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ObjectivesTo identify and thematically analyse how healthcare professionals (HCPs) integrate patient values and preferences (‘values integration’) in primary care for adults with non-communicable diseases (NCDs).DesignSystematic review and meta-aggregation methods were used for extraction, synthesis and analysis of qualitative evidence.Data sourcesRelevant records were sourced using keywords to search 12 databases (ASSIA, CINAHL, DARE, EMBASE, ERIC, Google Scholar, GreyLit, Ovid-MEDLINE, PsycINFO, PubMed-MEDLINE, Scopus and Web of Science).Eligibility criteriaRecords needed to be published between 2000 and 2020 and report qualitative methods and findings in English involving HCP participants regarding primary care for adult patients.Data extraction and synthesisRelevant data including participant quotations, authors’ observations, interpretations and conclusions were extracted, synthesised and analysed in a phased approach using a modified version of the Joanna Briggs Institute (JBI) Data Extraction Tool, as well as EPPI Reviewer and NVivo software. The JBI Critical Appraisal Checklist for Qualitative Research was used to assess methodological quality of included records.ResultsThirty-one records involving >1032 HCP participants and 1823 HCP-patient encounters were reviewed. Findings included 143 approaches to values integration in clinical care, thematically analysed and synthesised into four themes: (1) approaches of concern; (2) approaches of competence; (3) approaches of communication and (4) approaches of congruence. Confidence in the quality of included records was deemed high.ConclusionsHCPs incorporate patient values and preferences in healthcare through a variety of approaches including showing concern for the patient as a person, demonstrating competence at managing diseases, communicating with patients as partners and tailoring, adjusting and balancing overall care. Themes in this review provide a novel framework for understanding and addressing values integration in clinical care and provide useful insights for policymakers, educators and practitioners.PROSPERO registration numberCRD42020166002.

BackgroundThe use of telehealth steadily increases as it has become a viable modality to patient care. Early adopters attempt to use telehealth to deliver high-quality care. Patient satisfaction is a key indicator of how well the telemedicine modality met patient expectations.ObjectiveThe objective of this systematic review and narrative analysis is to explore the association of telehealth and patient satisfaction in regards to effectiveness and efficiency.MethodsBoolean expressions between keywords created a complex search string. Variations of this string were used in Cumulative Index of Nursing and Allied Health Literature and MEDLINE.Results2193 articles were filtered and assessed for suitability (n=44). Factors relating to effectiveness and efficiency were identified using consensus. The factors listed most often were improved outcomes (20%), preferred modality (10%), ease of use (9%), low cost 8%), improved communication (8%) and decreased travel time (7%), which in total accounted for 61% of occurrences.ConclusionThis review identified a variety of factors of association between telehealth and patient satisfaction. Knowledge of these factors could help implementers to match interventions as solutions to specific problems.

ObjectiveContinuity of care is a long-standing feature of healthcare, especially of general practice. It is associated with increased patient satisfaction, increased take-up of health promotion, greater adherence to medical advice and decreased use of hospital services. This review aims to examine whether there is a relationship between the receipt of continuity of doctor care and mortality.DesignSystematic review without meta-analysis.Data sourcesMEDLINE, Embase and the Web of Science, from 1996 to 2017.Eligibility criteria for selecting studiesPeer-reviewed primary research articles, published in English which reported measured continuity of care received by patients from any kind of doctor, in any setting, in any country, related to measured mortality of those patients.ResultsOf the 726 articles identified in searches, 22 fulfilled the eligibility criteria. The studies were all cohort or cross-sectional and most adjusted for multiple potential confounding factors. These studies came from nine countries with very different cultures and health systems. We found such heterogeneity of continuity and mortality measurement methods and time frames that it was not possible to combine the results of studies. However, 18 (81.8%) high-quality studies reported statistically significant reductions in mortality, with increased continuity of care. 16 of these were with all-cause mortality. Three others showed no association and one demonstrated mixed results. These significant protective effects occurred with both generalist and specialist doctors.ConclusionsThis first systematic review reveals that increased continuity of care by doctors is associated with lower mortality rates. Although all the evidence is observational, patients across cultural boundaries appear to benefit from continuity of care with both generalist and specialist doctors. Many of these articles called for continuity to be given a higher priority in healthcare planning. Despite substantial, successive, technical advances in medicine, interpersonal factors remain important.PROSPERO registration numberCRD42016042091.

BackgroundDespite anatomical correction, people born with oesophageal atresia±tracheoesophageal fistula (OA-TOF) experience lifelong morbidity. Core outcome sets (COSs) are recognised as a means of improving research quality and, as a consequence, improving patient outcomes; one was not available for this population.ObjectiveThe scope of the study was to develop a COS for people born with OA-TOF that would be applicable regardless of age or geographic location.Study designPatient input was paramount to this study. For long-list generation, in addition to the systematic review (SR), patients and representatives were invited to participate in focus groups, interviews or complete activity packs to ascertain outcomes that matter most to them. International consensus was then sought using a two-step Delphi survey followed by an online consensus meeting.ResultsEight outcomes were identified through patient events that had not been picked up from SR. 175 people completed the Delphi survey from 26 countries and health care professionals from 13 different disciplines. 24 outcomes met predefined criteria for inclusion and following discussion and voting in the consensus meeting, and 14/24 outcomes were agreed for inclusion in the COS.Conclusion14 outcomes have been agreed on to form the COS. 12 of these outcomes are relevant to people of all ages, 1 to paediatric population and 1 to adult cohorts. The COS is, therefore, truly applicable lifelong, which was the scope of the project. This COS will help reduce research heterogeneity, enabling better quality research outcomes and more comparable data.

ObjectiveTo review biomarker discovery studies using omics data for patient stratification which led to clinically validated FDA-cleared tests or laboratory developed tests, in order to identify common characteristics and derive recommendations for future biomarker projects.DesignScoping review.MethodsWe searched PubMed, EMBASE and Web of Science to obtain a comprehensive list of articles from the biomedical literature published between January 2000 and July 2021, describing clinically validated biomarker signatures for patient stratification, derived using statistical learning approaches. All documents were screened to retain only peer-reviewed research articles, review articles or opinion articles, covering supervised and unsupervised machine learning applications for omics-based patient stratification. Two reviewers independently confirmed the eligibility. Disagreements were solved by consensus. We focused the final analysis on omics-based biomarkers which achieved the highest level of validation, that is, clinical approval of the developed molecular signature as a laboratory developed test or FDA approved tests.ResultsOverall, 352 articles fulfilled the eligibility criteria. The analysis of validated biomarker signatures identified multiple common methodological and practical features that may explain the successful test development and guide future biomarker projects. These include study design choices to ensure sufficient statistical power for model building and external testing, suitable combinations of non-targeted and targeted measurement technologies, the integration of prior biological knowledge, strict filtering and inclusion/exclusion criteria, and the adequacy of statistical and machine learning methods for discovery and validation.ConclusionsWhile most clinically validated biomarker models derived from omics data have been developed for personalised oncology, first applications for non-cancer diseases show the potential of multivariate omics biomarker design for other complex disorders. Distinctive characteristics of prior success stories, such as early filtering and robust discovery approaches, continuous improvements in assay design and experimental measurement technology, and rigorous multicohort validation approaches, enable the derivation of specific recommendations for future studies.

ObjectivesExplore how patient-reported experience measures (PREMs) are collected, communicated and used to inform quality improvement (QI) across healthcare settings.DesignSystematic review.SettingVarious primary and secondary care settings, including general practice, and acute and chronic care hospitals.ParticipantsA full range of patient populations from (children through to the elderly) and staff (from healthcare practitioners to senior managers).MethodsScientific databases were searched (CINAHL, PsycINFO, MEDLINE and Cochrane Libraries) as was grey literature. Qualitative and quantitative studies describing collection of PREM data and subsequent QI actions in any healthcare setting were included. Risk of bias was assessed using established criteria. Of 5312 initial hits, 32 full texts were screened, and 11 were included.ResultsPatient experience data were most commonly collected through surveys and used to identify small areas of incremental change to services that do not require a change to clinician behaviour (eg, changes to admission processes and producing educational materials). While staff in most studies reported having made effective improvements, authors struggled to identify what those changes were or the impact they had.ConclusionsFindings suggest there is no single best way to collect or use PREM data for QI, but they do suggest some key points to consider when planning such an approach. For instance, formal training is recommended, as a lack of expertise in QI and confidence in interpreting patient experience data effectively may continue to be a barrier to a successful shift towards a more patient-centred healthcare service. In the context of QI, more attention is required on how patient experience data will be used to inform changes to practice and, in turn, measure any impact these changes may have on patient experience.

IntroductionDuctal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials).Methods and analysisCOMET is a phase III, randomised controlled clinical trial for patients with low-risk DCIS. The primary outcome is ipsilateral invasive breast cancer rate in women undergoing GCC compared with AS. Secondary objectives will be to compare surgical, oncological and patient-reported outcomes. Patients randomised to the GCC group will undergo surgery as well as radiotherapy when appropriate; those in the AS group will be monitored closely with surgery only on identification of invasive breast cancer. Patients in both the GCC and AS groups will have the option of endocrine therapy. The total planned accrual goal is 1200 patients.Ethics and disseminationThe COMET trial will be subject to biannual formal review at the Alliance Foundation Data Safety Monitoring Board meetings. Interim analyses for futility/safety will be completed annually, with reporting following Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.Trial registration numberNCT02926911; Pre-results.

ObjectiveTo evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.DesignSystematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses.Data sourcesPubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.MethodsA double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study.ResultsOf the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy.ConclusionsAll medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.

ObjectivesThis study aimed to (1) gauge patients understanding and expectations of real-world data and evidence (RWDE) research and (2) use this understanding and patients lived experience to co-create resources and a framework for embedding meaningful patient and public involvement and engagement (PPIE) in RWDE research within the pharmaceutical industry setting.Setting and participantsAn academic organisation, a pharmaceutical company and a PPIE panel of 12 patients or carers partnered to form the project team. The PPIE panel was purposively selected to maximise diversity.DesignParticipatory and co-design methods were used to engender an understanding of the PPIE perspective on RWDE research and the PPIE role within that. Interactive workshops explored understanding and expectations of RWDE research as well as perceived barriers and facilitators of PPIE within each stage of the RWDE research cycle. Workshops were audio and video recorded, with notes captured. Summaries were analysed thematically and shared back with the PPIE panel for validation and further reflection.ResultsWe identified a lack of trust and understanding of real-world data, its collection and use and the need to educate the public and researchers. Four themes were identified for meaningful PPIE in RWDE research; equality, diversity and inclusion; feeling valued; ownership and understanding and evaluating impact. We co-created learning resources (video, infographic) and a novel PPIE framework, incorporating potential PPIE activities, resources and support needs for use by researchers conducting RWDE research.ConclusionsTo our knowledge, this is the first project to explore the practicalities of PPIE in RWDE research from the perspective of patients and carers. Some findings confirm PPIE experience and guidance derived from other areas, with some specific insights into the pharmaceutical industry. These underpin the PPIE framework to enable robust and meaningful PPIE in RWDE research. This article includes a plain language summary in the supplement.

ObjectivesTo identify studies of existing instruments available for clinicians to record overall patient preferences and priorities for care, suitable for use in routine primary care practice in patients with multimorbidity. To examine the data for all identified tools with respect to validity, acceptability and effect on health outcomes.DesignSystematic Review.Data sourcesMEDLINE, EMBASE and Cochrane databases, each with a predefined search strategy.Eligibility criteriaCitations were included if they reported a tool used to record patient priorities or preferences for treatment, and quantitative or qualitative results following administration of the tool.ResultsOur search identified 189 potential studies of which 6 original studies and 2 discussion papers were included after screening for relevance. 5 of 6 studies (83%) were of cross-sectional design and of moderate quality. All studies reported on the usability of a tool in order to elicit patient preferences. No studies reported on changes to patient-specific healthcare outcomes as a consequence of recording preferences and priorities. 1 of 6 studies reported on eliciting patient preference in the context of multimorbidity. No studies incorporated patient preferences into an electronic medical record.ConclusionsGiven the importance of eliciting patient priorities and preferences in providing patient-centred care in the context of multimorbidity and polypharmacy, we found surprisingly few relevant tools. Some aspects of the tools used for single-disease contexts may also be useful in the context of multimorbidity. There is an urgent need to develop ways to make patient priorities explicitly visible in the clinical record and medical decision-making and to test the effect on patient-relevant outcomes.