How best to capture the impact of complementary therapies in palliative care: A systematic review to identify and assess the appropriateness and validity of multi-domain tools.

BACKGROUND: Complementary therapies are widely used in palliative care settings. Qualitative research found that people with advanced disease report a range of physical and psychological benefits from complementary therapies, however evidence of their effectiveness from clinical trials is inconclusive. This may be because trials are limited by use of inappropriate outcome measures. AIMS: To identify tools which capture the impact of massage, reflexology and aromatherapy in people with advanced disease. We (1) identified multi-domain tools used to evaluate these therapies in populations with any chronic health condition and (2) assessed whether tools were valid and psychometrically robust in populations with advanced disease. DESIGN: A two-stage systematic review was conducted using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines (PROSPERO: CRD42020161199). DATA SOURCES: Six databases were searched (August 2021). Study methodological quality, tool psychometric properties and evidence quality were assessed. A global comparison score was generated. RESULTS: Stage 1: 66 trials using 40 different multi-domain tools were identified. Stage 2: Of these tools, we identified papers for seven tools regarding development or validation in advanced disease populations. The majority of psychometric data were inconsistent or inconclusive. Data were mostly of low quality due to methodological issues. CONCLUSION: Of the tools identified, 'Functional Assessment of Cancer Therapy - General' appears to be the most suitable alternative tool against COMSIN criteria, for trials of massage, reflexology and aromatherapy in palliative care. Further tool validation is required before firm recommendations can be made. Co-development of a core outcome set could ensure relevant domains are assessed.

Complementary therapy in palliative care: A synthesis of qualitative and quantitative systematic reviews.

BACKGROUND: Interventions delivered in palliative care are complex and their evaluation through qualitative and quantitative research can lead to contrasting results. In a systematic review of trials, the effectiveness results of complementary therapies in palliative care were inconclusive; however, our qualitative synthesis showed participants perceived them to be beneficial. AIM: Use a novel methodology to synthesise evidence from qualitative and quantitative systematic reviews on complementary therapy in palliative care to explore the following: (1) If interventions delivered in trials reflect how participants in qualitative studies report they are delivered in real-life settings and (2) whether quality of life measures used in trials capture perceived benefits that are reported in qualitative studies. METHODS: Two matrix tables were formulated. In one, key components in delivery of the complementary therapy from the qualitative synthesis which are as follows: (1) relationship with therapist, (2) comfortable environment, (3) choices (e.g. area of massage) and (4) frequent sessions, were plotted against intervention description, to explore matches and mismatches. In the other, items included in quality of life scales were compared with perceived benefits of complementary therapy. RESULTS: None of the trials included all four key delivery components. The five quality of life scales used in the trials failed to capture the range of perceived benefits from the complementary therapies and many included inappropriate or redundant items. CONCLUSIONS: By integrating qualitative and quantitative review data, we determined the reasons trials may be inconclusive. This methodological exemplar provides a framework for understanding complexity in outcomes across trials and a direction for future research.

The effectiveness of interventions to improve the care and management of people with dementia in general hospitals: A systematic review.

BACKGROUND: People with dementia are at greater risk of being admitted to hospital where care may not be tailored to their needs. Interventions improving care and management are vital. AIM: Assess the effectiveness of interventions designed to improve the care and management of people with dementia in hospital. METHOD: Six medical and trial registry, and grey literature databases were searched (1999-1998/2018). Search terms included "Dementia," "Hospital," and "Intervention" and limited to experimental designs. Interventions designed to improve the care and management of people with dementia in the general hospital setting were examined. Outcomes included behavioural and psychological symptoms of dementia (BPSD), psychosocial, clinical, staff knowledge, and length of hospital stay. The CASP tools, Cochrane risk of bias tool, and GRADE system assessed methodological quality and certainty of evidence. RESULTS: 9003 unique citations were identified; 24 studies were included. Studies were limited in study design and their conduct was at a risk of bias. There is very low-quality evidence that multisensory behaviour therapy reduces BPSD. There is low-quality evidence that a multidisciplinary programme reduces postoperative complications and that robot-assisted therapy, music therapy, multimodal-comprehensive care, person-centred care, and family-centred function-focused care interventions improved staff knowledge, competence, efficacy, and communication. No studies reported reduced length of stay. CONCLUSIONS: Whilst we found that these interventions improved the care and management of people with dementia in hospital, it was low- to very low-quality evidence. New clinical recommendations cannot be made based on current evidence, and robust trial designs are necessary to inform evidence-based care.

The effectiveness of aromatherapy, massage and reflexology in people with palliative care needs: A systematic review.

BACKGROUND: Aromatherapy, massage and reflexology are widely used in palliative care. Despite this, there are questions about their suitability for inclusion in clinical guidelines. The need to understand their benefits is a public priority, especially in light of funding pressures. AIM: To synthesise current evidence on the effectiveness of aromatherapy, massage and reflexology in people with palliative care needs. DESIGN: A systematic review of randomised controlled trials (PROSPERO CRD42017081409) was undertaken following international standards including Cochrane guidelines. The quality of trials and their pooled evidence were appraised. Primary outcomes on effect were anxiety, pain and quality-of-life. DATA SOURCES: Eight citation databases and three trial registries were searched to June 2018. RESULTS: Twenty-two trials, involving 1956 participants were identified. Compared with a control, four evaluated aromatherapy, eight massage and six reflexology. A further four evaluated massage compared with aromatherapy. Trials were at an unclear risk of bias. Many had small samples. Heterogeneity prevented meta-analysis. In comparison with usual care, another therapy or an active control, evidence on the effectiveness of massage and aromatherapy in reducing anxiety, pain and improving quality-of-life was inconclusive. There was some evidence (low quality) that compared to an active control, reflexology reduced pain. CONCLUSIONS: This review identified a relatively large number of trials, but with poor and heterogeneous evidence. New clinical recommendations cannot be made based on current evidence. To help provide more definitive trial findings, it may be useful first to understand more about the best way to measure the effectiveness of these therapies in palliative care.

Aromatherapy, massage and reflexology: A systematic review and thematic synthesis of the perspectives from people with palliative care needs.

BACKGROUND: Effectiveness evidence of complementary therapies in people with advanced disease is uncertain, and yet people are still keen to engage in complementary therapy. Insights into people's experiences of complementary therapy in palliative care, the perceived benefits, and how they want it delivered, can inform clinical guidelines and suggest ways to test therapies more appropriately in future evaluations. AIMS: Explore in people with advanced disease (1) the experiences and perceptions of benefits and harms of aromatherapy, massage, and reflexology and (2) how they would like these therapies delivered. DESIGN: A systematic review and thematic synthesis of qualitative studies. Database search terms were related to palliative care, aromatherapy, reflexology and massage. Citations and full texts were reviewed independently against predefined inclusion criteria. Studies were appraised for quality. This review is registered at PROSPERO (22/11/2017 CRD42017081409). DATA SOURCES: MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, KoreaMed and ProQuest with a bibliography search to June 2018. RESULTS: Five qualitative studies in advanced cancer were identified. Three analytical themes were identified: (1) Experience during the therapy (enhanced well-being and escapism), (2) beyond the complementary therapy session (lasting benefits and overall evaluation), and (3) delivery of complementary therapy in palliative care (value of the therapist and delivery of the complementary therapy). CONCLUSIONS: People with advanced cancer experience benefits from aromatherapy, reflexology and massage including enhanced well-being, respite, and escapism from their disease. Complementary therapy interventions should be developed in consultation with the target population to ensure they are delivered and evaluated, where feasible, as they wish.

Development of a model for integrated care at the end of life in advanced dementia: A whole systems UK-wide approach.

BACKGROUND: The prevalence of dementia is rising worldwide and many people will die with the disease. Symptoms towards the end of life may be inadequately managed and informal and professional carers poorly supported. There are few evidence-based interventions to improve end-of-life care in advanced dementia. AIM: To develop an integrated, whole systems, evidence-based intervention that is pragmatic and feasible to improve end-of-life care for people with advanced dementia and support those close to them. DESIGN: A realist-based approach in which qualitative and quantitative data assisted the development of statements. These were incorporated into the RAND/UCLA appropriateness method to achieve consensus on intervention components. Components were mapped to underlying theory of whole systems change and the intervention described in a detailed manual. SETTING/PARTICIPANTS: Data were collected from people with dementia, carers and health and social care professionals in England, from expert opinion and existing literature. Professional stakeholders in all four countries of the United Kingdom contributed to the RAND/UCLA appropriateness method process. RESULTS: A total of 29 statements were agreed and mapped to individual, group, organisational and economic/political levels of healthcare systems. The resulting main intervention components are as follows: (1) influencing local service organisation through facilitation of integrated multi-disciplinary care, (2) providing training and support for formal and informal carers and (3) influencing local healthcare commissioning and priorities of service providers. CONCLUSION: Use of in-depth data, consensus methods and theoretical understanding of the intervention components produced an evidence-based intervention for further testing in end-of-life care in advanced dementia.

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.

Pharmacological interventions for pain in children and adolescents with life-limiting conditions.

BACKGROUND: Pain is one of the most common symptoms in children and young people (CYP) with life-limiting conditions (LLCs) which include a wide range of diagnoses including cancer. The current literature indicates that pain is not well managed, however the evidence base to guide clinicians is limited. There is a clear need for evidence from a systematic review to inform prescribing. OBJECTIVES: To evaluate the evidence on the effectiveness of different pharmacological interventions used for pain in CYP with LLCs. SEARCH METHODS: The following electronic databases were searched up to December 2014: CENTRAL (in the Cochrane Library), MEDLINE, EMBASE, PsycINFO and CINAHL. In addition, we searched conference proceedings and reference lists of included studies. For completeness, we also contacted experts in the field. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-randomised studies and other studies that included a clearly defined comparator group were included. The studies investigated pharmacological treatments for pain associated with LLCs in CYP. The treatment included those specifically developed to treat pain and those that acted as an adjuvant, where the treatment was not primarily developed to treat pain but has pain relieving properties. The LLC was identified by its inclusion in the Richard Hain Directory of LLCs. DATA COLLECTION AND ANALYSIS: Citations were screened by five review authors. Data were extracted by one review author and checked by a second. Two review authors assessed the risk of bias of included studies. A sufficient number of studies using homogeneous outcomes was not identified so a meta-analysis was not possible. MAIN RESULTS: We identified 24,704 citations from our database search. Nine trials with 379 participants fulfilled our inclusion criteria. Participants had cerebral palsy (CP) in five of the studies and osteogenesis imperfecta (OI) in the other four. Participants across the trials ranged in age from 2 to 19 years. All studies, apart from one cross-over trial, were parallel designed RCTs. Three of the trials on CP evaluated intrathecal baclofen (ITB) and two botulinum toxin A (BoNT-A). All of the OI trials evaluated the use of bisphosphonates (two alendronate and one pamidronate). No trials were identified that evaluated a commonly used analgesic in this patient group. Pain was a secondary outcome in five of the eight identified studies. Overall the quality of the trials was mixed. Only one study involved over 100 participants.For the two ITB studies for pain in CP, in the same study population but assessed at different time points in their disease, both found an effect on pain favouring the intervention compared to the control group (standard care or placebo) (mean difference (MD) 4.20, 95% confidence interval (CI) 2.15 to 6.25; MD 26.60, 95% CI 2.61 to 50.59, respectively). In these studies most of the adverse events related to the procedure or device for administration rather than the drug, such as swelling at the pump site. In one trial there were also eight serious adverse effects; these included difficulty swallowing and an epileptic seizure. The trial did not state if these occurred in the intervention group. At follow-up in both BoNT-A trials there was no evidence of a difference in pain between the trial arms among CP participants. The adverse events in the BoNT-A trials mostly involved those who received the intervention drug and involved seizures. Gastrointestinal problems were the most frequent adverse event in those who received alendronate. The trial investigating pamidronate found no evidence of a difference in pain compared to the control group. No adverse events were reported in this trial. AUTHORS' CONCLUSIONS: Published, controlled evidence on the pharmacological interventions for pain in CYP with LLCs is limited. The evidence that is currently available evaluated pain largely as a secondary outcome and the drugs used were all adjuvants and not always commonly used in general paediatric palliative care for pain. Based on current data this systematic review is unable to determine the effects of pharmacological interventions for pain for CYP with LLCs. Future trials with larger populations should examine the effects of the drugs commonly used as analgesics; with the rising prevalence of many LLCs this becomes more necessary.

Volunteer activity in specialist paediatric palliative care: a national survey.

OBJECTIVE: To assess the involvement of volunteers with direct patient/family contact in UK palliative care services for children and young people. METHOD: Cross-sectional survey using a web-based questionnaire. SETTING: UK specialist paediatric palliative care services. PARTICIPANTS: Volunteer managers/coordinators from all UK hospice providers (n=37) and one National Health Service palliative care service involving volunteers (covering 53 services in total). MAIN OUTCOMES: Service characteristics, number of volunteers, extent of volunteer involvement in care services, use of volunteers' professional skills and volunteer activities by setting. RESULTS: A total of 21 providers covering 31 hospices/palliative care services responded (30 evaluable responses). Referral age limit was 16-19 years in 23 services and 23-35 years in seven services; three services were Hospice at Home or home care only. Per service, there was a median of 25 volunteers with direct patient/family contact. Services providing only home care involved fewer volunteers than hospices with beds. Volunteers entirely ran some services, notably complementary therapy and pastoral/faith-based care. Complementary therapists, school teachers and spiritual care workers most commonly volunteered their professional skills. Volunteers undertook a wide range of activities including emotional support and recreational activities with children and siblings. CONCLUSIONS: This is the most detailed national survey of volunteer activity in palliative care services for children and young people to date. It highlights the range and depth of volunteers' contribution to specialist paediatric palliative care services and will help to provide a basis for future research, which could inform expansion of volunteers' roles.

Volunteers in specialist palliative care: a survey of adult services in the United Kingdom.

BACKGROUND: Worldwide, the demand for specialist palliative care is increasing but funding is limited. The role of volunteers is underresearched, although their contribution reduces costs significantly. Understanding what volunteers do is vital to ensure services develop appropriately to meet the challenges faced by providers of palliative care. OBJECTIVE: The study's objective is to describe current involvement of volunteers with direct patient/family contact in U.K. specialist palliative care. DESIGN: An online survey was sent to 290 U.K. adult hospices and specialist palliative care services involving volunteers covering service characteristics, involvement and numbers of volunteers, settings in which they are involved, extent of involvement in care services, specific activities undertaken in each setting, and use of professional skills. RESULTS: The survey had a 67% response rate. Volunteers were most commonly involved in day care and bereavement services. They entirely ran some complementary therapy, beauty therapy/hairdressing, and pastoral/faith-based care services, and were involved in a wide range of activities, including sitting with dying patients. CONCLUSIONS: This comprehensive survey of volunteer activity in U.K. specialist palliative care provides an up-to-date picture of volunteer involvement in direct contact with patients and their families, such as providing emotional care, and the extent of their involvement in day and bereavement services. Further research could focus on exploring their involvement in bereavement care.

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.

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.