Using PURPOSE-T in clinical practice: A realist evaluation.

AIM: To explain how the clinical and organisational context influenced the way the Pressure Ulcer Risk Primary or Secondary Evaluation Tool (PURPOSE-T) is used by nursing staff to support their clinical judgement and decision making about care planning and delivery. METHODS: A realist process evaluation was undertaken in a large acute hospital trust using mixed methods incorporating organisational policy review, staff semi-structured, ethnographic observation of clinical care and patient record review. Approximately 75 h of ethnographic field work involving 72 patients, 15 patient record reviews and 16 staff interviews were undertaken on 4 wards. FINDINGS: Findings suggest PURPOSE-T assisted nurses differently depending on their level of experience. Those with less experience use it as an educational guide, while those with more experience made an initial clinical judgement and used PURPOSE-T as a safety net to ensure they hadn't missed anything. Nurses were concerned about demonstrating good documentation of assessment, care planning and delivery in order to underpin consistent communication about care and because they had an underlying fear of being blamed if things went wrong. There is an array of other contextual features that impact the planning and delivery of pressure area care that go beyond the use of PURPOSE-T alone, including systematic equipment provision, competing patient safety initiatives and rehabilitation requirements. CONCLUSION: The findings reinforce the assertion that PU-RAIs are complex interventions and could inform the development of a more integrated system of care which takes into account the contextual features associated with PU prevention in modern hospitals.

Using an implementation science approach to implement and evaluate patient-reported outcome measures (PROM) initiatives in routine care settings.

PURPOSE: Patient-reported outcome and experience measures (PROMs/PREMs) are well established in research for many health conditions, but barriers persist for implementing them in routine care. Implementation science (IS) offers a potential way forward, but its application has been limited for PROMs/PREMs. METHODS: We compare similarities and differences for widely used IS frameworks and their applicability for implementing PROMs/PREMs through case studies. Three case studies implemented PROMs: (1) pain clinics in Canada; (2) oncology clinics in Australia; and (3) pediatric/adult clinics for chronic conditions in the Netherlands. The fourth case study is planning PREMs implementation in Canadian primary care clinics. We compare case studies on barriers, enablers, implementation strategies, and evaluation. RESULTS: Case studies used IS frameworks to systematize barriers, to develop implementation strategies for clinics, and to evaluate implementation effectiveness. Across case studies, consistent PROM/PREM implementation barriers were technology, uncertainty about how or why to use PROMs/PREMs, and competing demands from established clinical workflows. Enabling factors in clinics were context specific. Implementation support strategies changed during pre-implementation, implementation, and post-implementation stages. Evaluation approaches were inconsistent across case studies, and thus, we present example evaluation metrics specific to PROMs/PREMs. CONCLUSION: Multilevel IS frameworks are necessary for PROM/PREM implementation given the complexity. In cross-study comparisons, barriers to PROM/PREM implementation were consistent across patient populations and care settings, but enablers were context specific, suggesting the need for tailored implementation strategies based on clinic resources. Theoretically guided studies are needed to clarify how, why, and in what circumstances IS principles lead to successful PROM/PREM integration and sustainability.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

When trust, confidence, and faith collide: refining a realist theory of how and why inter-organisational collaborations in healthcare work.

BACKGROUND: Health systems are facing unprecedented socioeconomic pressures as well as the need to cope with the ongoing strain brought about by the COVID-19 pandemic. In response, the reconfiguration of health systems to encourage greater collaboration and integration has been promoted with a variety of collaborative shapes and forms being encouraged and developed. Despite this continued interest, evidence for success of these various arrangements is lacking, with the links between collaboration and improved performance often remaining uncertain. To date, many examinations of collaborations have been undertaken, but use of realist methodology may shed additional light on how and why collaboration works, and whom it benefits. METHODS: This paper seeks to test initial context-mechanism-outcome configurations (CMOCs) of interorganisational collaboration with the view to producing a refined realist theory. This phase of the realist synthesis used case study and evaluation literature; combined with supplementary systematic searches. These searches were screened for rigour and relevance, after which CMOCs were extracted from included literature and compared against existing ones for refinement, refutation, or affirmation. We also identified demi-regularities to better explain how these CMOCs were interlinked. RESULTS: Fifty-one papers were included, from which 338 CMOCs were identified, where many were analogous. This resulted in new mechanisms such as 'risk threshold' and refinement of many others, including trust, confidence, and faith, into more well-defined constructs. Refinement and addition of CMOCs enabled the creation of a 'web of causality' depicting how contextual factors form CMOC chains which generate outputs of collaborative behaviour. Core characteristics of collaborations, such as whether they were mandated or cross-sector, were explored for their proposed impact according to the theory. CONCLUSION: The formulation of this refined realist theory allows for greater understanding of how and why collaborations work and can serve to inform both future work in this area and the implementation of these arrangements. Future work should delve deeper into collaborative subtypes and the underlying drivers of collaborative performance. REVIEW REGISTRATION: This review is part of a larger realist synthesis, registered at PROSPERO with ID CRD42019149009 .

Hidden labour: the skilful work of clinical audit data collection and its implications for secondary use of data via integrated health IT.

BACKGROUND: Secondary use of data via integrated health information technology is fundamental to many healthcare policies and processes worldwide. However, repurposing data can be problematic and little research has been undertaken into the everyday practicalities of inter-system data sharing that helps explain why this is so, especially within (as opposed to between) organisations. In response, this article reports one of the most detailed empirical examinations undertaken to date of the work involved in repurposing healthcare data for National Clinical Audits. METHODS: Fifty-four semi-structured, qualitative interviews were carried out with staff in five English National Health Service hospitals about their audit work, including 20 staff involved substantively with audit data collection. In addition, ethnographic observations took place on wards, in 'back offices' and meetings (102 h). Findings were analysed thematically and synthesised in narratives. RESULTS: Although data were available within hospital applications for secondary use in some audit fields, which could, in theory, have been auto-populated, in practice staff regularly negotiated multiple, unintegrated systems to generate audit records. This work was complex and skilful, and involved cross-checking and double data entry, often using paper forms, to assure data quality and inform quality improvements. CONCLUSIONS: If technology is to facilitate the secondary use of healthcare data, the skilled but largely hidden labour of those who collect and recontextualise those data must be recognised. Their detailed understandings of what it takes to produce high quality data in specific contexts should inform the further development of integrated systems within organisations.

Analysis of a Web-Based Dashboard to Support the Use of National Audit Data in Quality Improvement: Realist Evaluation.

BACKGROUND: Dashboards can support data-driven quality improvements in health care. They visualize data in ways intended to ease cognitive load and support data comprehension, but how they are best integrated into working practices needs further investigation. OBJECTIVE: This paper reports the findings of a realist evaluation of a web-based quality dashboard (QualDash) developed to support the use of national audit data in quality improvement. METHODS: QualDash was co-designed with data users and installed in 8 clinical services (3 pediatric intensive care units and 5 cardiology services) across 5 health care organizations (sites A-E) in England between July and December 2019. Champions were identified to support adoption. Data to evaluate QualDash were collected between July 2019 and August 2021 and consisted of 148.5 hours of observations including hospital wards and clinical governance meetings, log files that captured the extent of use of QualDash over 12 months, and a questionnaire designed to assess the dashboard's perceived usefulness and ease of use. Guided by the principles of realist evaluation, data were analyzed to understand how, why, and in what circumstances QualDash supported the use of national audit data in quality improvement. RESULTS: The observations revealed that variation across sites in the amount and type of resources available to support data use, alongside staff interactions with QualDash, shaped its use and impact. Sites resourced with skilled audit support staff and established reporting systems (sites A and C) continued to use existing processes to report data. A number of constraints influenced use of QualDash in these sites including that some dashboard metrics were not configured in line with user expectations and staff were not fully aware how QualDash could be used to facilitate their work. In less well-resourced services, QualDash automated parts of their reporting process, streamlining the work of audit support staff (site B), and, in some cases, highlighted issues with data completeness that the service worked to address (site E). Questionnaire responses received from 23 participants indicated that QualDash was perceived as useful and easy to use despite its variable use in practice. CONCLUSIONS: Web-based dashboards have the potential to support data-driven improvement, providing access to visualizations that can help users address key questions about care quality. Findings from this study point to ways in which dashboard design might be improved to optimize use and impact in different contexts; this includes using data meaningful to stakeholders in the co-design process and actively engaging staff knowledgeable about current data use and routines in the scrutiny of the dashboard metrics and functions. In addition, consideration should be given to the processes of data collection and upload that underpin the quality of the data visualized and consequently its potential to stimulate quality improvement. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2019-033208.

Searching for Programme theories for a realist evaluation: a case study comparing an academic database search and a simple Google search.

BACKGROUND: Realist methodologies are increasingly being used to evaluate complex interventions in health and social care. Programme theory (ideas and assumptions of how a particular intervention works) development is the first step in a realist evaluation or a realist synthesis, with literature reviews providing important evidence to support this. Deciding how to search for programme theories is challenging and there is limited guidance available. Using an example of identifying programme theories for a realist evaluation of Pressure Ulcer Risk Assessment Instruments in clinical practice, the authors explore and compare several different approaches to literature searching and highlight important methodological considerations for those embarking on a programme theory review. METHODS: We compared the performance of an academic database search with a simple Google search and developed an optimised search strategy for the identification primary references (i.e. documents providing the clearest examples of programme theories) associated with the use of Pressure Ulcer Risk Assessment Instruments (PU-RAIs). We identified the number of primary references and the total number of references retrieved per source. We then calculated the number needed to read (NNR) expressed as the total number of titles and abstracts screened to identify one relevant reference from each source. RESULTS: The academic database search (comprising CINAHL, The Cochrane Library, EMBASE, HMIC, Medline) identified 2 /10 primary references with a NNR of 1395.The Google search identified 7/10 primary references with a NNR of 10.1. The combined NNR was 286.3. The optimised search combining Google and CINAHL identified 10/10 primary references with a NNR of 40.2. CONCLUSION: The striking difference between the efficiency of the review's academic database and Google searches in finding relevant references prompted an in-depth comparison of the two types of search. The findings indicate the importance of including grey literature sources such as Google in this particular programme theory search, while acknowledging the need for transparency of methods. Further research is needed to facilitate improved guidance for programme theory searches to enhance practice in the realist field and to save researcher time and therefore resource.

Exploring variation in the use of feedback from national clinical audits: a realist investigation.

BACKGROUND: National Clinical Audits (NCAs) are a well-established quality improvement strategy used in healthcare settings. Significant resources, including clinicians' time, are invested in participating in NCAs, yet there is variation in the extent to which the resulting feedback stimulates quality improvement. The aim of this study was to explore the reasons behind this variation. METHODS: We used realist evaluation to interrogate how context shapes the mechanisms through which NCAs work (or not) to stimulate quality improvement. Fifty-four interviews were conducted with doctors, nurses, audit clerks and other staff working with NCAs across five healthcare providers in England. In line with realist principles we scrutinised the data to identify how and why providers responded to NCA feedback (mechanisms), the circumstances that supported or constrained provider responses (context), and what happened as a result of the interactions between mechanisms and context (outcomes). We summarised our findings as Context+Mechanism = Outcome configurations. RESULTS: We identified five mechanisms that explained provider interactions with NCA feedback: reputation, professionalism, competition, incentives, and professional development. Professionalism and incentives underpinned most frequent interaction with feedback, providing opportunities to stimulate quality improvement. Feedback was used routinely in these ways where it was generated from data stored in local databases before upload to NCA suppliers. Local databases enabled staff to access data easily, customise feedback and, importantly, the data were trusted as accurate, due to the skills and experience of staff supporting audit participation. Feedback produced by NCA suppliers, which included national comparator data, was used in a more limited capacity across providers. Challenges accessing supplier data in a timely way and concerns about the quality of data submitted across providers were reported to constrain use of this mode of feedback. CONCLUSION: The findings suggest that there are a number of mechanisms that underpin healthcare providers' interactions with NCA feedback. However, there is variation in the mode, frequency and impact of these interactions. Feedback was used most routinely, providing opportunities to stimulate quality improvement, within clinical services resourced to collect accurate data and to maintain local databases from which feedback could be customised for the needs of the service.

A realist analysis of treatment programmes for sex offenders with intellectual disabilities.

BACKGROUND: The resources used in treatment for sex offenders with intellectual disabilities have had much research attention, but less has been written about how participants are expected to respond (programme mechanisms). METHODS: A realist evaluation of seven programmes from the UK, Canada, USA, Switzerland and Germany was conducted. In semi-structured interviews, programme designers elucidated how they are intended to work. The data analysis was driven by the realist concern to expose programme mechanisms and intended outcomes. RESULTS: Two main outcomes are increasing risk management capacities and cultivating prosocial identities. These are achieved through developing insights into a person's risks, work on (sexual) self-regulation skills, sexual boundaries and personal values and by developing meaningful social roles and positive relationships. CONCLUSIONS: Over time, there have been changes to some of the treatment resources used. However, there were little differences in terms of the intended programme mechanisms and outcomes, which remained surprisingly consistent.

RAMESES II reporting standards for realist evaluations.

BACKGROUND: Realist evaluation is increasingly used in health services and other fields of research and evaluation. No previous standards exist for reporting realist evaluations. This standard was developed as part of the RAMESES II project. The project's aim is to produce initial reporting standards for realist evaluations. METHODS: We purposively recruited a maximum variety sample of an international group of experts in realist evaluation to our online Delphi panel. Panel members came from a variety of disciplines, sectors and policy fields. We prepared the briefing materials for our Delphi panel by summarising the most recent literature on realist evaluations to identify how and why rigour had been demonstrated and where gaps in expertise and rigour were evident. We also drew on our collective experience as realist evaluators, in training and supporting realist evaluations, and on the RAMESES email list to help us develop the briefing materials. Through discussion within the project team, we developed a list of issues related to quality that needed to be addressed when carrying out realist evaluations. These were then shared with the panel members and their feedback was sought. Once the panel members had provided their feedback on our briefing materials, we constructed a set of items for potential inclusion in the reporting standards and circulated these online to panel members. Panel members were asked to rank each potential item twice on a 7-point Likert scale, once for relevance and once for validity. They were also encouraged to provide free text comments. RESULTS: We recruited 35 panel members from 27 organisations across six countries from nine different disciplines. Within three rounds our Delphi panel was able to reach consensus on 20 items that should be included in the reporting standards for realist evaluations. The overall response rates for all items for rounds 1, 2 and 3 were 94 %, 76 % and 80 %, respectively. CONCLUSION: These reporting standards for realist evaluations have been developed by drawing on a range of sources. We hope that these standards will lead to greater consistency and rigour of reporting and make realist evaluation reports more accessible, usable and helpful to different stakeholders.

Referral management centres as a means of reducing outpatients attendances: how do they work and what influences successful implementation and perceived effectiveness?

BACKGROUND: The rising volume of referrals to secondary care is a continuing concern in the NHS in England, with considerable resource implications. Referral management centres (RMCs) are one of a range of initiatives brought in to curtail this rise, but there is currently limited evidence for their effectiveness, and little is known about their mechanisms of action. This study aimed to gain a better understanding of how RMCs operate and the factors contributing to the achievement of their goals. Drawing on the principles of realist evaluation, we sought to elicit programme theories (the ideas and assumptions about how a programme works) and to identify the key issues to be considered when establishing or evaluating such schemes. METHODS: Qualitative study with a purposive sample of health professionals and managers involved in the commissioning, set-up and running of four referral management centres in England and with GPs referring through these centres. Semi-structured interviews were conducted with 18 participants. Interviews were audio-recorded and transcribed. Data were analysed thematically. RESULTS: Interview data highlighted the diverse aims and functions of RMCs, reflecting a range of underlying programme theories. These included the overarching theory that RMCs work by ensuring the best use of limited resources and three sub-theories, relating to how this could be achieved, namely, improving the quality of referrals and patient care, reducing referrals, and increasing efficiency in the referral process. The aims of the schemes, however, varied between sites and between stakeholders, and evolved significantly over time. Three themes were identified relating to the context in which RMCs were implemented and managed: the impact of practical and administrative difficulties; the importance and challenge of stakeholder buy-in; and the dependence of perceived effectiveness on the aims and priorities of the scheme. Many RMCs were described as successful by those involved, despite limited evidence of reduced referrals or cost-savings. CONCLUSIONS: The findings of this study have a number of implications for the development of similar schemes, with respect to the need to ensure clarity of aims and to identify indicators of success from the outset, to anticipate scheme evolution and plan for potential changes with respect to IT systems and referral processes. Also identified, is the need for further research that evaluates the effectiveness and cost effectiveness of particular models of RMC.

How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations?

PURPOSE: We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how patient-reported outcome measures (PROMs) data were referred to in the process of (1) eliciting and exploring patients' concerns; (2) making decisions about supportive treatment and (3) making decisions about chemotherapy and other systemic treatments. METHODS: We purposively sampled audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK randomised controlled trial of the feedback of PROMs data to doctors (Velikova et al. in J Clin Oncol 22(4):714-724 [1]). We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management. FINDINGS: Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy. High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy. Symptomatic treatment was more often offered for problems like nausea, constipation, pain and depression but much less so for fatigue. Doctors discussed fatigue by providing a cause for the fatigue (e.g. the chemotherapy), presenting this as 'something to be expected', minimising its impact or moving on to another topic. Chemotherapy regimens were not changed on the basis of the PROMs data alone, but PROMs data were sometimes used to legitimise changes. CONCLUSIONS: Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems, but doctors may not always know how to do this. Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation.

ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.

PURPOSE: An essential aspect of patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) is the integration of patient perspectives and experiences with clinical data to evaluate interventions. Thus, PCOR and CER require capturing patient-reported outcome (PRO) data appropriately to inform research, healthcare delivery, and policy. This initiative's goal was to identify minimum standards for the design and selection of a PRO measure for use in PCOR and CER. METHODS: We performed a literature review to find existing guidelines for the selection of PRO measures. We also conducted an online survey of the International Society for Quality of Life Research (ISOQOL) membership to solicit input on PRO standards. A standard was designated as "recommended" when >50 % respondents endorsed it as "required as a minimum standard." RESULTS: The literature review identified 387 articles. Survey response rate was 120 of 506 ISOQOL members. The respondents had an average of 15 years experience in PRO research, and 89 % felt competent or very competent providing feedback. Final recommendations for PRO measure standards included: documentation of the conceptual and measurement model; evidence for reliability, validity (content validity, construct validity, responsiveness); interpretability of scores; quality translation, and acceptable patient and investigator burden. CONCLUSION: The development of these minimum measurement standards is intended to promote the appropriate use of PRO measures to inform PCOR and CER, which in turn can improve the effectiveness and efficiency of healthcare delivery. A next step is to expand these minimum standards to identify best practices for selecting decision-relevant PRO measures.

Homeopathy for treatment of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. Evidence-based treatment guidelines have not been able to give guidance on the effects of homeopathic treatment for IBS because no systematic reviews have been carried out to assess the effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review. In clinical homeopathy a specific remedy is prescribed for a specific condition. This differs from individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation. OBJECTIVES: To assess the effectiveness and safety of homeopathic treatment for treating IBS. SEARCH METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), Cochrane IBD/FBD Group Specialised Register, Cochrane Complementary Medicine Field Specialised Register and the database of the Homeopathic Library (Hom-inform) from inception to February 2013. SELECTION CRITERIA: Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS. The overall quality of the evidence supporting this outcome was assessed using the GRADE criteria. We calculated the mean difference (MD) and 95% confidence interval (CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes. MAIN RESULTS: Three RCTs (213 participants) were included. No cohort or case-control studies were identified. Two studies published in 1976 and 1979 compared clinical homeopathy (homeopathic remedy) to placebo for constipation-predominant IBS. One study published in 1990 compared individualised homeopathic treatment (consultation plus remedy) to usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets asking the patient to take a high fibre diet) for the treatment of IBS in female patients. Due to the low quality of reporting in the included studies the risk of bias in all three studies was unclear on most criteria and high for some criteria. A meta-analysis of two small studies (129 participants with constipation-predominant IBS) found a statistically significant difference in global improvement between the homeopathic remedy asafoetida and placebo at a short-term follow-up of two weeks. Seventy-three per cent of patients in the homeopathy group improved compared to 45% of placebo patients (RR 1.61, 95% CI 1.18 to 2.18). There was no statistically significant difference in global improvement between the homeopathic remedies asafoetida plus nux vomica and placebo. Sixty-eight per cent of patients in the homeopathy group improved compared to 52% of placebo patients (1 study, N = 42, RR 1.31, 95% CI 0.80 to 2.15). GRADE analyses rated the overall quality of the evidence for the outcome global improvement as very low due to high or unknown risk of bias, short-term follow-up and sparse data. There was no statistically significant difference found between individualised homeopathic treatment and usual care (1 RCT, N = 20) for the outcome "feeling unwell", where the participant scored how "unwell" they felt before, and after treatment (MD 0.03; 95% CI -3.16 to 3.22). None of the included studies reported on adverse events. AUTHORS' CONCLUSIONS: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.

Modelling lifecycles of inter-organizational collaborations in healthcare: a systematic review and best-fit framework synthesis.

PURPOSE: Inter-organisational collaboration (IOC) across healthcare settings has been put forward as a solution to mounting financial and sustainability challenges. Whilst ingredients for successful IOC have been explored, there remains limited understanding of the development of IOCs over time. DESIGN/METHODOLOGY/APPROACH: The authors systematically reviewed the literature to identify models applied to IOCs in healthcare across databases such as Healthcare Management Information Consortium (HMIC) and MEDLINE, identifying 2,763 titles and abstracts with 26 final papers included. The authors then used a "best fit" framework synthesis methodology to synthesise fourteen models of IOC in healthcare and the wider public sector to formulate an applied composite model describing the process through which collaborations change over time. This synthesis comprised extracting stages and behaviours from included models, selecting an a priori framework upon which to code these stages and behaviours and then re-coding them to construct a new composite model. FINDINGS: Existing models often did not consider that organisations may undergo many IOCs in the organisations' lifetime nor included "contemplation" stages or those analogous to "dissolution", which might negatively impact papers using such models. The formulated' composite model utilises a life-cycle design comprising five non-linear phases, namely Contemplating, Connecting, Planning, Implementation and Maintenance or Dissolution and incorporates dynamic elements from Complex Adaptive Systems thinking to reflect the dynamic nature of collaborations. ORIGINALITY/VALUE: This is the first purpose-built model of the lifecycles of IOCs in healthcare. The model is intended to inform implementers, evaluators and researchers of IOCs alike.

Towards achieving interorganisational collaboration between health-care providers: a realist evidence synthesis.

Background: Interorganisational collaboration is currently being promoted to improve the performance of NHS providers. However, up to now, there has, to the best of our knowledge, been no systematic attempt to assess the effect of different approaches to collaboration or to understand the mechanisms through which interorganisational collaborations can work in particular contexts. Objectives: Our objectives were to (1) explore the main strands of the literature about interorganisational collaboration and to identify the main theoretical and conceptual frameworks, (2) assess the empirical evidence with regard to how different interorganisational collaborations may (or may not) lead to improved performance and outcomes, (3) understand and learn from NHS evidence users and other stakeholders about how and where interorganisational collaborations can best be used to support turnaround processes, (4) develop a typology of interorganisational collaboration that considers different types and scales of collaboration appropriate to NHS provider contexts and (5) generate evidence-informed practical guidance for NHS providers, policy-makers and others with responsibility for implementing and assessing interorganisational collaboration arrangements. Design: A realist synthesis was carried out to develop, test and refine theories about how interorganisational collaborations work, for whom and in what circumstances. Data sources: Data sources were gathered from peer-reviewed and grey literature, realist interviews with 34 stakeholders and a focus group with patient and public representatives. Review methods: Initial theories and ideas were gathered from scoping reviews that were gleaned and refined through a realist review of the literature. A range of stakeholder interviews and a focus group sought to further refine understandings of what works, for whom and in what circumstances with regard to high-performing interorganisational collaborations. Results: A realist review and synthesis identified key mechanisms, such as trust, faith, confidence and risk tolerance, within the functioning of effective interorganisational collaborations. A stakeholder analysis refined this understanding and, in addition, developed a new programme theory of collaborative performance, with mechanisms related to cultural efficacy, organisational efficiency and technological effectiveness. A series of translatable tools, including a diagnostic survey and a collaboration maturity index, were also developed. Limitations: The breadth of interorganisational collaboration arrangements included made it difficult to make specific recommendations for individual interorganisational collaboration types. The stakeholder analysis focused exclusively on England, UK, where the COVID-19 pandemic posed challenges for fieldwork. Conclusions: Implementing successful interorganisational collaborations is a difficult, complex task that requires significant time, resource and energy to achieve the collaborative functioning that generates performance improvements. A delicate balance of building trust, instilling faith and maintaining confidence is required for high-performing interorganisational collaborations to flourish. Future work: Future research should further refine our theory by incorporating other workforce and user perspectives. Research into digital platforms for interorganisational collaborations and outcome measurement are advocated, along with place-based and cross-sectoral partnerships, as well as regulatory models for overseeing interorganisational collaborations. Study registration: The study is registered as PROSPERO CRD42019149009. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 6. See the NIHR Journals Library website for further project information.

How can the collaboration between health-care providers be improved? There are continuing concerns about poor patient care across the NHS. One of the ways in which governments have tried to solve these issues is by getting services to work together, rather than separately, to solve any problems. The aim of our review is to learn about how, why and when different approaches to working together ­ which we call interorganisational collaboration ­ can be used to improve the performance of NHS providers. We reviewed published evidence and carried out interviews with NHS staff. We also carried out interviews and a focus group with patient and public representatives. Our review finds that interorganisational collaborations can work well when a series of elements are in place, which includes the need to build trust between everyone involved. Having a belief in the collaboration is also needed to help inspire others to get involved. To try and reduce possible problems, setting priorities and having clear methods to show how improvements can be achieved are important, as well as having an agreed contract in place to ensure that any conflicts are resolved. If done well, collaboration can improve resource allocation, coordination, communication and shared learning about best practice. Our review provides valuable evidence of how different approaches to interorganisational collaboration can be used by NHS providers to work together to improve services in different situations. Our review provides different options for organisations to reflect on how well they are collaborating, which includes the involvement of key stakeholders, such as patients, the public and communities.

Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations.

PURPOSE: While clinical care is frequently directed at making patients "feel better," patients' reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User's Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User's Guide. METHODS: Using the literature, an ISOQOL team outlined considerations for using PROs in clinical practice; options for designing the intervention; and strengths, weaknesses, and resource requirements associated with each option. RESULTS: Implementing routine PRO assessment involves a number of methodological and practical decisions, including (1) identifying the goals for collecting PROs in clinical practice, (2) selecting the patients, setting, and timing of assessments, (3) determining which questionnaire(s) to use, (4) choosing a mode for administering and scoring the questionnaire, (5) designing processes for reporting results, (6) identifying aids to facilitate score interpretation, (7) developing strategies for responding to issues identified by the questionnaires, and (8) evaluating the impact of the PRO intervention on the practice. CONCLUSIONS: Integrating PROs in clinical practice has the potential to enhance patient-centered care. The online version of the User's Guide will be updated periodically.

How, when, and why do inter-organisational collaborations in healthcare work? A realist evaluation.

BACKGROUND: Inter-organisational collaborations (IOCs) in healthcare have been viewed as an effective approach to performance improvement. However, there remain gaps in our understanding of what helps IOCs function, as well as how and why contextual elements affect their implementation. A realist review of evidence drawing on 86 sources has sought to elicit and refine context-mechanism-outcome configurations (CMOCs) to understand and refine these phenomena, yet further understanding can be gained from interviewing those involved in developing IOCs. METHODS: We used a realist evaluation methodology, adopting prior realist synthesis findings as a theoretical framework that we sought to refine. We drew on 32 interviews taking place between January 2020 and May 2021 with 29 stakeholders comprising IOC case studies, service users, as well as regulatory perspectives in England. Using a retroductive analysis approach, we aimed to test CMOCs against these data to explore whether previously identified mechanisms, CMOCs, and causal links between them were affirmed, refuted, or revised, and refine our explanations of how and why interorganisational collaborations are successful. RESULTS: Most of our prior CMOCs and their underlying mechanisms were supported in the interview findings with a diverse range of evidence. Leadership behaviours, including showing vulnerability and persuasiveness, acted to shape the core mechanisms of collaborative functioning. These included our prior mechanisms of trust, faith, and confidence, which were largely ratified with minor refinements. Action statements were formulated, translating theoretical findings into practical guidance. CONCLUSION: As the fifth stage in a larger project, our refined theory provides a comprehensive understanding of the causal chain leading to effective collaborative inter-organisational relationships. These findings and recommendations can support implementation of IOCs in the UK and elsewhere. Future research should translate these findings into further practical guidance for implementers, researchers, and policymakers.

An Evidence-Based Theory About PRO Use in Kidney Care: A Realist Synthesis.

BACKGROUND: There is international interest on the use of patient-reported outcomes (PROs) in nephrology. OBJECTIVES: Our objectives were to develop a kidney-specific program theory about use of PROs in nephrology that may enhance person-centered care, both at individual and aggregated levels of care, and to test and refine this theory through a systematic review of the empirical literature. Together, these objectives articulate what works or does not work, for whom, and why. METHODS: Realist synthesis methodology guided the electronic database and gray literature searches (in January 2017 and October 2018), screening, and extraction conducted independently by three reviewers. Sources included all nephrology patients and/or practitioners. Through a process of extraction and synthesis, each included source was examined to assess how contexts may trigger mechanisms to influence specific outcomes. RESULTS: After screening 19,961 references, 84 theoretical and 34 empirical sources were used. PROs are proposed to be useful for providing nephrology care through three types of use. The first type is use of individual-level PRO data at point of care, receiving the majority of theoretical and empirical explorations. Clinician use to support person-centered care, and patient use to support patient engagement, are purported to improve satisfaction, health, and quality of life. Contextual factors specific to the kidney care setting that may influence the use of PRO data include the complexity of kidney disease symptom burden, symptoms that may be stigmatized, comorbidities, and time or administrative constraints in dialysis settings. Electronic collection of PROs may facilitate PRO use given these contexts. The second type is use of aggregated PRO data at point of care, including public reporting of PROs to inform decisions at point of care and improve quality of care, and use of PROs for treatment decisions. The third type is use of aggregated PRO data by organizations, including publicly available PRO data to compare centers. In single-payer systems, regular collection of PROs by dialysis centers can be achieved through economic incentives. Both the second and third types of PRO use include pressures that may trigger quality improvement processes. CONCLUSION: The current state of the evidence is primarily theoretical. There is pressing need for empirical research to improve the evidence-base of PRO use at individual and aggregated levels of nephrology care.

Why do some inter-organisational collaborations in healthcare work when others do not? A realist review.

BACKGROUND: Inter-organisational collaboration is increasingly prominent within contemporary healthcare systems. A range of collaboration types such as alliances, networks, and mergers have been proposed as a means to turnaround organisations, by reducing duplication of effort, enabling resource sharing, and promoting innovations. However, in practice, due to the complexity of the process, such efforts are often rife with difficulty. Notable contributions have sought to make sense of this area; however, further understanding is needed in order to gain a better understanding of why some inter-organisational collaborations work when others do not, to be able to more effectively implement collaborations in the future. METHODS: Realist review methodology was used with the intention of formulating context-mechanism-outcome configurations (CMOCs) to explain how inter-organisational collaborations work and why, combining systematic and purposive literature search techniques. The systematic review encompassed searches for reviews, commentaries, opinion pieces, and case studies on HMIC, MEDLINE, PsycINFO, and Social Policy and Practice databases, and further searches were conducted using Google Scholar. Data were extracted from included studies according to relevance to the realist review. RESULTS: Fifty-three papers were included, informing the development of programme theories of how, why, and when inter-organisational collaborations in healthcare work. Formulation of our programme theories incorporated the concepts of partnership synergy and collaborative inertia and found that it was essential to consider mechanisms underlying partnership functioning, such as building trust and faith in the collaboration to maximise synergy and thus collaborative performance. More integrative or mandated collaboration may lean more heavily on contract to drive collaborative behaviour. CONCLUSION: As the first realist review of inter-organisational collaborations in healthcare as an intervention for improvement, this review provides actionable evidence for policymakers and implementers, enhancing understanding of mechanisms underlying the functioning and performing of inter-organisational collaborations, as well as how to configure the context to aid success. Next steps in this research will test the results against further case studies and primary data to produce a further refined theory. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019149009.