130 resultados para controlled trials


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Objective: Excessive alcohol consumption is common among people with psychotic disorders. While there is an extensive literature on the efficacy of psychological treatments for excessive drinking, few studies have examined interventions addressing this issue among people with psychotic disorders. Method: Systematic searches in PubMed and PsycINFO were conducted to identify randomized controlled trials comparing manual guided psychological interventions for excessive alcohol consumption among individuals with psychotic disorders. Of the 429 articles identified, 7 met inclusion criteria. Data were extracted from each study regarding study sample characteristics, design, results, clinical significance of alcohol consumption results, and methodological limitations. Results: Assessment interviews, brief motivational interventions and lengthier cognitive behavior therapy have been associated with reductions in alcohol consumption among people with psychosis. While brief interventions (i.e., 1-2 sessions) were generally as effective as longer duration psychological interventions (i.e., 10 session) for reducing alcohol consumption, longer interventions provided additional benefits for depression, functioning and other alcohol outcomes. Conclusion: Excessive alcohol consumption among people with psychotic disorders is responsive to psychological interventions. It is imperative that such approaches are integrated within standard care for people with psychosis.

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Background: Comorbidity of mental disorders and substance use continues to be a major problem. To inform the development of more effective interventions for these co-existing disorders, this paper aimed to determine if there are clear variations in the reasons for tobacco, alcohol or cannabis use across people with different mental disorders. Methods: Data from five randomized controlled trials on co-existing disorders that measured reasons for tobacco, alcohol or cannabis use using the Drug Use Motives Questionnaire, Reasons for Smoking Questionnaire or via free response are reported and combined. Two studies involved participants with depression, two involved participants with a psychotic disorder and one involved participants with a range of mental disorders. A series of logistic regressions were conducted to examine differences in reasons for tobacco, alcohol or cannabis use and to compare these reasons between people with psychotic disorders or depression. Results: Participants had a mean age of 38 (SD=12) and just over half (60%) were male. Forty-six percent of participants had a psychotic disorder and 54% experienced depression. Data from 976 participants across the five studies were included in the analyses. Tobacco and alcohol were primarily used to cope, while cannabis was primarily used for pleasure. People with psychotic disorders were more likely than people with depression to use tobacco for coping, pleasure and illness motives. People with depression, in contrast, were more likely to use alcohol for these reasons and social reasons. Conclusions: It may be important to tailor interventions for co-existing mental disorders and substance use by substance type and type of mental disorder. For example, interventions might be improved by including alternative coping strategies to tobacco and/or alcohol use, by addressing the social role of alcohol and by helping people with mental disorders using cannabis to gain pleasure from their lives in other ways.

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Background: There are strong logical reasons why energy expended in metabolism should influence the energy acquired in food-intake behavior. However, the relation has never been established, and it is not known why certain people experience hunger in the presence of large amounts of body energy. Objective: We investigated the effect of the resting metabolic rate (RMR) on objective measures of whole-day food intake and hunger. Design: We carried out a 12-wk intervention that involved 41 overweight and obese men and women [mean ± SD age: 43.1 ± 7.5 y; BMI (in kg/m2): 30.7 ± 3.9] who were tested under conditions of physical activity (sedentary or active) and dietary energy density (17 or 10 kJ/g). RMR, daily energy intake, meal size, and hunger were assessed within the same day and across each condition. Results: We obtained evidence that RMR is correlated with meal size and daily energy intake in overweight and obese individuals. Participants with high RMRs showed increased levels of hunger across the day (P < 0.0001) and greater food intake (P < 0.00001) than did individuals with lower RMRs. These effects were independent of sex and food energy density. The change in RMR was also related to energy intake (P < 0.0001). Conclusions: We propose that RMR (largely determined by fat-free mass) may be a marker of energy intake and could represent a physiologic signal for hunger. These results may have implications for additional research possibilities in appetite, energy homeostasis, and obesity. This trial was registered under international standard identification for controlled trials as ISRCTN47291569.

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Purpose of review: The study provides a review of current evidence about the role of complex nonpharmacological strategies in managing the multidimensional components of the breathlessness experience for individuals with life-limiting conditions. Recent findings: Evidence continues to demonstrate the significant impact of breathlessness on patients’ quality of life, day-to-day activity, and physical and psychosocial functioning. Recent evidence also confirms that patients draw on a number of self-initiated actions to cope with breathlessness, although many do not use strategies that are supported by a growing body of evidence from randomized controlled trials. Current literature supports the use of multicomponent, nonpharmacological interventions comprising strategies to improve breathing efficiency and reducing psychological distress to manage breathlessness. However trials of these approaches have mostly been conducted among patients with chronic obstructive pulmonary disease (COPD) or lung cancer, and few studies have investigated the benefits of nonpharmacological for patients in later stages of disease. Further investigation of interventions is required across a broader range of chronic life-limiting conditions. Addressing breathlessness and its co-occurring symptoms (symptom clusters) is also an area for future enquiry. Summary: The experience of breathlessness and strategies adopted by patients to manage the experience highlight the importance of multidimensional approaches to improve outcomes for patients with life-limiting conditions. There is good evidence to support the role of multicomponent, nonpharmacological interventions in reducing breathlessness for patients with COPD and lung cancer, although further studies are required to understand the particular clinical contexts in which such interventions are appropriate.

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Currently there is confusion about the value of using nutritional support to treat malnutrition and improve functional outcomes in chronic obstructive pulmonary disease (COPD). This systematic review and meta-analysis of randomised controlled trials (RCTs) aimed to clarify the effectiveness of nutritional support in improving functional outcomes in COPD. A systematic review identified 12 RCTs (n = 448) in stable COPD patients investigating the effects of nutritional support [dietary advice (1 RCT), oral nutritional supplements (ONS; 10 RCTs), enteral tube feeding (1 RCT)] versus control on functional outcomes. Meta-analysis of the changes induced by intervention found that whilst respiratory function (FEV(1,) lung capacity, blood gases) was unresponsive to nutritional support, both inspiratory and expiratory muscle strength (PI max +3.86 SE 1.89 cm H(2) O, P = 0.041; PE max +11.85 SE 5.54 cm H(2) O, P = 0.032) and handgrip strength (+1.35 SE 0.69 kg, P = 0.05) were significantly improved, and associated with weight gains of ≥ 2 kg. Nutritional support produced significant improvements in quality of life in some trials, although meta-analysis was not possible. It also led to improved exercise performance and enhancement of exercise rehabilitation programmes. This systematic review and meta-analysis demonstrates that nutritional support in COPD results in significant improvements in a number of clinically relevant functional outcomes, complementing a previous review showing improvements in nutritional intake and weight.

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Chemotherapy-induced nausea and vomiting (CINV) is a common side-effect of cytotoxic treatment. It continues to affect a significant proportion of patients despite the widespread use of anti-emetic medication. In folk-medicine, ginger (Zingiber officinale) has been used to prevent and treat nausea in many cultures for thousands of years. However, its use has not been validated in the chemotherapy context. To determine the potential use of ginger as a prophylactic or treatment of CINV, a systematic literature review was conducted. Reviewed studies comprised randomised controlled trials or cross-over trials that investigated the anti-CINV effect of ginger as the sole intervention independent variable in chemotherapy patients. Seven studies met the inclusion criteria. All studies were assessed on methodological quality and their limitations were identified. Studies were mixed in their support of ginger as an anti-CINV treatment in patients receiving chemotherapy, with three demonstrating a positive effect, two in favour but with caveats and two showing no effect on measures of CINV. Future studies are required to address the limitations identified before clinical use can be recommended.

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The aim of this systematic review was to examine the effect of Contrast Water Therapy (CWT) on recovery following exercise induced muscle damage. Controlled trials were identified from computerized literature searching and citation tracking performed up to February 2013. Eighteen trials met the inclusion criteria; all had a high risk of bias. Pooled data from 13 studies showed that CWT resulted in significantly greater improvements in muscle soreness at the five follow-up time points(<6, 24, 48, 72 and 96 hours) in comparison to passive recovery. Pooled data also showed that CWT significantly reduced muscle strength loss at each follow-up time (<6, 24, 48, 72 and 96 hours) in comparison to passive recovery. Despite comparing CWT to a large number of other recovery interventions, including cold water immersion, warm water immersion, compression, active recovery and stretching, there was little evidence for a superior treatment intervention. The current evidence base shows that CWT is superior to using passive recovery or rest after exercise; the magnitudes of these effects may be most relevant to an elite sporting population. There seems to be little difference in recovery outcome between CWT and other popular recovery interventions.

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Background/aims: Remote monitoring for heart failure has not only been evaluated in a large number of randomised controlled trials, but also in many systematic reviews and meta-analyses. The aim of this meta-review was to identify, appraise and synthesise existing systematic reviews that have evaluated the effects of remote monitoring in heart failure. Methods: Using a Cochrane methodology, we electronically searched all relevant online databases and search engines, performed a forward citation search as well as hand-searched bibliographies. Only fully published systematic reviews of invasive and/or non-invasive remote monitoring interventions were included. Two reviewers independently extracted data. Results: Sixty-five publications from 3333 citations were identified. Seventeen fulfilled the inclusion and exclusion criteria. Quality varied with A Measurement Tool to Assess Systematic Reviews (AMSTAR scores) ranging from 2 to 11 (mean 5.88). Seven reviews (41%) pooled results from individual studies for meta-analysis. Eight (47%) considered all non-invasive remote monitoring strategies. Four (24%) focused specifically on telemonitoring. Four (24%) included studies investigating both non-invasive and invasive technologies. Population characteristics of the included studies were not reported consistently. Mortality and hospitalisations were the most frequently reported outcomes 12 (70%). Only five reviews (29%) reported healthcare costs and compliance. A high degree of heterogeneity was reported in many of the meta-analyses. Conclusions: These results should be considered in context of two negative RCTs of remote monitoring for heart failure that have been published since the meta-analyses (TIM-HF and Tele-HF). However, high quality reviews demonstrated improved mortality, quality of life, reduction in hospitalisations and healthcare costs.

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I read with interest the article in Angiology that determined the role of anxiety level on radial artery spasm during transradial coronary angiography.1 As the importance of conducting more randomised controlled trials using anxiolytics to define the relation between anxiety and vasospasm was noted by the authors, I offer the following insights for investigators to consider when conducting such research. While previous research has already identified that moderate procedural sedation and opioid analgesia reduces the incidence of vasospasm,2 the identification of risk factors in the present study is hypothesis generating as to how outcomes might be even further improved. It is possible that selectively applying either even more intensive sedation and analgesia or complementary non-pharmacological stress-reducing therapies, such as music therapy or visualisation and attentive behaviour, to patients ‘at-risk’ of vasospasm (women and those with high levels of anxiety prior to the procedure) might lead to even better patient outcomes...

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BACKGROUND: US Centers for Disease Control guidelines recommend replacement of peripheral intravenous (IV) catheters no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation. Costs associated with routine replacement may be considerable. This is an update of a review first published in 2010. OBJECTIVES: To assess the effects of removing peripheral IV catheters when clinically indicated compared with removing and re-siting the catheter routinely. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases (PVD) Group Trials Search Co-ordinator searched the PVD Specialised Register (December 2012) and CENTRAL (2012, Issue 11). We also searched MEDLINE (last searched October 2012) and clinical trials registries. SELECTION CRITERIA: Randomised controlled trials that compared routine removal of peripheral IV catheters with removal only when clinically indicated in hospitalised or community dwelling patients receiving continuous or intermittent infusions. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: Seven trials with a total of 4895 patients were included in the review. Catheter-related bloodstream infection (CRBSI) was assessed in five trials (4806 patients). There was no significant between group difference in the CRBSI rate (clinically-indicated 1/2365; routine change 2/2441). The risk ratio (RR) was 0.61 but the confidence interval (CI) was wide, creating uncertainty around the estimate (95% CI 0.08 to 4.68; P = 0.64). No difference in phlebitis rates was found whether catheters were changed according to clinical indications or routinely (clinically-indicated 186/2365; 3-day change 166/2441; RR 1.14, 95% CI 0.93 to 1.39). This result was unaffected by whether infusion through the catheter was continuous or intermittent. We also analysed the data by number of device days and again no differences between groups were observed (RR 1.03, 95% CI 0.84 to 1.27; P = 0.75). One trial assessed all-cause bloodstream infection. There was no difference in this outcome between the two groups (clinically-indicated 4/1593 (0.02%); routine change 9/1690 (0.05%); P = 0.21). Cannulation costs were lower by approximately AUD 7.00 in the clinically-indicated group (mean difference (MD) -6.96, 95% CI -9.05 to -4.86; P ≤ 0.00001). AUTHORS' CONCLUSIONS: The review found no evidence to support changing catheters every 72 to 96 hours. Consequently, healthcare organisations may consider changing to a policy whereby catheters are changed only if clinically indicated. This would provide significant cost savings and would spare patients the unnecessary pain of routine re-sites in the absence of clinical indications. To minimise peripheral catheter-related complications, the insertion site should be inspected at each shift change and the catheter removed if signs of inflammation, infiltration, or blockage are present. OBJECTIVES: To assess the effects of removing peripheral IV catheters when clinically indicated compared with removing and re-siting the catheter routinely. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases (PVD) Group Trials Search Co-ordinator searched the PVD Specialised Register (December 2012) and CENTRAL (2012, Issue 11). We also searched MEDLINE (last searched October 2012) and clinical trials registries. SELECTION CRITERIA: Randomised controlled trials that compared routine removal of peripheral IV catheters with removal only when clinically indicated in hospitalised or community dwelling patients receiving continuous or intermittent infusions. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: Seven trials with a total of 4895 patients were included in the review. Catheter-related bloodstream infection (CRBSI) was assessed in five trials (4806 patients). There was no significant between group difference in the CRBSI rate (clinically-indicated 1/2365; routine change 2/2441). The risk ratio (RR) was 0.61 but the confidence interval (CI) was wide, creating uncertainty around the estimate (95% CI 0.08 to 4.68; P = 0.64). No difference in phlebitis rates was found whether catheters were changed according to clinical indications or routinely (clinically-indicated 186/2365; 3-day change 166/2441; RR 1.14, 95% CI 0.93 to 1.39). This result was unaffected by whether infusion through the catheter was continuous or intermittent. We also analysed the data by number of device days and again no differences between groups were observed (RR 1.03, 95% CI 0.84 to 1.27; P = 0.75). One trial assessed all-cause bloodstream infection. There was no difference in this outcome between the two groups (clinically-indicated 4/1593 (0.02%); routine change 9/1690 (0.05%); P = 0.21). Cannulation costs were lower by approximately AUD 7.00 in the clinically-indicated group (mean difference (MD) -6.96, 95% CI -9.05 to -4.86; P ≤ 0.00001). AUTHORS' CONCLUSIONS: The review found no evidence to support changing catheters every 72 to 96 hours. Consequently, healthcare organisations may consider changing to a policy whereby catheters are changed only if clinically indicated. This would provide significant cost savings and would spare patients the unnecessary pain of routine re-sites in the absence of clinical indications. To minimise peripheral catheter-related complications, the insertion site should be inspected at each shift change and the catheter removed if signs of inflammation, infiltration, or blockage are present.

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Background Women undergoing Cesarean Section (CS) are vulnerable to the adverse effects associated with perioperative core temperature drop, in part due to the tendency for CS to be performed under neuraxial anesthesia, blood and fluid loss, and vasodilation. Inadvertent perioperative hypothermia (IPH) is a common condition that affects patients undergoing surgery of all specialties and is detrimental to all age groups, including neonates. Previous systematic reviews on IPH prevention largely focus on either adult or all ages populations, and have mainly overlooked pregnant or CS patients as a distinct group. Not all recommendations made by systematic reviews targeting all adult patients may be transferable to CS patients. Alternative, effective methods for preventing or managing hypothermia in this group would be valuable. Objectives To synthesize the best available evidence in relation to preventing and/or treating hypothermia in mothers after CS surgery. Types of participants Adult patients over the age of 18 years, of any ethnic background, with or without co-morbidities, undergoing any mode of anesthesia for any type of CS (emergency or planned) at healthcare facilities who have received interventions to limit or manage perioperative core heat loss were included. Types of intervention(s) Active or passive warming methods versus usual care or placebo, that aim to limit or manage core heat loss as applied to women undergoing CS were included. Types of studies Randomized controlled trials (RCTs) that met the inclusion criteria, with reduction of perioperative hypothermia a primary or secondary outcome were considered. Types of outcomes Primary outcome: maternal core temperature measured during the preoperative, intraoperative and postoperative phases of care Secondary outcomes: newborn core temperature at birth, umbilical pH obtained immediately after birth, Apgar scores, length of Post Anesthetic Care Unit (PACU) stay, maternal thermal comfort. Search strategy A comprehensive search was undertaken of the following databases from their inception until May 2012: ProQuest, Web of Science, Scopus, Dissertation and Theses PQDT (via ProQuest), Current Contents, CENTRAL, Mednar, OpenGrey, Clinical Trials. There were no language restrictions. Methodological quality Retrieved papers were assessed for methodological quality by two independent reviewers prior to inclusion using JBI software. Disagreements were resolved via consultation with the third reviewer. An assessment of quality of the included papers was also made in relation to five key quality factors. Data collection Two independent reviewers extracted data from the included papers using a previously piloted customized data extraction tool. Results 12 studies with a combined total of 719 participants were included. Three broad intervention groups were identified; intravenous (IV) fluid warming, warming devices, leg wrapping. IV fluid warming, whether administered intraoperatively or preoperatively, was found to be effective at maintaining maternal (but not neonatal) temperature and preventing shivering, but does not improve thermal comfort. The effectiveness of IV fluid warming on Apgar scores and umbilical pH remains unclear. Warming devices, including forced air warming and under body carbon polymer mattresses, were effective at preventing hypothermia and reduced shivering, however were most effective if applied preoperatively. The effectiveness of warming devices to improve thermal comfort remains unclear. Preoperative forced air warming appears to aid maintenance of neonatal temperature, while intraoperative forced air warming does not. Forced air warming was not effective at improving Apgar scores and the effects for umbilical pH remain unclear. Conclusions Intravenous fluid warming, by any method, improves maternal temperature and reduces shivering for women undergoing CS. Preoperative body warming devices also improve maternal temperature, in addition to reducing shivering.

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Background Exploring self management in End Stage Renal Disease is extremely important for patients as they encounter several challenges including ongoing symptoms, complex treatments and restrictions, uncertainty about life and a dependency on technology, all of which impact upon their autonomy particularly after commencement of haemodialysis. Objective To summarise the effects of nursing interventions which effect selfmanagement of haemodialysis for patients with End Stage Renal Disease. Search strategy Search terms were chosen after reviewing text words and MeSH terms in relevant articles and databases. An extensive search of the literature from 1966 to June 2009 was conducted across a range of health databases including Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, PsycINFO and Web of Science. Further studies were identified from reference lists of all retrieved studies. Selection criteria We considered randomised controlled trials that compared interventions to improve self management of haemodialysis in patients with ESRD. In the absence of RCTs, comparative studies without randomisation as well as before and after studies were considered for inclusion. Methodological quality Study reports selected for retrieval were assessed by two independent reviewers for methodological quality prior to inclusion in the review using the standardised critical appraisal instruments for the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information package (SUMARI). Data collection and analysis Data was extracted using the JBI data extraction tool for evidence of effectiveness independently by pairs of review authors. The evidence was reported in narrative summaries due to heterogeneity of the interventions of the studies. Results and conclusions Five randomised controlled trials were included in the review. Overall, the evidence found that psychosocial and educational interventions influenced self management of haemodialysis in this patient population.

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Background The prevalence of type 2 diabetes is rising internationally. Patients with diabetes have a higher risk of cardiovascular events accounting for substantial premature morbidity and mortality, and health care expenditure. Given healthcare workforce limitations, there is a need to improve interventions that promote positive self-management behaviours that enable patients to manage their chronic conditions effectively, across different cultural contexts. Previous studies have evaluated the feasibility of including telephone and Short Message Service (SMS) follow up in chronic disease self-management programs, but only for single diseases or in one specific population. Therefore, the aim of this study is to evaluate the feasibility and short-term efficacy of incorporating telephone and text messaging to support the care of patients with diabetes and cardiac disease, in Australia and in Taiwan. Methods/design A randomised controlled trial design will be used to evaluate a self-management program for people with diabetes and cardiac disease that incorporates the use of simple remote-access communication technologies. A sample size of 180 participants from Australia and Taiwan will be recruited and randomised in a one-to-one ratio to receive either the intervention in addition to usual care (intervention) or usual care alone (control). The intervention will consist of in-hospital education as well as follow up utilising personal telephone calls and SMS reminders. Primary short term outcomes of interest include self-care behaviours and self-efficacy assessed at baseline and four weeks. Discussion If the results of this investigation substantiate the feasibility and efficacy of the telephone and SMS intervention for promoting self management among patients with diabetes and cardiac disease in Australia and Taiwan, it will support the external validity of the intervention. It is anticipated that empirical data from this investigation will provide valuable information to inform future international collaborations, while providing a platform for further enhancements of the program, which has potential to benefit patients internationally.

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Background This is an updated version of a Cochrane review first published in Issue 1, 2010 of The Cochrane Library. In many clinical areas, integrated care pathways are utilised as structured multidisciplinary care plans that detail essential steps in caring for patients with specific clinical problems. In particular, care pathways for the dying have been developed as a model to improve care of patients who are in the last days of life. The care pathways were designed with an aim of ensuring that the most appropriate management occurs at the most appropriate time and that it is provided by the most appropriate health professional. There have been sustained concerns about the safety of implementing end-of-life care pathways, particularly in the UK. Therefore, there is a significant need for clinicians and policy makers to be informed about the effects of end-of-life care pathways with a systematic review. Objectives To assess the effects of end-of-life care pathways, compared with usual care (no pathway) or with care guided by another end-of-life care pathway across all healthcare settings (e.g. hospitals, residential aged care facilities, community). In particular, we aimed to assess the effects on symptom severity and quality of life of people who are dying; those related to the care such as families, carers and health professionals; or a combination of these. Search Methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 6, 2013), MEDLINE, EMBASE, PsycINFO, CINAHL, review articles and reference lists of relevant articles.We conducted the original search in September 2009, and the updated search in June 2013. Selection Criteria All randomised controlled trials (RCTs), quasi-randomised trial or high-quality controlled before-and-after studies comparing use versus non-use of an end-of-life care pathway in caring for the dying. Data Collection and Analysis Two review authors assessed the results of the searches against the predetermined criteria for inclusion. Main Results The original review identified 920 titles. The updated search found 2042 potentially relevant titles (including the original 920), but no additional studies met criteria for inclusion in the review update. Authors’ Conclusions With sustained concerns about the safety of the pathway implementation and the lack of available evidence on important patient and relative outcomes, recommendations for the use of end-of-life pathways in caring for the dying cannot be made. Since the last version of this review, no new studies met criteria for inclusion in the review update. With recently documented concerns related to the potential adverse effects associated with Liverpool Care Pathway (the most commonly used end-of-life care pathway), we do not recommend decision making based on indirect or low-quality evidence. All health services using end-of-life care pathways are encouraged to have their use of the pathway, to date, independently audited. Any subsequent use should be based on carefully documented evaluations. Large RCTs or other well-designed controlled studies are urgently required for the evaluation of the use of end-of-life care pathways in caring for dying people in various clinical settings. In future studies, outcome measures should include benefits or harms concerning the outcomes of interest in this review in relation to patients, families, carers and health professionals.