Publications by authors named "Chris Gibbons"

66 Publications

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

Cochrane Database Syst Rev 2021 Oct 12;10:CD011589. Epub 2021 Oct 12.

Health Services & Policy Research, Exeter Collaboration for Academic Primary Care (APEx), NIHR School for Primary Care Research, NIHR ARC South West Peninsula (PenARC), University of Exeter, Exeter, UK.

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.
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http://dx.doi.org/10.1002/14651858.CD011589.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509115PMC
October 2021

Expected Versus Experienced Health-Related Quality of Life Among Patients Recovering From Cancer Surgery: A Prospective Cohort Study.

Ann Surg Open 2021 Jun 8;2(2):e060. Epub 2021 Apr 8.

Ariadne Labs, Brigham and Women's Hospital, Harvard. T.H. School of Public Health, Boston, MA.

Patient expectations of the impact of surgery on postoperative health-related quality of life (HRQL) may reflect the effectiveness of patient-provider communication. We sought to compare expected versus experienced HRQL among patients undergoing cancer surgery.

Methods: Adults undergoing cancer surgery were eligible for inclusion (2017-2019). Preoperatively, patients completed a smartphone-based survey assessing expectations for HRQL 1 week and 1, 3, and 6 months postoperatively based on the 8 short-form 36 (SF36) domains (physical functioning, physical role limitations, pain, general health, vitality, social functioning, emotional role limitations, and mental health). Experienced HRQL was then assessed through smartphone-based SF36 surveys 1, 3, and 6 months postoperatively. Correlations between 1- and 6-month trends in expected versus experienced HRQL were determined.

Results: Among 101 consenting patients, 74 completed preoperative expectations and SF36 surveys (73%). The mean age was 54 years (SD 14), 49 (66%) were female, and the most common operations were for breast (34%) and abdominal (31%) tumors. Patients expected HRQL to worsen 1 week after surgery and improve toward minimal disability over 6 months. There was poor correlation (≤±0.4) between 1- and 6-month trends in expected versus experienced HRQL in all SF36 domains except for moderate correlation in physical functioning (0.50, 95% confidence interval [0.22-0.78], < 0.001) and physical role limitations (0.41, 95% confidence interval [0.05-0.77], = 0.024). Patients expected better HRQL than they experienced.

Conclusions: Preoperative expectations of postoperative HRQL correlated poorly with lived experiences except in physical health domains. Surgeons should evaluate factors which inform expectations around physical and psychosocial health and use these data to enhance shared decision-making.
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http://dx.doi.org/10.1097/AS9.0000000000000060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8221715PMC
June 2021

Integrating Patient Reported Outcome Measures (PROMs) into routine nurse-led primary care for patients with multimorbidity: a feasibility and acceptability study.

Health Qual Life Outcomes 2021 Apr 26;19(1):133. Epub 2021 Apr 26.

Health Services and Policy Research, Exeter Collaboration for Academic Primary Care (APEx), University of Exeter, Magdalen Campus, Smeall Building, Room JS02, Exeter, EX1 2LU, UK.

Background: The use of Patient Reported Outcome Measures (PROMS) in clinical practice has the potential to promote patient-centred care and improve patients' quality of life. Individualized PROMs may be particularly helpful in identifying, prioritizing and monitoring health problems of patients with multimorbidity. We aimed to develop an intervention centred around PROMs feedback as part of Primary Care annual reviews for patients with multimorbidity and evaluate its feasibility and acceptability.

Methods: We developed a nurse-oriented intervention including (a) training of nurses on PROMs; (b) administration to patients with multimorbidity of individualized and standardized PROMS; and (c) feedback to both patients and nurses of PROMs scores and interpretation guidance. We then tailored the intervention to patients with two or more highly prevalent conditions (asthma, COPD, diabetes, heart failure, depression, and hip/knee osteoarthritis) and designed a non-controlled feasibility and acceptability evaluation in a convenience sample of primary care practices (5). PROMs were administered and scores fed back immediately ahead of scheduled annual reviews with nurses. Patients and nurses rated the acceptability of the intervention using with a brief survey including optional free comments. Thematic analysis of qualitative interviews with a sample of participating patients (10) and nurses (4) and of survey free comments was conducted for further in-depth evaluation of acceptability. Feasibility was estimated based on rates of participation and completion.

Results: Out of 68 recruited patients (mean age 70; 47% female), 68 completed the PROMs (100%), received feedback (100%) and confirmed nurse awareness of their scores (100%). Most patients (83%) "agreed"/"strongly agreed" that the PROMs feedback had been useful, a view supported by nurses in 89% of reviews. Thematic analysis of rich qualitative data on PROMS administration, feedback and role in annual reviews indicated that both patients and nurses perceived the intervention as acceptable and promising, emphasizing its comprehensiveness and patient-centredness.

Conclusions: We have developed and tested an intervention focusing on routine PROM assessment of patients with multimorbidity in Primary Care. Preliminary findings support its feasibility and a high degree of acceptability from both patients and nurses. The next step is to conduct a full-scale trial for evaluating the effectiveness of the proposed intervention.
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http://dx.doi.org/10.1186/s12955-021-01748-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8074460PMC
April 2021

How does the use of digital consulting change the meaning of being a patient and/or a health professional? Lessons from the Long-term Conditions Young People Networked Communication study.

Digit Health 2020 Jan-Dec;6:2055207620942359. Epub 2020 Jul 20.

Warwick Medical School, University of Warwick, UK.

Background: While studies have examined the impact of digital communication technology on healthcare, there is little exploration of how new models of digital care change the roles and identities of the health professional and patient. The purpose of the current study is to generate multidisciplinary reflections and questions around the use of digital consulting and the way it changes the meaning of being a patient and/or a health professional.

Method: We used a large pre-existing qualitative dataset from the Long-term Conditions Young People Networked Communication (LYNC) study which involved interviews with healthcare professionals and a group of 16-24 years patients with long-term physical and mental health conditions. We conducted a three-stage mixed methods analysis. First, using a small sample of interview data from the LYNC study, we identified three key themes to explore in the data and relevant academic literature. Second, in small groups we conducted secondary analysis of samples of patient and health professional LYNC interview data. Third, we ran a series of rapid evidence reviews.

Findings: We identified three key themes: workload/flow, impact of increased access to healthcare and vulnerabilities. Both health professionals and patients were 'on duty' in their role more often. Increased access to healthcare introduced more responsibilities to both patients and health professionals. Traditional concepts in medical ethics, confidentiality, empathy, empowerment/power, efficiency and mutual responsibilities are reframed in the context of digital consulting.

Conclusions: Our collaboration identified conflicts and constraints in the construction of digital patients and digital clinicians. There is evidence that digital technologies change the nature of a medical consultation and with it the identities and the roles of clinicians and patients which, in turn, calls for a redefinition of traditional concepts of medical ethics. Overall, digital consulting has the potential to significantly reduce costs while maintaining or improving patient care and clinical outcomes. Timely study of digital engagement in the National Health Service is a matter of critical importance.
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http://dx.doi.org/10.1177/2055207620942359DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7375714PMC
July 2020

International mixed methods study protocol to develop a patient-reported outcome measure for all types of chronic wounds (the WOUND-Q).

BMJ Open 2020 03 25;10(3):e032332. Epub 2020 Mar 25.

Department of Surgery, Patient Reported Outcome, Value, and Experience (PROVE) Center, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA

Introduction: Most patient-reported outcome measures (PROM) for chronic wounds are specific to a single wound type (eg, pressure ulcer) or part of the body. A barrier to outcome assessment in wound care and research is the lack of a rigorously designed PROM that can be used across wound types and locations. This mixed method study describes the protocol for an international collaboration to develop and validate a new PROM called the WOUND-Q for adults with chronic wounds.

Methods And Analysis: In phase I, the qualitative approach of interpretive description is used to elicit concepts important to people with wounds regarding outcome. Participants from Canada, Denmark, the Netherlands, and the USA are aged 18 years and older and have a wound that has lasted 3 months or longer. Interviews are digitally recorded, transcribed and coded. A conceptual framework and preliminary item pool are developed from the qualitative dataset. Draft scales are formed to cover important themes in the conceptual framework. These scales are refined using feedback from people with chronic wounds and wound care experts. After refinement, the scales are translated into Danish and Dutch, following rigorous methods, to prepare for an international field-test study. In phase II, data are collected in Canada, Denmark, the Netherlands, and the USA. An international sample of people with a large variety of chronic wounds complete the WOUND-Q. Rasch Measurement Theory analysis is used to identify the best subset of items to retain for each scale and to examine reliability and validity.

Ethics And Dissemination: This study is coordinated at Brigham and Women's Hospital (Boston, USA). Ethics board approval was received at each participating site for both study phases. Findings will be published in peer-reviewed journals and presented at national and international conferences and meetings.
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http://dx.doi.org/10.1136/bmjopen-2019-032332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170563PMC
March 2020

Predicting Patient Reported Outcomes of Cognitive Function Using Connectome-Based Predictive Modeling in Breast Cancer.

Brain Topogr 2020 01 19;33(1):135-142. Epub 2019 Nov 19.

School of Nursing, University of Texas at Austin, 1710 Red River St., Austin, TX, 78712, USA.

Being able to predict who will likely experience cancer related cognitive impairment (CRCI) could enhance patient care and potentially reduce economic and human costs associated with this adverse event. We aimed to determine if post-treatment patient reported CRCI could also be predicted from baseline resting state fMRI in patients with breast cancer. 76 newly diagnosed patients (n = 42 planned for chemotherapy; n = 34 not planned for chemotherapy) and 50 healthy female controls were assessed at 3 times points [T1 (prior to treatment); T2 (1 month post chemotherapy); T3 (1 year after T2)], and at yoked intervals for controls. Data collection included self-reported executive dysfunction, memory function, and psychological distress and resting state fMRI data converted to connectome matrices for each participant. Statistical analyses included linear mixed modeling, independent t tests, and connectome-based predictive modeling (CPM). Executive dysfunction increased over time in the chemotherapy group and was stable in the other two groups (p < 0.001). Memory function decreased over time in both patient groups compared to controls (p < 0.001). CPM models successfully predicted executive dysfunction and memory function scores (r > 0.31, p < 0.002). Support vector regression with a radial basis function (SVR RBF) showed the highest performance for executive dysfunction and memory function (r = 0.68; r = 0.44, p's < 0.001). Baseline neuroimaging may be useful for predicting patient reported cognitive outcomes which could assist in identifying patients in need of surveillance and/or early intervention for treatment-related cognitive effects.
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http://dx.doi.org/10.1007/s10548-019-00746-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006573PMC
January 2020

Streamlining the Assessment of Patient-Reported Outcomes in Weight Loss and Body Contouring Patients: Applying Computerized Adaptive Testing to the BODY-Q.

Plast Reconstr Surg 2019 05;143(5):946e-955e

From the Patient-Reported Outcomes, Value & Experience Center, Department of Surgery, Brigham and Women's Hospital; the Department of Surgery, Harvard Medical School; the Department of Pediatrics, McMaster University; the Department of Plastic and Reconstructive Surgery, Catharina Hospital; and the Department of Plastic and Reconstructive Surgery, Maastricht University Medical Center.

Background: The BODY-Q is a widely used patient-reported outcome measure of surgical outcomes in weight loss and body contouring patients. Reducing the length of the BODY-Q assessment could overcome implementation barriers in busy clinics. A shorter BODY-Q could be achieved by using computerized adaptive testing, a method to shorten and tailor assessments while maintaining reliability and accuracy. In this study, the authors apply computerized adaptive testing to the BODY-Q and assess computerized adaptive testing performance in terms of item reduction and accuracy.

Methods: Parameters describing the psychometric properties of 138 BODY-Q items (i.e., questions) were derived from the original validation sample (n = 734). The 138 items are arranged into 18 scales reflecting Appearance, Quality of Life, and Experience of Care domains. The authors simulated 1000 administrations of the computerized adaptive testing until a stopping rule, reflecting assessment accuracy of standard error less than 0.55, was met. The authors describe the reduction of assessment length in terms of the mean and range of items administered. The authors assessed accuracy by determining correlation between full test and computerized adaptive testing scores.

Results: The authors ran 54 simulations. Mean item reduction was 36.9 percent (51 items; range, 48 to 138 items). Highest item reduction was achieved for the Experience of Care domain (56.2 percent, 22.5 items). Correlation between full test scores and the BODY-Q computerized adaptive test scores averaged 0.99.

Conclusions: Substantial item reduction is possible by using BODY-Q computerized adaptive testing. Reduced assessment length using BODY-Q computerized adaptive testing could reduce patient burden while preserving the accuracy of clinical patient-reported outcomes for patients undergoing weight loss and body contouring operations.
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http://dx.doi.org/10.1097/PRS.0000000000005587DOI Listing
May 2019

Streamlining the Assessment of Patient-Reported Outcomes in Weight Loss and Body Contouring Patients: Applying Computerized Adaptive Testing to the BODY-Q.

Plast Reconstr Surg 2019 05;143(5):946e-955e

From the Patient-Reported Outcomes, Value & Experience Center, Department of Surgery, Brigham and Women's Hospital; the Department of Surgery, Harvard Medical School; the Department of Pediatrics, McMaster University; the Department of Plastic and Reconstructive Surgery, Catharina Hospital; and the Department of Plastic and Reconstructive Surgery, Maastricht University Medical Center.

Background: The BODY-Q is a widely used patient-reported outcome measure of surgical outcomes in weight loss and body contouring patients. Reducing the length of the BODY-Q assessment could overcome implementation barriers in busy clinics. A shorter BODY-Q could be achieved by using computerized adaptive testing, a method to shorten and tailor assessments while maintaining reliability and accuracy. In this study, the authors apply computerized adaptive testing to the BODY-Q and assess computerized adaptive testing performance in terms of item reduction and accuracy.

Methods: Parameters describing the psychometric properties of 138 BODY-Q items (i.e., questions) were derived from the original validation sample (n = 734). The 138 items are arranged into 18 scales reflecting Appearance, Quality of Life, and Experience of Care domains. The authors simulated 1000 administrations of the computerized adaptive testing until a stopping rule, reflecting assessment accuracy of standard error less than 0.55, was met. The authors describe the reduction of assessment length in terms of the mean and range of items administered. The authors assessed accuracy by determining correlation between full test and computerized adaptive testing scores.

Results: The authors ran 54 simulations. Mean item reduction was 36.9 percent (51 items; range, 48 to 138 items). Highest item reduction was achieved for the Experience of Care domain (56.2 percent, 22.5 items). Correlation between full test scores and the BODY-Q computerized adaptive test scores averaged 0.99.

Conclusions: Substantial item reduction is possible by using BODY-Q computerized adaptive testing. Reduced assessment length using BODY-Q computerized adaptive testing could reduce patient burden while preserving the accuracy of clinical patient-reported outcomes for patients undergoing weight loss and body contouring operations.
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http://dx.doi.org/10.1097/PRS.0000000000005587DOI Listing
May 2019

The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS): a view from the UK.

Patient Relat Outcome Meas 2018 24;9:345-352. Epub 2018 Oct 24.

Health Services and Policy Research Group, University of Exeter Medical School, Exeter, UK,

The interest in patient-reported outcome measures (PROMs) continues to increase as recognition of their potential utility rises in an effort to make health systems more patient-centered. The US National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) has used state of the art psychometric and statistical techniques to create a universal PROMs language, with potential application across the whole spectrum of health conditions, languages, and geographic locations. PROMIS offers a versatile platform where specific health domains are assessed using both standardized short forms and computerized adaptive tests, which are automatically tailored to individual patients. The scores of each health domain or a standardized profile of multiple domains are all scored on a common metric scale. PROMIS is increasingly recognized as the international gold standard for patient-centered assessment, although the use of these tools in the UK is limited. In this review, the developmental methodology of the PROMIS is described with discussion of its relevant strengths and limitations for use in the UK. We provide a case study of the largest application of the PROMIS tools in the UK as an example of straightforward integration into health-care research. Barriers to the uptake of PROMIS in the UK include the technology requirement, measurement tradition, and lack of a clear understanding of its benefits, and although potential stakeholders should cautiously consider its use, its impressive potential and increasing international utilization should be recognized.
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http://dx.doi.org/10.2147/PROM.S141378DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207259PMC
October 2018

UK government's alcohol policy needs societal perspective.

BMJ 2018 10 31;363:k4516. Epub 2018 Oct 31.

Town Hall, Sheffield S1 2HH, UK.

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http://dx.doi.org/10.1136/bmj.k4516DOI Listing
October 2018

Implementing Electronic Patient-Reported Outcome Measures in Outpatient Cosmetic Surgery Clinics: An Exploratory Qualitative Study.

Aesthet Surg J 2019 05;39(6):687-695

Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.

Background: Patient-reported outcome measure (PROM) data are increasingly being collected over the internet or on a smart device by means of electronic versions (e-PROMs). Limited evidence exists about factors influencing e-PROM implementation in outpatient clinics.

Objectives: The authors sought to identify barriers to collection of PRO data from different locations (home or cosmetic surgery office) by means of different modes (paper vs e-PROM) from the perspective of patients, plastic surgeons, and clinic administrative staff; and to explore patient preferences for the design of e-PROM platforms.

Methods: Semistructured interviews were conducted with 11 patients, 3 cosmetic surgeons, and administrative staff. Patients were shown 1 of the 3 PROMs (ie, the BODY-Q Satisfaction with Body scale, BREAST-Q Augmentation Module Satisfaction with Breast scale, or FACE-Q Satisfaction with Facial Appearance scale). The formats included paper and electronic (REDCap and TickiT) on a tablet and laptop computer. The interviews were audio-recorded and transcribed verbatim. Qualitative descriptive analysis was conducted.

Results: Patients and providers preferred electronic over paper format. The flexibility of the hardware, data entry point (remote location vs point-of-care), and the privacy of the data were the most recurring themes from the patient's perspective. The objective of collecting PROM data, role in peer-benchmarking, and return on investment were key to surgeons and administrative staff.

Conclusions: The e-PROMs were well accepted in the community setting by the patients and plastic surgeons alike. The design and interface features of e-PROMs were explored in this study, which may be useful for future, mixed method studies evaluating the implementation of e-PROMs.
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http://dx.doi.org/10.1093/asj/sjy280DOI Listing
May 2019

Embedding shared decision-making in the care of patients with severe and enduring mental health problems: The EQUIP pragmatic cluster randomised trial.

PLoS One 2018 22;13(8):e0201533. Epub 2018 Aug 22.

Division of Population Health, Health Services Research & Primary Care, School of Health Sciences, University of Manchester, Manchester, United Kingdom.

Background: Severe mental illness is a major driver of worldwide disease burden. Shared decision-making is critical for high quality care, and can enhance patient satisfaction and outcomes. However, it has not been translated into routine practice. This reflects a lack of evidence on the best way to implement shared decision-making, and the challenges of implementation in routine settings with limited resources. Our aim was to test whether we could deliver a practical and feasible intervention in routine community mental health services to embed shared decision-making for patients with severe mental illness, by improving patient and carer involvement in care planning.

Methods: We cluster randomised community mental health teams to the training intervention or usual care, to avoid contamination. Training was co-delivered to a total of 350 staff in 18 teams by clinical academics, working alongside patients and carers. The primary outcome was the Health Care Climate Questionnaire, a self-report measure of 'autonomy support'. Primary and secondary outcomes were collected by self-report, six months after allocation.

Findings: In total, 604 patients and 90 carers were recruited to main trial cohort. Retention at six months was 82% (n = 497). In the main analysis, results showed no statistically significant difference in the primary outcome between the intervention and usual care at 6 months (adjusted mean difference -0.064, 95% CI -0.343 to 0.215, p = 0.654). We found significant effects on only 1 secondary outcome.

Conclusions: An intervention to embed shared decision-making in routine practice by improving involvement in care planning was well attended and acceptable to staff, but had no significant effects on patient outcomes. Enhancing shared decision-making may require considerably greater investment of resources and effects may only be apparent over the longer term.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0201533PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6104914PMC
January 2019

Development of the Knowledge of Genome Sequencing (KOGS) questionnaire.

Patient Educ Couns 2018 11 11;101(11):1966-1972. Epub 2018 Jul 11.

North East Thames Regional Genetics Services, Great Ormond Street Hospital, London, UK; UCL Great Ormond Street Institute of Child Health, UK.

Objective: Whole-genome sequencing is being implemented in research and clinical care, yet tools to assess patients' knowledge are lacking. Our aim was to develop a robust measure of whole-genome sequencing knowledge suitable for patients and other stakeholders including research participants, public, students, and healthcare professionals.

Methods: An initial set of 17 items was developed via an iterative process including literature review, expert consultation, focus groups, and cognitive interviews with patients, and then administered to 243 individuals. We used exploratory factor analysis and item-response theory to confirm the psychometric suitability of the candidate items for assessing whole-genome sequencing knowledge.

Results: There was a strong main component after removing 5 items with low factor loadings. Item and scale homogeneity was achieved using Mokken scale analysis. Three further items were removed because they were misfits, inverse duplicates or resulted in local dependency. The remaining nine items fitted the two-parameter logistic IRT model which achieved excellent fit to the observed data. Cronbach's alpha was 0.79 indicating acceptable reliability.

Conclusion: The KOGS, developed using a rigorous psychometric approach, is a brief and reliable tool.

Practice Implications: The KOGS may prove useful for researchers and healthcare professionals using whole-genome sequencing with patients and other stakeholders.
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http://dx.doi.org/10.1016/j.pec.2018.07.011DOI Listing
November 2018

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental-physical multimorbidity: cluster-randomised trial.

Br J Psychiatry 2018 08 15;213(2):456-463. Epub 2018 May 15.

Department of Health Sciences,University of York,UKand Centre for Reviews and Dissemination,University of York,UK.

Background: Collaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity.

Method: A cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service.

Results: 191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, -0.48 to -0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069.

Conclusions: In the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.
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http://dx.doi.org/10.1192/bjp.2018.70DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6429252PMC
August 2018

Measurement invariance and general population reference values of the PROMIS Profile 29 in the UK, France, and Germany.

Qual Life Res 2018 Apr 19;27(4):999-1014. Epub 2018 Jan 19.

APEMAC, EA 4360, Paris Descartes University, Paris, France.

Purpose: Comparability of patient-reported outcome measures over different languages is essential to allow cross-national research. We investigate the comparability of the PROMIS Profile 29, a generic health-related quality of life measure, in general population samples in the UK, France, and Germany and present general population reference values.

Methods: A web-based survey was simultaneously conducted in the UK (n = 1509), France (1501), and Germany (1502). Along with the PROMIS Profile 29, we collected sociodemographic information as well as the EQ-5D. We tested measurement invariance by means of multigroup confirmatory factor analysis (CFA). Differences in the health-related quality of life between countries were modeled by linear regression analysis. We present general population reference data for the included PROMIS domains utilizing plausible value imputation and quantile regression.

Results: Multigroup CFA of the PROMIS Profile 29 showed that factor means are insensitive to potential measurement bias except in one item. We observed significant differences in patient-reported health between countries, which could be partially explained by the differences in overall ratings of health. The physical function and pain interference scales showed considerable floor effects in the normal population in all countries.

Conclusions: Scores derived from the PROMIS Profile 29 are largely comparable across the UK, France, and Germany. Due to the use of plausible value imputation, the presented general population reference values can be compared to data collected with other PROMIS short forms or computer-adaptive tests.
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http://dx.doi.org/10.1007/s11136-018-1785-8DOI Listing
April 2018

Treatment of fatigue in amyotrophic lateral sclerosis/motor neuron disease.

Cochrane Database Syst Rev 2018 Jan 2;1:CD011005. Epub 2018 Jan 2.

The Primary Care Unit, University of Cambridge, Forvie Site, Robinson Way, Cambridge, Cambridgeshire, UK, CB2 0SR.

Background: Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is terminal, progressive neurological condition for which there are no curative treatments. Among people with ALS/MND, fatigue is a common and debilitating symptom, which is characterised by reversible motor weakness and whole-body tiredness that is only partially relieved by rest. The effectiveness of pharmacological or non-pharmacological treatments for fatigue in ALS/MND is not yet established.

Objectives: To assess the effects of pharmacological and non-pharmacological interventions for fatigue in ALS/MND.

Search Methods: We searched the following databases on 5 September 2017: Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL Plus, and ERIC. We also searched two clinical trials registries.

Selection Criteria: We selected randomised and quasi-randomised controlled trials of any intervention which sought to reduce fatigue for people with ALS/MND. We included studies if reduction in fatigue was a primary or secondary outcome of the trial.

Data Collection And Analysis: We used the standard methodological procedures expected by Cochrane.

Main Results: We included one pharmacological (modafinil) study and three non-pharmacological studies (resistance exercise, respiratory exercise, and repetitive transcranial magnetic stimulation (rTMS)), involving a total of 86 participants with ALS/MND. None of the included studies were free from risk of bias. Since there was only one trial for each intervention, no meta-analysis was possible. All studies assessed fatigue using the Fatigue Severity Scale (FSS; scale from 9 to 63, higher scores indicate more fatigue). Information for assessing bias was often lacking in study reports, making the risk of bias unclear across several domains in all trials. Blinding of participants was not possible in exercise trials, but the outcome assessment was blinded.We found very low-quality evidence suggesting possible improvements in fatigue for modafinil treatment versus placebo (MD -11.00, 95% CI -23.08 to 1.08), respiratory exercise versus a sham intervention (MD -9.65, 95% CI -22.04 to 2.73), and rTMS versus sham rTMS (data not provided), which warrant further investigation to clarify the efficacy of these treatments for fatigue in ALS/MND. We found no clear improvements in fatigue for resistance exercise versus usual care (MD 0.20, 95% CI -10.98 to 11.38; very low-quality evidence).Three participants in the modafinil group dropped out of the modafinil study, two citing issues with headache and one with chest tightness; other adverse effects were anxiety, nausea, dizziness, and sialorrhoea (probably ALS-related). The trials reported no adverse effects of exercise or rTMS.We cannot be certain about the effects of any of the interventions studied because of imprecision (small numbers of participants, wide CI), and possible study limitations.

Authors' Conclusions: It is impossible to draw firm conclusions about the effectiveness of interventions to improve fatigue for people with ALS/MND as there are few randomised studies, and the quality of available evidence is very low.
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http://dx.doi.org/10.1002/14651858.CD011005.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494184PMC
January 2018

Lending a hand: could machine learning help hospital staff make better use of patient feedback?

BMJ Qual Saf 2018 02 29;27(2):93-95. Epub 2017 Nov 29.

Department of Health, Public Health England, London, UK.

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http://dx.doi.org/10.1136/bmjqs-2017-007151DOI Listing
February 2018

Computerized Adaptive Testing Provides Reliable and Efficient Depression Measurement Using the CES-D Scale.

J Med Internet Res 2017 09 20;19(9):e302. Epub 2017 Sep 20.

The Psychometrics Centre, Judge Business School, University of Cambridge, Cambridge, United Kingdom.

Background: The Center for Epidemiologic Studies Depression Scale (CES-D) is a measure of depressive symptomatology which is widely used internationally. Though previous attempts were made to shorten the CES-D scale, few have attempted to develop a Computerized Adaptive Test (CAT) version for the CES-D.

Objective: The aim of this study was to provide evidence on the efficiency and accuracy of the CES-D when administered using CAT using an American sample group.

Methods: We obtained a sample of 2060 responses to the CESD-D from US participants using the myPersonality application. The average age of participants was 26 years (range 19-77). We randomly split the sample into two groups to evaluate and validate the psychometric models. We used evaluation group data (n=1018) to assess dimensionality with both confirmatory factor and Mokken analysis. We conducted further psychometric assessments using item response theory (IRT), including assessments of item and scale fit to Samejima's graded response model (GRM), local dependency and differential item functioning. We subsequently conducted two CAT simulations to evaluate the CES-D CAT using the validation group (n=1042).

Results: Initial CFA results indicated a poor fit to the model and Mokken analysis revealed 3 items which did not conform to the same dimension as the rest of the items. We removed the 3 items and fit the remaining 17 items to GRM. We found no evidence of differential item functioning (DIF) between age and gender groups. Estimates of the level of CES-D trait score provided by the simulated CAT algorithm and the original CES-D trait score derived from original scale were correlated highly. The second CAT simulation conducted using real participant data demonstrated higher precision at the higher levels of depression spectrum.

Conclusions: Depression assessments using the CES-D CAT can be more accurate and efficient than those made using the fixed-length assessment.
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http://dx.doi.org/10.2196/jmir.7453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5628285PMC
September 2017

Understanding experiences of and preferences for service user and carer involvement in physical health care discussions within mental health care planning.

BMC Psychiatry 2017 04 13;17(1):138. Epub 2017 Apr 13.

Division of Nursing, Midwifery and Social Work, Faculty of Biology, Medicine and Health, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.

Background: People with severe mental illness suffer more physical comorbidity than the general population, which can require a tailored approach to physical health care discussions within mental health care planning. Although evidence pertaining to service user and carer involvement in mental health care planning is accumulating, current understanding of how physical health is prioritised within this framework is limited. Understanding stakeholder experiences of physical health discussions within mental health care planning, and the key domains that underpin this phenomena is essential to improve quality of care. Our study aimed to explore service user, carer and professional experiences of and preferences for service user and carer involvement in physical health discussions within mental health care planning, and develop a conceptual framework of effective user-led involvement in this aspect of service provision.

Methods: Six focus groups and four telephone interviews were carried out with twelve service users, nine carers, three service users with a dual service user and carer role, and ten mental health professionals recruited from one mental health Trust in the United Kingdom. Data was analysed utilising a thematic approach, analysed separately for each stakeholder group, and combined to aid comparisons.

Results: No service users or carers recalled being explicitly involved in physical health discussions within mental health care planning. Six prerequisites for effective service user and carer involvement in physical care planning were identified. Three themes confirmed general mental health care planning requirements: tailoring a collaborative working relationship, maintaining a trusting relationship with a professional, and having access to and being able to edit a living document. Three themes were novel to feeling involved in physical health care planning discussions: valuing physical health equally with mental health; experiencing coordination of care between physical-mental health professionals, and having a physical health discussion that is personalised.

Conclusions: High quality physical health care discussions within the care planning process demands action at multiple levels. A conceptual framework is presented which provides an evidence-based foundation for service level improvement. Further work is necessary to develop a new patient reported outcome measure to enable meaningful quantification of health care quality and patient experience.
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http://dx.doi.org/10.1186/s12888-017-1287-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5390472PMC
April 2017

Supervised Machine Learning Algorithms Can Classify Open-Text Feedback of Doctor Performance With Human-Level Accuracy.

J Med Internet Res 2017 03 15;19(3):e65. Epub 2017 Mar 15.

Primary Care Research Group, University of Exeter, Exeter, United Kingdom.

Background: Machine learning techniques may be an effective and efficient way to classify open-text reports on doctor's activity for the purposes of quality assurance, safety, and continuing professional development.

Objective: The objective of the study was to evaluate the accuracy of machine learning algorithms trained to classify open-text reports of doctor performance and to assess the potential for classifications to identify significant differences in doctors' professional performance in the United Kingdom.

Methods: We used 1636 open-text comments (34,283 words) relating to the performance of 548 doctors collected from a survey of clinicians' colleagues using the General Medical Council Colleague Questionnaire (GMC-CQ). We coded 77.75% (1272/1636) of the comments into 5 global themes (innovation, interpersonal skills, popularity, professionalism, and respect) using a qualitative framework. We trained 8 machine learning algorithms to classify comments and assessed their performance using several training samples. We evaluated doctor performance using the GMC-CQ and compared scores between doctors with different classifications using t tests.

Results: Individual algorithm performance was high (range F score=.68 to .83). Interrater agreement between the algorithms and the human coder was highest for codes relating to "popular" (recall=.97), "innovator" (recall=.98), and "respected" (recall=.87) codes and was lower for the "interpersonal" (recall=.80) and "professional" (recall=.82) codes. A 10-fold cross-validation demonstrated similar performance in each analysis. When combined together into an ensemble of multiple algorithms, mean human-computer interrater agreement was .88. Comments that were classified as "respected," "professional," and "interpersonal" related to higher doctor scores on the GMC-CQ compared with comments that were not classified (P<.05). Scores did not vary between doctors who were rated as popular or innovative and those who were not rated at all (P>.05).

Conclusions: Machine learning algorithms can classify open-text feedback of doctor performance into multiple themes derived by human raters with high performance. Colleague open-text comments that signal respect, professionalism, and being interpersonal may be key indicators of doctor's performance.
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http://dx.doi.org/10.2196/jmir.6533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5371715PMC
March 2017

Investigating the meaning of 'good' or 'very good' patient evaluations of care in English general practice: a mixed methods study.

BMJ Open 2017 03 2;7(3):e014718. Epub 2017 Mar 2.

Cambridge Centre for Health Services Research, Primary Care Unit, Institute of Public Health, Forvie Site, University of Cambridge School of Clinical Medicine, Cambridge, UK.

Objective: To examine concordance between responses to patient experience survey items evaluating doctors' interpersonal skills, and subsequent patient interview accounts of their experiences of care.

Design: Mixed methods study integrating data from patient questionnaires completed immediately after a video-recorded face-to-face consultation with a general practitioner (GP) and subsequent interviews with the same patients which included playback of the recording.

Setting: 12 general practices in rural, urban and inner city locations in six areas in England.

Participants: 50 patients (66% female, aged 19-96 years) consulting face-to-face with 32 participating GPs.

Main Outcome Measures: Positive responses to interpersonal skills items in a postconsultation questionnaire ('good' and 'very good') were compared with experiences reported during subsequent video elicitation interview (categorised as positive, negative or neutral by independent clinical raters) when reviewing that aspect of care.

Results: We extracted 230 textual statements from 50 interview transcripts which related to the evaluation of GPs' interpersonal skills. Raters classified 70.9% (n=163) of these statements as positive, 19.6% (n=45) neutral and 9.6% (n=22) negative. Comments made by individual patients during interviews did not always express the same sentiment as their responses to the questionnaire. Where questionnaire responses indicated that interpersonal skills were 'very good', 84.6% of interview statements concerning that item were classified as positive. However, where patients rated interpersonal skills as 'good', only 41.9% of interview statements were classified as positive, and 18.9% as negative.

Conclusions: Positive responses on patient experience questionnaires can mask important negative experiences which patients describe in subsequent interviews. The interpretation of absolute patient experience scores in feedback and public reporting should be done with caution, and clinicians should not be complacent following receipt of 'good' feedback. Relative scores are more easily interpretable when used to compare the performance of providers.
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http://dx.doi.org/10.1136/bmjopen-2016-014718DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353293PMC
March 2017

Turning the Page on Pen-and-Paper Questionnaires: Combining Ecological Momentary Assessment and Computer Adaptive Testing to Transform Psychological Assessment in the 21st Century.

Authors:
Chris J Gibbons

Front Psychol 2016 19;7:1933. Epub 2017 Jan 19.

Cambridge Centre for Health Services Research, University of CambridgeCambridge, UK; The Psychometrics Centre, Judge Business School, University of CambridgeCambridge, UK.

The current paper describes new opportunities for patient-centred assessment methods which have come about by the increased adoption of affordable smart technologies in biopsychosocial research and medical care. In this commentary, we review modern assessment methods including item response theory (IRT), computer adaptive testing (CAT), and ecological momentary assessment (EMA) and explain how these methods may be combined to improve psychological assessment. We demonstrate both how a 'naïve' selection of a small group of items in an EMA can lead to unacceptably unreliable assessments and how IRT can provide detailed information on the individual information that each item gives thus allowing short form assessments to be selected with acceptable reliability. The combination of CAT and IRT can ensure assessments are precise, efficient, and well targeted to the individual; allowing EMAs to be both brief and accurate.
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http://dx.doi.org/10.3389/fpsyg.2016.01933DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5244429PMC
January 2017

Electronic Quality of Life Assessment Using Computer-Adaptive Testing.

J Med Internet Res 2016 09 30;18(9):e240. Epub 2016 Sep 30.

Cambridge Centre for Health Services Research, University of Cambridge, Cambridge, United Kingdom.

Background: Quality of life (QoL) questionnaires are desirable for clinical practice but can be time-consuming to administer and interpret, making their widespread adoption difficult.

Objective: Our aim was to assess the performance of the World Health Organization Quality of Life (WHOQOL)-100 questionnaire as four item banks to facilitate adaptive testing using simulated computer adaptive tests (CATs) for physical, psychological, social, and environmental QoL.

Methods: We used data from the UK WHOQOL-100 questionnaire (N=320) to calibrate item banks using item response theory, which included psychometric assessments of differential item functioning, local dependency, unidimensionality, and reliability. We simulated CATs to assess the number of items administered before prespecified levels of reliability was met.

Results: The item banks (40 items) all displayed good model fit (P>.01) and were unidimensional (fewer than 5% of t tests significant), reliable (Person Separation Index>.70), and free from differential item functioning (no significant analysis of variance interaction) or local dependency (residual correlations < +.20). When matched for reliability, the item banks were between 45% and 75% shorter than paper-based WHOQOL measures. Across the four domains, a high standard of reliability (alpha>.90) could be gained with a median of 9 items.

Conclusions: Using CAT, simulated assessments were as reliable as paper-based forms of the WHOQOL with a fraction of the number of items. These properties suggest that these item banks are suitable for computerized adaptive assessment. These item banks have the potential for international development using existing alternative language versions of the WHOQOL items.
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http://dx.doi.org/10.2196/jmir.6053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5065679PMC
September 2016

Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities.

J Comp Eff Res 2016 08 18;5(5):507-19. Epub 2016 Jul 18.

Health Services & Policy Research Group, Exeter Collaboration for Academic Primary Care (APEx) (Person centerd Care), University of Exeter Medical School, University of Exeter, Exeter, UK.

Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing.
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http://dx.doi.org/10.2217/cer-2015-0014DOI Listing
August 2016

Evaluating and Quantifying User and Carer Involvement in Mental Health Care Planning (EQUIP): Co-Development of a New Patient-Reported Outcome Measure.

PLoS One 2016 10;11(3):e0149973. Epub 2016 Mar 10.

School of Nursing, Midwifery & Social Work, University of Manchester, Manchester, United Kingdom.

International and national health policy seeks to increase service user and carer involvement in mental health care planning, but suitable user-centred tools to assess the success of these initiatives are not yet available. The current study describes the development of a new reliable and valid, interval-scaled service-user and carer reported outcome measure for quantifying user/carer involvement in mental health care planning. Psychometric development reduced a 70-item item bank to a short form questionnaire using a combination of Classical Test, Mokken and Rasch Analyses. Test-retest reliability was calculated using t-tests of interval level scores between baseline and 2-4 week follow-up. Items were worded to be relevant to both service users and carers. Nine items were removed following cognitive debriefing with a service user and carer advisory group. An iterative process of item removal reduced the remaining 61 items to a final 14-item scale. The final scale has acceptable scalability (Ho = .69), reliability (alpha = .92), fit to the Rasch model (χ2(70) = 97.25, p = .02), and no differential item functioning or locally dependent items. Scores remained stable over the 4 week follow-up period, indicating good test-retest reliability. The 'Evaluating the Quality of User and Carer Involvement in Care Planning (EQUIP)' scale displays excellent psychometric properties and is capable of unidimensional linear measurement. The scale is short, user and carer-centred and will be of direct benefit to clinicians, services, auditors and researchers wishing to quantify levels of user and carer involvement in care planning.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0149973PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4786101PMC
July 2016

High rate of microbleed formation following primary intracerebral hemorrhage.

Int J Stroke 2015 Dec 26;10(8):1187-91. Epub 2015 Aug 26.

Department of Neurology, Indiana University, Indianapolis, IN, USA.

Background: We sought to investigate the frequency of microbleed development following intracerebral hemorrhage in a predominantly African-American population and to identify predictors of new microbleed formation.

Aims And/or Hypothesis: To investigate the frequency and predictors of new microbleeds following intracerebral hemorrhage.

Methods: The DECIPHER study was a prospective, longitudinal, magnetic resonance-based cohort study designed to evaluate racial/ethnic differences in risk factors for microbleeds and to evaluate the prognostic impact of microbleeds in this intracerebral hemorrhage population. We evaluated new microbleed formation in two time periods: from baseline to 30 days and from 30 days to year 1.

Results: Of 200 subjects enrolled in DECIPHER, 84 had magnetic resonance imaging at all required time points to meet criteria for this analysis. In the baseline to day 30 analysis, 11 (13·1%) had new microbleeds, compared with 25 (29·8%) in the day 30 to year 1 analysis. Logistic regression analysis demonstrated that baseline number of microbleeds [odds ratio 1·05 (95% confidence interval 1·01, 1·08), P = 0·01] was associated with new microbleed formation at 30 days. A logistic regression model predicting new microbleed at one-year included baseline number of microbleeds [odds ratio 1·05 (1·00, 1·11), P = 0·046], baseline age [odds ratio 1·05 (1·00, 1·10), P = 0·04], and white matter disease score [odds ratio 1·18 (0·96, 1·45). P = 0·115]. Overall, 28 of 84 (33·3%) intracerebral hemorrhage subjects formed new microbleeds at some point in the first year post-intracerebral hemorrhage.

Conclusions: We found that one-third of intracerebral hemorrhage subjects in this cohort surviving one-year developed new microbleeds, which suggests a dynamic and rapidly progressive vasculopathy. Future studies are needed to examine the impact of new microbleed formation on patient outcomes.
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http://dx.doi.org/10.1111/ijs.12607DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872710PMC
December 2015

A cluster randomised controlled trial and process evaluation of a training programme for mental health professionals to enhance user involvement in care planning in service users with severe mental health issues (EQUIP): study protocol for a randomised controlled trial.

Trials 2015 Aug 13;16:348. Epub 2015 Aug 13.

School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, England.

Background: Involving service users in planning their care is at the centre of policy initiatives to improve mental health care quality in England. Whilst users value care planning and want to be more involved in their own care, there is substantial empirical evidence that the majority of users are not fully involved in the care planning process. Our aim is to evaluate the effectiveness and cost-effectiveness of training for mental health professionals in improving user involvement with the care planning processes.

Methods/design: This is a cluster randomised controlled trial of community mental health teams in NHS Trusts in England allocated either to a training intervention to improve user and carer involvement in care planning or control (no training and care planning as usual). We will evaluate the effectiveness of the training intervention using a mixed design, including a 'cluster cohort' sample, a 'cluster cross-sectional' sample and process evaluation. Service users will be recruited from the caseloads of care co-ordinators. The primary outcome will be change in self-reported involvement in care planning as measured by the validated Health Care Climate Questionnaire. Secondary outcomes include involvement in care planning, satisfaction with services, medication side-effects, recovery and hope, mental health symptoms, alliance/engagement, well-being and quality of life. Cost- effectiveness will also be measured. A process evaluation informed by implementation theory will be undertaken to assess the extent to which the training was implemented and to gauge sustainability beyond the time-frame of the trial.

Discussion: It is hoped that the trial will generate data to inform mental health care policy and practice on care planning.

Trial Registration Number: ISRCTN16488358 (14 May 2014).
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http://dx.doi.org/10.1186/s13063-015-0896-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4535374PMC
August 2015

Does patient experience of multimorbidity predict self-management and health outcomes in a prospective study in primary care?

Fam Pract 2015 Jun 24;32(3):311-6. Epub 2015 Feb 24.

Institute of Population Health, NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Centre for Primary Care, Manchester Academic Health Science Centre (MAHSC), University of Manchester, Manchester, UK.

Background: There is a need to better understand the mechanisms which lead to poor outcomes in patients with multimorbidity, especially those factors that might be amenable to intervention.

Objective: This research aims to explore what factors predict self-management behaviour and health outcomes in patients with multimorbidity in primary care in the UK.

Methods: A prospective study design was used. Questionnaires were mailed out to 1460 patients with multimorbidity. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery and outcomes (three measures of self-management: behaviours, Self-monitoring and Insight and medication adherence; and a measure of self-reported health).

Results: In total, 36% (n = 499) of patients responded to the baseline survey and 80% of those respondents completed follow-up. Self-management behaviour at 4 months was predicted by illness perceptions around the consequences of individual conditions. Self-monitoring and Insight at 4 months was predicted by patient experience of 'Hassles' in health services. Self-reported medication adherence at 4 months was predicted by health status, Self-monitoring and Insight and 'Hassles' in health services. Perceived health status at 4 months was predicted by age and patient experience of multimorbidity.

Conclusions: This research shows that different factors, particularly around patients' experiences of health care and control over their treatment, impact on various types of self-management. Patient experience of multimorbidity was not a critical predictor of self-management but did predict health status in the short term. The findings can help to develop and target interventions that might improve outcomes in patients with multimorbidity.
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http://dx.doi.org/10.1093/fampra/cmv002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445135PMC
June 2015

Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease.

BMJ 2015 Feb 16;350:h638. Epub 2015 Feb 16.

Centre for Primary Care and Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK.

Objective: To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions.

Design: Cluster randomised controlled trial.

Setting: 36 general practices in the north west of England.

Participants: 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥ 10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) long term conditions other than diabetes or heart disease; 240 (62%) were men; 360 (90%) completed the trial.

Interventions: Collaborative care included patient preference for behavioural activation, cognitive restructuring, graded exposure, and/or lifestyle advice, management of drug treatment, and prevention of relapse. Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse. Usual care was standard clinical practice provided by general practitioners and practice nurses.

Main Outcome Measures: The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale (SCL-D13) at four months after baseline assessment. Secondary outcomes included anxiety symptoms (generalised anxiety disorder 7), self management (health education impact questionnaire), disability (Sheehan disability scale), and global quality of life (WHOQOL-BREF).

Results: 19 general practices were randomised to collaborative care and 20 to usual care; three practices withdrew from the trial before patients were recruited. 191 patients were recruited from practices allocated to collaborative care, and 196 from practices allocated to usual care. After adjustment for baseline depression score, mean depressive scores were 0.23 SCL-D13 points lower (95% confidence interval -0.41 to -0.05) in the collaborative care arm, equal to an adjusted standardised effect size of 0.30. Patients in the intervention arm also reported being better self managers, rated their care as more patient centred, and were more satisfied with their care. There were no significant differences between groups in quality of life, disease specific quality of life, self efficacy, disability, and social support.

Conclusions: Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity. The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity.

Trial Registration: ISRCTN80309252.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353275PMC
http://dx.doi.org/10.1136/bmj.h638DOI Listing
February 2015
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