Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial.

PURPOSE: Breast cancer survivors following disease-modifying treatment frequently experience multiple-concurrent symptoms (Jansana et al. in Int J Cancer 149(10):1755 1767, 2021), negatively impacting their quality of life and increasing the risk of polypharmacy (Alwhaibi et al. in J Oncol Pharm Pract 26(5):1052 1059, 2020). This study evaluates the feasibility and acceptability of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors, and investigates relationships between the symptom cluster and Traditional Chinese Medicine (TCM) syndrome diagnosis. METHODS: This was a single-arm, pre-test/post-test feasibility trial conducted at Chris O'Brien Lifehouse Hospital, Australia. Breast cancer survivors who completed treatment and experienced clinically significant levels of two or more symptoms (pain, fatigue, sleep disturbance, numbness/tingling) were eligible to participate in the individualized, pragmatic 6-week acupuncture intervention. The primary outcome was feasibility and acceptability. Effectiveness was explored using a symptom cluster mean score. RESULTS: Twenty women enrolled in the study over an 11-week period and 90% completed the study. Most women agreed or completely agreed that acupuncture was feasible (85%), acceptable (90%), and appropriate (90%). Both mean and composite symptom cluster scores were significantly reduced (p < 0.001), as were individual symptom scores in fatigue (p < 0.001), sleep disturbance (p = 0.04), and numbness/tingling (p = 0.01). TCM syndromes most closely associated with this symptom cluster were Spleen qi deficiency and Heart fire. No adverse events were reported. CONCLUSION: This study demonstrated that acupuncture was safe and feasible, justifying a powered randomized control trial. Preliminary findings suggest beneficial effects of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster for women with breast cancer. TCM syndromes identified in this trial may be used to guide acupuncture treatment protocols. CLINICAL TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000590763) on 21 April 2022.

Understanding the informal aspects of medication processes to maintain patient safety in hospitals: a sociotechnical ethnographic study in paediatric units.

Adverse drug events (ADEs) are common in hospitals, affecting one in six child in-patients. Medication processes are complex systems. This study aimed to explore the work-as-done of medication safety in three English paediatric units using direct observation and semi-structured interviews. We found that a combination of the physical environment, traditional work systems and team norms were among the systemic barriers to medicines safety. The layout of wards discouraged teamworking and reinforced professional boundaries. Workspaces were inadequate, and interruptions were uncontrollable. A less experienced workforce undertook prescribing and verification while more experienced nurses undertook administration. Guidelines were inadequate, with actors muddling through together. Formal controls against ADEs included checking (of prescriptions and administration) and barcode administration systems, but these did not integrate into workflows. Families played an important part in the safe administration of medication and provision of information about their children but were isolated from other parts of the system.

Formal medicines safety processes in paediatric units are disjointed and disconnected. This has led actors in the system (e.g. nursing and medical staff) to develop informal adaptations to increase resilience. There is a need to incorporate these adaptations into a systems-focussed consideration of safety processes, in order to properly inform the development of medication safety interventions.

Knowledge and attitudes towards medicinal cannabis and complementary and integrative medicine (CIM): a survey of healthcare professionals working in a cancer hospital in Australia.

PURPOSE: We investigated attitudes and practices of healthcare professionals (HCPs) to medicinal cannabis (MC) and complementary and integrative medicine (CIM), including individual therapies, such as acupuncture, massage, herbs, dietary supplements, nutrition and exercise. We explored whether healthcare occupation influenced attitudes to CIM and MC; referral pathways for advice on CIM; and interest in a pharmacy service to evaluate herbs and supplements. METHODS: Cross-sectional survey. All clinical staff at a comprehensive cancer hospital were invited to complete an anonymous questionnaire about CIM and MC. We used descriptive analysis to describe the respondent's knowledge and attitudes, and Fisher's exact test to test for differences by occupation, length of time at the hospital and age. RESULTS: Most of the 116 HCPs respondents supported integrating CIM into cancer care (94.8%) and wanted to learn more (90%) and to understand benefits and contraindications. Most respondents believed that CIM (87.9%) could benefit patients with cancer, and MC could benefit those with advanced cancer (49-51%). Whilst just over half (52.6%) felt confident discussing CIM with patients, only 10% felt they had sufficient knowledge to discuss MC. Most felt they did not have sufficient knowledge to specifically discuss mind and body practices (63.8%) or herbs and supplements (79%). HCPs (63%) would be more inclined to allow use of herbs and supplements with cancer treatment if a pharmacy service was available to evaluate interactions. Occupation, length of time at hospital and age influenced confidence and knowledge about CIM. CONCLUSIONS: The integration of evidence-based CIM and MC into cancer care is hampered by a lack of knowledge of benefits and contraindications, and gaps in education. Effective and safe integration may require targeted development of services such as pharmacy to evaluate the safety of herbs and supplements, and inclusion of cancer specialists who have received training in individual CIM therapies and MC.

Yoga for depression and anxiety symptoms in people with cancer: A systematic review and meta-analysis.

OBJECTIVE: Cancer and its treatment can lead to a variety of physical and emotional concerns impacting on those affected, including subclinical or clinical depression and anxiety, which in turn have a significant impact on wellbeing, quality of life and survival. The aim of this review was to evaluate the effect of yoga-based interventions on self-reported depression and anxiety symptoms in people with cancer in randomized controlled trials. METHOD: Six databases were searched to identify relevant studies. Systematic review procedures were followed including a quality assessment. Meta-analysis of suitable studies was conducted. RESULTS: 26 studies from our search criteria were eligible for inclusion for depressive and 16 for anxiety symptoms. Meta-analyses revealed evidence for significant medium effects of yoga on depression symptoms (N = 1,486, g = -0.419, 95% confidence interval [CI] = -0.558 to -0.281, p < 0.001) and anxiety (N = 977, g = -0.347, 95% CI = -0.473 to -0.221, p < 0.001) compared to controls. Subgroup analyses for depressive symptoms revealed significant effects for all analyses performed (type of cancer, type of control, treatment status, duration of intervention or frequency of yoga sessions), with effect sizes being comparable between subgroups. Similar findings were found for anxiety symptoms except for treatment status, where the only significant effect was found when yoga was delivered during active treatment. CONCLUSIONS: This review provides evidence that in people with cancer, yoga-based interventions are associated with amelioration of depression and anxiety symptoms and therefore a promising therapeutic modality for their management. However, the potential for risk of bias together with control group design challenges means the results should be interpreted with caution.

Patient-reported outcome measures and supportive care need assessment in patients attending an Australian comprehensive care centre: a multi-method study.

PURPOSE: Patient-reported outcome measures (PROMs) are useful clinical tools to recognise symptoms, patient needs and their severity. Whilst PROMs are routinely utilised in integrative oncology (IO) and supportive care (SC) services to improve patient care, they are not as common in general oncology. We explored our patients' symptom burden, the approach taken by clinicians to identify and manage patient needs, and barriers and facilitators to using PROMs in an Australian tertiary comprehensive cancer centre to inform wider implementation of PROMs. METHODS: From 2017 to 2018, PROM data collected for patients accessing IO and SC was retrospectively analysed. Semi-structured interviews with oncology doctors and nurses explored their approach to patient needs assessment and their use of PROMs. RESULTS: A total of 404 patients completed the Edmonton Symptom Assessment Scale (ESAS). The most frequently identified symptoms were sleep disturbance, fatigue and lack of wellbeing. Symptom clusters included drowsiness, fatigue and shortness of breath; anxiety and depression; sleep and pain; appetite and nausea. In total, 9 nurse consultants, 5 surgeons, 7 medical and 5 radiation oncologists were interviewed. Most participants took an intuitive approach to identifying and managing patient needs and did not routinely use PROMs. Perceived risks, barriers and facilitators to using PROMS are presented. CONCLUSIONS: High and complex symptom burden was found in our IO and SC patient population, reinforcing the need for screening. Whilst wider clinical use of PROMs within the hospital may improve clinical outcomes, the barriers and facilitators identified by Health Care Professionals (HCPs) need to be addressed before implementing PROMs more broadly.

Coverage of cancer services in Australia and providers' views on service gaps: findings from a national cross-sectional survey.

BACKGROUND: In response to the increasing cancer prevalence and the evolving health service landscape across the public and private health sectors in Australia, this study aimed to map cancer services and identify factors associated with service provision and important service gaps. METHODS: A prospective, cross-sectional survey was conducted throughout 2016. Extensive search strategies identified Government or privately-owned, hospital or community-based healthcare organisations with dedicated cancer services. One nominated staff member from each organisation answered a purpose specific online/paper questionnaire. Descriptive statistics, standardised rates, and single level and multilevel multinomial logistic regression were used to analyse the data. Analysis was augmented with a qualitative descriptive analysis of open-ended questions. RESULTS: From the 295 eligible organisations with a cancer service in Australia, 93.2% participated in the survey. After adjusting for remoteness, for-profit companies were significantly more likely than Government operated services to provide only one or two types of cancer services (e.g. radiotherapy) in a limited range of settings (e.g. day hospital with no in-patient or home care) (p < 0.001) and less likely to provide comprehensive cancer services (p < 0.001). After adjusting for ownership and the respondent's role in the organisation, respondents located in remote regions of Australia were more likely to identify cancer services that are dependent upon specialist medical practitioners as the most important service gaps in their region (p = 0.003). Despite 76.0% of organisations across Australia offering some type of supportive care or survivorship services, providers identified this group of services as the most pressing service gaps in major cities, rural and remote regions alike (standardised rate: 47.9% (95%CI: 43.6-57.4%); p < .000). This included the need for improved integration, outreach and affordability. CONCLUSIONS: The broad range of cancer services, settings and ownership identified by this survey highlights the complexity of the Australian healthcare system that cancer survivors must navigate and the challenges of providing comprehensive cancer care particularly in rural and remote regions. Whilst the significant role of supportive care and survivorship services are increasingly being recognised, the findings from this survey support calls for innovative service models and funding mechanisms that expand the focus from preventing and treating cancer to supporting cancer survivors throughout the cancer continuum and promoting the delivery of integrated and equitable cancer care across the public and private sectors.

Establishing an integrative oncology service in the Australian healthcare setting-the Chris O'Brien Lifehouse Hospital experience.

Comprehensive cancer centres are on the rise as patients seek a more holistic approach to maintaining their wellbeing when living with a cancer diagnosis. Many cancer centres worldwide now incorporate a selection of evidence-based complementary therapies and qualified therapists into their offerings. The Chris O'Brien Lifehouse, a comprehensive cancer centre in Sydney, Australia, provides integrative oncology services including acupuncture, massage, reflexology, dietetics and exercise physiology for individual patients, along with group programmes, and an integrative and supportive care medical specialist. The purpose of this paper is to reflect on one model of integrative oncology service and approach to integration and team and service development.

Guidance for establishing an integrative oncology service in the Australian healthcare setting-a discussion paper.

There is an obvious mismatch between the high reported rates of use of traditional and complementary medicines (T&CM) by Australian cancer patients and cancer survivors and the low numbers of Australian cancer services integrating T&CM. An estimated 65% of Australian cancer patients use at least one form of T&CM. Over half use T&CM in conjunction with conventional cancer therapy. Yet, less than 20% of Australian hospital cancer care facilities provide access to T&CM. This compares to around 70% of UK cancer care facilities offering at least one T&CM therapy. Barriers to developing integrative oncology services include determining an appropriate service model and revenue structure; concerns with ethical and legal issues such as regulations and credentialing; and inadequate high-quality scientific evidence demonstrating safety and effectiveness, including concerns about the possibility of adversely affecting chemotherapy or radiotherapy treatment. This paper aims to provide general guidance and practical strategies for those seeking to develop integrative oncology services in Australian cancer care facilities.

Single herbal medicine for diabetic retinopathy.

BACKGROUND: Diabetic retinopathy is one of the major causes of blindness and the number of cases has risen in recent years. Herbal medicine has been used to treat diabetes and its complications including diabetic retinopathy for thousands of years around the world. However, common practice is not always evidence-based. Evidence is needed to help people with diabetic retinopathy or doctors to make judicious judgements about using herbal medicine as treatment. OBJECTIVES: To evaluate the effectiveness and harm of single herbal medicine for diabetic retinopathy. SEARCH METHODS: We searched CENTRAL, which contains the Cochrane Eyes and Vision Trials Register, MEDLINE, Embase, OpenGrey, the ISRCTN registry, ClinicalTrials.gov and the ICTRP. The date of the search was 12 June 2018. We also searched the following Chinese databases in June 2013: Chinese BioMedical Literature Database (CBM), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), Wanfang China Dissertation Database (CDDB), Wanfang China Conference Paper Database (CCPD) and the Index to Chinese Periodical Literature. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs that investigated the effects of any single herb (or extracts from a single herb) as a treatment for people with diabetic retinopathy. We considered the following comparators: placebo, no treatment, non-herbal (conventional) medicine or surgical treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias in the studies. Our prespecified outcomes were: progression of diabetic retinopathy, visual acuity, microaneurysms and haemorrhages in the retina, blood glycated haemoglobin A1c (HbA1c) (%) and adverse effects. We performed meta-analyses using risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 10 studies involving 754 participants, of which nine were conducted in China and one in Poland. In all studies, participants in both groups received conventional treatment for diabetic retinopathy which included maintaining blood glucose and lipids using medicines and keeping a stable diabetic diet. In three studies, the comparator group also received an additional potentially active comparator in the form of a vasoprotective drug. The single herbs or extracts included Ruscus extract tablet, Sanqi Tongshu capsule, tetramethylpyrazine injection, Xueshuantong injection, Puerarin injection and Xuesaitong injection. The Sanqi Tongshu capsule, Xueshuantong injection and Xuesaitong injection were all made from the extract of Radix Notoginseng (San qi) and the main ingredient was sanchinoside. The risk of bias was high in all included studies mainly due to lack of masking (blinding). None of the studies reported the primary outcome of this review, progression of retinopathy.Combined analysis of herbal interventions suggested that people who took these herbs in combination with conventional treatment may have been more likely to gain 2 or more lines of visual acuity compared to people who did not take these herbs when compared to conventional intervention alone at the end of treatment (RR 1.26, 95% CI 1.08 to 1.48; 5 trials, 541 participants; low-certainty evidence). Subgroup analyses based on the different single herbs found no evidence for different effects of different herbs, but the power of this analysis was low. One study reported Sanqi Tongshu capsule might be associated with a greater reduction in microaneurysms and haemorrhages in the retina (very low-certainty evidence). The pooled analysis of two studies on tetramethylpyrazine or Xueshuantong injection showed such herbs may have had little effect on lowering HbA1c (MD 0.00, 95% CI -0.58 to 0.58; 215 participants; low-certainty evidence).There was very low-certainty evidence on adverse events. Two studies reported minor adverse events such as uncomfortable stomach, urticaria, dizziness and headache. There was no report of observation on adverse events in the other studies. AUTHORS' CONCLUSIONS: No conclusions could be drawn about the effect of any single herb or herbal extract on diabetic retinopathy from the current available evidence. It was difficult to exclude the placebo effect as a possible explanation for observed differences due to the lack of placebo control in the included studies. Further adequately designed trials are needed to establish the evidence.

A meta-ethnography of the facilitators and barriers to successful implementation of patient complaints processes in health-care settings.

OBJECTIVE: To synthesize experiences of the patient complaints process for patients and health-care professionals to identify facilitators and barriers in the successful implementation of patient complaints processes. This will assist the development of cultural change programmes, enabling complaints managers to incorporate stakeholder perspectives into future care. DESIGN: Systematic literature search and meta-ethnography, comprising reciprocal syntheses of "patient" and "professional" qualitative studies, combined to form a "line-of-argument" embodying both perspectives. DATA SOURCES: MEDLINE, CINAHL and PsycINFO (database inception to April 2015) were searched to identify international literature in primary and secondary health-care settings, involving qualitative data collection and analysis. Further studies were identified from hand-searching relevant journals, contacting authors, article reference lists and Google Scholar. RESULTS: A total of 13 papers, reporting 9 studies from the United Kingdom, Sweden, Australia and New Zealand, were included in the synthesis. Facilitators and barriers to the successful implementation of patient complaints processes were identified across the perspectives of both patients and health-care professionals. Patients sought to individualize the complaints process by targeting specific professionals who engaged in practices that undermined the identity of patients. In contrast, professionals obscured their own individualism through maintaining a collective identity and withholding personal judgement in relation to patient complaints. CONCLUSIONS: Complainants recognized health-care professionals as bearers of individual accountability for unsatisfactory care, in opposition to the stance of collective responsibility endorsed by professionals. Implementation of patient complaints processes must reconcile the need for individualized resolution, whilst striving to improve the future provision of health care through a collaborative approach between patients and professionals.

Integrative oncology and complementary medicine cancer services in Australia: findings from a national cross-sectional survey.

BACKGROUND: Individuals living with and beyond a cancer diagnosis are increasingly using complementary therapies and medicines (CM) to enhance the effectiveness of cancer treatment, manage treatment-related side effects, improve quality-of-life, and promote self-efficacy. In response to the increasing use and demand for CM by cancer patients, interest in the implementation of Integrative Oncology (IO) services that provide CM alongside conventional cancer care in Australia and abroad has developed. The extent that cancer services in Australia are integrating CM is uncertain. Thus, the aim of this study was to identify IO services in Australia and explore barriers and facilitators to IO service provision. METHODS: A national, cross-sectional survey of healthcare organisations was conducted in 2016. Organisations in the public and private sectors, including not-for-profit organisations that provided cancer care in hospital or community setting, were included. RESULTS: A response rate of 93.2% was achieved (n = 275/295). Seventy-one organisations (25.8%) across all states/territories, except the Northern Territory, offered IO albeit in a limited amount by many. Most common IO services included massage, psychological-wellbeing, and movement modalities in hospital outpatient or inpatient settings. There were only a few instances where biological-based complementary medicine (CM) therapies were prescribed. Funding was often mixed, including patient contributions, philanthropy, funding by the organisation, and volunteer practitioners. Of the 204 non-IO providers, 80.9% had never provided any IO service. Overwhelmingly, the most common barrier to IO was a lack of funding, followed by uncertainty about patient demand, choice of services, and establishing such services. Less-common barriers were a lack of evidence, and support from oncologists or management. More funding, education and training, and building the evidence-base for CM were the most commonly suggested solutions. CONCLUSION: IO is increasingly being provided in Australia, although service provision remains limited or non-existent in many areas. Mismatches appear to exist between low IO service provision, CM evidence, and high CM use by cancer patients. Greater strategic planning and policy guidance is indicated to ensure the appropriate provision of, and equitable access to IO services for all Australian cancer survivors.

Spatio-temporal elements of articulation work in the achievement of repeat prescribing safety in UK general practice.

Prescribing is the most common healthcare intervention, and is both beneficial and risky. An important source of risk in UK general practice is the management of 'repeat prescriptions', which are typically requested from and issued by non-clinically trained reception staff with only intermittent reauthorisation by a clinical prescriber. This paper ethnographically examines the formal and informal work employed by GPs and receptionists to safely conduct repeat prescribing work in primary care using Strauss's (1985, 1988, 1993) concept of 'articulation work' across eight UK general practices. The analytical lens of articulation work provided an investigative framing to contextually map the informal, invisible resources of resilience and strength employed by practice team members in the achievement of repeat prescribing safety, where risk and vulnerability were continually relocated across space and time. In particular, the paper makes visible the micro-level competencies and collaborative practices that were routinely employed by both GPs and receptionists across different socio-cultural contexts, with informal, cross-hierarchical communication usually considered more effective than the formal structures of communication that existed (e.g. protocols). While GPs held formal prescribing authority, this paper also examines the key role of receptionists in both the initiation and safe coordination of the repeat prescribing routine.

Ganoderma lucidum mushroom for the treatment of cardiovascular risk factors.

BACKGROUND: Ganoderma lucidum (also known as lingzhi or reishi) is a mushroom that has been consumed for its broad medicinal properties in Asia for over 2000 years. G lucidum is becoming increasingly popular in western countries as a complementary medicine for cardiovascular health. OBJECTIVES: To evaluate the effectiveness of G lucidum for the treatment of pharmacologically modifiable risk factors of cardiovascular disease in adults. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL Issue 6 of 12, 2014) on The Cochrane Library, MEDLINE (OVID, 1946 to June week 3 2014), EMBASE (OVID, 1980 to 2014 week 26), Science Direct (1823 to 2013), Current Controlled Trials (1990 to 2013), Australian New Zealand Clinical Trials Registry (2005 to 2013), Chinese Biomedical Literature Database (2007 to 2013), Chinese Medical Current Contents (2007 to 2013) and other databases. We checked reference lists of included studies, contacted content experts and handsearched The International Journal of Medicinal Mushrooms. We applied no language or publication restrictions. SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials of G lucidum for the treatment of cardiovascular risk factors. Primary outcomes were blood glucose level, blood pressure and lipid profile. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed risk of bias and cross checked data extraction and analysis. A third author arbitrated in the event of disagreement. MAIN RESULTS: Five trials with a total of 398 participants were eligible for inclusion. Of these, one study was published in Chinese and translated to English; one study was published but study authors provided the additional data used in this review; one study was unpublished and the study authors provided data; and two studies did not provide comparison group data suitable for statistical analyses. The three studies from which data were used for statistical analyses compared G lucidum (1.4 g to 3 g per day) to placebo over 12 to 16 weeks of intervention. Although inclusion criteria varied, all participants of these three studies had type 2 diabetes mellitus. Of the five included studies, risk of bias was low for one study and unclear for the remaining four.Results from two studies showed that G lucidum was not associated with statistically or clinically significant reduction in HbA1c (WMD -0.10%; 95% CI -1.05% to 0.85%; 130 participants), total cholesterol (WMD -0.07mmol/L; 95% CI -0.57 mmol/L to 0.42 mmol/L; 107 participants ), low-density lipoprotein cholesterol (WMD 0.02 mmol/L; 95% CI -0.41 mmol/L to 0.45 mmol/L; 107 participants), or body-mass index (WMD -0.32 kg/m(2); 95% CI -2.67 kg/m(2) to 2.03 kg/m(2;) 107 participants). All other analyses were from a single study of 84 participants. We found no improvement for fasting plasma glucose (WMD 0.30 mmol/L; 95% CI -0.95 mmol/L to 1.55 mmol/L). Measures of post-prandial blood glucose level found inconsistent results, being in favour of placebo for '2-hour post-prandial blood glucose' (WMD 0.7 mmol/L; 95% CI 0.29 mmol/L to 1.11 mmol/L) and in favour of G lucidum for 'plasma glucose under the curve at 4th hour' (WMD -49.4mg/dL/h; 95% CI -77.21 mg/dL/h to -21.59 mg/dL/h). As the Minimal Clinical Important Differences are unknown, the clinical significance of this effect is unclear. There were no statistically significant differences between groups for blood pressure or triglycerides. Participants who took G lucidum for four months were 1.67 times (RR 1.67 95% CI 0.86 to 3.24) more likely to experience an adverse event than those who took placebo but these were not serious side effects. AUTHORS' CONCLUSIONS: Evidence from a small number of randomised controlled trials does not support the use of G lucidum for treatment of cardiovascular risk factors in people with type 2 diabetes mellitus. Future research into the efficacy of G lucidum should be placebo-controlled and adhere to clinical trial reporting standards.

Process of care in outpatient Integrative healthcare facilities: a systematic review of clinical trials.

BACKGROUND: Patients currently integrate complementary medicine (CM) and allopathic, choosing a combination of therapies rather than a single therapy in isolation. Understanding integrative healthcare (IHC) extends beyond evaluation of specific therapies to encompass evaluations of multidisciplinary complex interventions. IHC is defined as a therapeutic strategy integrating conventional and complementary medical practices and practitioners in a shared care setting to administer an individualized treatment plan. We sought to review the outcomes of recent clinical trials, explore the design of the interventions and to discuss the methodological approaches and issues that arise when investigating a complex mix of interventions in order to guide future research. METHOD: Five databases were searched from inception to 30 March 2013. We included randomized and quasi-experimental clinical trials of IHC. Data elements covering process of care (initial assessment, treatment planning and review, means for integration) were extracted. RESULTS: Six thousand two hundred fifty six papers were screened, 5772 were excluded and 484 full text articles retrieved. Five studies met the inclusion criteria. There are few experimental studies of IHC. Of the five studies conducted, four were in people with lower back pain. The positive findings of these studies indicate that it is feasible to conduct a rigorous clinical trial of an integrative intervention involving allopathic and CM treatment. Further, such interventions may improve patient outcomes. CONCLUSIONS: The trials in our review provide a small yet critical base from which to refine and develop larger studies. Future studies need to be adequately powered to address efficacy, safety and include data on cost effectiveness.

Soft governance, restratification and the 2004 general medical services contract: the case of UK primary care organisations and general practice teams.

In the UK National Health Service, primary care organisation (PCO) managers have traditionally relied on the soft leadership of general practitioners based on professional self-regulation rather than direct managerial control. The 2004 general medical services contract (nGMS) represented a significant break from this arrangement by introducing new performance management mechanisms for PCO managers to measure and improve general practice work. This article examines the impact of nGMS on the governance of UK general practice by PCO managers through a qualitative analysis of data from an empirical study in four UK PCOs and eight general practices, drawing on Hood's four-part governance framework. Two hybrids emerged: (i) PCO managers emphasised a hybrid of oversight, competition (comptrol) and peer-based mutuality by granting increased support, guidance and autonomy to compliant practices; and (ii) practices emphasised a broad acceptance of increased PCO oversight of clinical work that incorporated a restratified elite of general practice clinical peers at both PCO and practice levels. Given the increased international focus on the quality, safety and efficiency in primary care, a key issue for PCOs and practices will be to achieve an effective, contextually appropriate balance between the counterposing governance mechanisms of peer-led mutuality and externally led comptrol.

The process of care in integrative health care settings - a qualitative study of US practices.

BACKGROUND: There is a lack of research on the organisational operations of integrative healthcare (IHC) practices. IHC is a therapeutic strategy integrating conventional and complementary medicine in a shared context to administer individualized treatment. To better understand the process of care in IHC - the way in which patients are triaged and treatment plans are constructed, interviews were conducted with integrative health care leaders and practitioners in the US. METHODS: Semi-structured interviews were conducted with a pragmatic group of fourteen leaders and practitioners from nine different IHC settings. All interviews were conducted face-to-face with the exception of one phone interview. Questions focussed on understanding the "process of care" in an integrative healthcare setting. Deductive categories were formed from the aims of the study, focusing on: organisational structure, processes of care (subcategories: patient intake, treatment and charting, use of guidelines or protocols), prevalent diseases or conditions treated, and the role of research in the organisation. The similarities and differences of the ITH entities emerged from this process. RESULTS: On an organisational level, conventional and CM services and therapies were co-located in all nine settings. For patients, this means there is more opportunity for 'seamless care'. Shared information systems enabled easy communication using internal messaging or email systems, and shared patient intake information. But beyond this infrastructure alignment for integrative health care was less supported. There were no use of protocols or guidelines within any centre, no patient monitoring mechanism beyond that which occurred within one-on-one appointments. Joint planning for a patient treatment was typically ad hoc through informal mechanisms. Additional duties typically come at a direct financial cost to fee-for-service practitioners. In contrast, service delivery and the process of care within hospital inpatient services followed a more formalised structure. CONCLUSIONS: IHC is a complex, emerging field with divergent meanings and interpretations. The structures and processes of the IHC entities reported provide insight to the variable ways in which IHC manifests whilst commonly holding a similar vision. This report contributes to understanding IHC, providing evidence for future planning, implementation and evaluation to meet patient needs and demands in this area.

A meta-ethnography of organisational culture in primary care medical practice.

PURPOSE: Over the past decade, there has been growing international interest in shaping local organisational cultures in primary healthcare. However, the contextual relevance of extant culture assessment instruments to the primary care context has been questioned. The aim of this paper is to derive a new contextually appropriate understanding of the key dimensions of primary care medical practice organisational culture and their inter-relationship through a synthesis of published qualitative research. DESIGN/METHODOLOGY/APPROACH: A systematic search of six electronic databases followed by a synthesis using techniques of meta-ethnography involving translation and re-interpretation. FINDINGS: A total of 16 papers were included in the meta-ethnography from the UK, the USA, Canada, Australia and New Zealand that fell into two related groups: those focused on practice organisational characteristics and narratives of practice individuality; and those focused on sub-practice variation across professional, managerial and administrative lines. It was found that primary care organisational culture was characterised by four key dimensions, i.e. responsiveness, team hierarchy, care philosophy and communication. These dimensions are multi-level and inter-professional in nature, spanning both practice and sub-practice levels. RESEARCH LIMITATIONS/IMPLICATIONS: The research contributes to organisational culture theory development. The four new cultural dimensions provide a synthesized conceptual framework for researchers to evaluate and understand primary care cultural and sub-cultural levels. PRACTICAL IMPLICATIONS: The synthesised cultural dimensions present a framework for practitioners to understand and change organisational culture in primary care teams. ORIGINALITY/VALUE: The research uses an innovative research methodology to synthesise the existing qualitative research and is one of the first to develop systematically a qualitative conceptual framing of primary care organisational culture.

Cost-effectiveness of Acupuncture for Chronic Nonspecific Low Back Pain.

Cost-effectiveness is a major criterion underpinning decisions in mainstream health care. Acupuncture is increasingly used in patients with chronic lower back pain (LBP), but there is a lack of evidence on cost-effectiveness. The objective of this study was to assess the cost-effectiveness of acupuncture in alleviating chronic LBP either alone or in conjunction with standard care compared with patients receiving routine care, and/or sham. To determine effectiveness, we undertook meta-analyses which found a significant improvement in pain in those receiving acupuncture and standard care compared with those receiving standard care alone. For acupuncture and standard care vs. standard care and sham, a weak positive effect was found for weeks 12 to 16, but this was not significant. For acupuncture alone vs. standard care alone, a significant positive effect was found at week 8, but not at weeks 26 or 52. The main outcome parameters for our cost-effectiveness analysis were the incremental cost-effectiveness ratio (ICER) of acupuncture treatment presented as cost (A$) per disability-adjusted life-year (DALY) saved. The WHO benchmark for a very highly cost-effective intervention is one that costs less than gross domestic product per capita per quality-adjusted life-year (QALY) gained or DALY averted, or less than around $A52,000 in 2009 (the base year for the analysis). According to this threshold, acupuncture as a complement to standard care for relief of chronic LBP is highly cost-effective, costing around $48,562 per DALY avoided. When comorbid depression is alleviated at the same rate as pain, cost is around $18,960 per DALY avoided. Acupuncture as a substitute for standard care was not found to be cost-effective unless comorbid depression was included. According to the WHO cost-effectiveness threshold values, acupuncture is a cost-effective treatment strategy in patients with chronic LBP.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.

INTRODUCTION: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme. METHODS AND ANALYSIS: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them. ETHICS AND DISSEMINATION: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000584730.