live with CHD and may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane systematic review previously published in 2011.ObjectivesTo assess the effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with usual care on mortality, morbidity and HRQL in patients with CHD. To explore the potential study level predictors of the effectiveness of exercise-based CR in patients with CHD.Search methodsWe updated searches from the previous Cochrane review, by searching Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 6, 2014) from December 2009 to July 2014. We also searched MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO) and Science Citation Index Expanded (December 2009 to July 2014).Selection criteriaWe included randomised controlled trials (RCTs) of exercise-based interventions with at least six months' follow-up, compared with a no exercise control. The study population comprised men and women of all ages who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or who have angina pectoris, or coronary artery disease. We included RCTs that reported at least one of the following outcomes: mortality, MI, revascularisations, hospitalisations, health-related quality of life (HRQL), or costs.Data collection and analysisTwo review authors independently screened all identified references for inclusion based on the above inclusion and exclusion criteria. One author extracted data from the included trials and assessed their risk of bias; a second review author checked data. We stratified meta-analysis by the duration of follow up of trials, i. e. short-term: 6 to 12 months, medium-term: 13 to 36 months, and long-term: > 3 years.Main resultsThis review included 63 trials which randomised 14,486 people with CHD. This latest update identified 16 new trials (3872 participants). The population included predominantly post-MI and post-revascularisation patients and the mean age of patients within the trials ranged from 47.5 to 71.0 years. Women accounted for fewer than 15% of the patients recruited. Overall trial reporting was poor, although there was evidence of an improvement in quality of reporting in more recent trials.As we found no significant difference in the impact of exercise-based CR on clinical outcomes across follow-up, we focused on reporting findings pooled across all trials at their longest follow-up (median 12 months). Exercise-based CR reduced cardiovascular mortality compared with no exercise control (27 trials; risk ratio (RR) 0.74, 95% CI 0.64 to 0.86). There was no reduction in total mortality with CR (47 trials, RR 0.96, 95% CI 0.88 to 1.04). The overall risk of hospital admissions was reduced with CR (15 trials; RR 0.82, 95% CI 0.70 to 0.96) but there was no significant impact on the risk of MI (36 trials; RR 0.90, 95% CI 0.79 to 1.04), CABG (29 trials; RR 0.96, 95% CI 0.80 to 1.16) or PCI (18 trials; RR 0.85, 95% CI 0.70 to 1.04).There was little evidence of statistical heterogeneity across trials for all event outcomes, and there was evidence of small study bias for MI and hospitalisation, but no other outcome. Predictors of clinical outcomes were examined across the longest follow-up of studies using univariate meta-regression. Results show that benefits in outcomes were independent of participants' CHD case mix (proportion of patients with MI), type of CR (exercise only vs comprehensive rehabilitation) dose of exercise, length of follow-up, trial publication date, setting (centre vs home-based), study location (continent), sample size or risk of bias.Given the heterogeneity in outcome measures and reporting methods, meta-analysis was not undertaken for HRQL. In five out of 20 trials reporting HRQL using validated measures, there was evidence of significant improvement in most or all of the sub-scales with exercise-based CR compared to control at follow-up. Four trial-based economic evaluation studies indicated exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years.The quality of the evidence for outcomes reported in the review was rated using the GRADE method. The quality of the evidence varied widely by outcome and ranged from low to moderate.Authors' conclusionsThis updated Cochrane review supports the conclusions of the previous version of this review that, compared with no exercise control, exercise-based CR reduces the risk of cardiovascular mortality but not total mortality. We saw a significant reduction in the risk of hospitalisation with CR but not in the risk of MI or revascularisation. We identified further evidence supporting improved HRQL with exercise-based CR. More recent trials were more likely to be well reported and include older and female patients. However, the population studied in this review still consists predominantly of lower risk individuals following MI or revascularisation. Further well conducted RCTs are needed to assess the impact of exercise-based CR in higher risk CHD groups and also those presenting with stable angina. These trials should include validated HRQL outcome measures, explicitly report clinical event outcomes including mortality and hospital admissions, and assess costs and cost-effectiveness.
1,092 citations
TL;DR: Psychological treatments appear effective in treating psychological symptoms of CHD patients and Uncertainly remains regarding the subgroups of patients who would benefit most from treatment and the characteristics of successful interventions.
Abstract: Background: Psychological symptoms are strongly associated with coronary heart disease (CHD), and many psychological treatments are offered following cardiac events or procedures.
Objectives: Update the existing Cochrane review to (1) determine the independent effects of psychological interventions in patients with CHD (principal outcome measures included total or cardiac‐related mortality, cardiac morbidity, depression, and anxiety) and (2) explore study‐level predictors of the impact of these interventions.
Search methods: The original review searched Cochrane Controleed Trials Register (CCTR, Issue 4, 2001), MEDLINE, EMBASE, PsycINFO, and CINAHL to December 2001. This was updated by searching the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE, PsycINFO and CINAHL from 2001 to January 2009. In addition, we searched reference lists of papers, and expert advice was sought for the original and update review.
Selection criteria: Randomised controlled trials of psychological interventions compared to usual care, administered by trained staff. Only studies estimating the independent effect of the psychological component with a minimum follow‐up of six months. Adults with specific diagnosis of CHD.
Data collection and analysis: Titles and abstracts of all references screened for eligibility by two reviewers independently; data extracted by the lead author and checked by a second reviewer. Authors contacted where possible to obtain missing information.
Main results: There was no strong evidence that psychological intervention reduced total deaths, risk of revascularisation, or non‐fatal infarction. Amongst a smaller group of studies reporting cardiac mortality there was a modest positive effect of psychological intervention (relative risk: 0.80 (95% CI 0.64 to 1.00)). Furthermore, psychological intervention did result in small/moderate improvements in depression, standardised mean difference (SMD): ‐0.21 (95% CI ‐0.35, ‐0.08) and anxiety, SMD: –0.25 (95% CI ‐0.48 to –0.03). Results for mortality indicated some evidence of small‐study bias, though results for other outcomes did not. Meta regression analyses revealed four significant predictors of intervention effects on depression were found: (1) an aim to treat type‐A behaviours (s = ‐0.32, p = 0.03) were more effective than other interventions. In contrast, interventions which (2) aimed to educate patients about cardiac risk factors (s = 0.23, p = 0.03), (3) included client‐led discussion and emotional support as core therapeutic components (s = 0.31, p < 0.01), or (4) included family members in the treatment process (s = 0.26, p < 0.01) were significantly less effective.
Authors' conclusions: Psychological treatments appear effective in treating psychological symptoms of CHD patients. Uncertainly remains regarding the subgroups of patients who would benefit most from treatment and the characteristics of successful interventions.
317 citations
TL;DR: This work highlights the burden that social isolation may have on the health and well-being of older people and highlights the potential HRQL gains from addressing social isolation, with those at risk of social isolation also a key target group.
Abstract: Purpose
To investigate for socially isolated older people, and older people at risk of social isolation: (1) health status and health-related quality of life (HRQL); (2) the relationship between social isolation and health status/HRQL; (3) the relationship between two alternative measures of health status/HRQL.
307 citations
TL;DR: Pavey et al. as mentioned in this paper used the terms of a commissioning contract issued by the Secretary of State for Health (SSH) to produce a series of articles for the National Archives of Ireland.
Abstract: Copyright @ Queen’s Printer and Controller of HMSO 2011. This work was produced by Pavey et al. under the terms of a commissioning contract issued by the Secretary of State for Health.
304 citations
01 Jan 2011
TL;DR: There remains considerable uncertainty as to the effectiveness of ERS for increasing activity, fitness or health indicators or whether they are an efficient use of resources in sedentary people without a medical diagnosis.
Abstract: Free to read at publisher
- Background
Exercise referral schemes (ERS) aim to identify inactive adults in the primary-care setting. The GP or health-care professional then refers the patient to a third-party service, with this service taking responsibility for prescribing and monitoring an exercise programme tailored to the needs of the individual.
- Objective
To assess the clinical effectiveness and cost-effectiveness of ERS for people with a diagnosed medical condition known to benefit from physical activity (PA). The scope of this report was broadened to consider individuals without a diagnosed condition who are sedentary.
- Data sources
MEDLINE; EMBASE; PsycINFO; The Cochrane Library, ISI Web of Science; SPORTDiscus and ongoing trial registries were searched (from 1990 to October 2009) and included study references were checked.
- Methods
Systematic reviews: the effectiveness of ERS, predictors of ERS uptake and adherence, and the cost-effectiveness of ERS; and the development of a decision-analytic economic model to assess cost-effectiveness of ERS.
- Results
Seven randomised controlled trials (UK, n = 5; non-UK, n = 2) met the effectiveness inclusion criteria, five comparing ERS with usual care, two compared ERS with an alternative PA intervention, and one to an ERS plus a self-determination theory (SDT) intervention. In intention-to-treat analysis, compared with usual care, there was weak evidence of an increase in the number of ERS participants who achieved a self-reported 90-150 minutes of at least moderate-intensity PA per week at 6-12 months' follow-up [pooled relative risk (RR) 1.11, 95% confidence interval 0.99 to 1.25]. There was no consistent evidence of a difference between ERS and usual care in the duration of moderate/vigorous intensity and total PA or other outcomes, for example physical fitness, serum lipids, health-related quality of life (HRQoL). There was no between-group difference in outcomes between ERS and alternative PA interventions or ERS plus a SDT intervention. None of the included trials separately reported outcomes in individuals with medical diagnoses. Fourteen observational studies and five randomised controlled trials provided a numerical assessment of ERS uptake and adherence (UK, n = 16; non-UK, n = 3). Women and older people were more likely to take up ERS but women, when compared with men, were less likely to adhere. The four previous economic evaluations identified suggest ERS to be a cost-effective intervention. Indicative incremental cost per quality-adjusted life-year (QALY) estimates for ERS for various scenarios were based on a de novo model-based economic evaluation. Compared with usual care, the mean incremental cost for ERS was £169 and the mean incremental QALY was 0.008, with the base-case incremental cost-effectiveness ratio at £20,876 per QALY in sedentary people without a medical condition and a cost per QALY of £14,618 in sedentary obese individuals, £12,834 in sedentary hypertensive patients, and £8414 for sedentary individuals with depression. Estimates of cost-effectiveness were highly sensitive to plausible variations in the RR for change in PA and cost of ERS.
- Limitations
We found very limited evidence of the effectiveness of ERS. The estimates of the cost-effectiveness of ERS are based on a simple analytical framework. The economic evaluation reports small differences in costs and effects, and findings highlight the wide range of uncertainty associated with the estimates of effectiveness and the impact of effectiveness on HRQoL. No data were identified as part of the effectiveness review to allow for adjustment of the effect of ERS in different populations.
- Conclusions
There remains considerable uncertainty as to the effectiveness of ERS for increasing activity, fitness or health indicators or whether they are an efficient use of resources in sedentary people without a medical diagnosis. We failed to identify any trial-based evidence of the effectiveness of ERS in those with a medical diagnosis. Future work should include randomised controlled trials assessing the cinical effectiveness and cost-effectivenesss of ERS in disease groups that may benefit from PA.
- Funding
The National Institute for Health Research Health Technology Assessment programme.
287 citations
TL;DR: Identification of factors that are predictive of either reduced HRQoL or increased expenditure is central to the better future targeting and optimization of existing and emerging interventions and management strategies for epilepsy.
Abstract: Summary
Purpose: Given the high burden of epilepsy on both health-related quality of life (HRQoL) and costs, identification of factors that are predictive of either reduced HRQoL or increased expenditure is central to the better future targeting and optimization of existing and emerging interventions and management strategies for epilepsy.
Methods: Searches of Medline, Embase, and Cochrane Library (up to July 2010) to identify studies examining the association between demographic, psychosocial, and condition-related factors and HRQoL, resource utilization or costs in adults with epilepsy. For each study, predictor factor associations were summarized on the basis of statistical significance and direction; the results were then combined across studies.
Key Findings: Ninety-three HRQoL and 16 resource utilization/cost studies were included. Increases in seizure frequency, seizure severity, level of depression, and level of anxiety and presence of comorbidity were strongly associated with reduced HRQoL. The majority of studies were cross-sectional in design and had an overall methodologic quality that was judged to be “moderate” for HRQoL studies and “poor” for health care resource or costs studies. In the 53 multivariate studies, age, gender, marital status, type of seizure, age at diagnosis, and duration of epilepsy did not appear to be associated with HRQoL, whereas the predictive influence of educational and employment status, number of antiepileptic drugs (AEDs) and AED side effects was unclear. The association between predictive factors and HRQoL appeared to be consistent across individuals whether refractory or seizures controlled or managed by AEDs. There were insufficient multivariate studies (five) to reliably comment on the predictors of resource utilization or cost in epilepsy.
Significance: In addition to seizure control, effective epilepsy management requires the early detection of those most at risk of psychological dysfunction and comorbidity, and the targeting of appropriate interventions. There is need for more rigorous studies with appropriate multivariate statistical methods that prospectively investigate the predictors of HRQoL, resource utilization, and costs in epilepsy.
283 citations
TL;DR: Estimates of benefits from dietary salt restriction are consistent with the predicted small effects on clinical events attributable to the small BP reduction achieved, and there is still insufficient power to exclude clinically important effects of reduced dietary salt on mortality or CVD morbidity.
283 citations
TL;DR: In this paper, the authors assess the impact of exercise referral schemes on physical activity and health outcomes and find no difference in outcomes between the two groups compared with the other two comparator groups.
Abstract: Objective To assess the impact of exercise referral schemes on physical activity and health outcomes. Design Systematic review and meta-analysis. Data sources Medline, Embase, PsycINFO, Cochrane Library, ISI Web of Science, SPORTDiscus, and ongoing trial registries up to October 2009. We also checked study references. Study selection Design: randomised controlled trials or non-randomised controlled (cluster or individual) studies published in peer review journals. Population: sedentary individuals with or without medical diagnosis. Exercise referral schemes defined as: clear referrals by primary care professionals to third party service providers to increase physical activity or exercise, physical activity or exercise programmes tailored to individuals, and initial assessment and monitoring throughout programmes. Comparators: usual care, no intervention, or alternative exercise referral schemes. Results Eight randomised controlled trials met the inclusion criteria, comparing exercise referral schemes with usual care (six trials), alternative physical activity intervention (two), and an exercise referral scheme plus a self determination theory intervention (one). Compared with usual care, follow-up data for exercise referral schemes showed an increased number of participants who achieved 90-150 minutes of physical activity of at least moderate intensity per week (pooled relative risk 1.16, 95% confidence intervals 1.03 to 1.30) and a reduced level of depression (pooled standardised mean difference −0.82, −1.28 to −0.35). Evidence of a between group difference in physical activity of moderate or vigorous intensity or in other health outcomes was inconsistent at follow-up. We did not find any difference in outcomes between exercise referral schemes and the other two comparator groups. None of the included trials separately reported outcomes in individuals with specific medical diagnoses. Substantial heterogeneity in the quality and nature of the exercise referral schemes across studies might have contributed to the inconsistency in outcome findings. Conclusions Considerable uncertainty remains as to the effectiveness of exercise referral schemes for increasing physical activity, fitness, or health indicators, or whether they are an efficient use of resources for sedentary people with or without a medical diagnosis.
241 citations
TL;DR: No substantial evidence is provided supporting the use of community mentoring as an effective means of alleviating social isolation in older people and further evidence is needed on the effectiveness of community-based interventions targeting social isolation.
Abstract: Social isolation affects a significant proportion of older people and is associated with poor health outcomes. The current evidence base regarding the effectiveness of interventions targeting social isolation is poor, and the potential utility of mentoring for this purpose has not previously been rigorously evaluated. The purpose of this study was to examine the effectiveness of a community-based mentoring service for improving mental health, social engagement and physical health for socially isolated older people. This prospective controlled trial compared a sample of mentoring service clients (intervention group) with a matched control group recruited through general practice. One hundred and ninety five participants from each group were matched on mental wellbeing and social activity scores. Assessments were conducted at baseline and at six month follow-up. The primary outcome was the Short Form Health Survey v2 (SF-12) mental health component score (MCS). Secondary outcomes included the SF-12 physical health component score (PCS), EuroQol EQ-5D, Geriatric Depression Score (GDS-10), social activity, social support and morbidities. We found no evidence that mentoring was beneficial across a wide range of participant outcomes measuring health status, social activity and depression. No statistically significant between-group differences were observed at follow-up in the primary outcome (p = 0.48) and in most secondary outcomes. Identifying suitable matched pairs of intervention and control group participants proved challenging. The results of this trial provide no substantial evidence supporting the use of community mentoring as an effective means of alleviating social isolation in older people. Further evidence is needed on the effectiveness of community-based interventions targeting social isolation. When using non-randomised designs, there are considerable challenges in the recruitment of suitable matches from a community sample. SCIE Research Register for Social Care 105923
58 citations
TL;DR: In this article, a systematic review of the effectiveness and cost-effectiveness of weight management schemes for the under fives restricting the inclusion criteria to controlled trials with objective measures was conducted.
Abstract: Overweight and obesity in pre-school children are an increasing problem, with poor diet and exercise habits laying the foundation for serious health risks in later life. Yet most research into childhood obesity has focused on school-age children. Two previous systematic reviews of pre-school children have included uncontrolled designs and self-report outcomes potentially biasing the results in favour of the interventions. We have conducted a systematic review of the effectiveness and cost-effectiveness of weight management schemes for the under fives restricting the inclusion criteria to controlled trials with objective measures. We found four effectiveness randomized controlled trials of prevention. No treatment or cost-effectiveness studies were found. Only one study in a Latino community showed a statistically significant advantage from the intervention in a slower rate of increase in body mass index. However, trends in decrease in body mass index and weight loss favoured the intervention groups in other studies. From the studies characteristics we hypothesize that important features to include in future interventions may be; cultural sensitivity, sustained moderate to vigorous exercise, active engagement of the parents in the programme and as role models of healthy living and active engagement of the children in nutrition education. Further randomized controlled trials are needed in this population.
53 citations
TL;DR: The cost-effectiveness of ERS is highly sensitive to small changes in the effectiveness and cost of E RS and is subject to some significant uncertainty mainly due to limitations in the clinical effectiveness evidence base.
Abstract: Exercise referral schemes (ERS) aim to identify inactive adults in the primary care setting. The primary care professional refers the patient to a third party service, with this service taking responsibility for prescribing and monitoring an exercise programme tailored to the needs of the patient. This paper examines the cost-effectiveness of ERS in promoting physical activity compared with usual care in primary care setting. A decision analytic model was developed to estimate the cost-effectiveness of ERS from a UK NHS perspective. The costs and outcomes of ERS were modelled over the patient's lifetime. Data were derived from a systematic review of the literature on the clinical and cost-effectiveness of ERS, and on parameter inputs in the modelling framework. Outcomes were expressed as incremental cost per quality-adjusted life-year (QALY). Deterministic and probabilistic sensitivity analyses investigated the impact of varying ERS cost and effectiveness assumptions. Sub-group analyses explored the cost-effectiveness of ERS in sedentary people with an underlying condition. Compared with usual care, the mean incremental lifetime cost per patient for ERS was £169 and the mean incremental QALY was 0.008, generating a base-case incremental cost-effectiveness ratio (ICER) for ERS at £20,876 per QALY in sedentary individuals without a diagnosed medical condition. There was a 51% probability that ERS was cost-effective at £20,000 per QALY and 88% probability that ERS was cost-effective at £30,000 per QALY. In sub-group analyses, cost per QALY for ERS in sedentary obese individuals was £14,618, and in sedentary hypertensives and sedentary individuals with depression the estimated cost per QALY was £12,834 and £8,414 respectively. Incremental lifetime costs and benefits associated with ERS were small, reflecting the preventative public health context of the intervention, with this resulting in estimates of cost-effectiveness that are sensitive to variations in the relative risk of becoming physically active and cost of ERS. ERS is associated with modest increase in lifetime costs and benefits. The cost-effectiveness of ERS is highly sensitive to small changes in the effectiveness and cost of ERS and is subject to some significant uncertainty mainly due to limitations in the clinical effectiveness evidence base.
TL;DR: In this paper, the authors describe Medically Unexplained Physical Symptoms (MUPS) as common and difficult to treat and discuss the treatment of MUPS in a clinical setting.
Abstract: Background Medically unexplained physical symptoms (MUPS) are common and difficult to treat.
TL;DR: Topical diclofenac appears to be generally well tolerated for cutaneous use in acute and chronic musculoskeletal conditions and is rated as ‘good’ to ‘excellent’ by >90% physicians and patients.
Abstract: Background:Topical non-steroidal anti-inflammatory drugs (NSAIDs) are clinically proven for the management of musculoskeletal conditions. It is important that prescribers and patients are aware of the safety profile of topical NSAIDs.Objectives:To evaluate the risk of adverse events (AEs) associated with topical diclofenac for the treatment of acute and chronic musculoskeletal conditions.Design:Systematic review and meta-analysis of blinded, randomized, placebo-, vehicle- or active-controlled trials.Results:The risk of any type of AE experienced with topical diclofenac was slightly higher compared with placebo/vehicle (RR 1.11), but was more than 50% lower than the risk observed with active topical comparators (RR 0.53). Absolute risk values indicated differences in the risk of AEs depending on the diclofenac formulation used; in particular, lower rates of local skin reactions were observed with diclofenac patches (e.g. 2.5% in placebo/vehicle-controlled studies) and gels (4.2%) compared with dicl...
TL;DR: A meta-analysis showed that TCF gel was statistically significantly more effective than other topical treatments in terms of achieving a response defined according to both IGA and TSS criteria.
Abstract: Objectives:To evaluate the two-compound formulation (TCF) calcipotriol and betamethasone dipropionate (BDP) gel versus other topical therapies for scalp psoriasis in adults using direct and indirect comparisons.Methods:A systematic review identified 10 randomised controlled trials (RCTs) of topical treatments used in clinical practice for moderately severe scalp psoriasis. A meta-analysis was undertaken to obtain estimates of clinical effectiveness using recommended efficacy and safety outcome measures. We determined the proportion of responding patients using two definitions: i) ‘controlled disease’ using the Investigator Global Assessment (IGA) rating scale and ii) a score of 0 or 1 on the Total Sign Score (TSS). Tolerability was extracted in terms of percentages of patients experiencing all adverse events (AEs), skin AEs and withdrawals due to AEs. Direct comparisons were performed where head-to-head data were available. For other comparators where TCF gel was compared indirectly, ‘pairs’ of tr...
TL;DR: The evidence points to a relatively small effect difference which was stable but not sufficient in terms of the suggested thresholds, andsufficiency and stability measures are useful tools that need to be tested in further case studies.
Abstract: Most systematic reviews conclude that another clinical trial is needed. Measures of sufficiency and stability may indicate whether this is true. Objectives: To show how evidence accumulated on centre-based versus home-based cardiac rehabilitation, including estimates of sufficiency and stability Systematic reviews of clinical trials of home versus centre-based cardiac rehabilitation were used to develop a cumulative meta-analysis over time. We calculated the standardised mean difference (SMD) in effect, confidence intervals and indicators of sufficiency and stability. Sufficiency refers to whether the meta-analytic database adequately demonstrates that an intervention works - is statistically superior to another. It does this by assessing the number of studies with null results that would be required to make the meta-analytic effect non-statistically significant. Stability refers to whether the direction and size of the effect is stable as new studies are added to the meta-analysis. The standardised mean effect difference reduced over fourteen comparisons from a non-significant difference favouring home-based cardiac rehabilitation to a very small difference favouring hospital (SMD -0.10, 95% CI -0.32 to 0.13). This difference did not reach the sufficiency threshold (failsafe ratio 0.039 < 1) but did achieve the criteria for stability (cumulative slope 0.003 < 0.005). The evidence points to a relatively small effect difference which was stable but not sufficient in terms of the suggested thresholds. Sufficiency should arguably be based on substantive significance and decided by patients. Research on patient preferences should be the priority. Sufficiency and stability measures are useful tools that need to be tested in further case studies.
TL;DR: Human physiology answers to a far higher authority than WHO, WASH, or the Salt Institute and at each step an analysis should be done to check for unintended consequences.
21 Sep 2011
TL;DR: By retracing the history of particular surrogate outcome failures, Moynihan dismisses the assessment of surrogate outcomes in future clinical trials and instead recommends collecting only final outcomes such as survival.
Abstract: By retracing the history of particular surrogate outcome failures,1 Moynihan dismisses the assessment of surrogate outcomes in future clinical trials and instead recommends collecting only final outcomes such as survival.2 We agree that, when possible, decisions on the adoption and coverage of health technologies …
TL;DR: The suggested solution is to provide specialist care similar to that given to people after heart attacks, citing that such specialised units ‘could do for heart failure’.
Abstract: To the Editor The full National Heart Failure Audit report1 and a recent editorial in the Lancet endorse the report's conclusion that it ‘provides a powerful incentive to reorganise heart failure care in the UK’.1 2 The suggested solution is to provide specialist care similar to that given to people after heart attacks citing that such specialised units ‘could do for heart failure …
TL;DR: This study compares the treatment outcome of trials that use a surrogate versus a final patient-relevant primary outcome in well-conducted clinical trials.
Abstract: Background Ideally, decisions on the value of health technologies should be based on evidence from well-conducted clinical trials that assess clinically important final patientrelevant outcomes, such as mortality or impaired quality of life. Pressure to reduce the delay in the availability of technologies to patients has led to an increased reliance on the use of surrogate outcomes [1]. A key tenant of surrogate outcomes is unbiased quantification of the predictive treatment effect on the final patient-relevant clinical outcomes. This study compares the treatment outcome of trials that use a surrogate versus a final patient-relevant primary outcome.
TL;DR: The CACTUS Study is a randomised pragmatic trial with a nested qualitative study comparing traditional acupuncture with usual care in people who consult frequently with medically unexplained symptoms.
Abstract: The CACTUS Study is a randomised pragmatic trial with a nested qualitative study comparing traditional acupuncture with usual care in people who consult frequently with medically unexplained symptoms.1 2 Margaret McCartney has based her Observations article about it on several inaccuracies (quotations from her article in italics below).3
(1) The “wellbeing score” was better in the control group than in the acupuncture group . This statement is untrue: an adjusted mean difference in favour of acupuncture was seen with wellbeing (wellbeing questionnaire, W-BQ12: 4.4 (1.6 to 7.2); P=0.002). This difference remained significant after missing values were imputed (3.4 (0.5 to 6.3); P=0.02).
(2) The graphical …