Rehabilitation of persistent poor hand function after trauma: A systematic review of randomised controlled trials.

Patient-reported outcome measures (PROMs), including patient-reported outcomes (PROs), are one of two primary sources of data about patients on dialysis ([1][1]); the other is biologically based patient data. The Food and Drug Administration definition of a PRO is “any report coming from patients

BackgroundDespite the increasing use of patient-reported outcome measures (PROMs) for collecting self-reported data among hospital outpatients, clinicians’ use of these data remains suboptimal. Insight into this issue and strategies to enhance the use of PROMs are critical but limited.ObjectiveThis study aimed to examine clinicians’ use of PROM data for value-based outpatient consultations and identify efforts to enhance their use of PROMs in a Dutch university hospital. First, we aimed to investigate clinicians’ use of outpatients’ PROM data in 2023, focusing on adoption, implementation, and maintenance. Second, we aimed to develop insights into the organizational-level strategies implemented to enhance clinicians’ use of PROM data from 2020 to 2023. This included understanding the underlying rationales for these strategies and identifying strategies that appeared to be missing to address barriers or leverage facilitators. Third, we aimed to explore the key factors driving and constraining clinicians’ use of PROMs in 2023.MethodsWe integrated data from 4 sources: 1-year performance data on clinicians’ use of PROMs (n=70 subdepartments), internal hospital documents from a central support team (n=56), a survey among clinicians (n=47), and interviews with individuals contributing to the organizational-level implementation of PROMs (n=20). The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework was used to analyze clinicians’ adoption, implementation, and maintenance of PROMs. Strategies were analyzed using the Expert Recommendations for Implementing Change taxonomy, and results were structured around the constructs of capability, opportunity, and motivation.ResultsOn average, around 2023, clinicians accessed PROM data for approximately 3 of 20 (14%) patients during their outpatient consultation, despite numerous strategies to improve this practice. We identified issues in adoption, implementation, and maintenance. The hospital’s strategies, shaped organically and pragmatically, were related to 27 (37%) out of 73 Expert Recommendations for Implementing Change strategies. These strategies focused on enhancing clinicians’ capability, opportunity, and motivation. We found shortcomings in the quality of execution and completeness of strategies in relation to addressing all barriers and leveraging facilitators. We identified variations in the factors influencing the use of PROMs among frequent PROM users, occasional users, and nonusers. Challenges to effective facilitation were apparent, with certain desired strategies being unfeasible or impeded.ConclusionsEnhancing clinicians’ use of PROMs has remained challenging despite various strategies aimed at improving their capability, opportunity, and motivation. The use of PROMs may require more substantial changes than initially expected, necessitating a shift in clinicians’ professional attitudes and practices. Hospitals can facilitate rather than manage clinicians’ genuine use of PROMs. They must prioritize efforts to engage clinicians with PROMs for value-based outpatient care. Specific attention to their professionalization may be warranted. Tailored strategies, designed to address within-group differences in clinicians’ needs and motivation, hold promise for future efforts.

Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

BackgroundPersons with high-grade glioma face both neurological and cancer-related symptoms from the tumor itself and its treatment affecting their daily lives. Survival alone is not an adequate outcome, the quality of the survivorship experience needs to be regarded with equal importance. Patient-reported outcome (PRO) measures can be used to evaluate treatment effects and symptom management interventions.PurposeThe aim of this review was to identify the use, challenges, and potential of PRO measures in survivors of high-grade glioma.MethodsA narrative expert opinion review was performed on the subject. In addition to our own experiences we searched PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, and PsycINFO for brain tumor-specific PRO measures used in the population of adult patients with high-grade glioma, both original articles and reviews were included.ResultsThere are several PRO measures that have been validated for patients with primary brain tumors including high-grade glioma. PRO measures are used both in clinical trials to evaluate the effect of treatment on health-related quality of life, and in daily clinical practice for holistic needs assessment and symptom management. Common PRO measures used for patients with high-grade glioma are European Organization for Research and Treatment of Cancer general instrument for patients with cancer together with brain tumor module, Functional Assessment of Cancer Therapy-Brain, and MD Anderson Symptom Inventory for Brain Tumor. Neurologic and cognitive disorders often occur in patients with high-grade glioma, which affects patients’ ability to self-report over time, making it more challenging in this population. PRO as a primary outcome seems underutilized.ConclusionFor clinical research, PRO measures need to be used together with other clinical outcome measures rather than replacing traditional outcome measures. Moving to more use of PRO measures in survivorship care has potential to improve patient-caregiver-healthcare team communication, symptom management, and quality of care. Implementing PROs in survivorship care should also involve caregivers and a response based on the results.

Health-related quality of life (HRQoL) impacts of thrombotic thrombocytopenic purpura (TTP) have been captured in clinical studies using patient-reported outcome (PRO) measures (PROMs) that are validated for other diseases. However, the validity evidence to support the use of existing PROMs in patients with TTP is unknown. In a systematic review of the literature, including studies of adults and children with TTP, we assessed the validity evidence for use of PROMs in clinical research and clinical practice, characterized HRQoL, described the integration of PROMs in clinical practice and evaluated PRO scores for patients with TTP compared with reference populations. From an initial 4518 studies, we identified 14 studies using 16 PROMs to assess general HRQoL domains in patients in remission. No identified studies assessed the validity of PROMs for the context of use of TTP and no studies described PROM integration into TTP clinical practice or evaluated PROMs that were specific for patients with TTP. Moreover, PRO scores were worse in patients with TTP compared with reference populations and other chronic conditions. We conclude that, in patients with TTP, PROMs pick up on important patient experiences not captured by clinical outcomes at present. There is, therefore, a need for studies that assess the validity of existing PROMs in patients with TTP to determine if TTP-specific PROMs specific to patients with TTP should be developed.

Purpose: We aimed to map the physiotherapy practice in Sweden of clinical tests and patient-reported outcome measures in low-back pain (LBP), and to study advantages and barriers in using patient-reported outcome measures.Methods: An online survey was mailed to 4934 physiotherapists in primary health care in Sweden. Multiple choice questions investigated the use of clinical tests and patient-reported outcome measures in assessing patients with LBP. Open questions investigating the advantages and barriers to the use of patient-reported outcome measures were analyzed with content analysis.Results: The response rate was 25% (n = 1217). Clinical tests were used “always/often” by >60% of the participants, while most patient-reported outcome measures were used by <15%. Advantages in using patient-reported outcome measures were: the clinical reasoning process, to increase the quality of assessment, to get the patient’s voice, education and motivation of patients, and communication with health professionals. Barriers were lack of time and knowledge, administrative aspects, the interaction between physiotherapist and patient and, the applicability and validity of the patient-reported outcome measures.Conclusion: Our findings show that physiotherapists working in primary health care use clinical testing in LBP to a great extent, while various patient-reported outcome measures are used to a low-to-very-low extent. Several barriers to the use of patient-reported outcome measures were reported such as time, knowledge, and administrative issues, while important findings on advantages were to enhance the clinical reasoning process and to educate and motivate the patient. Barriers might be changed through education or organizational change-work. To enhance the use of patient-reported outcome measures and thus person-centered care in low-back pain, recommendation, and education on various patient-reported outcome measures need to be advocated.Implications for rehabilitationTo increase the effects of rehabilitation in low-back pain, yellow flags, and other factors need to be taken into the consideration in the assessment which means the use of patient-reported outcome measures in addition to clinical testing.The use of patient-reported outcome measures is an advantage in the clinical reasoning process to enhance the quality of assessment and to educate and motivate the patient.Barriers to use patient-reported outcome measures are mainly lack of time and knowledge, and administrative aspects.Through education or organizational change-work, barriers to the use of patient-reported outcome measures might be changed.

Quality of Life for Patients Diagnosed with Diabetic Foot

BackgroundKidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients’ health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization.MethodsThe EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist.DiscussionWhile using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems.Trial registrationProtocol version (1.0) and trial registration data are available on www.clinicaltrials.gov, identifier: NCT03535922, registered May 24, 2018.

Hand function assessment heavily relies on specific task scenarios, making it challenging to ensure validity and reliability. In addition, the wide range of assessment tools, limited and expensive data recording, and analysis systems further aggravate the issue. However, smartphones provide a promising opportunity to address these challenges. Thus, the built-in, high-efficiency sensors in smartphones can be used as effective tools for hand function assessment. This review aims to evaluate existing studies on hand function evaluation using smartphones. An information specialist searched 8 databases on June 8, 2023. The search criteria included two major concepts: (1) smartphone or mobile phone or mHealth and (2) hand function or function assessment. Searches were limited to human studies in the English language and excluded conference proceedings and trial register records. Two reviewers independently screened all studies, with a third reviewer involved in resolving discrepancies. The included studies were rated according to the Mixed Methods Appraisal Tool. One reviewer extracted data on publication, demographics, hand function types, sensors used for hand function assessment, and statistical or machine learning (ML) methods. Accuracy was checked by another reviewer. The data were synthesized and tabulated based on each of the research questions. In total, 46 studies were included. Overall, 11 types of hand dysfunction-related problems were identified, such as Parkinson disease, wrist injury, stroke, and hand injury, and 6 types of hand dysfunctions were found, namely an abnormal range of motion, tremors, bradykinesia, the decline of fine motor skills, hypokinesia, and nonspecific dysfunction related to hand arthritis. Among all built-in smartphone sensors, the accelerometer was the most used, followed by the smartphone camera. Most studies used statistical methods for data processing, whereas ML algorithms were applied for disease detection, disease severity evaluation, disease prediction, and feature aggregation. This systematic review highlights the potential of smartphone-based hand function assessment. The review suggests that a smartphone is a promising tool for hand function evaluation. ML is a conducive method to classify levels of hand dysfunction. Future research could (1) explore a gold standard for smartphone-based hand function assessment and (2) take advantage of smartphones' multiple built-in sensors to assess hand function comprehensively, focus on developing ML methods for processing collected smartphone data, and focus on real-time assessment during rehabilitation training. The limitations of the research are 2-fold. First, the nascent nature of smartphone-based hand function assessment led to limited relevant literature, affecting the evidence's completeness and comprehensiveness. This can hinder supporting viewpoints and drawing conclusions. Second, literature quality varies due to the exploratory nature of the topic, with potential inconsistencies and a lack of high-quality reference studies and meta-analyses.

The Role of Patient-reported Outcomes and Medication Adherence Assessment in Patient-focused Drug Development for Solid Organ Transplantation.

BackgroundWith the rise of digital health technologies and telemedicine, the need for evidence-based evaluation is growing. Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are recommended as an essential part of the evaluation of telemedicine. For the first time, a systematic review has been conducted to investigate the use of PROMs and PREMs in the evaluation studies of telemedicine covering all application types and medical purposes.ObjectiveThis study investigates the following research questions: in which scenarios are PROMs and PREMs collected for evaluation purposes, which PROM and PREM outcome domains have been covered and how often, which outcome measurement instruments have been used and how often, does the selection and quantity of PROMs and PREMs differ between study types and application types, and has the use of PROMs and PREMs changed over time.MethodsWe conducted a systematic literature search of the MEDLINE and Embase databases and included studies published from inception until April 2, 2020. We included studies evaluating telemedicine with patients as the main users; these studies reported PROMs and PREMs within randomized controlled trials, controlled trials, noncontrolled trials, and feasibility trials in English and German.ResultsOf the identified 2671 studies, 303 (11.34%) were included; of the 303 studies, 67 (22.1%) were feasibility studies, 70 (23.1%) were noncontrolled trials, 20 (6.6%) were controlled trials, and 146 (48.2%) were randomized controlled trials. Health-related quality of life (n=310; mean 1.02, SD 1.05), emotional function (n=244; mean 0.81, SD 1.18), and adherence (n=103; mean 0.34, SD 0.53) were the most frequently assessed outcome domains. Self-developed PROMs were used in 21.4% (65/303) of the studies, and self-developed PREMs were used in 22.3% (68/303). PROMs (n=884) were assessed more frequently than PREMs (n=234). As the evidence level of the studies increased, the number of PROMs also increased (τ=−0.45), and the number of PREMs decreased (τ=0.35). Since 2000, not only has the number of studies using PROMs and PREMs increased, but the level of evidence and the number of outcome measurement instruments used have also increased, with the number of PREMs permanently remaining at a lower level.ConclusionsThere have been increasingly more studies, particularly high-evidence studies, which use PROMs and PREMs to evaluate telemedicine. PROMs have been used more frequently than PREMs. With the increasing maturity stage of telemedicine applications and higher evidence level, the use of PROMs increased in line with the recommendations of evaluation guidelines. Health-related quality of life and emotional function were measured in almost all the studies. Simultaneously, health literacy as a precondition for using the application adequately, alongside proper training and guidance, has rarely been reported. Further efforts should be pursued to standardize PROM and PREM collection in evaluation studies of telemedicine.

Headache disorders determine relevant personal and societal burden, and thus the use of patient-reported outcome measures (PROMs) investigating the level of disability and health-related quality of life (HRQoL) have been increasingly used in headache research. The aim of this review was to address the status of research on disability and HRQoL, by addressing results from recently published clinical trials as well as in longitudinal observational studies on headache patients. PubMed has been searched for papers in which measures of HRQoL and/or disability were used as primary or secondary outcome on adult subjects with primary headache, and published in 2010-2012. Among the 70 records retrieved, 12 papers were selected for narrative synthesis. They included data on 2,621 patients with episodic migraine with and without aura, chronic daily headache, and/or chronic migraine with and without medication overuse. The selected trials investigated the efficacy of different pharmacological prophylaxis, of some surgical approaches, of education programmes and osteopathic manipulative treatment; two studies reported longitudinal observations of patients currently under treatment. Overall, the results of our review showed that headache frequency as well as HRQoL and disability were positively impacted by treatment interventions; positive outcomes were less evident in two studies, and similar results were found in the two observational studies. Our findings confirmed that the most commonly used PROMs, including disease-specific tools to assess disability and HRQoL and SF-36, are sensitive to the beneficial effects occurring over time in functioning and quality of life domains in headache patients. They also suggest that the personal and societal costs of headache disorders are likely to be reduced when headache patients receive appropriate treatments and when continuity of care is offered. In terms of future directions, we note that the systematic use of appropriate PROMs should be encouraged both in the clinical practice and in the research field, as they offer a valid option to assess the global effect of treatments on patient-perceived sense of well-being and quality of performance.

Different patient-reported outcome (PRO) measures have been used and validated in studies of patients with heart failure (HF), including disease-specific measures like the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ). However, there is limited research available regarding the content validity (i.e., comprehensiveness, relevance, and comprehensibility) of those measures specifically as it relates to patients with acute HF (AHF). This study used a stepwise approach to identify PRO measures used in AHF studies and evaluate their content validity through a landscape analysis, concept mapping, and cognitive debriefing (CD) interviews with US-based patients. A landscape analysis was performed to identify PRO measures used in AHF studies. To assess concept coverage, items in each PRO measure were mapped to concepts (i.e., signs/symptoms and impacts on daily life) from the AHF conceptual model developed by Moshkovich et al. (2020). PRO measures with the most comprehensive and/or appropriate concept coverage were further evaluated through CD interviews with US adults who had been hospitalized for AHF within the last six months. The landscape analysis resulted in the identification of 15 PRO measures for use in AHF; nine were deemed appropriate for concept mapping. Following mapping, four measures were selected for further research based on their comprehensive concept coverage (KCCQ, PROMIS®+HF-27), effectiveness at measuring health utility (EQ-5D-5L), and suitability for measuring shortness of breath (a dyspnea numeric rating scale [NRS]). The KCCQ, in particular, showed good concept coverage, addressing more than half (n=12) of the key concepts in the Moshkovich et al. (2020) model. Twenty adults with AHF, representing NYHA classes I (n=4), II (n=8), and III (n=8), a mean age of 64 years (range: 39-81), and an average of 110 days since hospitalization (range: 26-183), participated in CD interviews. Participants found each measure easy to understand and answer, with items relevant to their experience of AHF. Participants found the recall periods, ranging from 24-hours to 2-weeks, appropriate and easy to use. This study’s stepwise approach allowed for the systematic identification and evaluation of the content validity of four PRO measures—the KCCQ, dyspnea NRS, EQ-5D-5L, and PROMIS®+HF-27—for use with adults with AHF. This research fills a gap in the current published literature regarding measures appropriate for use with adults with AHF.

Background: Patient-reported outcome measures (PROMs) are commonly used to evaluate hand function in people with rheumatoid arthritis (RA). A decision will always need to be made about which appropriate PROMs to use. The present review therefore aims to describe the available hand function PROMs for use in people with RA by appraising their methodological quality and psychometric properties using a contemporaneous method.Methods/design: The proposed systematic review will include published studies written in English, which report evidence for psychometric properties and/or practical properties of hand function PROMs in RA. Four major databases (MEDLINE, Embase, PsycINFO, and CINAHL) will be searched from inception to May 2019. A three-staged search strategy will be applied: (1) electronic bibliographic databases for published studies, (2) ‘named measures’ searching approach, and (3) reference lists of studies with included PROMs. The proposed systematic review will be conducted in compliance with the consensus-based standards for the selection of health measurement instruments (COSMIN) guideline for systematic review of PROMs. Accordingly, the methodological quality of the included studies will be assessed against the updated COSMIN risk of bias checklist, and each study’s results will be assessed for their psychometric quality.Conclusion: The proposed systematic review seeks to provide rigour, and transparent evaluation of PROMs used to evaluate hand function in the RA population. The findings will provide clarity for healthcare professionals and researchers on the appropriate PROMs for hand function assessment. It will also provide a summary of hand function PROM recommendations for RA.

Routine outcome monitoring of common mental health disorders (CMHDs), using patient reported outcome measures (PROMs), has been promoted across primary care, psychological therapy and multidisciplinary mental health care settings, but is likely to be costly, given the high prevalence of CMHDs. There has been no systematic review of the use of PROMs in routine outcome monitoring of CMHDs across these three settings. To assess the effects of routine measurement and feedback of the results of PROMs during the management of CMHDs in 1) improving the outcome of CMHDs; and 2) in changing the management of CMHDs. We searched the Cochrane Depression Anxiety and Neurosis group specialised controlled trials register (CCDANCTR-Studies and CCDANCTR-References), the Oxford University PROMS Bibliography (2002-5), Ovid PsycINFO, Web of Science, The Cochrane Library, and International trial registries, initially to 30 May 2014, and updated to 18 May 2015. We selected cluster and individually randomised controlled trials (RCTs) including participants with CMHDs aged 18 years and over, in which the results of PROMs were fed back to treating clinicians, or both clinicians and patients. We excluded RCTs in child and adolescent treatment settings, and those in which more than 10% of participants had diagnoses of eating disorders, psychoses, substance use disorders, learning disorders or dementia. At least two authors independently identified eligible trials, assessed trial quality, and extracted data. We conducted meta-analysis across studies, pooling outcome measures which were sufficiently similar to each other to justify pooling. We included 17 studies involving 8787 participants: nine in multidisciplinary mental health care, six in psychological therapy settings, and two in primary care. Pooling of outcome data to provide a summary estimate of effect across studies was possible only for those studies using the compound Outcome Questionnaire (OQ-45) or Outcome Rating System (ORS) PROMs, which were all conducted in multidisciplinary mental health care or psychological therapy settings, because both primary care studies identified used single symptom outcome measures, which were not directly comparable to the OQ-45 or ORS.Meta-analysis of 12 studies including 3696 participants using these PROMs found no evidence of a difference in outcome in terms of symptoms, between feedback and no-feedback groups (standardised mean difference (SMD) -0.07, 95% confidence interval (CI) -0.16 to 0.01; P value = 0.10). The evidence for this comparison was graded as low quality however, as all included studies were considered at high risk of bias, in most cases due to inadequate blinding of assessors and significant attrition at follow-up.Quality of life was reported in only two studies, social functioning in one, and costs in none. Information on adverse events (thoughts of self-harm or suicide) was collected in one study, but differences between arms were not reported.It was not possible to pool data on changes in drug treatment or referrals as only two studies reported these. Meta-analysis of seven studies including 2608 participants found no evidence of a difference in management of CMHDs between feedback and no-feedback groups, in terms of the number of treatment sessions received (mean difference (MD) -0.02 sessions, 95% CI -0.42 to 0.39; P value = 0.93). However, the evidence for this comparison was also graded as low quality. We found insufficient evidence to support the use of routine outcome monitoring using PROMs in the treatment of CMHDs, in terms of improving patient outcomes or in improving management. The findings are subject to considerable uncertainty however, due to the high risk of bias in the large majority of trials meeting the inclusion criteria, which means further research is very likely to have an important impact on the estimate of effect and is likely to change the estimate. More research of better quality is therefore required, particularly in primary care where most CMHDs are treated.Future research should address issues of blinding of assessors and attrition, and measure a range of relevant symptom outcomes, as well as possible harmful effects of monitoring, health-related quality of life, social functioning, and costs. Studies should include people treated with drugs as well as psychological therapies, and should follow them up for longer than six months.