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  1. Article ; Online: Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device.

    Wyatt, Jeremy C / Scott, Philip / Ordish, Johan / South, Matthew / Thomas, Mark / Jones, Caroline / Lacey-Bryant, Sue

    Learning health systems

    2023  Volume 7, Issue 4, Page(s) e10386

    Abstract: Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom.: Methods: A briefing paper was circulated to a multi-disciplinary group ... ...

    Abstract Introduction: To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom.
    Methods: A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions.
    Results: This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level.
    Conclusions: If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as "software as a medical device." However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.
    Language English
    Publishing date 2023-08-25
    Publishing country United States
    Document type Journal Article
    ISSN 2379-6146
    ISSN (online) 2379-6146
    DOI 10.1002/lrh2.10386
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: User perspectives on long-term remote active electronic self-monitoring of mood symptoms in bipolar spectrum disorders.

    Gordon-Smith, Katherine / Saunders, Kate E A / Morton, Thomas / Savage, Julia / South, Matthew / Geddes, John / Craddock, Nick / Jones, Ian / Jones, Lisa

    Journal of affective disorders

    2022  Volume 324, Page(s) 325–333

    Abstract: Background: User feedback is crucial in the development of electronic self-monitoring tools for bipolar spectrum disorders (BSD). Previous studies have examined user experiences in small samples self-monitoring over relatively short time periods. We ... ...

    Abstract Background: User feedback is crucial in the development of electronic self-monitoring tools for bipolar spectrum disorders (BSD). Previous studies have examined user experiences in small samples self-monitoring over relatively short time periods. We aimed to explore the experiences of a large sample of individuals with BSD engaged in long-term remote active electronic self-monitoring.
    Methods: An online survey, containing closed and open questions, was sent to participants with BSD enrolled on the Bipolar Disorder Research Network (BDRN) True Colours mood-monitoring system. Questions related to experiences of using True Colours, including viewing mood graphs, and sharing data with healthcare professionals (HCPs) and/or family/friends.
    Results: Response rate was 62.7 % (n = 362). 88.4 % reported finding using True Colours helpful. Commonly reported benefits were having a visual record of mood changes, patterns/triggers and identifying early warning signs. Limitations included questions not being comprehensive or revealing anything new. One third had shared their graphs, with 89.9 % finding it helpful to share with HCPs and 78.7 % helpful to share with family/friends. Perceived benefits included aiding communication and limitations included lack of interest/understanding from others.
    Limitations: Responder bias may be present. Findings may not be generalisable to all research cohorts.
    Conclusions: The majority of participants valued long-term self-monitoring. Personalisation and ease of use were important. A potential challenge is continued use when mood is long-term stable, highlighting the need for measures to be sensitive to small changes. Sharing self-monitoring data with HCPs may enhance communication of the lived experience of those with BSD. Future research should examine HCPs' perspectives.
    MeSH term(s) Humans ; Bipolar Disorder/diagnosis ; Mood Disorders/diagnosis ; Affect ; Surveys and Questionnaires ; Health Personnel
    Language English
    Publishing date 2022-12-27
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 135449-8
    ISSN 1573-2517 ; 0165-0327
    ISSN (online) 1573-2517
    ISSN 0165-0327
    DOI 10.1016/j.jad.2022.12.090
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: OpenClinical.net: Artificial intelligence and knowledge engineering at the point of care.

    Fox, John / South, Matthew / Khan, Omar / Kennedy, Catriona / Ashby, Peter / Bechtel, John

    BMJ health & care informatics

    2020  Volume 27, Issue 2

    Abstract: Objective: OpenClinical.net is a way of disseminating clinical guidelines to improve quality of care whose distinctive feature is to combine the benefits of clinical guidelines and other human-readable material with the power of artificial intelligence ... ...

    Abstract Objective: OpenClinical.net is a way of disseminating clinical guidelines to improve quality of care whose distinctive feature is to combine the benefits of clinical guidelines and other human-readable material with the power of artificial intelligence to give patient-specific recommendations. A key objective is to empower healthcare professionals to author, share, critique, trial and revise these 'executable' models of best practice.
    Design: OpenClinical.net
    Results: PRO
    Conclusion: OpenClinical.net is a showcase for a PRO
    MeSH term(s) Artificial Intelligence ; Decision Support Systems, Clinical ; Humans ; Knowledge Bases ; Point-of-Care Systems ; Practice Guidelines as Topic
    Language English
    Publishing date 2020-07-29
    Publishing country England
    Document type Journal Article ; Review
    ISSN 2632-1009
    ISSN (online) 2632-1009
    DOI 10.1136/bmjhci-2020-100141
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Acute aortic dissection during pregnancy: Trials and tribulations.

    Rimmer, Lara / Heyward-Chaplin, Jessica / South, Matthew / Gouda, Mohamed / Bashir, Mohamad

    Journal of cardiac surgery

    2020  Volume 36, Issue 5, Page(s) 1799–1805

    Abstract: Background: Type A acute aortic dissection (TAAD) during pregnancy is a life-threatening event for both the mother and the unborn baby. Pregnancy has been recognized as an independent risk factor for TAAD, postulated to be due to physiological changes ... ...

    Abstract Background: Type A acute aortic dissection (TAAD) during pregnancy is a life-threatening event for both the mother and the unborn baby. Pregnancy has been recognized as an independent risk factor for TAAD, postulated to be due to physiological changes that cause hyperdynamic circulation. This review seeks to outline the current controversies around this unique group.
    Methods: A comprehensive literature search was carried out across large databases to assimilate relevant papers regarding acute aortic dissection in pregnant women.
    Results: The presentation can be atypical in many cases and further concern from clinicians of fetal radiation exposure can result in missed or delayed diagnoses. Investigation via the quickest form of imaging, whether computed tomography, magnetic resonance imaging, or transesophageal echocardiography, should be carried out promptly due to the high risk of mortality. Surgical management of TAAD in pregnancy revolves primarily around the decision to deliver the fetus concomitantly or to perform the aortic repair with the fetus in utero.
    Conclusions: Management of this group includes rapid and dynamic assessment without delay. From conception to postpartum, there are multiple stages in which to manage these women. Challenges in carrying out management in the form of operative techniques and cardiopulmonary bypass place the fetus at risk and must be approached with caution, particularly as there is little evidence-base for many of these decisions. Further research into reducing maternal and fetal mortality is necessary.
    MeSH term(s) Aneurysm, Dissecting/diagnostic imaging ; Aneurysm, Dissecting/surgery ; Cardiopulmonary Bypass ; Echocardiography, Transesophageal ; Female ; Humans ; Postpartum Period ; Pregnancy ; Pregnancy Complications, Cardiovascular/diagnostic imaging ; Pregnancy Complications, Cardiovascular/surgery
    Language English
    Publishing date 2020-09-29
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 639059-6
    ISSN 1540-8191 ; 0886-0440
    ISSN (online) 1540-8191
    ISSN 0886-0440
    DOI 10.1111/jocs.15068
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Using item response theory (IRT) to improve the efficiency of the Simple Clinical Colitis Activity Index (SCCAI) for patients with ulcerative colitis.

    Walsh, Alissa / Cao, Rena / Wong, Darren / Kantschuster, Ramona / Matini, Lawrence / Wilson, Jean / Kormilitzin, Andrey / South, Matthew / Travis, Simon / Bauermeister, Sarah

    BMC gastroenterology

    2021  Volume 21, Issue 1, Page(s) 132

    Abstract: Background: The SCCAI was designed to facilitate assessment of disease activity in ulcerative colitis (UC). We aimed to interrogate the metric properties of individual items of the SCCAI using item response theory (IRT) analysis, to simplify and improve ...

    Abstract Background: The SCCAI was designed to facilitate assessment of disease activity in ulcerative colitis (UC). We aimed to interrogate the metric properties of individual items of the SCCAI using item response theory (IRT) analysis, to simplify and improve its performance.
    Methods: The original 9-item SCCAI was collected through TrueColours, a real-time software platform which allows remote entry and monitoring of patients with UC. Data were securely uploaded onto Dementias Platform UK Data Portal, where they were analysed in Stata 16.1 SE. A 2-parameter (2-PL) logistic IRT model was estimated to evaluate each item of the SCCAI for its informativeness (discrimination). A revised scale was generated and re-assessed following systematic removal of items.
    Results: SCCAI data for 516 UC patients (41 years, SD = 15) treated in Oxford were examined. After initial item deletion (Erythema nodosum, Pyoderma gangrenosum), a 7-item scale was estimated. Discrimination values (information) ranged from 0.41 to 2.52 indicating selected item inefficiency with three items < 1.70 which is a suggested discriminatory value for optimal efficiency. Systematic item deletions found that a 4-item scale (bowel frequency day; bowel frequency nocturnal; urgency to defaecation; rectal bleeding) was more informative and discriminatory of trait severity (discrimination values of 1.50 to 2.78). The 4-item scale possesses higher scalability and unidimensionality, suggesting that the responses to items are either direct endorsement (patient selection by symptom) or non-endorsement of the trait (disease activity).
    Conclusion: Reduction of the SCCAI from the original 9-item scale to a 4-item scale provides optimum trait information that will minimise response burden. This new 4-item scale needs validation against other measures of disease activity such as faecal calprotectin, endoscopy and histopathology.
    MeSH term(s) Colitis, Ulcerative/diagnosis ; Feces ; Humans ; Leukocyte L1 Antigen Complex ; Pyoderma Gangrenosum ; Severity of Illness Index
    Chemical Substances Leukocyte L1 Antigen Complex
    Language English
    Publishing date 2021-03-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041351-8
    ISSN 1471-230X ; 1471-230X
    ISSN (online) 1471-230X
    ISSN 1471-230X
    DOI 10.1186/s12876-021-01621-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Modelling clinical narrative as computable knowledge: The NICE computable implementation guidance project.

    Scott, Philip / Heigl, Michaela / McCay, Charles / Shepperdson, Polly / Lima-Walton, Elia / Andrikopoulou, Elisavet / Brunnhuber, Klara / Cornelius, Gary / Faulding, Susan / McAlister, Ben / Rowark, Shaun / South, Matthew / Thomas, Mark R / Whatling, Justin / Williams, John / Wyatt, Jeremy C / Greaves, Felix

    Learning health systems

    2023  Volume 7, Issue 4, Page(s) e10394

    Abstract: Introduction: Translating narrative clinical guidelines to computable knowledge is a long-standing challenge that has seen a diverse range of approaches. The UK National Institute for Health and Care Excellence (NICE) Content Advisory Board (CAB) aims ... ...

    Abstract Introduction: Translating narrative clinical guidelines to computable knowledge is a long-standing challenge that has seen a diverse range of approaches. The UK National Institute for Health and Care Excellence (NICE) Content Advisory Board (CAB) aims ultimately to (1) guide clinical decision support and other software developers to increase traceability, fidelity and consistency in supporting clinical use of NICE recommendations, (2) guide local practice audit and intervention to reduce unwarranted variation, (3) provide feedback to NICE on how future recommendations should be developed.
    Objectives: The first phase of work was to explore a range of technical approaches to transition NICE toward the production of natively digital content.
    Methods: Following an initial 'collaborathon' in November 2022, the NICE Computable Implementation Guidance project (NCIG) was established. We held a series of workstream calls approximately fortnightly, focusing on (1) user stories and trigger events, (2) information model and definitions, (3) horizon-scanning and output format. A second collaborathon was held in March 2023 to consolidate progress across the workstreams and agree residual actions to complete.
    Results: While we initially focussed on technical implementation standards, we decided that an intermediate logical model was a more achievable first step in the journey from narrative to fully computable representation. NCIG adopted the WHO Digital Adaptation Kit (DAK) as a technology-agnostic method to model user scenarios, personae, processes and workflow, core data elements and decision-support logic. Further work will address indicators, such as prescribing compliance, and implementation in document templates for primary care patient record systems.
    Conclusions: The project has shown that the WHO DAK, with some modification, is a promising approach to build technology-neutral logical specifications of NICE recommendations. Implementation of concurrent computable modelling by multidisciplinary teams during guideline development poses methodological and cultural questions that are complex but tractable given suitable will and leadership.
    Language English
    Publishing date 2023-09-28
    Publishing country United States
    Document type Journal Article
    ISSN 2379-6146
    ISSN (online) 2379-6146
    DOI 10.1002/lrh2.10394
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Mental health prior to and during the COVID-19 pandemic in individuals with bipolar disorder: Insights from prospective longitudinal data.

    Lewis, Katie J S / Gordon-Smith, Katherine / Saunders, Kate E A / Dolman, Clare / South, Matthew / Geddes, John / Craddock, Nick / Di Florio, Arianna / Jones, Ian / Jones, Lisa

    Bipolar disorders

    2022  Volume 24, Issue 6, Page(s) 658–666

    Abstract: Objectives: Many studies have examined the impact of COVID-19 on the mental health of the public, but few have focused on individuals with existing severe mental illness with longitudinal data before and during the pandemic.: Aims: To investigate the ...

    Abstract Objectives: Many studies have examined the impact of COVID-19 on the mental health of the public, but few have focused on individuals with existing severe mental illness with longitudinal data before and during the pandemic.
    Aims: To investigate the impact of the COVID-19 pandemic on the mental health of people with bipolar disorder (BD).
    Methods: In an ongoing study of people with BD who used an online mood monitoring tool, True Colours, 356 participants provided weekly data on their mental health. Symptoms of depression, mania, insomnia, and suicidal thoughts were compared in 2019 and 2020. From May 2020, participants also provided weekly data on the effect of the COVID-19 pandemic on anxiety, coping strategies, access to care, and medications.
    Results: On average, symptoms of depression, mania, insomnia, and suicidal thoughts did not significantly differ in 2020 compared to 2019, but there was evidence of heterogeneity. There were high rates of anxiety about the pandemic and its impact on coping strategies, which increased to over 70% of responders in January 2021. A significant proportion of participants reported difficulty accessing routine care (27%) and medications (21%).
    Conclusions: Although mood symptoms did not significantly increase during the pandemic overall, we observed heterogeneity among our BD sample and other impacted areas. Individuals' unique histories and psychosocial circumstances are key and should be explored in future qualitative studies. The significant impacts of the pandemic may take time to manifest, particularly among those who are socioeconomically disadvantaged, highlighting the need for further long-term prospective studies.
    MeSH term(s) Anxiety/epidemiology ; Anxiety/etiology ; Bipolar Disorder/diagnosis ; Bipolar Disorder/epidemiology ; COVID-19/epidemiology ; Depression ; Humans ; Mania ; Mental Health ; Pandemics ; Prospective Studies ; Sleep Initiation and Maintenance Disorders
    Language English
    Publishing date 2022-03-28
    Publishing country Denmark
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1472242-2
    ISSN 1399-5618 ; 1398-5647
    ISSN (online) 1399-5618
    ISSN 1398-5647
    DOI 10.1111/bdi.13204
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Development of a Clinical Decision Support System for Living Kidney Donor Assessment Based on National Guidelines.

    Knight, Simon R / Cao, Khoa N / South, Matthew / Hayward, Nicki / Hunter, James P / Fox, John

    Transplantation

    2018  Volume 102, Issue 10, Page(s) e447–e453

    Abstract: Background: Live donor nephrectomy is an operation that places the donor at risk of complications without the possibility of medical benefit. Rigorous donor selection and assessment is therefore essential to ensure minimization of risk and for this ... ...

    Abstract Background: Live donor nephrectomy is an operation that places the donor at risk of complications without the possibility of medical benefit. Rigorous donor selection and assessment is therefore essential to ensure minimization of risk and for this reason robust national guidelines exist. Previous studies have demonstrated poor adherence to donor guidelines.
    Methods: We developed a clinical decision support system (CDSS), based on national living donor guidelines, to facilitate the identification of contraindications, additional investigations, special considerations, and the decision as to nephrectomy side in potential living donors. The CDSS was then tested with patient data from 45 potential kidney donors.
    Results: The CDSS comprises 17 core tasks completed by either patient or nurse, and 17 optional tasks that are triggered by certain patient demographics or conditions. Decision rules were able to identify contraindications, additional investigations, special considerations, and predicted operation side in our patient cohort. Seventeen of 45 patients went on to donate a kidney, of whom 7 had major contraindications defined in the national guidelines, many of which were not identified by the clinical team. Only 43% of additional investigations recommended by national guidelines were completed, with the most frequently missed investigations being oral glucose tolerance testing and routine cancer screening.
    Conclusions: We have demonstrated the feasibility of turning a complex set of national guidelines into an easy-to-use machine-readable CDSS. Comparison with real-world decisions suggests that use of this CDSS may improve compliance with guidelines and informed consent tailored to individual patient risks.
    MeSH term(s) Clinical Decision-Making/methods ; Decision Support Systems, Clinical/organization & administration ; Decision Support Systems, Clinical/standards ; Donor Selection/organization & administration ; Donor Selection/standards ; Female ; Guideline Adherence/organization & administration ; Guideline Adherence/standards ; Health Plan Implementation ; Humans ; Informed Consent/standards ; Kidney/surgery ; Kidney Transplantation/adverse effects ; Living Donors ; Nephrectomy/adverse effects ; Nursing Assessment/organization & administration ; Nursing Assessment/standards ; Practice Guidelines as Topic ; Preoperative Care/methods ; Preoperative Care/standards ; Retrospective Studies ; Surveys and Questionnaires
    Language English
    Publishing date 2018-08-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 208424-7
    ISSN 1534-6080 ; 0041-1337
    ISSN (online) 1534-6080
    ISSN 0041-1337
    DOI 10.1097/TP.0000000000002374
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Patient-reported Outcomes: the ICHOM Standard Set for Inflammatory Bowel Disease in Real-life Practice Helps Quantify Deficits in Current Care.

    Wong, Darren / Matini, Lawrence / Kormilitzin, Andrey / Kantschuster, Ramona / Simadibrata, Daniel Martin / Lyden, Sara / Wilson, Jean / Brain, Oliver A / Palmer, Rebecca / Ambrose, Tim / Satsangi, Jack / South, Matthew / Geddes, John / Bodger, Keith / Travis, Simon P L / Walsh, Alissa

    Journal of Crohn's & colitis

    2022  Volume 16, Issue 12, Page(s) 1874–1881

    Abstract: Background: Patient-reported outcome measures [PROMs] are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for ... ...

    Abstract Background: Patient-reported outcome measures [PROMs] are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for Inflammatory Bowel Disease [IBD].
    Methods: Patients treated for ulcerative colitis [UC] or Crohn's disease [CD] in our centre were offered enrolment into the web-based TrueColours-IBD programme. Through this programme, e-mail prompts linking to validated questionnaires were sent for symptoms, quality of life, and ICHOM IBD outcomes.
    Results: The first 1299 consecutive patients enrolled [779 UC, 520 CD] were studied with median 270 days of follow-up (interquartile range [IQR] 116, 504). 671 [52%] were female, mean age 42 years (standard deviation [sd] 16), mean body mass index [BMI] 26 [sd 5.3]. At registration, 483 [37%] were using advanced therapies. Median adherence to fortnightly quality of life reporting and quarterly outcomes was 100% [IQR 48, 100%] and 100% [IQR 75, 100%], respectively. In the previous 12 months, prednisolone use was reported by 229 [29%] patients with UC vs 81 [16%] with CD, p <0.001; 202 [16%] for <3 months; and 108 [8%] for >3 months. An IBD-related intervention was reported by 174 [13%] patients, and 80 [6%] reported an unplanned hospital admission. There were high rates of fatigue [50%] and mood disturbance [23%].
    Conclusions: Outcomes reported by patients illustrate the scale of the therapeutic deficit in current care. Proof of principle is demonstrated that PROM data can be collected continuously with little burden on health care professionals. This may become a metric for quality improvement programmes or to compare outcomes.
    Language English
    Publishing date 2022-07-22
    Publishing country England
    Document type Journal Article
    ZDB-ID 2390120-2
    ISSN 1876-4479 ; 1873-9946
    ISSN (online) 1876-4479
    ISSN 1873-9946
    DOI 10.1093/ecco-jcc/jjac099
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article: Making the most of the waiting room: Electronic patient engagement, a mixed methods study.

    Coathup, Victoria / Finlay, Teresa / Teare, Harriet Ja / Kaye, Jane / South, Matthew / Watt, Fiona E / Luqmani, Raashid

    Digital health

    2018  Volume 4, Page(s) 2055207617751304

    Abstract: Objective: The purpose of this study was to explore whether patients with musculoskeletal conditions would agree to use digital technologies to learn about research registries and make a decision about signing up whilst in the clinic waiting room.: ... ...

    Abstract Objective: The purpose of this study was to explore whether patients with musculoskeletal conditions would agree to use digital technologies to learn about research registries and make a decision about signing up whilst in the clinic waiting room.
    Methods: Patients were recruited from four hospital clinics across Oxfordshire. We used an explanatory mixed methods design with two sequential phases comprising an exploratory, cross-sectional questionnaire (
    Results: As participants' age increased, they were more likely to report a preference for face-to-face recruitment methods compared to those using digital technologies. Findings from the focus groups indicated this was primarily due to a fear of technology and physical limitations associated with a patient's condition. Patients also reported a preference for making a decision about signing up at a later date, which was attributed to patients feeling distracted whilst in the waiting room due to anxieties related to their upcoming appointment.
    Conclusions: Many patients with musculoskeletal conditions in the UK may be interested in learning about opportunities to participate in research whilst using digital technologies within the waiting room. The results suggest the need for choice regarding the presentation and format of information and whether it can be accessed at a later date at home.
    Language English
    Publishing date 2018-01-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2819396-9
    ISSN 2055-2076
    ISSN 2055-2076
    DOI 10.1177/2055207617751304
    Database MEDical Literature Analysis and Retrieval System OnLINE

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