Commentary on: Graj E, Sheen J, Dudley A, et al. Adverse health events associated with clinical placement: a systematic review. Nurse Educ Today 2019;76:178–190. doi:10.1016/j.nedt.2019.01.024.
Risks and hazards faced by health discipline students in clinical placement settings are commonly subtle, and occur in both direct and indirect fashions to the student. Future research should seek to explore the interrelationship between the type of clinical experience, educational progression and other contextual factors found in clinical placement settings, as related to student risks.
Risks and hazards faced by health discipline students in clinical placement settings are commonly subtle, and occur in both direct and indirect fashions to the student.
Future research should seek to explore the interrelationship between the type of clinical experience, educational progression and other contextual factors found in clinical placement settings, as related to student risks.
The review completed by Graj et al
Over the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.
Economic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model’s states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.
Full ethics approval was granted by Yorkshire & The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.
International Standard Randomised Controlled Trial Number (49 470 934); Pre-result.
To review when, how, and in what context knowledge mobilization (KMb) has crossed patient‐practitioner‐researcher boundaries.
KMb is essential in contemporary health care, yet little is known about how patients are engaged.
Ten academic databases and grey literature.
We followed integrative review methodology to identify publications from 2006–2019 which contributed to understanding of cross‐boundary KMb. We extracted data using a bespoke spreadsheet and the Template for Intervention Description and Replication (TIDieR) framework. We used meta‐summary to organize key findings.
Thirty‐three papers collectively provide new insights into ‘when’ and ‘how’ KMb has crossed patient‐researcher‐practitioner boundaries and the impact this has achieved. Knowledge is mobilized to improve care, promote health, or prevent ill health. Most studies focus on creating or re‐shaping knowledge to make it more useful. Knowledge is mobilized in small community groups, in larger networks, and intervention studies. Finding the right people to engage in activities is crucial, as activities can be demanding and time‐consuming. Devolving power to communities and using local people to move knowledge can be effective. Few studies report definitive outcomes of KMb.
Cross‐boundary KMb can and does produce new and shared knowledge for health care. Positive outcomes can be achieved using diverse public engagement strategies. KMb process and theory is an emerging discipline, further research is needed on effective cross‐boundary working and on measuring the impact of KMb.
This review provides new and nuanced understandings of how KMb theory has been used to bridge patient‐researcher‐practitioner boundaries. We have assessed ‘how’, ‘when’, and in what context patients, practitioners and researchers have attempted to mobilize knowledge and identified impact. We have developed a knowledge base about good practice and what can and potentially should be avoided in cross‐boundary KMb.
Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes.
A cohort of 145 children and young people with CF aged 6–16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.
This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes.
Ethical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment.
Aspects of the built environment that support physical activity are associated with better population health outcomes. Few experimental data exist to support these observations. This protocol describes the study of the creation of urban trials on cardiovascular disease (CVD)-related morbidity and mortality in a large urban centre.
Between 2008 and 2010, the city of Winnipeg, Canada, built four, paved, multiuse (eg, cycling, walking and running), two-lane trails that are 5–8 km long and span ~60 neighbourhoods. Linking a population-based health data with census and environmental data, we will perform an interrupted time series analysis to assess the impact of this natural experiment on CVD-related morbidity and mortality among individuals 30–65 years of age residing within 400–1200 m of the trail. The primary outcome of interest is a composite measure of incident major adverse CVD events (ie, CVD-related mortality, ischaemic heart disease, stroke and congestive heart failure). The secondary outcome of interest is a composite measure of incident CVD-related risk factors (ie, diabetes, hypertension and dyslipidaemia). Outcomes will be assessed quarterly in the 10 years before the intervention and 5 years following the intervention, with a 4-year interruption. We will adjust analyses for differences in age, sex, ethnicity, immigration status, income, gentrification and other aspects of the built environment (ie, greenspace, fitness/recreation centres and walkability). We will also assess trail use and trail user profiles using field data collection methods.
Ethical approvals for the study have been granted by the Health Research Ethics Board at the University of Manitoba and the Health Information Privacy Committee within the Winnipeg Regional Health Authority. We have adopted an integrated knowledge translation approach. Information will be disseminated with public and government partners.
Parkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK.
Conduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS.
An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.
A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan
East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences.
Adults with knee instability related to neuromuscular disorders or central nervous conditions often experience mobility problems and rely on orthoses to improve function and mobility. Patient views of device effectiveness and acceptability are underexplored. Our study aimed to elicit device users’ perspectives regarding fitting, acceptability, effectiveness and use of orthoses, and identify important treatment outcomes.
Qualitative descriptive study using in-depth semistructured interviews. Interview transcriptions were coded and thematically analysed, using ‘Framework’.
A purposive sample of 24 adult users of orthotic devices. Nineteen patients were recruited across three National Health Service sites, and five people through charities/patient support groups in England. Half of the participants had been diagnosed with poliomyelitis, and the remainder with multiple sclerosis, Charcot-Marie-Tooth disease, spinal injury or spina bifida, and stroke. The median age of participants was 64.5 years (range 36–80 years).
Patients’ medical condition impacted significantly on daily life. Participants relied on orthotic devices to enable engagement in daily activities. Patient goals for mobility were linked to individual circumstances. Desired treatment outcomes included reduction in pain, trips and falls, with improved balance and stability. Effectiveness, reliability, comfort and durability were the most valued features of orthoses and associated with reported use. Obtaining suitable footwear alongside orthotic devices was a significant concern. Time pressures during device fitting were viewed negatively.
Orthotic devices for knee instability play a crucial role in promoting, maintaining and enhancing physical and psychological health and well-being, enabling patients to work, engage in family life and enjoy social activities. Future research should consider how best to measure the impact of orthotic devices on patient quality of life and daily functioning outside the clinic setting, as well as device use and any adverse effects.
This qualitative study was retrospectively registered as Current Controlled Trials ISRCTN65240228.
The Improving the Wellbeing of people with Opioid Treated CHronic Pain (I-WOTCH) randomised controlled trial uses a multicomponent self-management intervention to help people taper their opioid use. This approach is not widely used and its efficacy is unknown. A process evaluation alongside the trial will help to assess how the intervention was delivered, looking at the dose of intervention received and the fidelity of the delivery. We will explore how the intervention may have brought about change through the experiences of the participants receiving and the staff delivering the intervention and whether there were contextual factors involved.
A mixed methods process evaluation will assess how the processes of the I-WOTCH intervention fared and whether these affected the outcomes. We will collect quantitative data, for example, group attendance analysed with statistical methods. Qualitative data, for example, from interviews and feedback forms will be analysed using framework analysis. We will use a ‘following a thread’ and a mixed methods matrix for the final integrated analysis.
The I-WOTCH trial and process evaluation were granted full ethics approval by Yorkshire and The Humber—South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). All data were collected in accordance with data protection guidelines. Participants provided written informed consent for the main trial, and all interviewees provided additional written informed consent. The results of the process evaluation will be published and presented at conferences.
To validate case ascertainment algorithms for identifying individuals experiencing homelessness in health administrative databases between 2007 and 2014; and to estimate homelessness prevalence trends in Ontario, Canada, between 2007 and 2016.
A population-based retrospective validation study.
Ontario, Canada, from 2007 to 2014 (validation) and 2007 to 2016 (estimation).
Our reference standard was the known housing status of a longitudinal cohort of housed (n=137 200) and homeless or vulnerably housed (n=686) individuals. Two reference standard definitions of homelessness were adopted: the housing episode and the annual housing experience (any homelessness within a calendar year).
Sensitivity, specificity, positive and negative predictive values and positive likelihood ratios of 30 case ascertainment algorithms for detecting homelessness using up to eight health service databases.
Sensitivity estimates ranged from 10.8% to 28.9% (housing episode definition) and 18.5% to 35.6% (annual housing experience definition). Specificities exceeded 99% and positive likelihood ratios were high using both definitions. The most optimal algorithm estimates that 59 974 (95% CI 55 231 to 65 208) Ontarians (0.53% of the adult population) experienced homelessness in 2016, a 67.3% increase from 2007.
In Ontario, case ascertainment algorithms for identifying homelessness had low sensitivity but very high specificity and positive likelihood ratio. The use of health administrative databases may offer opportunities to track individuals experiencing homelessness over time and inform efforts to improve housing and health status in this vulnerable population.
To examine the strengths and weaknesses of multi‐context (international) qualitative evidence syntheses in comparison with single‐context (typically single‐country) reviews. We compare a multi‐country synthesis with single‐context syntheses on facility‐based delivery in Nigeria and Kenya.
Qualitative evidence increasingly contributes to decision‐making. International organizations commission multi‐context reviews of qualitative evidence to gain a comprehensive picture of similarities and differences across comparable (e.g., low‐ and middle‐income) countries. Such syntheses privilege breadth over contextual detail, risking inappropriate interpretation and application of review findings. Decision‐makers value single‐context syntheses that account for the contexts of their populations and health services. We explore how findings from multi‐ and single‐context syntheses contribute against a conceptual framework (adequacy, coherence, methodological limitations and relevance) that underpins the GRADE Confidence in Evidence of Reviews of Qualitative Evidence approach.
Included studies and findings from a multi‐context qualitative evidence synthesis (2001–2013) and two single‐context syntheses (Nigeria, 2006–2017; and Kenya, 2002–2016; subsequently updated and revised).
Single‐context reviews contribute cultural, ethnic and religious nuances and specific health system factors (e.g., use of a voucher system). Multi‐context reviews contribute to universal health concerns and to generic health system concerns (e.g., access and availability).
Nurse decision‐makers require relevant, timely and context‐sensitive evidence to inform clinical and managerial decision‐making. This discussion paper informs future commissioning and use of multi‐ and single‐context qualitative evidence syntheses.
Multi‐ and single‐context syntheses fulfil complementary functions. Single‐context syntheses add nuances not identifiable in the remit and timescales of a multi‐context review.
Chronic non-malignant pain has a major impact on the well-being, mood and productivity of those affected. Opioids are increasingly prescribed to manage this type of pain, but with a risk of other disabling symptoms, when their effectiveness has been questioned. This trial is designed to implement and evaluate a patient-centred intervention targeting withdrawal of strong opioids in people with chronic pain.
A pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of a group-based multicomponent intervention combined with individualised clinical facilitator led support for the management of chronic non-malignant pain against the control intervention (self-help booklet and relaxation compact disc). An embedded process evaluation will examine fidelity of delivery and investigate experiences of the intervention. The two primary outcomes are activities of daily living (measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (8A)) and opioid use. The secondary outcomes are pain severity, quality of life, sleep quality, self-efficacy, adverse events and National Health Service (NHS) healthcare resource use. Participants are followed up at 4, 8 and 12 months, with a primary endpoint of 12 months. Between-group differences will indicate effectiveness; we are looking for a difference of 3.5 points on our pain interference outcome (scale 40 to 77). We will undertake an NHS perspective cost-effectiveness analysis using quality adjusted life years.
Full approval was given by Yorkshire & The Humber - South Yorkshire Research Ethics Committee on 13 September, 2016 (16/YH/0325). Appropriate local approvals were sought for each area in which recruitment was undertaken. The current protocol version is 1.6 date 19 December 2018. Publication of results in peer- reviewed journals will inform the scientific and clinical community. We will disseminate results to patient participants and study facilitators in a study newsletter as well as a lay summary of results on the study website.
In England, the NHS111 service provides assessment and triage by telephone for urgent health problems. A digital version of this service has recently been introduced. We aimed to systematically review the evidence on digital and online symptom checkers and similar services.
We searched Medline, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Management Information Consortium, Web of Science and ACM Digital Library up to April 2018, supplemented by phrase searches for known symptom checkers and citation searching of key studies.
Studies of any design that evaluated a digital or online symptom checker or health assessment service for people seeking advice about an urgent health problem.
Data extraction and quality assessment (using the Cochrane Collaboration version of QUADAS for diagnostic accuracy studies and the National Heart, Lung and Blood Institute tool for observational studies) were done by one reviewer with a sample checked for accuracy and consistency. We performed a narrative synthesis of the included studies structured around pre-defined research questions and key outcomes.
We included 29 publications (27 studies). Evidence on patient safety was weak. Diagnostic accuracy varied between different systems but was generally low. Algorithm-based triage tended to be more risk averse than that of health professionals. There was very limited evidence on patients’ compliance with online triage advice. Study participants generally expressed high levels of satisfaction, although in mainly uncontrolled studies. Younger and more highly educated people were more likely to use these services.
The English ‘digital 111’ service has been implemented against a background of uncertainty around the likely impact on important outcomes. The health system may need to respond to short-term changes and/or shifts in demand. The popularity of online and digital services with younger and more educated people has implications for health equity.
Systematic reviews of high-quality randomised controlled trials are necessary to identify effective interventions to impact burn wound infection (BWI) outcomes. Evidence synthesis requires that BWI is reported in a consistent manner. Cochrane reviews investigating interventions for burns report that the indicators used to diagnose BWI are variable or not described, indicating a need to standardise reporting. BWI is complex and diagnosed by clinician judgement, informed by patient-reported symptoms, clinical signs, serum markers of inflammation and bacteria in the wound. Indicators for reporting BWI should be important for diagnosis, frequently observed in patients with BWI and assessed as part of routine healthcare. A minimum (core) set of indicators of BWI, reported consistently, will facilitate evidence synthesis and support clinical decision-making.
The Infection Consensus in Burns study aims to identify a core indicator set for reporting the diagnosis of BWI in research studies.
(1) Evidence review: a systematic review of indicators used in trials and observational studies reporting BWI outcomes to identify a long list of candidate indicators; (2) refinement of the long list into a smaller set of survey questions with an expert steering group; (3) a two-round Delphi survey with 100 multidisciplinary expert stakeholders, to achieve consensus on a short list of indicators; (4) a consensus meeting with expert stakeholders to agree on the BWI core indicator set.
Participants will be recruited through professional bodies, such that ethical approval from the National Health Service (NHS) Health Research Authority (HRA) is not needed. The core indicator set will be disseminated through peer-reviewed publication, co-production with journal editors, research funders and professional bodies, and presentation at national conferences.
To investigate delays from symptom onset to rheumatology assessment for patients with a new onset of rheumatoid arthritis (RA) or unclassified arthritis.
Newly presenting adults with either RA or unclassified arthritis were recruited from rheumatology clinics. Data on the length of time between symptom onset and first seeing a GP (patient delay), between first seeing a general practitioner (GP) and being referred to a rheumatologist (general practitioner delay) and being seen by a rheumatologist following referral (hospital delay) were captured.
822 patients participated (563 female, mean age 55 years). The median time between symptom onset and seeing a rheumatologist was 27.2 weeks (IQR 14.1–66 weeks); only 20% of patients were seen within the first 3 months following symptom onset. The median patient delay was 5.4 weeks (IQR 1.4–26.3 weeks). Patients who purchased over-the-counter medications or used ice/heat packs took longer to seek help than those who did not. In addition, those with a palindromic or an insidious symptom onset delayed for longer than those with a non-palindromic or acute onset. The median general practitioner delay was 6.9 weeks (IQR 2.3–20.3 weeks). Patients made a mean of 4 GP visits before being referred. The median hospital delay was 4.7 weeks (IQR 2.9–7.5 weeks).
This study identified delays at all levels in the pathway towards assessment by a rheumatologist. However, delays in primary care were particularly long. Patient delay was driven by the nature of symptom onset. Complex multi-faceted interventions to promote rapid help seeking and to facilitate prompt onward referral from primary care should be developed.
Accidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3 months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence.
This multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score.
Approval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review.
The aim of this study was to provide guidance to improve the completeness and clarity of meta‐ethnography reporting.
Evidence‐based policy and practice require robust evidence syntheses which can further understanding of people's experiences and associated social processes. Meta‐ethnography is a rigorous seven‐phase qualitative evidence synthesis methodology, developed by Noblit and Hare. Meta‐ethnography is used widely in health research, but reporting is often poor quality and this discourages trust in and use of its findings. Meta‐ethnography reporting guidance is needed to improve reporting quality.
The eMERGe study used a rigorous mixed‐methods design and evidence‐based methods to develop the novel reporting guidance and explanatory notes.
The study, conducted from 2015 ‐ 2017, comprised of: (1) a methodological systematic review of guidance for meta‐ethnography conduct and reporting; (2) a review and audit of published meta‐ethnographies to identify good practice principles; (3) international, multidisciplinary consensus‐building processes to agree guidance content; (4) innovative development of the guidance and explanatory notes.
Recommendations and good practice for all seven phases of meta‐ethnography conduct and reporting were newly identified leading to 19 reporting criteria and accompanying detailed guidance.
The bespoke eMERGe Reporting Guidance, which incorporates new methodological developments and advances the methodology, can help researchers to report the important aspects of meta‐ethnography. Use of the guidance should raise reporting quality. Better reporting could make assessments of confidence in the findings more robust and increase use of meta‐ethnography outputs to improve practice, policy, and service user outcomes in health and other fields. This is the first tailored reporting guideline for meta‐ethnography. This article is being simultaneously published in the following journals: Journal of Advanced Nursing, Psycho‐oncology, Review of Education, and BMC Medical Research Methodology.