Search

BackgroundGuidelines recommend measuring blood pressure (BP) in both arms, adopting the higher arm readings for diagnosis and management. Data to support this recommendation are lacking. We evaluated associations of higher and lower arm systolic BPs with diagnostic and treatment thresholds, and prognosis in hypertension, using data from the Inter-arm Blood Pressure Difference-Individual Participant Data Collaboration.MethodsOne-stage multivariable Cox regression models, stratified by study, were used to examine associations of higher or lower reading arm BPs with cardiovascular mortality, all-cause mortality, and cardiovascular events, in individual participant data meta-analyses pooled from 23 cohorts. Cardiovascular events were modelled for Framingham and atherosclerotic cardiovascular disease risk scores. Model fit was compared throughout using Akaike information criteria. Proportions reclassified across guideline recommended intervention thresholds were also compared.ResultsWe analyzed 53 172 participants: mean age 60 years; 48% female. Higher arm BP, compared with lower arm, reclassified 12% of participants at either 130 or 140 mm Hg systolic BP thresholds (both P

Systolic interarm differences in blood pressure have been associated with all-cause mortality and cardiovascular disease. We undertook individual participant data meta-analyses to (1) quantify independent associations of systolic interarm difference with mortality and cardiovascular events; (2) develop and validate prognostic models incorporating interarm difference, and (3) determine whether interarm difference remains associated with risk after adjustment for common cardiovascular risk scores. We searched for studies recording bilateral blood pressure and outcomes, established agreements with collaborating authors, and created a single international dataset: the Inter-arm Blood Pressure Difference - Individual Participant Data (INTERPRESS-IPD) Collaboration. Data were merged from 24 studies (53 827 participants). Systolic interarm difference was associated with all-cause and cardiovascular mortality: continuous hazard ratios 1.05 (95% CI, 1.02-1.08) and 1.06 (95% CI, 1.02-1.11), respectively, per 5 mm Hg systolic interarm difference. Hazard ratios for all-cause mortality increased with interarm difference magnitude from a ≥5 mm Hg threshold (hazard ratio, 1.07 [95% CI, 1.01-1.14]). Systolic interarm differences per 5 mm Hg were associated with cardiovascular events in people without preexisting disease, after adjustment for Atherosclerotic Cardiovascular Disease (hazard ratio, 1.04 [95% CI, 1.00-1.08]), Framingham (hazard ratio, 1.04 [95% CI, 1.01-1.08]), or QRISK cardiovascular disease risk algorithm version 2 (QRISK2) (hazard ratio, 1.12 [95% CI, 1.06-1.18]) cardiovascular risk scores. Our findings confirm that systolic interarm difference is associated with increased all-cause mortality, cardiovascular mortality, and cardiovascular events. Blood pressure should be measured in both arms during cardiovascular assessment. A systolic interarm difference of 10 mm Hg is proposed as the upper limit of normal. Registration: URL: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42015031227.

AimsTo undertake an individual patient data (IPD) meta-analysis to assess the impact of exercise-based cardiac rehabilitation (ExCR) in patients with heart failure (HF) on mortality and hospitalisation, and differential effects of ExCR according to patient characteristics: age, sex, ethnicity, New York Heart Association functional class, ischaemic aetiology, ejection fraction, and exercise capacity.Methods and resultsRandomised trials of exercise training for at least 3 weeks compared with no exercise control with 6-month follow-up or longer, providing IPD time to event on mortality or hospitalisation (all-cause or HF-specific). IPD were combined into a single dataset. We used Cox proportional hazards models to investigate the effect of ExCR and the interactions between ExCR and participant characteristics. We used both two-stage random effects and one-stage fixed effect models. IPD were obtained from 18 trials including 3912 patients with HF with reduced ejection fraction. Compared to control, there was no statistically significant difference in pooled time to event estimates in favour of ExCR although confidence intervals (CIs) were wide [all-cause mortality: hazard ratio (HR) 0.83, 95% CI 0.67-1.04; HF-specific mortality: HR 0.84, 95% CI 0.49-1.46; all-cause hospitalisation: HR 0.90, 95% CI 0.76-1.06; and HF-specific hospitalisation: HR 0.98, 95% CI 0.72-1.35]. No strong evidence was found of differential intervention effects across patient characteristics.ConclusionExercise-based cardiac rehabilitation did not have a significant effect on the risk of mortality and hospitalisation in HF with reduced ejection fraction. However, uncertainty around effect estimates precludes drawing definitive conclusions.

Evidence suggests that digitally delivered cardiac rehabilitation (CR) is likely to be an effective alternative to centre-based CR. However, there is limited understanding of the behaviour change techniques (BCTs) and intervention characteristics included in digital CR programmes. This systematic review aimed to identify the BCTs and intervention characteristics that have been used in digital CR programmes, and to study those associated with effective programmes. Twenty-five randomised controlled trials were included in the review. Digital CR was associated with significant improvements in daily steps, light physical activity, medication adherence, functional capacity, and low-density lipoprotein-cholesterol when compared to usual care, and produced effects on these outcomes comparable to centre-based CR. The evidence for improved quality of life was mixed. Interventions that were effective at improving behavioural outcomes frequently employed BCTs relating to feedback and monitoring, goals and planning, natural consequences, and social support. Completeness of reporting on the TIDieR checklist across studies ranged from 42% to 92%, with intervention material descriptions being the most poorly reported item. Digital CR appears effective at improving outcomes for patients with cardiovascular disease. The integration of certain BCTs and intervention characteristics may lead to more effective interventions, however better intervention reporting is required. [ABSTRACT FROM AUTHOR]

Background: Different waveforms of spinal cord stimulation (SCS) have now been evaluated for the management of painful diabetic neuropathy (PDN). However, no direct or indirect comparison between SCS waveforms has been performed to date.Purpose: To conduct a systematic review and network meta-analysis to evaluate the effectiveness of SCS for PDN.Data Sources: MEDLINE, CENTRAL, Embase, and WikiStim were searched from inception until December 2021.Study Selection: Randomized controlled trials (RCTs) of SCS for PDN were included.Data Extraction: Pain intensity, proportion of patients achieving at least a 50% reduction in pain intensity, and health-related quality of life (HRQoL) data were extracted.Data Synthesis: Significant reductions in pain intensity were observed for low-frequency SCS (LF-SCS) (mean difference [MD] -3.13 [95% CI -4.19 to -2.08], moderate certainty) and high-frequency SCS (HF-SCS) (MD -5.20 [95% CI -5.77 to -4.63], moderate certainty) compared with conventional medical management (CMM) alone. There was a significantly greater reduction in pain intensity on HF-SCS compared with LF-SCS (MD -2.07 [95% CI -3.26 to -0.87], moderate certainty). Significant differences were observed for LF-SCS and HF-SCS compared with CMM for the outcomes proportion of patients with at least 50% pain reduction and HRQoL (very low to moderate certainty). No significant differences were observed between LF-SCS and HF-SCS (very low to moderate certainty).Limitations: Limited number of RCTs and no head-to-head RCTs conducted.Conclusions: Our findings confirm the pain relief and HRQoL benefits of the addition of SCS to CMM for patients with PDN. However, in the absence of head-to-head RCT evidence, the relative benefits of HF-SCS compared with LF-SCS for patients with PDN remain uncertain. [ABSTRACT FROM AUTHOR]

Spinal cord stimulation (SCS) is increasingly used to treat painful diabetic neuropathy (PDN). At the time of a recent meta-analysis in this field, data were only available from randomized controlled trials (RCTs) of traditional low-frequency SCS (LF-SCS). However, outcomes from high-frequency 10 kHz SCS treatment are now available. Our study aimed to systematically review the contemporary evidence for SCS in patients with lower limb pain due to PDN and include an indirect comparison of the high- and low-frequency modalities. We searched the PubMed/CENTRAL databases up to 18 August 2022, for peer-reviewed RCTs of SCS that enrolled PDN patients with lower limb pain symptoms. The quality of the evidence was assessed with the Cochrane Risk of Bias tool. Using SCS treatment arm data from the RCTs, we indirectly compared the absolute treatment effect of 10 kHz SCS and LF-SCS. Results are presented in tables and forest plots. This systematic review was reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines. Three RCTs met our eligibility criteria, including the recent 10 kHz SCS RCT (N = 216, 90 implanted) and 2 others that examined LF-SCS (N = 36, 17 implanted; N = 60, 37 implanted). Our analysis of 6-month data found clinically meaningful pain relief with each SCS modality. However, significantly greater pain reduction was identified for 10 kHz SCS over LF-SCS: average pain reduction in the 10 kHz SCS cohort was 73.7% compared with 47.5% in the pooled LF-SCS group (p < 0.0001). In the permanent implant subset, the 50% pain reduction responder rate was 83.3% in the 10 kHz SCS cohort versus 63.0% in the pooled LF-SCS group (p = 0.0072). The overall risk of bias of each included RCT was deemed high, mainly due to the absence of patient blinding. Our analysis indicates that paresthesia-free 10 kHz SCS can provide superior pain relief and responder rate over LF-SCS for managing PDN patients refractory to conventional medical management. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Advanced Nursing (John Wiley & Sons, Inc.) is the property of John Wiley & Sons, Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background The projected reduced mortality effect of reduced sodium intake in model-based studies conflicts with the observed increased mortality associated with low sodium intake in population studies. This may reflect an overestimation of the dose-response relation between sodium reduction (SR) and blood pressure (BP) used in mortality modeling studies. Objectives The present meta-regression analysis sought to estimate the dose-response relations between SR and BP in study groups with mean BP above or below the 75th percentile of the general population. Methods Based on a literature search from 1 January 1946 to 11 April 2018, we identified 133 randomized controlled trials allocating healthy or hypertensive individuals to SR or usual sodium intake. Multivariable regression analyses of the mean SR versus the mean blood pressure effect adjusted for effect modifiers were performed. Results In study groups with mean BP above the 75th percentile [131/78 mm Hg systolic BP (SBP)/diastolic BP (DBP)], there was strong evidence of a linear dose-response relation between SR and BP. For SBP, the dose-response relation was −7.7 mm Hg/100 mmol SR (95% CI: −10.4, −5.0), and for DBP it was −3.0 mm Hg/100 mmol SR (95% CI: −4.6, −1.4). In study groups with mean BP ≤ 131/78 mm Hg, the relation between SR and BP was weak. For SBP it was −1.46 mm Hg/100 mmol SR (95% CI: −2.7, −0.20) and for DBP it was: −0.07 mm Hg/100 mmol SR (95% CI: −1.5, 1.4). Conclusions Only study groups with a BP in the highest 25th percentile of the population showed a clinically significant drop in BP with SR. The policy of lowering dietary sodium intake in the general population may need to be reframed to target patients with hypertension. This study was registered at PROSPERO 2015 as CRD42015017773. [ABSTRACT FROM AUTHOR]

Background: Previous systematic reviews have indicated that exercise-based cardiac rehabilitation (ExCR) for patients with heart failure (HF) has a beneficial effect on health-related quality-of-life (HRQoL) and exercise capacity. However, there is uncertainty regarding potential differential effects of ExCR across HF patient subgroups.Objectives: The authors sought to undertake an individual participant data (IPD) meta-analysis to: 1) assess the impact of ExCR on HRQoL and exercise capacity in patients with HF; and 2) investigate differential effects of ExCR according to a range of patient characteristics: age, sex, ethnicity, New York Heart Association functional class, ischemic etiology, ejection fraction, and exercise capacity.Methods: A single dataset was produced, comprising randomized trials where ExCR (delivered for 3 weeks or more) was compared with a no exercise control group. Each trial provided IPD on HRQoL or exercise capacity (or both), with follow-up of 6 months or more. One- and 2-stage meta-analysis models were used to investigate the effect of ExCR overall and the interactions between ExCR and participant characteristics.Results: IPD was obtained from 13 trials for 3,990 patients, predominantly (97%) with reduced ejection fraction HF. Compared with the control group, there was a statistically significant difference in favor of ExCR for HRQoL and exercise capacity. At 12-month follow-up, improvements were seen in 6-min walk test (mean 21.0 m; 95% confidence interval: 1.57 to 40.4 m; p = 0.034) and Minnesota Living With HF score (mean improvement 5.9; 95% confidence interval: 1.0 to 10.9; p = 0.018). No consistent evidence was found of differential intervention effects across patient subgroups.Conclusions: These results, based on an IPD meta-analysis of randomized trials, confirm the benefit of ExCR on HRQoL and exercise capacity and support the Class I recommendation of current international clinical guidelines that ExCR should be offered to all HF patients. (Exercise Training for Chronic Heart Failure [ExTraMATCH II]: protocol for an individual participant data meta-analysis; PROSPERO: international database of systematic reviews CRD42014007170). [ABSTRACT FROM AUTHOR]

Purpose: Alternative modes of cardiopulmonary exercise testing are needed and an arm cycle (AC) is a promising alternative to the gold standard of the leg cycle (LC). The aim of this study was to undertake a systematic review comparing maximal oxygen consumption (VO2max) obtained from AC and LC in patient populations with cardiovascular disease (CVD) and pulmonary disease (PD). Methods: A systematic review was undertaken with literature searches on December 5, 2016. Studies were included if they directly compared aerobic capacity values obtained from AC and LC in patients with CVD or PD. Results across studies were pooled using random effects meta-analysis and univariate meta-regression were used to assess potential associations between variables. Results: A total of 14 studies in 411 patients were included. On average, VO2max of LC exceeded AC mean difference by 3.48 mL·kg-1·min-1, (95% confidence interval [CI]: 1.94, 5.03) and a mean AC/LC ratio of 0.83, (95%CI: 0.77, 0.90). VO2max differences between AC and LC were similar in patients with CVD compared with PD but were found to be higher in older individuals and those with higher VO2max. Conclusions: Although AC offers an important alternative form of exercise testing for patients with CVD or PD, clinicians must take into account that VO2max values obtained from AC are consistently lower than those obtained on LC. However, the results of this article offer an evidence-based estimation for the proportional differences between AC values and LC values for groups with CVD or groups with PD. [ABSTRACT FROM AUTHOR]

Objective: To undertake a systematic review and meta-analysis to assess the impact of cardiac rehabilitation (CR) on physical activity (PA) levels of patients with heart disease and the methodological quality of these studies.Methods: Databases (MEDLINE, EMBASE, CENTRAL, CINAHL, PsychINFO and SportDiscus) were searched without language restriction from inception to January 2017 for randomised controlled trials (RCTs) comparing CR to usual care control in adults with heart failure (HF) or coronary heart disease (CHD) and measuring PA subjectively or objectively. The direction of PA difference between CR and control was summarised using vote counting (ie, counting the positive, negative and non-significant results) and meta-analysis.Results: Forty RCTs, (6480 patients: 5825 CHD, 655 HF) were included with 26% (38/145) PA results showing a statistically significant improvement in PA levels with CR compared with control. This pattern of results appeared consistent regardless of type of CR intervention (comprehensive vs exercise-only) or PA measurement (objective vs subjective). Meta-analysis showed PA increases in the metrics of steps/day (1423, 95% CI 757.07 to 2089.43, p<0.0001) and proportion of patients categorised as physically active (relative risk 1.55, 95% CI 1.19 to 2.02, p=0.001). The included trials were at high risk of bias, and the quality of the PA assessment and reporting was relatively poor.Conclusion: Overall, there is moderate evidence of an increase in PA with CR participation compared with control. High-quality trials are required, with robust PA measurement and data analysis methods, to assess if CR definitely leads to important improvements in PA. [ABSTRACT FROM AUTHOR]

Introduction: The cardiopulmonary exercise test (CPET) assesses maximal oxygen uptake (VO2max) and is commonly performed on a leg cycle ergometer (LC). However, some individuals would rather perform the CPET on an arm cycle ergometer (AC). Objective: The objectives of this study were to undertake a systematic review and meta-analysis of the difference in VO2max achieved by AC compared to LC in healthy adults and to explore factors that may be predictive of this difference. Methods: MEDLINE, EMBASE, CINAHL, and PEDro were searched in April 2015. The differences in VO2max (ACLCdiff) were pooled across studies using random effects meta-analysis and three different methods were used to estimate the ratio between the values obtained from the tests (ACLCratio). Results: This paper included 41 studies with a total of 581 participants. The mean ACLCdiff across studies was 12.5 ml/kg/min and 0.89 1/min with a mean ACLCratio of 0.70. The ACLCdiff was lower in studies with higher mean age and lower aerobic capacity. Conclusion: There is linear association between the AC and LC values in healthy adults. The AC values were on average 70% of the LC values. The magnitude of this difference appeared to be reduced in studies on older and less active populations. [ABSTRACT FROM AUTHOR]

Importance: Relapse prevention in recurrent depression is a significant public health problem, and antidepressants are the current first-line treatment approach. Identifying an equally efficacious nonpharmacological intervention would be an important development.Objective: To conduct a meta-analysis on individual patient data to examine the efficacy of mindfulness-based cognitive therapy (MBCT) compared with usual care and other active treatments, including antidepressants, in treating those with recurrent depression.Data Sources: English-language studies published or accepted for publication in peer-reviewed journals identified from EMBASE, PubMed/Medline, PsycINFO, Web of Science, Scopus, and the Cochrane Controlled Trials Register from the first available year to November 22, 2014. Searches were conducted from November 2010 to November 2014.Study Selection: Randomized trials of manualized MBCT for relapse prevention in recurrent depression in full or partial remission that compared MBCT with at least 1 non-MBCT treatment, including usual care.Data Extraction and Synthesis: This was an update to a previous meta-analysis. We screened 2555 new records after removing duplicates. Abstracts were screened for full-text extraction (S.S.) and checked by another researcher (T.D.). There were no disagreements. Of the original 2555 studies, 766 were evaluated against full study inclusion criteria, and we acquired full text for 8. Of these, 4 studies were excluded, and the remaining 4 were combined with the 6 studies identified from the previous meta-analysis, yielding 10 studies for qualitative synthesis. Full patient data were not available for 1 of these studies, resulting in 9 studies with individual patient data, which were included in the quantitative synthesis.Results: Of the 1258 patients included, the mean (SD) age was 47.1 (11.9) years, and 944 (75.0%) were female. A 2-stage random effects approach showed that patients receiving MBCT had a reduced risk of depressive relapse within a 60-week follow-up period compared with those who did not receive MBCT (hazard ratio, 0.69; 95% CI, 0.58-0.82). Furthermore, comparisons with active treatments suggest a reduced risk of depressive relapse within a 60-week follow-up period (hazard ratio, 0.79; 95% CI, 0.64-0.97). Using a 1-stage approach, sociodemographic (ie, age, sex, education, and relationship status) and psychiatric (ie, age at onset and number of previous episodes of depression) variables showed no statistically significant interaction with MBCT treatment. However, there was some evidence to suggest that a greater severity of depressive symptoms prior to treatment was associated with a larger effect of MBCT compared with other treatments.Conclusions and Relevance: Mindfulness-based cognitive therapy appears efficacious as a treatment for relapse prevention for those with recurrent depression, particularly those with more pronounced residual symptoms. Recommendations are made concerning how future trials can address remaining uncertainties and improve the rigor of the field. [ABSTRACT FROM AUTHOR]

We sought to assess the extent to which pain relief in chronic back and leg pain ( CBLP) following spinal cord stimulation ( SCS) is influenced by patient-related factors, including pain location, and technology factors. A number of electronic databases were searched with citation searching of included papers and recent systematic reviews. All study designs were included. The primary outcome was pain relief following SCS, we also sought pain score (pre- and post- SCS). Multiple predictive factors were examined: location of pain, history of back surgery, initial level of pain, litigation/worker's compensation, age, gender, duration of pain, duration of follow-up, publication year, continent of data collection, study design, quality score, method of SCS lead implant, and type of SCS lead. Between-study association in predictive factors and pain relief were assessed by meta-regression. Seventy-four studies ( N = 3,025 patients with CBLP) met the inclusion criteria; 63 reported data to allow inclusion in a quantitative analysis. Evidence of substantial statistical heterogeneity ( P < 0.0001) in level of pain relief following SCS was noted. The mean level of pain relief across studies was 58% (95% CI: 53% to 64%, random effects) at an average follow-up of 24 months. Multivariable meta-regression analysis showed no predictive patient or technology factors. SCS was effective in reducing pain irrespective of the location of CBLP. This review supports SCS as an effective pain relieving treatment for CBLP with predominant leg pain with or without a prior history of back surgery. Randomized controlled trials need to confirm the effectiveness and cost-effectiveness of SCS in the CLBP population with predominant low back pain. [ABSTRACT FROM AUTHOR]

Background: The magnitude of the 'white coat effect', the alerting rise in blood pressure, is greater for doctors than nurses. This could bias interpretation of studies on nurse-led care in hypertension, and risks overestimating or overtreating high blood pressure by doctors in clinical practice.Aim: To quantify differences between blood pressure measurements made by doctors and nurses.Design and Setting: Systematic review and meta-analysis using searches of MEDLINE, CENTRAL, CINAHL, Embase, journal collections, and conference abstracts.Method: Studies in adults reporting mean blood pressures measured by doctors and nurses at the same visit were selected, and mean blood pressures extracted, by two reviewers. Study risk of bias was assessed using modified Cochrane criteria. Outcomes were pooled across studies using random effects meta-analysis.Results: In total, 15 studies (11 hypertensive; four mixed hypertensive and normotensive populations) were included from 1899 unique citations. Compared with doctors' measurements, nurse-measured blood pressures were lower (weighted mean differences: systolic -7.0 [95% confidence interval {CI} = -4.7 to -9.2] mmHg, diastolic -3.8 [95% CI = -2.2 to -5.4] mmHg). For studies at low risk of bias, differences were lower: systolic -4.6 (95% CI = -1.9 to -7.3) mmHg; diastolic -1.7 (95% CI = -0.1 to -3.2) mmHg. White coat hypertension was diagnosed more frequently based on doctors' than on nurses' readings: relative risk 1.6 (95% CI =1.2 to 2.1).Conclusions: The white coat effect is smaller for blood pressure measurements made by nurses than by doctors. This systematic difference has implications for hypertension diagnosis and management. Caution is required in pooling data from studies using both nurse- and doctor-measured blood pressures. [ABSTRACT FROM AUTHOR]

Background: Volunteering has been advocated by the United Nations, and American and European governments as a way to engage people in their local communities and improve social capital, with the potential for public health benefits such as improving wellbeing and decreasing health inequalities. Furthermore, the US Corporation for National and Community Service Strategic Plan for 2011-2015 focused on increasing the impact of national service on community needs, supporting volunteers' wellbeing, and prioritising recruitment and engagement of underrepresented populations. The aims of this review were to examine the effect of formal volunteering on volunteers' physical and mental health and survival, and to explore the influence of volunteering type and intensity on health outcomes. Methods: Experimental and cohort studies comparing the physical and mental health outcomes and mortality of a volunteering group to a non-volunteering group were identified from twelve electronic databases (Cochrane Library, Medline, Embase, PsychINFO, CINAHL, ERIC, HMIC, SSCI, ASSIA, Social Care Online, Social Policy and Practice) and citation tracking in January 2013. No language, country or date restrictions were applied. Data synthesis was based on vote counting and random effects meta-analysis of mortality risk ratios. Results: Forty papers were selected: five randomised controlled trials (RCTs, seven papers); four non-RCTs; and 17 cohort studies (29 papers). Cohort studies showed volunteering had favourable effects on depression, life satisfaction, wellbeing but not on physical health. These findings were not confirmed by experimental studies. Meta-analysis of five cohort studies found volunteers to be at lower risk of mortality (risk ratio: 0.78; 95% CI: 0.66, 0.90). There was insufficient evidence to demonstrate a consistent influence of volunteering type or intensity on outcomes. Conclusion: Observational evidence suggested that volunteering may benefit mental health and survival although the causal mechanisms remain unclear. Consequently, there was limited robustly designed research to guide the development of volunteering as a public health promotion intervention. Future studies should explicitly map intervention design to clear health outcomes as well as use pragmatic RCT methodology to test effects. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: We conducted a systematic review to assess the effect of exercise training in patients with heart failure with preserved ejection fraction (HFPEF). Methods: A number of electronic databases were searched up to November 2011 to identify comparative studies of exercise training in HFPEF. Where possible, outcome data from included studies were pooled using meta-analysis. Results: Three randomised controlled trials, one non-randomised controlled trial and one pre-post study were included, for a total of 228 individuals. The combined duration of exercise programmes and follow-up ranged from 12 to 24weeks. No deaths, hospital admissions or serious adverse events were observed during or immediately following exercise training. Compared to control, the change in exercise capacity at follow-up was higher with exercise training (between group mean difference: 3.0ml/kg/min, 95% CI: 2.4 to 2.6). In the four studies, that reported the Minnesota Living with Heart Failure questionnaire, there was evidence of a larger gain in health-related quality of life with exercise training (7.3units, 3.3 to 11.4). The largest study showed some evidence of improvement in the E/E′ ratio with exercise training, but this was not confirmed in the other studies (overall −0.9, −3.8 to 2.0); E/A ratios were not changed. Conclusions: Exercise training for patients with HFPEF confers benefit in terms of enhancements in exercise capacity and health-related quality of life and appears to be safe. The impact on diastolic function remains unclear. Further trials should provide data on long term effects, prognostic relevance and cost-effectiveness. [Copyright &y& Elsevier]

The article focuses on a study which investigates whether a difference in systolic blood pressure (SBP) between arms is associated with peripheral vascular disease and attributed to subclavian stenosis. The study used random effects meta-analysis to combine estimates of the association between the differences. The findings show that the difference of 10 millimeter (mm) mercury (Hg) is strongly associated with sunclavian stenosis, while poor in 15 mm Hg or more on vascular disease.

BackgroundAlthough meta-analyses of randomized controlled trials (RCTs) of salt reduction report a reduction in the level of blood pressure (BP), the effect of reduced dietary salt on cardiovascular disease (CVD) events remains unclear.MethodsWe searched for RCTs with follow-up of at least 6 months that compared dietary salt reduction (restricted salt dietary intervention or advice to reduce salt intake) to control/no intervention in adults, and reported mortality or CVD morbidity data. Outcomes were pooled at end of trial or longest follow-up point.ResultsSeven studies were identified: three in normotensives, two in hypertensives, one in a mixed population of normo- and hypertensives and one in heart failure. Salt reduction was associated with reductions in urinary salt excretion of between 27 and 39 mmol/24 h and reductions in systolic BP between 1 and 4 mm Hg. Relative risks (RRs) for all-cause mortality in normotensives (longest follow-up-RR: 0.90, 95% confidence interval (CI): 0.58-1.40, 79 deaths) and hypertensives (longest follow-up RR 0.96, 0.83-1.11, 565 deaths) showed no strong evidence of any effect of salt reduction CVD morbidity in people with normal BP (longest follow-up: RR 0.71, 0.42-1.20, 200 events) and raised BP at baseline (end of trial: RR 0.84, 0.57-1.23, 93 events) also showed no strong evidence of benefit. Salt restriction increased the risk of all-cause mortality in those with heart failure (end of trial RR 2.59, 1.04-6.44, 21 deaths).We found no information on participant's health-related quality of life.ConclusionsDespite collating more event data than previous systematic reviews of RCTs (665 deaths in some 6,250 participants) there is still insufficient power to exclude clinically important effects of reduced dietary salt on mortality or CVD morbidity. Our estimates of benefits from dietary salt restriction are consistent with the predicted small effects on clinical events attributable to the small BP reduction achieved.A more detailed review has been published and will be updated in the Cochrane Database of Systematic Reviews [Taylor RS, Ashton KE, Moxham T, Hooper L, Ebrahim S. Reduced dietary salt for the prevention of cardiovascular disease. Cochrane Database of Systematic Reviews (CDSR) 2011, Issue 7 (see www.thecochranelibrary.com for information). This is a version of a Cochrane review, which is available in The Cochrane Library. Cochrane systematic reviews are regularly updated to include new research, and in response to feedback from readers. The results of a Cochrane review can be interpreted differently, depending on people's perspectives and circumstances. Please consider the conclusions presented carefully. They are the opinions of review authors, and are not necessarily shared by The Cochrane Collaboration.American Journal of Hypertension (2011). doi:10.1038/ajh.2011.115 [ABSTRACT FROM AUTHOR]

Aims: To determine the effect of exercise training on clinical events and health-related quality of life (HRQoL) of patients with systolic heart failure. [ABSTRACT FROM PUBLISHER]

Abstract: Background: To determine the effectiveness of home-based cardiac rehabilitation programmes compared with (i) usual care and (ii) supervised centre-based cardiac rehabilitation on mortality, health related quality of life and modifiable cardiac risk factors of patients with coronary heart disease. Methods: Systematic review and meta-analysis of randomised controlled trials. Main outcome measures: mortality, smoking cessation, exercise capacity, systolic blood pressure, total cholesterol, psychological status, and health related quality of life. Results: Eighteen included trials for home versus usual rehabilitation and six trials of home versus supervised centre-based rehabilitation were identified. The home-based interventions were clinically heterogeneous, trials often small, with quality poorly reported. Compared with usual care, home-based cardiac rehabilitation had a 4 mm Hg (95% CI 6.5, 1.5) greater reduction in systolic blood pressure, and a reduced relative risk of being a smoker at follow-up (RR 0.71, 95% CI 0.51, 1.00). Differences in exercise capacity, total cholesterol, anxiety and depression were all in favour of the home-based group. In patients post-myocardial infarction exercise capacity was significantly improved in the home rehabilitation group by 1.1 METS (95% CI 0.2, 2.1) compared to usual care. The comparison of home-based with supervised centre-based cardiac rehabilitation revealed no significant differences in exercise capacity, systolic blood pressure and total cholesterol. Conclusions: Current evidence does not show home-based cardiac rehabilitation to be significantly inferior to centre-based rehabilitation for low-risk cardiac patients. However, the numbers of patients included are less than 750 and ongoing trials will contribute to the debate on the acceptability, effectiveness and cost-effectiveness of home-based cardiac rehabilitation. [Copyright &y& Elsevier]

Background: Fenestrated endovascular aneurysm repair (fEVAR) is a new approach for complex abdominal aortic aneurysms, limited to a few specialist centers, with limited evidence base. We developed a cost-effectiveness decision model of fEVAR compared to open surgical repair (OSR) to investigate the likely direction of costs and benefits and inform further research projects on this technology. Methods: A systematic review with meta-analysis and a four-state Markov model were used to estimate the cost-effectiveness of fEVAR versus OSR. We used a recent coverage with evidence development framework to characterize the main sources of uncertainty and inform decisions about the type of further research that would be most worthwhile and feasible. Results: Seven observational comparative studies were identified, of which four presented odds ratios adjusted for confounders. The odds ratios for operative mortality varied widely between studies. Assuming a central estimate of the odds ratio of 0.54 (95% CI 0.05–6.24), the decision model estimated that the incremental cost per quality adjusted life year (QALY) was £74,580/QALY with a probability of 9 and 16% of being cost-effective at standard cost-effectiveness thresholds of £20,000/QALY and £30,000/QALY, respectively. The Expected Value of Perfect Information over 10 years at a threshold of £20,000/QALY was £11.2 million. Operative mortality contributed to most of the uncertainty in the decision model. Conclusions: In the case of "maturing technologies", decision modelling indicates the likely direction of costs and benefits and guides the development of further research projects. In our analysis of fEVAR versus OSR, decision uncertainty, particularly around operative mortality, might be effectively resolved by a short-term RCT, or possibly a well-conducted comparative observational study. Decision makers may consider that a conditional coverage decision is warranted with assessments required to make this type of recommendation depending on local priorities and circumstances. [ABSTRACT FROM AUTHOR]

The article focuses on the study of whether treatment effects of randomised controlled trials in surrogate primary outcomes are different from final patient relevant primary outcomes or not. It is mentioned that advantage of surrogate outcomes are its short duration and size which reduces the cost of trials. It is concluded that surrogate primary outcomes trial are more likely to report larger treatment effects than trials reporting final patient relevant outcomes.

Topic: Preoperative corneal neovascularization (CNV) is thought to be associated with an increased rate of corneal graft failure and potentially also graft rejection. Clinical Relevance: New therapeutic options that offer differential influence on the ingrowths or regression of either corneal blood or lymphatic vessels force us to re-evaluate the known data about the role of CNV in keratoplasty. Methods: Electronic databases and corneal registries were searched (up through September 2008). Results were reported both descriptively for each study and using random effects meta-analysis. Potential moderating factors for the association between vascularization and graft failure and rejection were examined using metaregression analysis. Results: Nineteen studies reporting on a total of 24 944 grafts undergoing keratoplasty were included. An increase in the risk of graft failure and rejection in the presence of pathologic CNV was seen in studies with a pooled risk ratio of 1.32 (95% confidence interval [CI], 1.15–1.49) for graft failure and 2.07 (95% CI, 0.98–3.15) for graft rejection. There was evidence of incremental increase of risk for graft failure and rejection as more corneal quadrants were affected by neovascularization. The 2 factors predictive of increased risk of neovascularization and graft failure were increased recipient age (P = 0.003) and male gender (P = 0.046). Conclusions: Graft failure and rejection risk increase with an increasing number of corneal quadrants affected by neovascularization before keratoplasty. These data support the study of novel topical antiangiogenic therapies at the cornea to precondition such a cornea for future corneal grafting. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. [Copyright &y& Elsevier]

Abstract: The drive for good quality evidence has highlighted the importance of well-conducted systematic reviews and meta-analyses that critically evaluate and grade studies for new or existing therapies. A systematic review and meta-analysis was performed to review the efficacy, safety, and cost effectiveness of spinal cord stimulation (SCS) in complex regional pain syndrome (CRPS) and refractory neuropathic back and leg pain/failed back surgery syndrome (FBSS). The results support the use of SCS in patients with refractory neuropathic back and leg pain/FBSS (Grade B evidence) and CRPS type I (Grade A evidence)/type II (Grade D evidence). SCS not only reduces pain, improves quality of life, reduces analgesic consumption, and allows some patients to return to work, with minimal significant adverse events, but may also result in significant cost savings over time. [Copyright &y& Elsevier]

Abstract: Spinal cord stimulation (SCS) has been suggested as a treatment option for patients with painful diabetic neuropathy (PDN). We conducted a systematic review and undertook a meta-analysis on individual patient data from randomised controlled trials (RCTs) to assess the effectiveness of SCS for the management of PDN. Electronic databases were searched from inception to May 2020 for RCTs of SCS for PDN. Searches identified 2 eligible RCTs (total of 93 patients with PDN) and 2 long-term follow-up studies of one of the RCTs. Individual patient data were obtained from the authors of one of these RCTs. Meta-analysis showed significant and clinically meaningful reductions in pain intensity for SCS compared with best medical therapy alone, pooled mean difference (MD) -3.13 (95% confidence interval [CI]: -4.19 to -2.08) on a 10-point scale at the 6-month follow-up. More patients receiving SCS achieved at least a 50% reduction in pain intensity compared with best medical therapy, pooled risk ratio 0.08 (95% CI: 0.02-0.38). Increases were observed for health-related quality of life assessed as EQ-5D utility score (pooled MD 0.16, 95% CI: 0.02-0.30) and visual analogue scale (pooled MD 11.21, 95% CI: 2.26-20.16). Our findings demonstrate that SCS is an effective therapeutic adjunct to best medical therapy in reducing pain intensity and improving health-related quality of life in patients with PDN. Large well-reported RCTs with long-term follow-up are required to confirm these results. [ABSTRACT FROM AUTHOR]

Objectives: Spinal cord stimulation (SCS) is a recognized treatment for chronic pain. This systematic review aims to assess economic evaluations of SCS for the management of all chronic pain conditions, summarize key findings, and assess the quality of studies to inform healthcare resource allocation decisions and future research.Methods: Economic evaluations were identified by searching general medical and economic databases complemented with screening of reference lists of identified studies. No restrictions on language or treatment comparators were applied. Relevant data were extracted. The quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.Results: Fourteen studies met the inclusion criteria and were judged to be of acceptable quality. Economic evaluations assessed SCS for the management of refractory angina pectoris, failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), diabetic peripheral neuropathy (DPN), and peripheral arterial disease. Model-based studies typically applied a 2-stage model, i.e. decision tree followed by Markov model. Time horizon varied from 1 year to lifetime. Cost-effectiveness ranged widely from dominant (SCS cost-saving and more effective) to incremental cost-effectiveness ratio of >£100,000 per quality-adjusted life-year. Cost-effectiveness appeared to depend on the time horizon, choice of comparator, and indication. Ten of the studies indicated SCS as cost-saving or cost-effective compared with the alternative strategies.Conclusion: The results consistently suggest that SCS is cost-effective when considering a long-term time horizon, particularly for the management of FBSS and CRPS. Further studies are needed to assess the cost-effectiveness of SCS for ischemic pain and DPN. [ABSTRACT FROM AUTHOR]

The aims of this review were to systematically identify the current evidence base of placebo (or "sham") randomised controlled trials (RCTs) of spinal cord stimulation (SCS) for neuropathic pain and to undertake a meta-analysis to investigate the effectiveness of SCS when compared with a placebo comparator arm. Electronic databases were searched from inception until January 2019 for RCTs of SCS using a placebo/sham control. Searches identified 8 eligible placebo-controlled randomised trials of SCS for neuropathic pain. Meta-analysis shows a statistically significant reduction in pain intensity during the active stimulation treatment periods compared with the control treatment periods, pooled mean difference -1.15 (95% confidence interval -1.75 to -0.55, P = 0.001) on a 10-point scale. Exploratory study-level subgroup analysis suggests a larger treatment effect in RCTs using a placebo control (defined as studies where the device was inactive and at least one of the study procedures was different between the arms) than a sham control (defined as all study procedures being equal between arms including SCS device behaviour). Our findings demonstrate limited evidence that SCS is effective in reducing pain intensity when compared with a placebo intervention. Our analyses suggest that the magnitude of treatment effect varies across trials and, in part, depends on the quality of patient blinding and minimisation of carryover effects. Improved reporting and further methodological research is needed into placebo and blinding approaches in SCS trials. Furthermore, we introduce a differentiation between placebo and sham concepts that may be generalisable to trials evaluating surgical or medical procedures. [ABSTRACT FROM AUTHOR]

Aims To assess the effectiveness of home-based cardiac rehabilitation (CR) for heart failure compared to either usual medical care (i.e. no CR) or centre-based CR on mortality, morbidity, exercise capacity, health-related quality of life, drop out, adherence rates, and costs. Methods Randomised controlled trials were initially identified from previous systematic reviews of CR. We undertook updated literature searches of MEDLINE, EMBASE, CINAHL, PsycINFO and Cochrane Library to December 2015. A total of 19 trials with median follow up of 3 months were included — 17 comparisons of home-based CR to usual care (995 patients) and four comparing home and centre-based CR (295 patients). Results Compared to usual care, home-based CR improved VO 2max (mean difference: 1.6 ml/kg/min, 0.8 to 2.4) and total Minnesota Living with Quality of Life score (− 3.3, − 7.5 to 1.0), with no difference in mortality, hospitalisation or study drop out. Outcomes and costs were similar between home-based and centre-based CR with the exception of higher levels of trial completion in the home-based group (relative risk: 1.2, 1.0 to 1.3). Conclusions Home-based CR results in short-term improvements in exercise capacity and health-related quality of life of heart failure patients compared to usual care. The magnitude of outcome improvement is similar to centre-based CR. Home-based CR appears to be safe with no evidence of increased risk of hospitalisation or death. These findings support the provision of home-based CR for heart failure as an evidence-based alternative to the traditional centre-based model of provision. [ABSTRACT FROM AUTHOR]

Background: Although recommended in guidelines for the management of coronary heart disease (CHD), concerns have been raised about the applicability of evidence from existing meta-analyses of exercise-based cardiac rehabilitation (CR).Objectives: The goal of this study is to update the Cochrane systematic review and meta-analysis of exercise-based CR for CHD.Methods: The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and Science Citation Index Expanded were searched to July 2014. Retrieved papers, systematic reviews, and trial registries were hand-searched. We included randomized controlled trials with at least 6 months of follow-up, comparing CR to no-exercise controls following myocardial infarction or revascularization, or with a diagnosis of angina pectoris or CHD defined by angiography. Two authors screened titles for inclusion, extracted data, and assessed risk of bias. Studies were pooled using random effects meta-analysis, and stratified analyses were undertaken to examine potential treatment effect modifiers.Results: A total of 63 studies with 14,486 participants with median follow-up of 12 months were included. Overall, CR led to a reduction in cardiovascular mortality (relative risk: 0.74; 95% confidence interval: 0.64 to 0.86) and the risk of hospital admissions (relative risk: 0.82; 95% confidence interval: 0.70 to 0.96). There was no significant effect on total mortality, myocardial infarction, or revascularization. The majority of studies (14 of 20) showed higher levels of health-related quality of life in 1 or more domains following exercise-based CR compared with control subjects.Conclusions: This study confirms that exercise-based CR reduces cardiovascular mortality and provides important data showing reductions in hospital admissions and improvements in quality of life. These benefits appear to be consistent across patients and intervention types and were independent of study quality, setting, and publication date. [ABSTRACT FROM AUTHOR]

Abstract: Patients with neuropathic pain (NeuP) experience substantially lower health-related quality of life (HRQoL) than the general population. The aim of this systematic review and meta-analysis is to test the hypothesis that NeuP is associated with low levels of health utility. A structured search of electronic databases (MEDLINE, EMBASE, Cochrane Library and CINAHL) was undertaken. Reference lists of retrieved reports were also reviewed. Studies reporting utility single-index measures (preference based) in NeuP were included. Random effects meta-analysis was used to pool EQ-5D index utility estimates across NeuP conditions. The association of utilities and pre-defined factors (NeuP condition, patient age, sex, duration and severity of pain and method of utility scoring) was examined using meta-regression. Twenty-four studies reporting health utility values in patients with NeuP were included in the review. Weighted pooled utility score across the studies varied from a mean of 0.15 for failed back surgery syndrome to 0.61 for post-herpetic neuralgia and diabetic neuropathy. Although there was substantial heterogeneity (P <0.0001) across studies, we found little variation in utility as a function of patient and study characteristics. The single exception was a significant relationship (P <0.0001) between increasing neuropathic pain severity and a reduction in utility. This study confirms the hypothesis that patients with NeuP experience low utilities and therefore low HRQoL. However, the contribution of non-NeuP co-morbidity remains unclear. Neuropathic pain severity emerged as a primary predictor of the negative health impact of NeuP. [Copyright &y& Elsevier]