Psychological interventions for emotional well-being in adults with advanced progressive life-limiting illness.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To determine the benefits and harms of psychological interventions compared to treatment as usual, waiting list, active control, or another psychological intervention to improve emotional well-being in adults with an advanced progressive life-limiting illness.

Do palliative care patients and relatives think it would be acceptable to use Bispectral index (BIS) technology to monitor palliative care patients' levels of consciousness? A qualitative exploration with interviews and focus groups for the I-CAN-CARE research programme.

BACKGROUND: Bispectral index (BIS) monitoring uses electroencephalographic data as an indicator of patients' consciousness level. This technology might be a useful adjunct to clinical observation when titrating sedative medications for palliative care patients. However, the use of BIS in palliative care generally, and in the UK in particular, is under-researched. A key area is this technology's acceptability for palliative care service users. Ahead of trialling BIS in practice, and in order to ascertain whether such a trial would be reasonable, we conducted a study to explore UK palliative care patients' and relatives' perceptions of the technology, including whether they thought its use in palliative care practice would be acceptable. METHODS: A qualitative exploration was undertaken. Participants were recruited through a UK hospice. Focus groups and semi-structured interviews were conducted with separate groups of palliative care patients, relatives of current patients, and bereaved relatives. We explored their views on acceptability of using BIS with palliative care patients, and analysed their responses following the five key stages of the Framework method. RESULTS: We recruited 25 participants. There were ten current hospice patients in three focus groups, four relatives of current patients in one focus group and one individual interview, and eleven bereaved relatives in three focus groups and two individual interviews. Our study participants considered BIS acceptable for monitoring palliative care patients' consciousness levels, and that it might be of use in end-of-life care, provided that it was additional to (rather than a replacement of) usual care, and patients and/or family members were involved in decisions about its use. Participants also noted that BIS, while possibly obtrusive, is not invasive, with some seeing it as equivalent to wearable technological devices such as activity watches. CONCLUSIONS: Participants considered BIS technology might be of benefit to palliative care as a non-intrusive means of assisting clinical assessment and decision-making at the end of life, and concluded that it would therefore be acceptable to trial the technology with patients.

Drug therapy for delirium in terminally ill adults.

BACKGROUND: Delirium is a syndrome characterised by an acute disturbance of attention and awareness which develops over a short time period and fluctuates in severity over the course of the day. It is commonly experienced during inpatient admission in the terminal phase of illness. It can cause symptoms such as agitation and hallucinations and is distressing for terminally ill people, their families and staff. Delirium may arise from any number of causes and treatment should aim to address these causes. When this is not possible, or treatment is unsuccessful, drug therapy to manage the symptoms may become necessary. This is the second update of the review first published in 2004. OBJECTIVES: To evaluate the effectiveness and safety of drug therapies to manage delirium symptoms in terminally ill adults. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO from inception to July 2019, reference lists of retrieved papers, and online trial registries. SELECTION CRITERIA: We included randomised controlled trials of drug therapies in any dose by any route, compared to another drug therapy, a non-pharmacological approach, placebo, standard care or wait-list control, for the management of delirium symptoms in terminally ill adults (18 years or older). DATA COLLECTION AND ANALYSIS: We independently screened citations, extracted data and assessed risk of bias. Primary outcomes were delirium symptoms; agitation score; adverse events. Secondary outcomes were: use of rescue medication; cognitive status; survival. We applied the GRADE approach to assess the overall quality of the evidence for each outcome and we include eight 'Summary of findings' tables. MAIN RESULTS: We included four studies (three new to this update), with 399 participants. Most participants had advanced cancer or advanced AIDS, and mild- to moderate-severity delirium. Meta-analysis was not possible because no two studies examined the same comparison. Each study was at high risk of bias for at least one criterion. Most evidence was low to very low quality, downgraded due to very serious study limitations, imprecision or because there were so few data. Most studies reported delirium symptoms; two reported agitation scores; three reported adverse events with data on extrapyramidal effects; and none reported serious adverse events. 1. Haloperidol versus placebo There may be little to no difference between placebo and haloperidol in delirium symptoms within 24 hours (mean difference (MD) 0.34, 95% confidence interval (CI) -0.07 to 0.75; 133 participants). Haloperidol may slightly worsen delirium symptoms compared with placebo at 48 hours (MD 0.49, 95% CI 0.10 to 0.88; 123 participants with mild- to moderate-severity delirium). Haloperidol may reduce agitation slightly compared with placebo between 24 and 48 hours (MD -0.14, 95% -0.28 to -0.00; 123 participants with mild- to moderate-severity delirium). Haloperidol probably increases extrapyramidal adverse effects compared with placebo (MD 0.79, 95% CI 0.17 to 1.41; 123 participants with mild- to moderate-severity delirium). 2. Haloperidol versus risperidone There may be little to no difference in delirium symptoms with haloperidol compared with risperidone within 24 hours (MD -0.42, 95% CI -0.90 to 0.06; 126 participants) or 48 hours (MD -0.36, 95% CI -0.92 to 0.20; 106 participants with mild- to moderate-severity delirium). Agitation scores and adverse events were not reported for this comparison. 3. Haloperidol versus olanzapine We are uncertain whether haloperidol reduces delirium symptoms compared with olanzapine within 24 hours (MD 2.36, 95% CI -0.75 to 5.47; 28 participants) or 48 hours (MD 1.90, 95% CI -1.50 to 5.30, 24 participants). Agitation scores and adverse events were not reported for this comparison. 4. Risperidone versus placebo Risperidone may slightly worsen delirium symptoms compared with placebo within 24 hours (MD 0.76, 95% CI 0.30 to 1.22; 129 participants); and at 48 hours (MD 0.85, 95% CI 0.32 to 1.38; 111 participants with mild- to moderate-severity delirium). There may be little to no difference in agitation with risperidone compared with placebo between 24 and 48 hours (MD -0.05, 95% CI -0.19 to 0.09; 111 participants with mild- to moderate-severity delirium). Risperidone may increase extrapyramidal adverse effects compared with placebo (MD 0.73 95% CI 0.09 to 1.37; 111 participants with mild- to moderate-severity delirium). 5. Lorazepam plus haloperidol versus placebo plus haloperidol We are uncertain whether lorazepam plus haloperidol compared with placebo plus haloperidol improves delirium symptoms within 24 hours (MD 2.10, 95% CI -1.00 to 5.20; 50 participants with moderate to severe delirium), reduces agitation within 24 hours (MD 1.90, 95% CI 0.90 to 2.80; 52 participants), or increases adverse events (RR 0.70, 95% CI -0.19 to 2.63; 31 participants with moderate to severe delirium). 6. Haloperidol versus chlorpromazine We are uncertain whether haloperidol reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 0.37, 95% CI -4.58 to 5.32; 24 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with chlorpromazine (MD 0.46, 95% CI -4.22 to 5.14; 24 participants). 7. Haloperidol versus lorazepam We are uncertain whether haloperidol reduces delirium symptoms compared with lorazepam at 48 hours (MD -4.88, 95% CI -9.70 to 0.06; 17 participants). Agitation scores were not reported. We are uncertain whether haloperidol increases adverse events compared with lorazepam (MD -6.66, 95% CI -14.85 to 1.53; 17 participants). 8. Lorazepam versus chlorpromazine We are uncertain whether lorazepam reduces delirium symptoms compared with chlorpromazine at 48 hours (MD 5.25, 95% CI 0.38 to 10.12; 19 participants), or increases adverse events (MD 7.12, 95% CI 1.08 to 15.32; 18 participants). Agitation scores were not reported. SECONDARY OUTCOMES: use of rescue medication, cognitive impairment, survival There were insufficient data to draw conclusions or assess GRADE. AUTHORS' CONCLUSIONS: We found no high-quality evidence to support or refute the use of drug therapy for delirium symptoms in terminally ill adults. We found low-quality evidence that risperidone or haloperidol may slightly worsen delirium symptoms of mild to moderate severity for terminally ill people compared with placebo. We found moderate- to low-quality evidence that haloperidol and risperidone may slightly increase extrapyramidal adverse events for people with mild- to moderate-severity delirium. Given the small number of studies and participants on which current evidence is based, further research is essential.

Acceptance and commitment therapy for adults with advanced cancer (CanACT): A feasibility randomised controlled trial.

OBJECTIVE: To understand the feasibility of recruiting people with advanced cancer into a randomised controlled trial of acceptance and commitment therapy (ACT) vs a standardised talking control (TC) and delivering ACT to this population; to explore the acceptability of outcome measures and generate normative data. METHODS: This was a feasibility two-arm randomised controlled trial. Participants were attendees with advanced cancer at one of three hospice-based day-therapy units in London, United Kingdom, who demonstrated low scores on the Functional Assessment of Cancer Therapies-General (FACT-G). The primary end point was 3 months. RESULTS: The recruitment target was 54 participants; 42 people were recruited and randomised to up to eight individual sessions of ACT (n = 20) or TC (n = 22). Eighteen out of 42 (43%) of participants completed the primary outcome at 3 months, and at least one follow-up was available in 30/42 (71%) participants. An exploratory analysis revealed a non-significant adjusted mean difference after 3 months in the main outcome FACT-G of -3.41 (CI = -18.61-11.79) with TC having better functioning. Over 6 months, the adjusted mean difference between trial arms was 2.25 (CI = -6.03-10.52) in favour of ACT. CONCLUSIONS: It is feasible to recruit people with advanced cancer in a trial of ACT versus TC. Future research should test the effectiveness of ACT in a fully powered trial.

Interventions for sexual dysfunction following treatments for cancer in women.

BACKGROUND: The proportion of people living with and surviving cancer is growing. This has led to increased awareness of the importance of quality of life, including sexual function, in those affected by cancer. Sexual dysfunction is a potential long-term complication of many cancer treatments. This includes treatments that have a direct impact on the pelvic area and genitals, and also treatments that have a more generalised (systemic) impact on sexual function.This is an update of the original Cochrane review published in Issue 4, 2007, on interventions for treating sexual dysfunction following treatments for cancer for men and women. Since publication in 2007, there has been an increase in the number of trials for both men and women and this current review critiques only those for women. A review in press will present those for men. OBJECTIVES: To evaluate the effectiveness of interventions for treating sexual dysfunction in women following treatments for cancer. To assess adverse events associated with interventions. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Dissertation Abstracts and the NHS Research Register. The searches were originally run in January 2007 and we updated these to September 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that assessed the effectiveness of a treatment for sexual dysfunction. The trial participants were women who had developed sexual dysfunction as a consequence of a cancer treatment. We sought evaluations of interventions that were pharmaceutical, mechanical, psychotherapeutic, complementary or that involved physical exercise. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed trial quality. We considered meta-analysis for trials with comparable key characteristics. MAIN RESULTS: Since the original version of this review we have identified 11 new studies in women. The one study identified in the earlier version of this review was excluded in this update as it did not meet our narrower inclusion criteria to include only interventions for the treatment, not prevention, of sexual dysfunction.In total 1509 female participants were randomised across 11 trials. All trials explored interventions following treatment either for gynaecological or breast cancer. Eight trials evaluated a psychotherapeutic or psycho-educational intervention. Two trials evaluated a pharmaceutical intervention and one pelvic floor exercises. All involved heterosexual women. Eight studies were at a high risk of bias as they involved a sample of fewer than 50 participants per trial arm. The trials varied not only in intervention content but in outcome measurements, thereby restricting combined analysis. In the trials evaluating a psychotherapeutic intervention the effect on sexual dysfunction was mixed; in three trials benefit was found for some measures of sexual function and in five trials no benefit was found. Evidence from the other three trials, two on different pharmaceutical applications and one on exercise, differed and was limited by small sample sizes. Only the trial of a pH-balanced vaginal gel found significant improvements in sexual function. The trials of pharmaceutical interventions measured harm: neither reported any. Only one psychological intervention trial reported that no harm occurred because of the intervention; the other trials of psychological support did not measure harm. AUTHORS' CONCLUSIONS: Since the last version of this review, the new studies do not provide clear information on the impact of interventions for sexual dysfunction following treatments for cancer in women. The sexual dysfunction interventions in this review are not representative of the range that is available for women, or of the wider range of cancers in which treatments are known to increase the risk of sexual problems. Further evaluations are needed.

Promoting lifestyle behaviour change and well-being in hospital patients: a pilot study of an evidence-based psychological intervention.

BACKGROUND: Lifestyle risk behaviours show an inverse social gradient, clustering in vulnerable groups. We designed and piloted an intervention to address barriers to lifestyle behaviour change among hospital patients. METHODS: We designed our intervention using effective components of behaviour change interventions informed by psychological theory. Delivered by a health psychologist based at the Royal Free London NHS Foundation Trust, the 4-week intervention included detailed baseline assessment, personalized goal setting, psychological skills development, motivation support and referral to community services. Primary outcomes were feasibility and patient acceptability. We also evaluated changes to health and well-being. RESULTS: From 1 July 2013 to 31 September 2014, 686 patients were referred, 338 (49.3%) attended a first appointment and 172 (25.1%) completed follow-up. Furthermore, 72.1% of attenders were female with the median age 55 years and poor self-reported baseline health. After 4 weeks, self-efficacy, health and well-being scores significantly improved: 63% of lifestyle goals and 89% of health management goals were fully achieved; 58% of referrals to community lifestyle behaviour change services and 79% of referrals to other services (e.g. Citizen's Advice Bureau) were accepted; 99% were satisfied/very satisfied with the service. CONCLUSIONS: Our hospital-based intervention was feasible, acceptable and showed preliminary health and well-being gains.

'I am actually doing something to keep well. That feels really good': Experiences of exercise within hospice care.

Background: Patients with advanced cancer frequently experience functional impairment and reduced quality of life. Therapeutic exercise can provide benefit and be made accessible through the use of tailored programmes. Most studies examining exercise programmes for people with advanced cancer have used quantitative outcome measures and focussed on objective physical function, therefore offer a limited perspective on the experience of exercise participation. Methods: This qualitative study explored patients' experiences of an exercise programme within a palliative care setting. The interviews focussed on the perceived impact on all aspects of quality of life. Results: Nine people with advanced cancer, attending a hospice-based exercise programme, completed a one-to-one interview with a senior physiotherapist to explore the physical, emotional, and social impacts of their participation. Interviews were audiotaped, transcribed verbatim and analysed using interpretive phenomenological analysis. Patients reported an awareness of the positive physical, psychological, and social consequences of exercising. Their experiences reflected on all dimensions of quality of life, the impact of others and the sense of meaning gained through participation in exercise. Conclusion: Our findings highlight that exercise in palliative care should not be viewed solely a physical intervention, but one that has potential to enhance many aspects of patients' quality of life.

Laxatives for the management of constipation in people receiving palliative care.

BACKGROUND: This article describes the second update of a Cochrane review on the effectiveness of laxatives for the management of constipation in people receiving palliative care. Previous versions were published in 2006 and 2010 where we also evaluated trials of methylnaltrexone; these trials have been removed as they are included in another review in press. In these earlier versions, we drew no conclusions on individual effectiveness of different laxatives because of the limited number of evaluations. This is despite constipation being common in palliative care, generating considerable suffering due to the unpleasant physical symptoms and the availability of a wide range of laxatives with known differences in effect in other populations. OBJECTIVES: To determine the effectiveness and differential efficacy of laxatives used to manage constipation in people receiving palliative care. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), MEDLINE, EMBASE, CINAHL and Web of Science (SCI & CPCI-S) for trials to September 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating laxatives for constipation in people receiving palliative care. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity. MAIN RESULTS: We identified five studies involving the laxatives lactulose, senna, co-danthramer, misrakasneham, docusate and magnesium hydroxide with liquid paraffin. Overall, the study findings were at an unclear risk of bias. As all five studies compared different laxatives or combinations of laxatives, it was not possible to perform a meta-analysis. There was no evidence on whether individual laxatives were more effective than others or caused fewer adverse effects. AUTHORS' CONCLUSIONS: This second update found that laxatives were of similar effectiveness but the evidence remains limited due to insufficient data from a few small RCTs. None of the studies evaluated polyethylene glycol or any intervention given rectally. There is a need for more trials to evaluate the effectiveness of laxatives in palliative care populations. Extrapolating findings on the effectiveness of laxatives evaluated in other populations should proceed with caution. This is because of the differences inherent in people receiving palliative care that may impact, in a likely negative way, on the effect of a laxative.

Exploratory study of frequent attenders in general practice to better understand why patients seek help.

BACKGROUND: Frequent attenders (defined as the top 10% of health care users or those making ≥10 visits per year) account for 30-50% of GP consultations. This has significant resource implications. AIM: To understand the characteristics of frequent attenders (≥18-years) at an outer London general practice (list 5,876; deprivation index 5th decile) and reasons for attending. METHOD: A retrospective case note review was conducted using SystmOne of people attending on ≥10 occasions to see a health professional between March 2022 and February 2023. Data were extracted by hand: age, gender, reason and type of consultation, diagnoses, referrals, Charlson Comorbidity Index (CCI), mortality at one year. Patient notes for ≥30 contacts were reviewed by a senior GP. RESULTS: 544 people (9.3%) attended ≥10 appointments. Of these, five interacted with a GP ≥50 occasions (Group 1;mean age:74.6yrs/female: 4 /CCI:5.0), eight ≥40 occasions (Group 2; 69.6yrs/6.0/5.5) and 35 ≥30 occasions (Group 3;70yrs/27/4.7). Forty-eight people accounted for 882 appointments, 29% face to face and 71% by telephone. Frequency increased with age and CCI. Patients in group 3 underwent more investigations (6.0/6.0/10.0). There was no difference in mean numbers of clinicians seen (6.4/7.1/7.4) or referrals (5.0/4.0/5.0) between the three groups. Frequent attenders tended to fall into two groups: people with chronic diseases, typically associated with anxiety and complex needs, and people with ongoing mental health conditions. Coding was challenging due to complexity. CONCLUSION: Frequent attenders presented due to their medical complexity or mental health disorders rather than medically unexplained symptoms. Most interactions with a GP are understandable.

Spiritual beliefs near the end of life: a prospective cohort study of people with cancer receiving palliative care.

OBJECTIVES: Despite growing research interest in spirituality and health, and recommendations on the importance of spiritual care in advanced cancer and palliative care, relationships between spiritual belief and psychological health near death remain unclear. We investigated (i) relationships between strength of spiritual beliefs and anxiety and depression, intake of psychotropic/analgesic medications and survival in patients with advanced disease; and (ii) whether the strength of spiritual belief changes as death approaches. METHODS: We conducted a prospective cohort study of 170 patients receiving palliative care at home, 97% of whom had a diagnosis of advanced cancer. Data on strength of spiritual beliefs (Beliefs and Values Scale [BVS]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), psychotropic/analgesic medications, daily functioning, global health and social support were collected at recruitment then 3 and 10 weeks later. Mortality data were collected up to 34 months after the first patient was recruited. RESULTS: Regression analysis showed a slight increase in strength of spiritual belief over time approaching statistical significance (+0.16 BVS points per week, 95% CI [-0.01, 0.33], p = 0.073). Belief was unrelated to anxiety and depression (-0.15 points decrease in HADS for 10 points increased in BVS (95% CI [-0.57, 0.27], p = 0.49) or consumption of psychotropic medication). There was a non-significant trend for decreasing analgesic prescription with increasing belief. Mortality was higher over 6 months in participants with lower belief at recruitment. CONCLUSION: Results suggest that although religious and spiritual beliefs might increase marginally as death approaches, they do not affect levels of anxiety or depression in patients with advanced cancer.

Drug therapy for symptoms associated with anxiety in adult palliative care patients.

BACKGROUND: This is an update of the review published on 'Drug therapy for anxiety in adult palliative care patients' in Issue 1, 2004 of The Cochrane Library. Anxiety is common in palliative care patients. It can be a natural response to impending death, but it may represent a clinically significant issue in its own right. It may also result from pain, or other untreated or poorly managed symptoms. When anxiety is severe or distressing drug therapy may be considered in addition to supportive care. OBJECTIVES: This review aimed to identify and evaluate randomised controlled trials examining the effectiveness of drug therapy for symptoms of anxiety in adult palliative care patients. SEARCH METHODS: We searched the following sources: CENTRAL (The Cochrane Library 2012, Issue 2), MEDLINE (1966 to 2012), EMBASE (1980 to 2012), CINAHL (1982 to 2012), PsycLit (1974 to 2000) and PsycInfo (1990 to 2012) for literature pertaining to this topic published in any language using a detailed search strategy. SELECTION CRITERIA: We sought prospective, randomised trials, with or without blinding, involving the use of drug therapy for the treatment of symptoms of anxiety in adult palliative care patients. Pharmacological agents included 5-HT3 receptor antagonists, anxiolytic agents, antiepileptic agents, antidepressive agents, antipsychotic agents, benzodiazepines, butyrophenones, phenothiazines, antihistamines, barbiturates, sedative hypnotics, antiepileptic drugs and beta-blockers. DATA COLLECTION AND ANALYSIS: We identified and excluded six studies using the original search strategy, with a further two studies being identified and excluded for this 2012 update. We therefore identified a total of eight potential studies but none met the criteria for inclusion in this review. MAIN RESULTS: No data were available to enable an assessment to be made of the effectiveness of drugs to treat symptoms of anxiety in palliative care patients. AUTHORS' CONCLUSIONS: There remains insufficient evidence to draw a conclusion about the effectiveness of drug therapy for symptoms of anxiety in adult palliative care patients. To date no studies have been found that meet the inclusion criteria for this review. Prospective controlled clinical trials are required in order to establish the benefits and harms of drug therapy for the treatment of anxiety in palliative care.

Drug therapy for delirium in terminally ill adult patients.

BACKGROUND: Delirium is a syndrome characterised by a disturbance of consciousness (often fluctuating), cognition and perception. In terminally ill patients it is one of the most common causes of admission to clinical care. Delirium may arise from any number of causes and treatment should be directed at addressing these causes rather than the symptom cluster. In cases where this is not possible, or treatment does not prove successful, the use of drug therapy to manage the symptoms may become necessary. This is an update of the review published on 'Drug therapy for delirium in terminally ill adult patients' in The Cochrane Library 2004, Issue 2 ( Jackson 2004). OBJECTIVES: To evaluate the effectiveness of drug therapies to treat delirium in adult patients in the terminal phase of a disease. SEARCH METHODS: We searched the following sources: CENTRAL (The Cochrane Library 2012, Issue 7), MEDLINE (1966 to 2012), EMBASE (1980 to 2012), CINAHL (1982 to 2012) and PSYCINFO (1990 to 2012). SELECTION CRITERIA: Prospective trials with or without randomisation or blinding involving the use of drug therapies for the treatment of delirium in adult patients in the terminal phase of a disease. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality using standardised methods and extracted trial data. We collected outcomes related to efficacy and adverse effects. MAIN RESULTS: One trial met the criteria for inclusion. In the 2012 update search we retrieved 3066 citations but identified no new trials. The included trial evaluated 30 hospitalised AIDS patients receiving one of three agents: chlorpromazine, haloperidol and lorazepam. The trial under-reported key methodological features. It found overall that patients in the chlorpromazine group and those in the haloperidol group had fewer symptoms of delirium at follow-up (to below the diagnostic threshold using the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) and that both were equally effective (at two days mean difference (MD) 0.37; 95% confidence interval (CI) -4.58 to 5.32; between two and six days MD -0.21; 95% CI -5.35 to 4.93). Chlorpromazine and haloperidol were found to be no different in improving cognitive status in the short term (at 48 hours) but at subsequent follow-up cognitive status was reduced in those taking chlorpromazine. Improvements from baseline to day two for patients randomised to lorazepam were not apparent. All patients on lorazepam (n = 6) developed adverse effects, including oversedation and increased confusion, leading to trial drug discontinuation. AUTHORS' CONCLUSIONS: There remains insufficient evidence to draw conclusions about the role of drug therapy in the treatment of delirium in terminally ill patients. Thus, practitioners should continue to follow current clinical guidelines. Further research is essential.

Spiritual and religious interventions for well-being of adults in the terminal phase of disease.

BACKGROUND: As terminal disease progresses, health deteriorates and the end of life approaches, people may ask "Why this illness? Why me? Why now?" Such questions may invoke, rekindle or intensify spiritual or religious concerns. Although the processes by which these associations occur are poorly understood, there is some research evidence for associations that are mainly positive between spiritual and religious awareness and wellness, such as emotional health. OBJECTIVES: This review aimed to describe spiritual and religious interventions for adults in the terminal phase of a disease and to evaluate their effectiveness on well-being. SEARCH METHODS: We searched 14 databases to November 2011, including the Cochrane Central Register of Controlled Trials and MEDLINE. SELECTION CRITERIA: We included randomised controlled trials (RCTS) if they involved adults in the terminal phase of a disease and if they evaluated outcomes for an intervention that had a spiritual or religious component. Primary outcomes were well-being, coping with the disease and quality of life. DATA COLLECTION AND ANALYSIS: In accordance with the inclusion criteria, two review authors independently screened citations. One review author extracted data which was then checked by another review author. We considered meta-analysis for studies with comparable characteristics. MAIN RESULTS: Five RCTs (1130 participants) were included. Two studies evaluated meditation, the others evaluated multi-disciplinary palliative care interventions that involved a chaplain or spiritual counsellor as a member of the intervention team. The studies evaluating meditation found no overall significant difference between those receiving meditation or usual care on quality of life or well-being. However, when meditation was combined with massage in the medium term it buffered against a reduction in quality of life. In the palliative care intervention studies there was no significant difference in quality of life or well-being between the trial arms. Coping with the disease was not evaluated in the studies. The quality of the studies was limited by under-reporting of design features. AUTHORS' CONCLUSIONS: We found inconclusive evidence that interventions with spiritual or religious components for adults in the terminal phase of a disease may or may not enhance well-being. Such interventions are under-evaluated. All five studies identified were undertaken in the same country, and in the multi-disciplinary palliative care interventions it is unclear if all participants received support from a chaplain or a spiritual counsellor. Moreover, it is unclear in all the studies whether the participants in the comparative groups received spiritual or religious support, or both, as part of routine care or from elsewhere. The paucity of quality research indicates a need for more rigorous studies.

Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention.

Patients with advanced dementia often receive poor end-of-life care. We aimed to design and pilot a palliative care and advance care plan (ACP) intervention. Patients had undergone emergency hospital admission and had severe dementia. The intervention consisted of a palliative care patient assessment which informed an ACP discussion with the carer, who was offered the opportunity to write an ACP for the person with dementia. Carer-patient dyads were randomized to 'usual care' or the intervention. Carer-related outcome measures included the Kessler Distress Scale, Decision Satisfaction Inventory, Client Satisfaction Questionnaire and the Euroqol-5D, measured at baseline, six weeks, six months and three months after bereavement. The Satisfaction with End of Life Care in Dementia Scale was completed if the patient died. The 32 patient participants were physically frail and in the advanced stages of dementia: 62% had pressure damage to the skin, all needed feeding assistance and 95% were in pain. Nearly 50% died during the six-month follow-up period. Carers were difficult to recruit during acute admission; 33 patients and carers entered the study (22 intervention arm; 11 control arm). Only seven carers made ACPs. The care planning discussion was well received, but few carers wrote an ACP, despite intensive support from an experienced nurse specialist. Advance care planning is, in theory, a necessary intervention for people with severe dementia; the reluctance of carers to write plans needs to be explored further.

Laxatives or methylnaltrexone for the management of constipation in palliative care patients.

BACKGROUND: Constipation is common in palliative care; it can generate considerable suffering due to the unpleasant physical symptoms. In the first Cochrane Review on effectiveness of laxatives for the management of constipation in palliative care patients, published in 2006, no conclusions could be drawn because of the limited number of evaluations. This article describes the first update of this review. OBJECTIVES: To determine the effectiveness of laxatives or methylnaltrexone for the management of constipation in palliative care patients. SEARCH STRATEGY: We searched databases including MEDLINE and CENTRAL (The Cochrane Library) in 2005 and in the update to August 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) evaluating laxatives for constipation in palliative care patients. In the update we also included RCTs on subcutaneous methylnaltrexone; an opioid-receptor antagonist that is now licensed for the treatment of opioid-induced constipation in palliative care when response to usual laxative therapy is insufficient. DATA COLLECTION AND ANALYSIS: Two authors assessed trial quality and extracted data. The appropriateness of combining data from the studies depended upon clinical and outcome measure homogeneity. MAIN RESULTS: We included seven studies involving 616 participants; all under-reported methodological features. In four studies the laxatives lactulose, senna, co-danthramer, misrakasneham, and magnesium hydroxide with liquid paraffin were evaluated. In three methylnaltrexone.In studies comparing the different laxatives evidence was inconclusive. Evidence on subcutaneous methylnaltrexone was clearer; in combined analysis (287 participants) methylnaltrexone, in comparison with a placebo, significantly induced laxation at 4 hours (odds ratio 6.95; 95% confidence interval 3.83 to 12.61). In combined analyses there was no difference in the proportion experiencing side effects, although participants on methylnaltrexone suffered more flatulence and dizziness. No evidence of opioid withdrawal was found. In one study severe adverse events, commonly abdominal pain, were reported that were possibly related to methylnaltrexone. A serious adverse event considered to be related to the methylnaltrexone also occurred; this involved a participant having severe diarrhoea, subsequent dehydration and cardiovascular collapse. AUTHORS' CONCLUSIONS: The 2010 update found evidence on laxatives for management of constipation remains limited due to insufficient RCTs. However, the conclusions of this update have changed since the original review publication in that it now includes evidence on methylnaltrexone. Here it found that subcutaneous methylnaltrexone is effective in inducing laxation in palliative care patients with opioid-induced constipation and where conventional laxatives have failed. However, the safety of this product is not fully evaluated. Large, rigorous, independent trials are needed.

Advance care planning in advanced cancer: can it be achieved? An exploratory randomized patient preference trial of a care planning discussion.

OBJECTIVE: Little is known about the effectiveness of advance care planning in the United Kingdom, although policy documents recommend that it should be available to all those with life-limiting illness. METHOD: An exploratory patient preference randomized controlled trial of advance care planning discussions with an independent mediator (maximum three sessions) was conducted in London outpatient oncology clinics and a nearby hospice. Seventy-seven patients (mean age 62 years, 39 male) with various forms of recurrent progressive cancer participated, and 68 (88%) completed follow-up at 8 weeks. Patients completed visual analogue scales assessing perceived ability to discuss end-of-life planning with healthcare professionals or family and friends (primary outcome), happiness with the level of communication, and satisfaction with care, as well as a standardized measure of anxiety and depression. RESULTS: Thirty-eight patients (51%) showed preference for the intervention. Discussions with professionals or family and friends about the future increased in the intervention arms, whether randomized or preference, but happiness with communication was unchanged or worse, and satisfaction with services decreased. Trial participation did not cause significant anxiety or depression and attrition was low. SIGNIFICANCE OF RESULTS: A randomized trial of advance care planning is possible. This study provides new evidence on its acceptability and effectiveness for patients with advanced cancer.

Advance care planning discussions in advanced cancer: analysis of dialogues between patients and care planning mediators.

OBJECTIVE: Advance care planning (ACP) provides patients with an opportunity to consider, discuss, and plan their future care with health professionals. Numerous policy documents recommend that ACP should be available to all with life-limiting illness. METHOD: Forty patients with recurrent progressive cancer completed one or more ACP discussions with a trained planning mediator using a standardized topic guide. Fifty-two interviews were transcribed verbatim and analyzed for qualitative thematic content. RESULTS: Most patients had not spoken extensively to health professionals or close persons about the future. Their concerns related to experiencing distressing symptoms or worrying how family members would cope. Some patients wished for more accurate information and were unaware of their options for care. Many felt it was doctors' responsibility to initiate such discussions, but perceived that their doctors were reluctant to do so. However, some patients felt that the time was not yet right for these conversations. SIGNIFICANCE OF RESULTS: This article reports on the recorded content of ACP discussions. The extent to which patients want to engage in ACP is variable, and support and training are needed for health professionals to initiate such discussions. Our findings do not fully support the current United Kingdom policy of introducing ACP early in life-threatening disease.

Clinician estimates of prognosis: accuracy and impact-a retrospective inpatient hospice study.

OBJECTIVE: To evaluate the accuracy and impact of clinicians' estimates of prognosis (CEP) in patients referred for hospice inpatient care. METHODS: Retrospective review of 12 months' referrals to a London hospice unit. Data extracted included date of referral, admission and death and CEP. RESULTS: N=383. Mean age 72 years (range 24-101). CEP accuracy: Median survival where CEP was 'days' (n=141) was 7 days (0-164); CEP 'weeks' (n=167) was 14 days (1-538); CEP 'months' (n=75) was 32 days (2-507). Kaplan-Meier survival curves showed significant difference between CEP of 'months' and 'weeks' (p<0.0001); 'months' and 'days' (p<0.0001); but not 'days' and 'weeks' (p=0.1). CEP impact: admission waiting time increased with increasing CEP: CEP 'days' (n=105) median 1 day (0-14); CEP 'weeks' (n=154) median 2 days (0-46); CEP 'months' (n=69) median 3 days (0-46). No significant difference was demonstrated in the number of discharge planning conversations between groups (0.9/patient). CONCLUSIONS: CEP was accurate in over half of the cases but did not adequately discriminate between those with prognoses of days or weeks. CEP may affect the prioritisation given to patients by hospices. Inaccurate CEP on referral forms may influence other aspects of care; however, further research is needed.