The effectiveness of non-pharmacological sleep interventions for improving inpatient sleep in hospital: A systematic review and meta-analysis.

BACKGROUND: Sleep disturbance is common in hospital. The hospital environment can have a negative impact on sleep quality, through factors such as noise, light, temperature, and nursing care disruptions. Poor sleep can lead to delays in recovery, wound healing, and increase risk of post-operative infection. METHODS: We conducted a systematic review evaluating the effectiveness of non-pharmacological sleep interventions for improving inpatient sleep. The primary outcome was sleep quality, the secondary outcome was length of hospital stay, the harm outcome was adverse events. MEDLINE, Embase, CINAHL, PsycINFO and the Cochrane Library were searched from inception to 17th February 2022. Meta-analysis was conducted using a fixed effects model, with narrative synthesis for studies with no useable data. Risk of bias was assessed with the Cochrane tool. RESULTS: 76 studies identified with 5375 people randomised comparing 85 interventions. Interventions focused on physical sleep aids (n = 26), relaxation (n = 25), manual therapy (n = 12), music (n = 9), psychological therapy (n = 5), light therapy (n = 3), sleep protocols (n = 2), milk and honey (n = 1), exercise (n = 1), and nursing care (n = 1). In meta-analysis, medium to large improvements in sleep quality were noted for sleep aids, relaxation, music, and manual therapies. Results were generally consistent in studies at lower risk of bias. Length of hospital stay and adverse events were reported for some studies, with benefit in some trials but this was not consistent across all interventions. CONCLUSIONS: Physical sleep aids, relaxation, manual therapy and music interventions have a strong evidence base for improving inpatient sleep quality. Research is needed to evaluate how to optimise interventions into routine care.

Immediate and delayed autologous abdominal microvascular flap breast reconstruction in patients receiving adjuvant, neoadjuvant or no radiotherapy: a meta-analysis of clinical and quality-of-life outcomes.

BACKGROUND: Effects of postmastectomy radiotherapy (PMRT) on autologous breast reconstruction (BRR) are controversial regarding surgical complications, cosmetic appearance and quality of life (QOL). This systematic review evaluated these outcomes after abdominal free flap reconstruction in patients undergoing postoperative adjuvant radiotherapy (PMRT), preoperative radiotherapy (neoadjuvant radiotherapy) and no radiotherapy, aiming to establish evidence-based optimal timings for radiotherapy and BRR to guide contemporary management. METHODS: The study was registered on PROSPERO (CRD42017077945). Embase, MEDLINE, Google Scholar, CENTRAL, Science Citation Index and ClinicalTrials.gov were searched (January 2000 to August 2018). Study quality and risk of bias were assessed using GRADE and Cochrane's ROBINS-I respectively. RESULTS: Some 12 studies were identified, involving 1756 patients (350 PMRT, 683 no radiotherapy and 723 neoadjuvant radiotherapy), with a mean follow-up of 27·1 (range 12·0-54·0) months for those having PMRT, 16·8 (1·0-50·3) months for neoadjuvant radiotherapy, and 18·3 (1·0-48·7) months for no radiotherapy. Three prospective and nine retrospective cohorts were included. There were no randomized studies. Five comparative radiotherapy studies evaluated PMRT and four assessed neoadjuvant radiotherapy. Studies were of low quality, with moderate to serious risk of bias. Severe complications were similar between the groups: PMRT versus no radiotherapy (92 versus 141 patients respectively; odds ratio (OR) 2·35, 95 per cent c.i. 0·63 to 8·81, P = 0·200); neoadjuvant radiotherapy versus no radiotherapy (180 versus 392 patients; OR 1·24, 0·76 to 2·04, P = 0·390); and combined PMRT plus neoadjuvant radiotherapy versus no radiotherapy (272 versus 453 patients; OR 1·38, 0·83 to 2·32, P = 0·220). QOL and cosmetic studies used inconsistent methodologies. CONCLUSION: Evidence is conflicting and study quality was poor, limiting recommendations for the timing of autologous BRR and radiotherapy. The impact of PMRT and neoadjuvant radiotherapy appeared to be similar.

ANTECEDENTES: En pacientes sometidas a una reconstrucción mamaria (breast reconstruction, BRR) con tejido autólogo se discuten los efectos de la radioterapia post-mastectomía (post-mastectomy radiotherapy, PMRT) en las complicaciones quirúrgicas, el resultado estético y la calidad de vida (quality of life, QOL). Esta revisión sistemática evaluó dichos resultados tras una reconstrucción mamaria con un colgajo libre abdominal en pacientes tratadas con PMRT, radioterapia preoperatoria (Neo RT) y sin radioterapia (RT), a fin de establecer los momentos óptimos de la RT y BRR basados en la evidencia, como guía del tratamiento actual. MÉTODOS: El estudio se registró en la base de datos PROSPERO (CRD42017077945). Se realizaron búsquedas en Embase, MEDLINE, Google Scholar, CENTRAL, Science Citation Index y Clinicaltrials.gov (enero de 2000-agosto de 2018). La calidad de los estudios y el riesgo de sesgo se evaluaron mediante las herramientas GRADE y ROBINS-I de la Cochrane, respectivamente. RESULTADOS: Se identificaron 12 estudios que incluían 1.756 pacientes (350 PMRT, 683 sin RT y 723 Neo RT), con una mediana de seguimiento de 27,1 meses (rango 12,0-54,0) para PMRT, 16,8 meses (1,0-50,3) para Neo RT y 18,3 meses (1,0-48,7) para sin RT. Se incluyeron tres cohortes prospectivas y nueve retrospectivas. No hubo estudios aleatorizados. Los estudios comparativos de RT evaluaron la PMRT (n = 5) y la Neo RT (n = 4). Todos los estudios fueron de baja calidad, con riesgos de sesgo de moderados a graves. Las complicaciones graves fueron similares entre los grupos: PMRT (n = 92) versus sin RT (n = 141), razón de oportunidades (odds ratio, OR) 2,35, i.c. del 95% 0,63-8,81), P = 0,200; Neo RT (n = 180) versus no RT (n = 392) (OR 1,24, i.c. del 95% 0,76-2,04), P = 0,390; o RT combinada (PMRT y neoadyuvante) (n = 272) versus no RT (n = 453) (OR 1,38, i.c. del 95% 0,83-2,32), P = 0,220. Los estudios de calidad de vida y de resultados estéticos utilizaron metodologías poco consistentes. CONCLUSIÓN: La evidencia es contradictoria y la calidad de los estudios muy pobre, hechos que limitan las posibles recomendaciones para el momento de la BRR con tejido autólogo y la RT. El impacto de la PMRT o la Neo RT parecen ser similares.

Systematic review of the clinical effectiveness for long-term follow-up of total hip arthroplasty.

Objectives: Total hip arthroplasty (THA) is highly successful but national registries indicate that average age has lowered and that younger patients are at higher risk of revision. Long-term follow-up of THA was historically recommended to identify aseptically failing THA, minimising the risks associated with extensive changes, but follow-up services are now in decline. A systematic review was conducted to search for evidence of the clinical or cost-effectiveness of hip arthroplasty surveillance. Methods: The study was registered with PROSPERO International Prospective Register of Systematic Reviews and conducted according to PRISMA guidelines; databases included MEDLINE and Embase, and all studies were quality assessed. Original studies (2005 to 2017) reporting follow-up of adults with THA in situ >5 years were included. Researchers extracted quantitative and qualitative data from each study. Results: For eligibility, 4,137 studies were screened: 114 studies were included in the final analysis, representing 22 countries worldwide. Data extracted included study endpoint, patient detail, loss to follow-up, revisions, scores and radiographic analysis. Six themes were derived from inductive content analysis of text: support for long-term follow-up, subgroups requiring follow-up, effect of materials/techniques on THA survival, effect of design, indicators for revision, review process. Main findings-follow-up was specifically recommended to monitor change (eg asymptomatic loosening), when outcomes of joint construct are unknown, and for specific patient subgroups. Outcome scores alone are not enough, and radiographic review should be included. Conclusion: There were no studies directly evaluating the clinical effectiveness of the long-term follow-up of THA but expert opinions from a range of international authors advocated its use for defined subgroups to provide patient-centred care. In the absence of higher level evidence, these opinions, in conjunction with emerging outputs from the national joint registries, should be used to inform services for long-term follow-up of THA.

Is social support associated with patient-reported outcomes after joint replacement? A systematic review and meta-analysis.

BACKGROUND: Identifying prognostic factors for outcomes after joint replacement could improve the provision of stratified care. This systematic review evaluated whether social support is a prognostic factor for better patient-reported outcomes after total hip replacement (THR) and total knee replacement (TKR). METHODS: MEDLINE, Embase and PsycINFO were searched from inception to April 2019. Cohort studies evaluating the association between social support and patient-reported outcomes at three months or longer after THR or TKR were included. Data were extracted from study reports. Study quality was assessed using the QUIPS tool. Data were synthesized using meta-analysis and narrative synthesis. The review was registered on PROSPERO (CRD42016041485). FINDINGS: Searches identified 5,810 articles and 56 studies with data from 119,165 patients were included. In meta-analysis, the presence of social support had a beneficial effect on long-term post-operative WOMAC (mean difference 2.88; 95% CIs 1.30; 4.46) and Oxford Knee Score (0.29; 0.12, 0.45). Social support measured using a validated questionnaire was found to be associated with WOMAC pain (0.04; 0.00, 0.08) but not WOMAC function (-0.01; -0.12, 0.11). The presence of social support had a positive association with some SF-36 subscales but not others. For all outcomes, results of narrative synthesis were inconsistent. INTERPRETATION: There is evidence that social support is a prognostic factor for some outcomes after joint replacement. Development and evaluation of complex interventions to improve social support and social integration is warranted. FUNDING: This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol.

Systematic review of the impact of breast-conserving surgery on cancer outcomes of multiple ipsilateral breast cancers.

BACKGROUND: The clinical effectiveness of treating ipsilateral multifocal (MF) and multicentric (MC) breast cancers using breast-conserving surgery (BCS) compared with the standard of mastectomy is uncertain. Inconsistencies relate to definitions, incidence, staging and intertumoral heterogeneity. The primary aim of this systematic review was to compare clinical outcomes after BCS versus mastectomy for MF and MC cancers, collectively defined as multiple ipsilateral breast cancers (MIBC). METHODS: Comprehensive electronic searches were undertaken to identify complete papers published in English between May 1988 and July 2015, primarily comparing clinical outcomes of BCS and mastectomy for MIBC. All study designs were included, and studies were appraised critically using the Newcastle-Ottawa Scale. The characteristics and results of identified studies were summarized. RESULTS: Twenty-four retrospective studies were included in the review: 17 comparative studies and seven case series. They included 3537 women with MIBC undergoing BCS; breast cancers were defined as MF in 2677 women, MC in 292, and reported as MIBC in 568. Six studies evaluated MIBC treated by BCS or mastectomy, with locoregional recurrence (LRR) rates of 2-23 per cent after BCS at median follow-up of 59·5 (i.q.r. 56-81) months. BCS and mastectomy showed apparently equivalent rates of LRR (risk ratio 0·94, 95 per cent c.i. 0·65 to 1·36). Thirteen studies compared BCS in women with MIBC versus those with unifocal cancers, reporting LRR rates of 2-40 per cent after BCS at a median follow-up of 64 (i.q.r. 57-73) months. One high-quality study reported 10-year actuarial LRR rates of 5·5 per cent for BCS in 300 women versus 6·5 per cent for mastectomy among 887 women. CONCLUSION: The available studies were mainly of moderate quality, historical and underpowered, with limited follow-up and biased case selection favouring BCS rather than mastectomy for low-risk patients. The evidence was inconclusive, weakening support for the St Gallen consensus and supporting a future randomized trial.

Complications following laryngeal sacculectomy in brachycephalic dogs.

OBJECTIVES: To evaluate the effect of sacculectomy on the immediate postoperative complication rate in dogs affected with brachycephalic obstructive airway syndrome. MATERIALS AND METHODS: Retrospective review of clinical records of brachycephalic dogs with everted saccules that underwent surgery for brachycephalic obstructive airway syndrome between 2009 and 2014. Dogs were grouped as those having nares resection and staphylectomy only and those having nares resection, staphylectomy and laryngeal sacculectomy. Complications were scored as mild, moderate or severe. RESULTS: In total, 37 dogs were included in the sacculectomy group and 44 in the comparator group. Dogs that had undergone sacculectomy were more likely to develop postoperative complications, with 18 of 37 developing complications, nine of which were moderate to severe. In the group without sacculectomy, nine of 44 dogs developed complications, of which one was severe. Different breed distribution between groups might also impact this outcome. CLINICAL SIGNIFICANCE: The results suggest that sacculectomy might increase morbidity following brachycephalic airway surgery, but repeat studies are required to confirm this result. Further information is also required to determine whether the short-term risks of sacculectomy are outweighed by superior long-term functional outcome.

Systematic review of management of chronic pain after surgery.

BACKGROUND: Pain present for at least 3 months after a surgical procedure is considered chronic postsurgical pain (CPSP) and affects 10-50 per cent of patients. Interventions for CPSP may focus on the underlying condition that indicated surgery, the aetiology of new-onset pain or be multifactorial in recognition of the diverse causes of this pain. The aim of this systematic review was to identify RCTs of interventions for the management of CPSP, and synthesize data across treatment type to estimate their effectiveness and safety. METHODS: MEDLINE, Embase, PsycINFO, CINAHL and the Cochrane Library were searched from inception to March 2016. Trials of pain interventions received by patients at 3 months or more after surgery were included. Risk of bias was assessed using the Cochrane risk-of-bias tool. RESULTS: Some 66 trials with data from 3149 participants were included. Most trials included patients with chronic pain after spinal surgery (25 trials) or phantom limb pain (21 trials). Interventions were predominantly pharmacological, including antiepileptics, capsaicin, epidural steroid injections, local anaesthetic, neurotoxins, N-methyl-d-aspartate receptor antagonists and opioids. Other interventions included acupuncture, exercise, postamputation limb liner, spinal cord stimulation, further surgery, laser therapy, magnetic stimulation, mindfulness-based stress reduction, mirror therapy and sensory discrimination training. Opportunities for meta-analysis were limited by heterogeneity. For all interventions, there was insufficient evidence to draw conclusions on effectiveness. CONCLUSION: There is a need for more evidence about interventions for CPSP. High-quality trials of multimodal interventions matched to pain characteristics are needed to provide robust evidence to guide management of CPSP.

Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry.

OBJECTIVES: We used the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) to investigate the risk of revision due to prosthetic joint infection (PJI) for patients undergoing primary and revision hip arthroplasty, the changes in risk over time, and the overall burden created by PJI. METHODS: We analysed revision total hip arthroplasties (THAs) performed due to a diagnosis of PJI and the linked index procedures recorded in the NJR between 2003 and 2014. The cohort analysed consisted of 623 253 index primary hip arthroplasties, 63 222 index revision hip arthroplasties and 7585 revision THAs performed due to a diagnosis of PJI. The prevalence, cumulative incidence functions and the burden of PJI (total procedures) were calculated. Overall linear trends were investigated with log-linear regression. RESULTS: We demonstrated a prevalence of revision THA due to prosthetic joint infection of 0.4/100 procedures following primary and 1.6/100 procedures following revision hip arthroplasty. The prevalence of revision due to PJI in the three months following primary hip arthroplasty has risen 2.3-fold (95% confidence interval (CI) 1.3 to 4.1) between 2005 and 2013, and 3.0-fold (95% CI 1.1 to 8.5) following revision hip arthroplasty. Over 1000 procedures are performed annually as a consequence of hip PJI, an increase of 2.6-fold between 2005 and 2013. CONCLUSIONS: Although the risk of revision due to PJI following hip arthroplasty is low, it is rising and, coupled with the established and further predicted increased incidence of both primary and revision hip arthroplasty, this represents a growing and substantial treatment burden.Cite this article: E. Lenguerrand, M. R. Whitehouse, A. D. Beswick, S. A. Jones, M. L. Porter, A. W. Blom. Revision for prosthetic joint infection following hip arthroplasty: Evidence from the National Joint Registry. Bone Joint Res 2017;6:391-398. DOI: 10.1302/2046-3758.66.BJR-2017-0003.R1.

Systematic review of risk prediction scores for surgical site infection or periprosthetic joint infection following joint arthroplasty.

Accurate identification of individuals at high risk of surgical site infections (SSIs) or periprosthetic joint infections (PJIs) influences clinical decisions and development of preventive strategies. We aimed to determine progress in the development and validation of risk prediction models for SSI or PJI using a systematic review. We searched for studies that have developed or validated a risk prediction tool for SSI or PJI following joint replacement in MEDLINE, EMBASE, Web of Science and Cochrane databases; trial registers and reference lists of studies up to September 2016. Nine studies describing 16 risk scores for SSI or PJI were identified. The number of component variables in a risk score ranged from 4 to 45. The C-index ranged from 0·56 to 0·74, with only three risk scores reporting a discriminative ability of >0·70. Five risk scores were validated internally. The National Healthcare Safety Network SSIs risk models for hip and knee arthroplasties (HPRO and KPRO) were the only scores to be externally validated. Except for HPRO which shows some promise for use in a clinical setting (based on predictive performance and external validation), none of the identified risk scores can be considered ready for use. Further research is urgently warranted within the field.

Rates of hip and knee joint replacement amongst different ethnic groups in England: an analysis of National Joint Registry data.

OBJECTIVE: Despite a health care system that is free at the point of delivery, ethnic minorities may not always get care equitable to that of White patients in England. We examined whether ethnic differences exist in joint replacement rates and surgical practice in England. DESIGN: 373,613 hip and 428,936 knee National Joint Registry (NJR) primary replacement patients had coded ethnicity in Hospital Episode Statistics (HES). Age and gender adjusted observed/expected ratios of hip and knee replacements amongst ethnic groups were compared using indirect standardisation. Associations between ethnic group and type of procedure were explored and effects of demographic, clinical and hospital-related factors examined using multivariable logistic regression. RESULTS: Adjusted standardised observed/expected ratios were substantially lower in Blacks and Asians than Whites for hip replacement (Blacks 0.33 [95% CI, 0.31-0.35], Asians 0.20 [CI, 0.19-0.21]) and knee replacement (Blacks 0.64 [CI, 0.61-0.67], Asians 0.86 % [CI, 0.84-0.88]). Blacks were more likely to receive uncemented hip replacements (Blacks 52%, Whites 37%, Asians 44%; P < 0.001). Black men and women aged <70 years were less likely to receive unicondylar or patellofemoral knee replacements than Whites (men 10% vs 15%, P = 0.001; women 6% vs 14%, P < 0.001). After adjustment for demographic, clinical and hospital-related factors, Blacks were more likely to receive uncemented hip replacement (OR 1.43 [CI, 1.11-1.84]). CONCLUSIONS: In England, hip and knee replacement rates and prosthesis type given differ amongst ethnic groups. Whether these reflect differences in clinical need or differential access to treatment requires urgent investigation.

The Alpha-Defensin Immunoassay and Leukocyte Esterase Colorimetric Strip Test for the Diagnosis of Periprosthetic Infection: A Systematic Review and Meta-Analysis.

BACKGROUND: Synovial biomarkers have recently been adopted as diagnostic tools for periprosthetic joint infection (PJI), but their utility is uncertain. The purpose of this systematic review and meta-analysis was to synthesize the evidence on the accuracy of the alpha-defensin immunoassay and leukocyte esterase colorimetric strip test for the diagnosis of PJI compared with the Musculoskeletal Infection Society diagnostic criteria. METHODS: We performed a systematic review to identify diagnostic technique studies evaluating the accuracy of alpha-defensin or leukocyte esterase in the diagnosis of PJI. MEDLINE and Embase on Ovid, ACM, ADS, arXiv, CERN DS (Conseil Européen pour la Recherche Nucléaire Document Server), CrossRef DOI (Digital Object Identifier), DBLP (Digital Bibliography & Library Project), Espacenet, Google Scholar, Gutenberg, HighWire, IEEE Xplore (Institute of Electrical and Electronics Engineers digital library), INSPIRE, JSTOR (Journal Storage), OAlster (Open Archives Initiative Protocol for Metadata Harvesting), Open Content, Pubget, PubMed, and Web of Science were searched for appropriate studies indexed from inception until May 30, 2015, along with unpublished or gray literature. The classification of studies and data extraction were performed independently by 2 reviewers. Data extraction permitted meta-analysis of sensitivity and specificity with construction of receiver operating characteristic curves for each test. RESULTS: We included 11 eligible studies. The pooled diagnostic sensitivity and specificity of alpha-defensin (6 studies) for PJI were 1.00 (95% confidence interval [CI], 0.82 to 1.00) and 0.96 (95% CI, 0.89 to 0.99), respectively. The area under the curve (AUC) for alpha-defensin and PJI was 0.99 (95% CI, 0.98 to 1.00). The pooled diagnostic sensitivity and specificity of leukocyte esterase (5 studies) for PJI were 0.81 (95% CI, 0.49 to 0.95) and 0.97 (95% CI, 0.82 to 0.99), respectively. The AUC for leukocyte esterase and PJI was 0.97 (95% CI, 0.95 to 0.98). There was substantial heterogeneity among studies for both diagnostic tests. CONCLUSIONS: The diagnostic accuracy for PJI was high for both tests. Given the limited number of studies and the large cost difference between the tests, more independent research on these tests is warranted. LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Reactive and Inelastic Channels in the Ca*···FCH3 Transition State: A Simple Branching Mechanism.

To study the excited state dynamics between a calcium atom and the CH3F molecule, a Ca···CH3F 1:1 complex has been prepared by a supersonic expansion with laser ablation of calcium metal in the gas phase. Tunable laser excitation of these complexes in molecular states correlating to Ca (1)P1(4s4p) + CH3F allows observing two competitive channels: the direct dissociation and the reactive channel into CaF* + CH3. The translational recoil, as well as the alignment of the fragments Ca* and CaF* have been analyzed by velocity map imaging and time-of-flight mass spectrometry. This revealed that both the dissociation and reaction processes are quasi direct and are of comparable intensity. We provide a simple interpretation for this process: the electronically excited potential surface of the Ca*···FCH3 complex initiates a fast predissociation from a suspended well to two repulsive surfaces that lead either to Ca (1)P1(4s4p) (Ω = 1) + CH3F or to CaF((2)Δ) + CH3.

A systematic review and meta-analysis of complications following the posterior and lateral surgical approaches to total hip arthroplasty.

INTRODUCTION: Total hip arthroplasty is one of the most commonly performed orthopaedic procedures. Despite this, medical evidence to inform the choice of surgical approach is lacking. Currently in the UK, the two most frequently performed approaches to the hip are the posterior and the direct lateral. METHODS: This systematic review was performed according to Cochrane guidelines following an extensive search for prospective controlled trials published in any language before January 2014. Of the 728 records identified from searches, 6 prospective studies (including 3 randomised controlled trials) involving 517 participants provided data towards this review. FINDINGS: Compared with the lateral approach, the posterior approach conferred a significant reduction in the risk of Trendelenburg gait (odds ratio [OR]: 0.31, p=0.0002) and stem malposition (OR: 0.24, p=0.02), and a non-significant reduction in dislocation (OR: 0.37, p=0.16) and heterotopic ossification (OR: 0.41, p=0.13). Neither approach conferred a functional advantage. We draw attention to the paucity of evidence and the need for a further randomised trial.

Mortality after total hip replacement surgery: A systematic review.

Total hip replacement causes a short-term increase in the risk of mortality. It is important to quantify this and to identify modifiable risk factors so that the risk of post-operative mortality can be minimised. We performed a systematic review and critical evaluation of the current literature on the topic. We identified 32 studies published over the last 10 years which provide either 30-day or 90-day mortality data. We estimate the pooled incidence of mortality during the first 30 and 90 days following hip replacement to be 0.30% (95% CI 0.22 to 0.38) and 0.65% (95% CI 0.50 to 0.81), respectively. We found strong evidence of a temporal trend towards reducing mortality rates despite increasingly co-morbid patients. The risk factors for early mortality most commonly identified are increasing age, male gender and co-morbid conditions, particularly cardiovascular disease. Cardiovascular complications appear to have overtaken fatal pulmonary emboli as the leading cause of death after hip replacement. Cite this article: Bone Joint Res 2014;3:175-82.

Multiple risk factor interventions for primary prevention of coronary heart disease.

BACKGROUND: Primary prevention programmes in many countries attempt to reduce mortality and morbidity due to coronary heart disease (CHD) through risk factor modification. It is widely believed that multiple risk factor intervention using counselling and educational methods is efficacious and cost-effective and should be expanded. Recent trials examining risk factor changes have cast considerable doubt on the effectiveness of these multiple risk factor interventions. OBJECTIVES: To assess the effects of multiple risk factor intervention for reducing cardiovascular risk factors, total mortality, and mortality from CHD among adults without clinical evidence of established cardiovascular disease. SEARCH STRATEGY: MEDLINE was searched for the original review to 1995. This was updated by searching the Cochrane Central Register of Controlled Trials on The Cochrane Library Issue 3 2001, MEDLINE (2000 to September 2001) and EMBASE (1998 to September 2001). SELECTION CRITERIA: Intervention studies using counselling or education to modify more than one cardiovascular risk factor in adults from general populations, occupational groups, or high risk groups. Trials of less than 6 months duration were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted by two reviewers independently. Investigators were contacted to obtain missing information. MAIN RESULTS: A total of 39 trials were found of which ten reported clinical event data. In the ten trials with clinical event end-points, the pooled odds ratios for total and CHD mortality were 0.96 (95% confidence intervals (CI) 0.92 to 1.01) and 0.96 (95% CI 0.89 to 1.04) respectively. Net changes in systolic and diastolic blood pressure, and blood cholesterol were (weighted mean differences) -3.6 mmHg (95% CI -3.9 to -3.3 mmHg), -2.8 mmHg (95% CI -2.9 to -2.6 mmHg) and -0.07 mMol/l (95% CI -0.8 to -0.06 mMol/l) respectively. Odds of reduction in smoking prevalence was 20% (95% CI 8% to 31%). Statistical heterogeneity between the studies with respect to mortality and risk factor changes was due to trials focusing on hypertensive participants and those using considerable amounts of drug treatment. AUTHORS' CONCLUSIONS: The pooled effects suggest multiple risk factor intervention has no effect on mortality. However, a small, but potentially important, benefit of treatment (about a 10% reduction in CHD mortality) may have been missed. Risk factor changes were relatively modest, were related to the amount of pharmacological treatment used, and in some cases may have been over-estimated because of regression to the mean effects, lack of intention to treat analyses, habituation to blood pressure measurement, and use of self-reports of smoking. Interventions using personal or family counselling and education with or without pharmacological treatments appear to be more effective at achieving risk factor reduction and consequent reductions in mortality in high risk hypertensive populations. The evidence suggests that such interventions have limited utility in the general population.

Accuracy and impact of risk assessment in the primary prevention of cardiovascular disease: a systematic review.

OBJECTIVE: To determine the accuracy of assessing cardiovascular disease (CVD) risk in the primary prevention of CVD and its impact on clinical outcomes. DESIGN: Systematic review. DATA SOURCES: Published studies retrieved from Medline and other databases. Reference lists of identified articles were inspected for further relevant articles. SELECTION OF STUDIES: Any study that compared the predicted risk of coronary heart disease (CHD) or CVD, with observed 10-year risk based on the widely recommended Framingham methods (review A). Randomised controlled trials examining the effect on clinical outcomes of a healthcare professional assigning a cardiovascular risk score to people predominantly without CVD (review B). REVIEW METHODS: Data were extracted on the ratio of the predicted to the observed 10-year risk of CVD and CHD (review A), and on cardiovascular or coronary fatal or non-fatal events, risk factor levels, absolute cardiovascular or coronary risk, prescription of risk-reducing drugs and changes in health-related behaviour (review B). RESULTS: 27 studies with data from 71,727 participants on predicted and observed risk for either CHD or CVD were identified. For CHD, the predicted to observed ratios ranged from an underprediction of 0.43 (95% CI 0.27 to 0.67) in a high-risk population to an overprediction of 2.87 (95% CI 1.91 to 4.31) in a lower-risk population. In review B, four randomised controlled trials confined to people with hypertension or diabetes found no strong evidence that a cardiovascular risk assessment performed by a clinician improves health outcomes. CONCLUSION: The performance of the Framingham risk scores varies considerably between populations and evidence supporting the use of cardiovascular risk scores for primary prevention is scarce.

Platelet aggregation in whole blood is a paradoxical predictor of ischaemic stroke: Caerphilly Prospective Study revisited.

The Caerphilly Prospective Study demonstrates a paradoxical association of increased ischaemic stroke risk with decreased whole blood adenosine diphosphate (ADP) induced platelet sensitivity. A reanalysis of this association examines whether other haematological indices and prevalent disease at baseline may explain this finding. There were 1506 men free of clinical cardiovascular disease at baseline, with 85 men manifesting a first ischaemic stroke event over 8.3 years of follow-up in this population-based prospective cohort study. Using two different approaches, the paradoxical findings are confirmed and associations are slightly stronger after accounting for red cell, platelet, and white cell indices. A U-shaped relation of stroke with platelet count is noted. These findings are consistent with the existence of sub-clinical endothelial disease and compensatory mechanisms down-regulating ADP-induced aggregation sensitivity. They support an allostasis model of causality for understanding the paradox. A public health approach to prevention could have measurable impact if intervention strategies can be developed to alter early stages of disease appropriate to such mechanisms of causation.