Understanding how shared decision-making approaches and patient aids influence patients with advanced cancer when deciding on palliative treatments and care: A realist review.

BACKGROUND: Patients with advanced incurable cancer face difficult decisions about palliative treatment options towards their end of life. However, they are often not provided with the appropriate information and support that is needed to make informed decisions. This review aimed to identify contexts and mechanisms associated with communication tools, patient decision-aids and shared decision-making (SDM) approaches that influence patient outcomes. METHODS: We used a realist review method to search for published studies of patients (adults > 18) with advanced cancer who were expected to make a decision about palliative treatment and/or supportive care in consultation with healthcare practitioners. We appraised and synthesised literature describing the contexts of (when and how) decision aids and SDM approaches are used, and how these contexts interact with mechanisms (resources and reasoning) which impact patient outcomes. Stakeholders including academics, palliative healthcare professionals (HCPs) and people with lived experience of supporting people with advanced incurable cancer contributed to identifying explanatory accounts. These accounts were documented, analysed and consolidated to contribute to the development of a programme theory. RESULTS: From the 33 included papers, we consolidated findings into 20 explanatory accounts to develop a programme theory that explains key contexts and mechanisms that influence patient and SDM. Contexts include underlying patients' and HCPs' attitudes and approaches. These need to be understood in relation to key mechanisms, including presenting information in multiple formats and providing adequate time and opportunities to prepare for and revisit decisions. Contexts influenced mechanisms which then influence the levels of patient decisional satisfaction, conflict and regret. CONCLUSIONS: Our programme theory highlights mechanisms that are important in supporting shared treatment decisions for advanced noncurative cancer. The findings are informative for developing and evaluating interventions to improve understanding and involvement in SDM for patients with advanced incurable cancer. PATIENT AND PUBLIC CONTRIBUTION: We included patient and public involvement (PPI) representatives in four stakeholder meetings. PPI helped to define the scope of the review, identify their unique experiences and perspectives, synthesise their perspectives with our review findings, make decisions about which theories we included in our programme theory and develop recommendations for policy and practice and future research.

Symptom burden and lived experiences of patients, caregivers and healthcare professionals on the management of malignant bowel obstruction: A qualitative systematic review.

BACKGROUND: Malignant bowel obstruction occurs in up to 50% of people with advanced ovarian and 15% of people with gastrointestinal cancers. Evaluation and comparison of interventions to manage symptoms are hampered by inconsistent evaluations of efficacy and lack of agreed core outcomes. The patient perspective is rarely incorporated. AIM: To synthesise the qualitative data regarding patient, caregiver and healthcare professionals' views and experience of malignant bowel obstruction to inform the development of a core outcome set for the evaluation of malignant bowel obstruction. DESIGN: A qualitative systematic review was conducted, with narrative synthesis. The review protocol was registered prospectively (https://www.crd.york.ac.uk/prospero, CRD42020176393). DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsycINFO and Scopus databases were searched for studies published between 2010 and 2021. Reference lists were screened for further relevant publications, and citation tracking was performed. RESULTS: Nine papers were included, reporting on seven studies which described the views and experiences of malignant bowel obstruction through the perspectives of 75 patients, 13 caregivers and 62 healthcare professionals. Themes across the papers included symptom burden, diverse experiences of interventions, impact on patient quality of life, implications and trajectory of malignant bowel obstruction, mixed experience of communication and the importance of realistic goals of care. CONCLUSION: Some of the most devastating sequelae of malignant bowel obstruction, such as pain and psychological distress, are not included routinely in its clinical or research evaluation. These data will contribute to a wider body of work to ensure the patient and caregiver perspective is recognised in the development of a core outcome set.

End of life care for people with severe mental illness: Mixed methods systematic review and thematic synthesis (the MENLOC study).

BACKGROUND: Parity of esteem means that end-of-life care for people with severe mental illness should be of equal quality to that experienced by all. AIM: To synthesise international, English language, research and UK policy and guidance relating to the organisation, provision, and receipt of end-of-life care for people with severe mental illness. DESIGN: A mixed methods systematic review was conducted following the Evidence for Policy and Practice Information and Co-ordinating Centre approach and informed by a stakeholder group. We employed thematic synthesis to bring together data from both qualitative and quantitative studies, and from non-research material. We assessed the strength of synthesised findings using the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approaches. DATA SOURCES: Ten electronic databases were searched from inception to December 2019, along with 62 organisational websites. Quality appraisal was conducted using Critical Appraisal Skills Programme checklists or other study design-specific alternatives as necessary. RESULTS: Of the 11,904 citations retrieved, 34 research publications were included plus 28 non-research items. The majority of research was of high or acceptable quality. An overarching synthesis including 52 summary statements, with assessments of confidence in the underpinning evidence, was produced using four themes: Structure of the system; Professional issues; Contexts of care; and Living with severe mental illness. CONCLUSIONS: Implications for services and practice reflect evidence in which there is a high degree of confidence. Partnership should be developed across the mental health and end-of-life systems, and ways found to support people to die where they choose. Staff caring for people with severe mental illness at the end-of-life need education, support and supervision. End-of-life care for people with severe mental illness requires a team approach, including advocacy. Proactive physical health care for people with severe mental illness is needed to tackle problems of delayed diagnosis.

What elements of a systems' approach to bereavement are most effective in times of mass bereavement? A narrative systematic review with lessons for COVID-19.

BACKGROUND: The global COVID-19 pandemic has left health and social care systems facing the challenge of supporting large numbers of bereaved people in difficult and unprecedented social conditions. Previous reviews have not comprehensively synthesised the evidence on the response of health and social care systems to mass bereavement events. AIM: To synthesise the evidence regarding system-level responses to mass bereavement events, including natural and human-made disasters as well as pandemics, to inform service provision and policy during the COVID-19 pandemic and beyond. DESIGN: A rapid systematic review was conducted, with narrative synthesis. The review protocol was registered prospectively (www.crd.york.ac.uk/prospero, CRD 42020180723). DATA SOURCES: MEDLINE, Global Health, PsycINFO and Scopus databases were searched for studies published between 2000 and 2020. Reference lists were screened for further relevant publications, and citation tracking was performed. RESULTS: Six studies were included reporting on system responses to mass bereavement following human-made and natural disasters, involving a range of individual and group-based support initiatives. Positive impacts were reported, but study quality was generally low and reliant on data from retrospective evaluation designs. Key features of service delivery were identified: a proactive outreach approach, centrally organised but locally delivered interventions, event-specific professional competencies and an emphasis on psycho-educational content. CONCLUSION: Despite the limitations in the quantity and quality of the evidence base, consistent messages are identified for bereavement support provision during the pandemic. High quality primary studies are needed to ensure service improvement in the current crisis and to guide future disaster response efforts.

Palliative Care Evidence Review Service (PaCERS): a knowledge transfer partnership.

The importance of linking evidence into practice and policy is recognised as a key pillar of a prudent approach to healthcare; it is of importance to healthcare professionals and decision-makers across the world in every speciality. However, rapid access to evidence to support service redesign, or to change practice at pace, is challenging. This is particularly so in smaller specialties such as Palliative Care, where pressured multidisciplinary clinicians lack time and skill sets to locate and appraise the literature relevant to a particular area. Therefore, we have initiated the Palliative Care Evidence Review Service (PaCERS), a knowledge transfer partnership through which we have developed a clear methodology to conduct evidence reviews to support professionals and other decision-makers working in palliative care.PaCERS methodology utilises modified systematic review methods as there is no agreed definition or an accepted methodology for conducting rapid reviews. This paper describes the stages involved based on our iterative recent experiences and engagement with stakeholders, who are the potential beneficiaries of the research. Uniquely, we emphasise the process and opportunities of engagement with the clinical workforce and policy-makers throughout the review, from developing and refining the review question at the start through to the importance of demonstrating impact. We are faced with the challenge of the trade-off between the timely transfer of evidence against the risk of impacting on rigour. To address this issue, we try to ensure transparency throughout the review process. Our methodology aligns with key principles of knowledge synthesis in defining a process that is transparent, robust and improving the efficiency and timeliness of the review.Our reviews are clinically or policy driven and, although we use modified systematic review methods, one of the key differences between published review processes and our review process is in our relationship with the requester. This streamlining approach to synthesising evidence in a timely manner helps to inform decisions faced by clinicians and decision-makers in healthcare settings, supporting, at pace, knowledge transfer and mobilisation.

A realist review of one-to-one breastfeeding peer support experiments conducted in developed country settings.

The World Health Organisation guidance recommends breastfeeding peer support (BFPS) as part of a strategy to improve breastfeeding rates. In the UK, BFPS is supported by National Institute for Health and Care Excellence guidance and a variety of models are in use. The experimental evidence for BFPS in developed countries is mixed and traditional methods of systematic review are ill-equipped to explore heterogeneity, complexity, and context influences on effectiveness. This review aimed to enhance learning from the experimental evidence base for one-to-one BFPS intervention. Principles of realist review were applied to intervention case studies associated with published experimental studies. The review aimed (a) to explore heterogeneity in theoretical underpinnings and intervention design for one-to-one BFPS intervention; (b) inform design decisions by identifying transferable lessons developed from cross-case comparison of context-mechanism-outcome relationships; and (c) inform evaluation design by identifying context-mechanism-outcome relationships associated with experimental conditions. Findings highlighted poor attention to intervention theory and considerable heterogeneity in BFPS intervention design. Transferable mid-range theories to inform design emerged, which could be grouped into seven categories: (a) congruence with local infant feeding norms, (b) integration with the existing system of health care, (c) overcoming practical and emotional barriers to access, (d) ensuring friendly, competent, and proactive peers, (e) facilitating authentic peer-mother interactions, (f) motivating peers to ensure positive within-intervention amplification, and (g) ensuring positive legacy and maintenance of gains. There is a need to integrate realist principles into evaluation design to improve our understanding of what forms of BFPS work, for whom and under what circumstances.

Can shared decision-making reduce medical malpractice litigation? A systematic review.

BACKGROUND: To explore the likely influence and impact of shared decision-making on medical malpractice litigation and patients' intentions to initiate litigation. METHODS: We included all observational, interventional and qualitative studies published in all languages, which assessed the effect or likely influence of shared decision-making or shared decision-making interventions on medical malpractice litigation or on patients' intentions to litigate. The following databases were searched from inception until January 2014: CINAHL, Cochrane Register of Controlled Trials, Cochrane Database of Systematic Reviews, EMBASE, HMIC, Lexis library, MEDLINE, NHS Economic Evaluation Database, Open SIGLE, PsycINFO and Web of Knowledge. We also hand searched reference lists of included studies and contacted experts in the field. Downs & Black quality assessment checklist, the Critical Appraisal Skill Programme qualitative tool, and the Critical Appraisal Guidelines for single case study research were used to assess the quality of included studies. RESULTS: 6562 records were screened and 19 articles were retrieved for full-text review. Five studies wee included in the review. Due to the number and heterogeneity of included studies, we conducted a narrative synthesis adapted from the ESRC guidance for narrative synthesis. Four themes emerged. The analysis confirms the absence of empirical data necessary to determine whether or not shared decision-making promoted in the clinical encounter can reduce litigation. Three out of five included studies provide retrospective and simulated data suggesting that ignoring or failing to diagnose patient preferences, particularly when no effort has been made to inform and support understanding of possible harms and benefits, puts clinicians at a higher risk of litigation. Simulated scenarios suggest that documenting the use of decision support interventions in patients' notes could offer some level of medico-legal protection. Our analysis also indicated that a sizeable proportion of clinicians prefer ordering more tests and procedures, irrespective of patient informed preferences, as protection against litigation. CONCLUSIONS: Given the lack of empirical data, there is insufficient evidence to determine whether or not shared decision-making and the use of decision support interventions can reduce medical malpractice litigation. Further investigation is required. TRIAL REGISTRATION: This review was registered on PROSPERO. REGISTRATION NUMBER: CRD42012002367 .

Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials.

PURPOSE: medication problems are thought to cause between 10 and 30% of all hospital admissions in older people. This systematic review aimed to evaluate the effectiveness of interventions led by hospital or community pharmacists in reducing unplanned hospital admissions for older people. METHODS: eighteen databases were searched with a customised search strategy. Relevant websites and reference lists of included trials were checked. Randomised controlled trials were included that evaluated pharmacist-led interventions compared with usual care, with unplanned admissions or readmissions as an outcome. Two authors independently extracted data and assessed methodological quality. RESULTS: twenty-seven randomised controlled trials (RCTs) were identified; seven trials were excluded. The 20 included trials comprised 16 for older people and 4 for older people with heart failure. Interventions led by hospital pharmacists (seven trials) or community pharmacists (nine trials) did not reduce unplanned admissions in the older population (risk ratios 0.97 95% CI: 0.88, 1.07; 1.07 95% CI: 0.96, 1.20). Three trials in older people with heart failure showed that interventions delivered by a hospital pharmacist reduced the relative risk of admissions. However, these trials were heterogeneous in intensity and duration of follow-up. One trial had a high risk of bias. CONCLUSIONS: evidence from three randomised controlled trials suggests that interventions led by hospital pharmacists reduce unplanned hospital admissions in older patients with heart failure, although these trials were heterogeneous. Data from 16 trials do not support the concept that interventions led by hospital or community pharmacists for the general older population reduces unplanned admissions.

Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults.

BACKGROUND: Dental pain can have a considerable detrimental effect on an individual's quality of life. Symptomatic apical periodontitis and acute apical abscess are common causes of dental pain and arise from an inflamed or necrotic dental pulp, or infection of the pulpless root canal system. Clinical guidelines recommend that the first-line treatment for teeth with symptomatic apical periodontitis or an acute apical abscess should be removal of the source of inflammation or infection by local, operative measures, and that systemic antibiotics are currently only recommended for situations where there is evidence of spreading infection (cellulitis, lymph node involvement, diffuse swelling) or systemic involvement (fever, malaise). Despite this, there is evidence that dentists continue to prescribe antibiotics for these conditions. There is concern that this could contribute to the development of antibiotic-resistant bacterial colonies both within the individual and within the community as a whole. OBJECTIVES: To evaluate the effects of systemic antibiotics provided with or without surgical intervention (such as extraction, incision and drainage of a swelling or endodontic treatment), with or without analgesics, for symptomatic apical periodontitis or acute apical abscess in adults. SEARCH METHODS: We searched the following electronic databases: Cochrane Oral Health Group's Trials Register (to 1 October 2013); Cochrane Central Register of Controlled Trials (The Cochrane Library 2013, Issue 9); MEDLINE via OVID (1946 to 1 October 2013); EMBASE via OVID (1980 to 1 October 2013) and CINAHL via EBSCO (1980 to 1 October 2013). We searched the World Health Organization (WHO) International Trials Registry Platform and the US National Institutes of Health Trials Registry (ClinicalTrials.gov) on 1 October 2013 to identify ongoing trials. We searched for grey literature using OpenGrey (to 1 October 2013) and ZETOC Conference Proceedings (1993 to 1 October 2013). We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Randomised controlled trials of systemic antibiotics in adults with a clinical diagnosis of symptomatic apical periodontitis or acute apical abscess, with or without surgical intervention (considered in this situation to be extraction, incision and drainage or endodontic treatment) and with or without analgesics. DATA COLLECTION AND ANALYSIS: Two review authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MD) (standardised mean difference (SMD) when different scales were reported) and 95% confidence intervals (CI) for continuous data and, where results were meta-analysed, we used a fixed-effect model as there were fewer than four studies. We contacted study authors to obtain missing information. MAIN RESULTS: We included two trials in this review, with 62 participants included in the analyses. Both trials were conducted in university dental schools in the USA and compared the effects of oral penicillin V potassium (penicillin VK) versus a matched placebo given in conjunction with a surgical intervention (total or partial pulpectomy) and analgesics to adults with acute apical abscess or symptomatic necrotic tooth (no signs of spreading infection or systemic involvement (fever, malaise)). We assessed one study as having a high risk of bias and the other study as having unclear risk of bias.The primary outcome variables presented were participant-reported pain and swelling (one trial also reported participant-reported percussion pain). One study reported the type and number of analgesics taken by participants. One study recorded the incidence of postoperative endodontic flare-ups (people who returned with symptoms that necessitated further treatment). Adverse effects as reported in one study were diarrhoea (one participant, placebo group) and fatigue and reduced energy postoperatively (one participant, antibiotic group). No studies reporting quality of life measurements were suitable for inclusion. Objective 1: systemic antibiotics versus placebo with surgical intervention and analgesics for symptomatic apical periodontitis or acute apical abscess. Two studies provided data for the comparison between systemic antibiotics (penicillin VK) and a matched placebo for adults with acute apical abscess or a symptomatic necrotic tooth. Participants in one study all underwent a total pulpectomy of the affected tooth while participants in the other study had their tooth treated by either partial or total pulpectomy. Participants in both trials received oral analgesics. There were no statistically significant differences in participant-reported measures of pain or swelling at any of the time points assessed within the review. The MD for pain (short ordinal numerical scale 0 to 3) was -0.03 (95% CI -0.53 to 0.47) at 24 hours; 0.32 (95% CI -0.22 to 0.86) at 48 hours and 0.08 (95% CI -0.38 to 0.54) at 72 hours. The SMD for swelling was 0.27 (95% CI -0.23 to 0.78) at 24 hours; 0.04 (95% CI -0.47 to 0.55) at 48 hours and 0.02 (95% CI -0.49 to 0.52) at 72 hours. The body of evidence was assessed as at very low quality. Objective 2: systemic antibiotics without surgical intervention for adults with symptomatic apical periodontitis or acute apical abscess. We found no studies that compared the effects of systemic antibiotics with a matched placebo delivered without a surgical intervention for symptomatic apical periodontitis or acute apical abscess in adults. AUTHORS' CONCLUSIONS: There is very low quality evidence that is insufficient to determine the effects of systemic antibiotics on adults with symptomatic apical periodontitis or acute apical abscess.

Supportive and palliative care needs in advanced non-malignant liver disease: systematic review.

Advanced cirrhosis confers a significant symptom burden and has a 50% 2-year mortality rate in those with decompensated disease. There is increasing demand for supportive and palliative care (SAPC) for these patients, yet no consensus on the best model of delivery. It is necessary to identify the needs of such patients and their carers, and evaluate whether they are being met.A literature search was conducted using key words pertaining to adult patients with liver cirrhosis and their SAPC needs. Study quality was assessed and findings grouped by theme. 51 full texts were selected for inclusion, 8 qualitative studies, 33 quantitative studies, 7 systematic reviews, 2 mixed methods studies and 1 Delphi methods. Key findings were grouped into three main themes: SAPC needs, access to SAPC and models of care.Patients with cirrhosis have significant psychological and physical symptom burden with many unmet needs. These data failed to identify the best service model of care. The impact of specialist palliative care (SPC) referral was limited by small numbers and late referrals. With the majority of studies conducted in the USA, it is unclear how well these findings translate to other healthcare systems. Comparison between hepatology led services and SPC was limited by inconsistent outcome measures and prevented pooling of data sets. These data also had limited evaluation of patient-reported outcome measures. We propose the development of a core outcome set to ensure consistent and meaningful evaluation of the SAPC needs of patients with advanced non-malignant liver cirrhosis.

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures.

BACKGROUND: Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved. OBJECTIVES: To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures. SEARCH METHODS: We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies. SELECTION CRITERIA: Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided. DATA COLLECTION AND ANALYSIS: Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data. MAIN RESULTS: We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I(2) 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I(2) 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I(2) 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I(2) 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I(2) 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I(2) 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I(2) 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I(2) 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I(2) 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results.  AUTHORS' CONCLUSIONS: Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers to investigate interventions which seek to improve information delivery and consideration of information to enhance informed consent.  The interventions used consistently improve patient knowledge, an important prerequisite for informed consent.  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable. Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions. Only one study attempted to measure informed consent as a unified concept.

Is case management effective in reducing the risk of unplanned hospital admissions for older people? A systematic review and meta-analysis.

BACKGROUND: Case management is a collaborative practice involving coordination of care by a range of health professionals, both within the community and at the interface of primary and secondary care. It has been promoted as a way of reducing unplanned admissions in older people. OBJECTIVE: The objective was to systematically review evidence from randomized controlled trials regarding the effectiveness of case management in reducing the risk of unplanned hospital admissions in older people. METHODS: Eighteen databases were searched from inception to June 2010. Relevant websites were searched with key words and reference lists of included studies checked. A risk-of-bias tool was used to assess included studies and data extraction performed using customized tables. The primary outcome of interest was enumeration of unplanned hospital admission or readmissions. RESULTS: Eleven trials of case management in the older population were included. Risk of bias was generally low. Six were trials of hospital-initiated case management. Three were suitable for meta-analysis, of which two showed a reduction in unplanned admissions. Overall, there was no statistically significant reduction in unplanned admissions [relative rate: 0.71 (95% confidence interval, CI: 0.49 to 1.03)]. Three trials reported reduced length of stay. Five trials were of community-initiated case management. None showed a reduction in unplanned admissions. Three were suitable for meta-analysis [mean difference in unplanned admissions: 0.05 (95% CI: -0.04 to 0.15)]. CONCLUSIONS: The identified trials included a range of case management interventions. Nine of the 11 trials showed no reduction of unplanned hospital admissions with case management compared with the same with usual care.

"Many miles to go ": a systematic review of the implementation of patient decision support interventions into routine clinical practice.

BACKGROUND: Two decades of research has established the positive effect of using patient-targeted decision support interventions: patients gain knowledge, greater understanding of probabilities and increased confidence in decisions. Yet, despite their efficacy, the effectiveness of these decision support interventions in routine practice has yet to be established; widespread adoption has not occurred. The aim of this review was to search for and analyze the findings of published peer-reviewed studies that investigated the success levels of strategies or methods where attempts were made to implement patient-targeted decision support interventions into routine clinical settings. METHODS: An electronic search strategy was devised and adapted for the following databases: ASSIA, CINAHL, Embase, HMIC, Medline, Medline-in-process, OpenSIGLE, PsycINFO, Scopus, Social Services Abstracts, and the Web of Science. In addition, we used snowballing techniques. Studies were included after dual independent assessment. RESULTS: After assessment, 5322 abstracts yielded 51 articles for consideration. After examining full-texts, 17 studies were included and subjected to data extraction. The approach used in all studies was one where clinicians and their staff used a referral model, asking eligible patients to use decision support. The results point to significant challenges to the implementation of patient decision support using this model, including indifference on the part of health care professionals. This indifference stemmed from a reported lack of confidence in the content of decision support interventions and concern about disruption to established workflows, ultimately contributing to organizational inertia regarding their adoption. CONCLUSIONS: It seems too early to make firm recommendations about how best to implement patient decision support into routine practice because approaches that use a 'referral model' consistently report difficulties. We sense that the underlying issues that militate against the use of patient decision support and, more generally, limit the adoption of shared decision making, are under-investigated and under-specified. Future reports from implementation studies could be improved by following guidelines, for example the SQUIRE proposals, and by adopting methods that would be able to go beyond the 'barriers' and 'facilitators' approach to understand more about the nature of professional and organizational resistance to these tools. The lack of incentives that reward the use of these interventions needs to be considered as a significant impediment.

What matters to families about the healthcare of preterm or low birth weight infants: A qualitative evidence synthesis.

OBJECTIVE: We examined what matters to families about the healthcare provided to preterm or LBW infants in hospital and the community, to ensure that care meets the needs of infants and parents. METHODS: We searched databases to identify eligible studies examining the views and expectations of families. Study quality was assessed using the CASP checklist for qualitative studies. The GRADE-CERQual approach was used to assess confidence in review findings. Studies were sampled and data analysed using thematic synthesis. RESULTS: 222 studies (227 papers) were eligible for inclusion. 54 studies (57 papers) were sampled based on data richness, methodological quality, and representation across settings. Eight analytical themes were identified. Confidence in results was moderate to high. What mattered was a positive outcome for the child; active involvement in care; being supported to cope at home after discharge; emotional support; the healthcare environment; information needs met; logistical support available; and positive relationships with staff. CONCLUSION: Although parents and family members reported a variety of experiences in the care of their infant, we found high consistency in what matters to families. PRACTICE IMPLICATIONS: This review identifies approaches to improve experiences of parents which are consistent with the Family Centred Care model of healthcare.

Exploring the effect of case management in homelessness per components: A systematic review of effectiveness and implementation, with meta-analysis and thematic synthesis.

Background: Adequate housing is a basic human right. The many millions of people experiencing homelessness (PEH) have a lower life expectancy and more physical and mental health problems. Practical and effective interventions to provide appropriate housing are a public health priority. Objectives: To summarise the best available evidence relating to the components of case-management interventions for PEH via a mixed methods review that explored both the effectiveness of interventions and factors that may influence its impact. Search Methods: We searched 10 bibliographic databases from 1990 to March 2021. We also included studies from Campbell Collaboration Evidence and Gap Maps and searched 28 web sites. Reference lists of included papers and systematic reviews were examined and experts contacted for additional studies. Selection Criteria: We included all randomised and non-randomised study designs exploring case management interventions where a comparison group was used. The primary outcome of interest was homelessness. Secondary outcomes included health, wellbeing, employment and costs. We also included all studies where data were collected on views and experiences that may impact on implementation. Data Collection and Analysis: We assessed risk of bias using tools developed by the Campbell Collaboration. We conducted meta-analyses of the intervention studies where possible and carried out a framework synthesis of a set of implementation studies identified by purposive sampling to represent the most 'rich' and 'thick' data. Main Results: We included 64 intervention studies and 41 implementation studies. The evidence base was dominated by studies from the USA and Canada. Participants were largely (though not exclusively) people who were literally homeless, that is, living on the streets or in shelters, and who had additional support needs. Many studies were assessed as having a medium or high risk of bias. However, there was some consistency in outcomes across studies that improved confidence in the main findings. Case Management and Housing Outcomes: Case management of any description was superior to usual care for homelessness outcomes (standardised mean difference [SMD] = -0.51 [95% confidence interval [CI]: -0.71, -0.30]; p < 0.01). For studies included in the meta-analyses, Housing First had the largest observed impact, followed by Assertive Community Treatment, Critical Time Intervention and Intensive Case Management. The only statistically significant difference was between Housing First and Intensive Case Management (SMD = -0.6 [-1.1, -0.1]; p = 0.03) at ≥12 months. There was not enough evidence to compare the above approaches with standard case management within the meta-analyses. A narrative comparison across all studies was inconclusive, though suggestive of a trend in favour of more intensive approaches. Case Management and Mental Health Outcomes: The overall evidence suggested that case management of any description was not more or less effective compared to usual care for an individual's mental health (SMD = 0.02 [-0.15, 0.18]; p = 0.817). Case Management and Other Outcomes: Based on meta-analyses, case management was superior to usual care for capability and wellbeing outcomes up to 1 year (an improvement of around one-third of an SMD; p < 0.01) but was not statistically significantly different for substance use outcomes, physical health, and employment. Case Management Components: For homelessness outcomes, there was a non-significant trend for benefits to be greater in the medium term (≤3 years) compared to long term (>3 years) (SMD = -0.64 [-1.04, -0.24] vs. -0.27 [-0.53, 0]; p = 0.16) and for in-person meetings in comparison to mixed (in-person and remote) approaches (SMD = -0.73 [-1.25,-0.21]) versus -0.26 [-0.5,-0.02]; p = 0.13). There was no evidence from meta-analyses to suggest that an individual case manager led to better outcomes then a team, and interventions with no dedicated case manager may have better outcomes than those with a named case manager (SMD = -0.36 [-0.55, -0.18] vs. -1.00 [-2.00, 0.00]; p = 0.02). There was not enough evidence from meta-analysis to assess whether the case manager should have a professional qualification, or if frequency of contact, case manager availability or conditionality (barriers due to conditions attached to service provision) influenced outcomes. However, the main theme from implementation studies concerned barriers where conditions were attached to services. Characteristics of Persons Experiencing Homelessness: No conclusions could be drawn from meta-analysis other than a trend for greater reductions in homelessness for persons with high complexity of need (two or more support needs in addition to homelessness) as compared to those with medium complexity of need (one additional support need); effect sizes were SMD = -0.61 [-0.91, -0.31] versus -0.36 [-0.68, -0.05]; p = 0.3. The Broader Context of Delivery of Case Management Programmes: Other major themes from the implementation studies included the importance of interagency partnership; provision for non-housing support and training needs of PEH (such as independent living skills), intensive community support following the move to new housing; emotional support and training needs of case managers; and an emphasis on housing safety, security and choice. Cost Effectiveness: The 12 studies with cost data provided contrasting results and no clear conclusions. Some case management costs may be largely off-set by reductions in the use of other services. Cost estimates from three North American studies were $45-52 for each additional day housed. Authors' Conclusions: Case management interventions improve housing outcomes for PEH with one or more additional support needs, with more intense interventions leading to greater benefits. Those with greater support needs may gain greater benefit. There is also evidence for improvements to capabilities and wellbeing. Current approaches do not appear to lead to mental health benefits. In terms of case management components, there is evidence in support of a team approach and in-person meetings and, from the implementation evidence, that conditions associated with service provision should be minimised. The approach within Housing First could explain the finding that overall benefits may be greater than for other types of case management. Four of its principles were identified as key themes within the implementation studies: No conditionality, offer choice, provide an individualised approach and support community building. Recommendations for further research include an expansion of the research base outside North America and further exploration of case management components and intervention cost-effectiveness.

Collaboration between local health and local government agencies for health improvement.

BACKGROUND: In many countries, national, regional and local inter- and intra-agency collaborations have been introduced to improve health outcomes. Evidence is needed on the effectiveness of locally developed partnerships which target changes in health outcomes and behaviours. OBJECTIVES: To evaluate the effects of interagency collaboration between local health and local government agencies on health outcomes in any population or age group. SEARCH METHODS: We searched the Cochrane Public Health Group Specialised Register, AMED, ASSIA, CENTRAL, CINAHL, DoPHER, EMBASE, ERIC, HMIC, IBSS, MEDLINE, MEDLINE In-Process, OpenGrey, PsycINFO, Rehabdata, Social Care Online, Social Services Abstracts, Sociological Abstracts, TRoPHI and Web of Science from 1966 through to January 2012. 'Snowballing' methods were used, including expert contact, citation tracking, website searching and reference list follow-up. SELECTION CRITERIA: Randomized controlled trials (RCTs), controlled clinical trials (CCTs), controlled before-and-after studies (CBAs) and interrupted time series (ITS) where the study reported individual health outcomes arising from interagency collaboration between health and local government agencies compared to standard care. Studies were selected independently in duplicate, with no restriction on population subgroup or disease. DATA COLLECTION AND ANALYSIS: Two authors independently conducted data extraction and assessed risk of bias for each study. MAIN RESULTS: Sixteen studies were identified (28,212 participants). Only two were considered to be at low risk of bias. Eleven studies contributed data to the meta-analyses but a narrative synthesis was undertaken for all 16 studies. Six studies examined mental health initiatives, of which one showed health benefit, four showed modest improvement in one or more of the outcomes measured but no clear overall health gain, and one showed no evidence of health gain. Four studies considered lifestyle improvements, of which one showed some limited short-term improvements, two failed to show health gains for the intervention population, and one showed more unhealthy lifestyle behaviours persisting in the intervention population. Three studies considered chronic disease management and all failed to demonstrate health gains. Three studies considered environmental improvements and adjustments, of which two showed some health improvements and one did not.Meta-analysis of three studies exploring the effect of collaboration on mortality showed no effect (pooled relative risk of 1.04 in favour of control, 95% CI 0.92 to 1.17). Analysis of five studies (with high heterogeneity) looking at the effect of collaboration on mental health resulted in a standardised mean difference of -0.28, a small effect favouring the intervention (95% CI -0.51 to -0.06). From two studies, there was a statistically significant but clinically modest improvement in the global assessment of function symptoms score scale, with a pooled mean difference (on a scale of 1 to 100) of -2.63 favouring the intervention (95% CI -5.16 to -0.10).For physical health (6 studies) and quality of life (4 studies) the results were not statistically significant, the standardised mean differences were -0.01 (95% CI -0.10 to 0.07) and -0.08 (95% CI -0.44 to 0.27), respectively. AUTHORS' CONCLUSIONS: Collaboration between local health and local government is commonly considered best practice. However, the review did not identify any reliable evidence that interagency collaboration, compared to standard services, necessarily leads to health improvement. A few studies identified component benefits but these were not reflected in overall outcome scores and could have resulted from the use of significant additional resources. Although agencies appear enthusiastic about collaboration, difficulties in the primary studies and incomplete implementation of initiatives have prevented the development of a strong evidence base. If these weaknesses are addressed in future studies (for example by providing greater detail on the implementation of programmes; using more robust designs, integrated process evaluations to show how well the partners of the collaboration worked together, and measurement of health outcomes) it could provide a better understanding of what might work and why. It is possible that local collaborative partnerships delivering environmental Interventions may result in health gain but the evidence base for this is very limited.Evaluations of interagency collaborative arrangements face many challenges. The results demonstrate that collaborative community partnerships can be established to deliver interventions but it is important to agree goals, methods of working, monitoring and evaluation before implementation to protect programme fidelity and increase the potential for effectiveness.

Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences.

BACKGROUND: Phase 1 drug trials are popular treatment options for patients with advanced disease, despite the greater levels of uncertainty associated with them. However, their meaning and consequences for patient-participants remains under-explored. This review synthesises the qualitative evidence of patients' experiences of participating in phase 1 oncology trials, exploring their decisions to take part and the impacts of these trials on patient wellbeing. METHODS: A comprehensive literature search involving medical subject headings (MeSH) and keywords was undertaken in the following databases: MEDLINE, EMBASE, PsycINFO, Scopus, CINAHL, and Cochrane CENTRAL, with supplementary searches also conducted. Studies were independently screened for inclusion by two researchers. Included studies were critically appraised and data extracted using standardised forms. Qualitative results were analysed using thematic synthesis. RESULTS: Three main themes were identified across 13 studies: decision-making and joining the trial; experiences of taking part in the trial and hope and coping. Patients primarily joined trials hoping for therapeutic benefits, sentiments which prevailed and shaped their experiences across their trial journey. Rather than indicate therapeutic misconception based on poor understanding, patient perspectives more commonly pointed to differences between hope and expectation and cultural narratives of staying positive, trying everything and trusting in experts. CONCLUSIONS: These findings challenge information-based models of consent, favouring coping frameworks which account for the role of hope and meaning-making during serious illness. Personalised consideration of existential and quality-of-life matters before and during trials is recommended, including palliative and supportive care alternatives to active treatment. REVIEW REGISTRATION: The review was registered with PROSPERO international prospective register of systematic reviews (CRD 42020163250).

End-of-life care for people with severe mental illness: mixed methods systematic review and thematic synthesis of published case studies (the MENLOC study).

OBJECTIVES: People with severe mental illness (SMI) have significant comorbidities and reduced life expectancy. The objective of the review reported in this paper was to synthesise material from case studies relating to the organisation, provision and receipt of care for people with SMI who have an end-of-life (EoL) diagnosis. DESIGN: Systematic review and thematic synthesis. DATA SOURCES: MEDLINE, PsycINFO, EMBASE, HMIC, AMED, CINAHL, CENTRAL, ASSIA, DARE and Web of Science from inception to December 2019. Supplementary searching for additional material including grey literature along with 62 organisational websites. RESULTS: Of the 11 904 citations retrieved, 42 papers reporting 51 case studies were identified and are reported here. Twenty-five of the forty-two case study papers met seven, or more quality criteria, with eight meeting half or less. Attributes of case study subjects included that just over half were men, had a mean age of 55 years, psychotic illnesses dominated and the EoL condition was in most cases a cancer. Analysis generated themes as follows diagnostic delay and overshadowing, decision capacity and dilemmas, medical futility, individuals and their networks, care provision. CONCLUSIONS: In the absence of high-quality intervention studies, this evidence synthesis indicates that cross disciplinary care is supported within the context of established therapeutic relationships. Attention to potential delay and diagnostic overshadowing is required in care provision. The values and preferences of individuals with severe mental illness experiencing an end-of-life condition should be recognised. PROSPERO REGISTRATION NUMBER: CRD42018108988.

PROTOCOL: Exploring the effect of case management in homelessness per components: A systematic review of effectiveness and implementation, with meta-analysis and thematic synthesis.

This is the protocol for a Campbell review. The objectives are as follows: To carry out a mixed methods review to summarise current evidence relating to the components of case-management interventions for people experiencing homelessness.

Collaboration between local health and local government agencies for health improvement.

BACKGROUND: In many countries, national, regional and local inter- and intra-agency collaborations have been introduced in order to improve health outcomes. Evidence is needed on the effectiveness of locally-developed partnerships which target changes in individual health outcomes and behaviours. OBJECTIVES: To evaluate the effects of interagency collaboration between local health and local government agencies on health outcomes. SEARCH STRATEGY: Twenty-five databases were searched using a highly sensitive search strategy. 'Snowballing' methods were also used, including expert contact, website searching and reference list follow up. SELECTION CRITERIA: Randomized controlled trials (RCTs), controlled clinical trials (CCTs), controlled before-and-after studies (CBAs) and interrupted time series (ITS) where the study reported on interagency collaboration between health and local government agencies. Studies were selected independently in duplicate by two of five authors. DATA COLLECTION AND ANALYSIS: From the team of five review authors, two authors independently conducted data extraction and assessed risk of bias for each study. MAIN RESULTS: Eleven studies were identified, presenting information on a total of 26,686 participants. Owing to the heterogeneity between studies a narrative synthesis was undertaken. The included studies covered a range of topics. Six studies examined mental health initiatives, of which one study showed health benefit; four showed modest improvement in one or more of the outcomes measured, but no clear overall health gain; and one study showed no evidence of health gain. Two studies were related to lifestyle improvements of which one failed to show health gains for the intervention population, while the other showed more unhealthy lifestyle behaviours persisting in the intervention population. Three studies were related to chronic disease management and all three failed to demonstrate health gains. AUTHORS' CONCLUSIONS: Collaboration between local health and local government is commonly considered best practice. However, the review did not identify any reliable evidence that inter­agency collaboration, compared to standard services, leads to health improvement. A few studies identified component benefits but these were not reflected in overall outcome scores and could have resulted from the use of significant additional resources. Although agencies appear enthusiastic about collaboration, methodological flaws in the primary studies and incomplete implementation of initiatives have prevented the development of a strong evidence base. If these flaws are addressed in future studies (for example by providing greater detail on the implementation of programs, using more robust designs, with integrated process evaluations and measurement of health outcomes) it could provide a better understanding of what might work and why.When updating this review, we will analyse any partnership or process evaluations of our included studies to try to identify markers of success in local collaborative partnerships that could inform policy developments in the future.