Assessment of patient-reported outcomes after polytrauma: protocol for a systematic review.
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ABSTRACT:
SUBMITTER: Gnass I
PROVIDER: S-EPMC5857702 | biostudies-literature | 2018 Mar
REPOSITORIES: biostudies-literature
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Assessment of patient-reported outcomes after polytrauma: protocol for a systematic review.
Gnass Irmela I Ritschel Michaela M Andrich Silke S Kuske Silke S Moschinski Kai K Herrmann-Frank Annegret A Metzendorf Maria-Inti MI Flohé Sascha S Sturm Johannes J Windolf Joachim J Icks Andrea A
BMJ open 20180316 3
<h4>Introduction</h4>Survivors of polytrauma experience long-term and short-term burden that influences their lives. The patients' view of relevant short-term and long-term outcomes should be captured in instruments that measure quality of life and other patient-reported outcomes (PROs) after a polytrauma. The aim of this systematic review is to (1) collect instruments that assess PROs (quality of life, social participation and activities of daily living) during follow-up after polytrauma, (2) d ...[more]
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Project description:ObjectivesWe (1) collected instruments that assess health-related quality of life (HRQoL), activities of daily living (ADL) and social participation during follow-up after polytrauma, (2) described their use and (3) investigated other relevant patient-reported outcomes (PROs) assessed in the studies.DesignSystematic Review using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline.Data sourcesMEDLINE, Embase, CINAHL, PsycINFO, CENTRAL, as well as the trials registers ClinicalTrials.gov and WHO ICTRP were searched from January 2005 to April 2018.Eligibility criteriaAll original empirical research published in English or German including PROs of patients aged 18-75 years with an Injury Severity Score≥16 and/or an Abbreviated Injury Scale≥3. Studies with defined injuries or diseases (e.g. low-energy injuries) and some text types (e.g. grey literature and books) were excluded. Systematic reviews and meta-analyses were excluded, but references screened for appropriate studies.Data extraction and synthesisData extraction, narrative content analysis and a critical appraisal (e.g. UK National Institute for Health and Care Excellence) were performed by two reviewers independently.ResultsThe search yielded 3496 hits; 54 publications were included. Predominantly, HRQoL was assessed, with Short Form-36 Health Survey applied most frequently. ADL and (social) participation were rarely assessed. The methods most used were postal surveys and single assessments of PROs, with a follow-up period of one to one and a half years. Other relevant PRO areas reported were function, mental disorders and pain.ConclusionsThere is a large variation in the assessment of PROs after polytrauma, impairing comparability of outcomes. First efforts to standardise the collection of PROs have been initiated, but require further harmonisation between central players. Additional knowledge on rarely reported PRO areas (e.g. (social) participation, social networks) may lead to their consideration in health services provision.Prospero registration numberCRD42017060825.
| S-EPMC8679059 | biostudies-literature
Project description:The aim of this review was to summarize literature in view of patient-reported outcome (PRO) instruments for glaucoma and provide guidance on how outcomes are best assessed based on evidence about their content and validity. A systematic literature review was performed on papers describing the developmental process and/or psychometric properties of glaucoma or vision-specific PRO-instruments. Each of them was assessed on their adherence to a framework of quality criteria. Fifty-three articles were identified addressing 27 PRO-instruments. In all, 18 PRO's were developed for glaucoma and 9 for diverse ophthalmologic conditions. Seven instruments addressed functional status, 11 instruments quality of life and 9 instruments disease and treatment-related factors. Most of the instruments demonstrated only partially adherence to predefined quality standards. The tools for assessing functional status were of poor quality, while the Glaucoma Quality of Life Questionnaire and the Vision Quality of Life Index were well-developed QoL measures, yet only validated using classical techniques. The Rasch-scaled QoL-tools, IVI and VCM1 need to improve their item-content for glaucoma patients. The questionnaires to measure adherence should improve their validity and the Treatment Satisfaction Survey for Intra Ocular Pressure pops out as the highest quality tool for measuring topical treatment side effects. This review revealed that most PRO-instruments demonstrated poor developmental quality, more specifically a lack of conceptual framework and item generation strategies not involving the patients' perspective. Psychometric characteristics were mostly tested using classical validation techniques.
| S-EPMC3171264 | biostudies-other
Project description:BACKGROUND:Interprofessional collaboration (IPC) is a core demand of policymakers, funding parties, and health care professionals in practice. Although the causal mechanism from increased IPC to improved patient outcomes seems to be intuitive, there is a lack of credible causal evidence concerning the effects not only on the objective but also on the subjective patient outcomes. The aim of the planned systematic review is to focus on the effect of IPC on patient-reported outcomes and experiences in inpatient care. METHODS:A systematic literature review will be undertaken by searching the following electronic databases: PubMed, Web of Science/Social Science Citation Index, Cochrane Library (CENTRAL), Current Contents (LIVIVO), CINAHL, and EMBASE. Additional studies will be identified through forward and backward citation tracking, manually searching the Internet and Google Scholar, and consultation of experts. Data will be synthesized through narrative description, grouping, and thematic analysis of the extracted data. If heterogeneity for some studies and outcomes is sufficiently low, a quantitative meta-analysis of effect sizes and standard errors will be applied. DISCUSSION:The systematic review will synthesize the evidence regarding the effectiveness of IPC and how it is perceived by patients in inpatient care. As the patients' perspective becomes increasingly relevant in the context of quality improvement, the results can help decision-makers in policy- and health care institutions to understand and develop strategies to ensure a high quality of care. SYSTEMATIC REVIEW REGISTRATION:PROSPERO registration number: CRD42017073900 ; date of registration in PROSPERO 07 August 2017.
| S-EPMC6102939 | biostudies-literature
Project description:BackgroundRecent events in health care reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) after surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs.MethodsWe performed a search of the literature published before November 1, 2012. Articles were included in the review if (1) primary data were presented, (2) patient expectations regarding a surgical procedure were measured, (3) PROs were measured, and (4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into 5 subgroups: Satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality.ResultsFrom the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 studies (47%), and poorer PROs for 9 studies (15%). Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations.ConclusionPatient expectations are inconsistently correlated with PROs after surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policymakers seeking to integrate PROs into measures of surgical quality.
| S-EPMC4170731 | biostudies-literature
Project description:BackgroundGaucher's disease (GD), a rare condition, represents the most common lysosomal storage disorder. The cardinal manifestations of GD are fatigue, hepatosplenomegaly, anemia, thrombocytopenia, bone pain, and bone infarction, thereby culminating in a marked deterioration of patients' quality of life (QoL). Patient-reported outcomes (PROs) offer valuable insights into the impact of GD on patients' QoL and symptoms. This systematic review aimed to identify and analyze PROs and outcome measures in GD patients.MethodsWe systematically searched PubMed, Web of Science Core Collections, EMBASE, SCOPUS, Cochrane Library, PsycINFO, Wan Fang Data, China National Knowledge Infrastructure (CNKI), and the Chinese Biomedical Literature Database (CBM). The methodological quality of the included studies was assessed using a mixed methods assessment tool.ResultsA total of 33 studies were identified, encompassing 24 distinct patient-reported outcome instruments, with the most frequently employed instrument being the SF-36. The study designs included eighteen cross-sectional studies, seven pre- and post-intervention investigations, three randomized controlled trials, two cohort studies, two qualitative inquiries, and one validation study. These studies explored diverse domains such as the QoL and cardinal symptoms (e.g., fatigue, pain, bleeding, cognition, social relationships, and psychological functioning) in patients with GD. Furthermore, significant attention was directed towards the appraisal of the therapeutic benefits of various interventions in patients with GD. A novel GD-specific instrument has also been developed, which has two applied versions: a 24-item variant for routine clinical monitoring and a 17-item form for use in clinical trials.ConclusionPROs have garnered increased attention and concern in the realm of GD. Despite this progress, it is noteworthy that the instruments used to measure PROs in GD are still predominantly generic instruments. While researchers have endeavored to develop and validate a disease-specific instrument, currently the use of this instrument is limited. Owing to several challenges, including the small number of patients, heterogeneity of the disease, and cross-regional discrepancies in study findings, GD poses substantial difficulties in the measurement of QoL and development of instruments. Consequently, patients with GD require more dependable measurement instruments that accurately reflect their QoL, efficacy of treatment, and facilitate healthcare decision-making.
| S-EPMC10463869 | biostudies-literature
Project description:BackgroundEvidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.Methods and findingsWe searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.ConclusionsPRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.
| S-EPMC4198295 | biostudies-literature
Project description:BackgroundMulti-cancer early detection tests have been developed to enable earlier detection of multiple cancer types through screening. As reflected by patient-reported outcomes (PROs), the psychosocial impact of cancer screening is not yet clear. Our aim is to evaluate the impact of cancer screening through PRO assessment.MethodsA systematic review was conducted using MEDLINE, EMBASE, and reference lists of articles from January 2000 to August 2020 for relevant publications assessing the psychosocial impact of cancer screening before and within 1 year after screening in the general asymptomatic population, including following receipt of results. Studies focused on diagnostic evaluation or involving patients previously diagnosed with cancer were excluded.ResultsIn total, 31 studies (12 randomized controlled trials; 19 observational studies) were included, reflecting PRO assessments associated with lung, breast, colorectal, anal, ovarian, cervical, and prostate cancer screening procedures. The most commonly assessed construct was symptoms of anxiety, using the State-Trait Anxiety Inventory. Cancer-specific distress and worry were also assessed using a broad range of measures. Overall, individuals tolerated screening procedures well with no major psychosocial effects. Of note, increases in symptoms of anxiety and levels of distress and worry were generally found prior to communication of screening results and following communication of indeterminate or positive results that required further testing. These negative psychosocial effects were, however, not long-lasting and returned to baseline relatively soon after screening. Furthermore, individuals with higher cancer risk, such as current smokers and those with a family history of cancer, tended to have higher levels of anxiety and distress throughout the screening process, including following negative or indeterminate results.ConclusionsThe psychosocial impact of cancer screening is relatively low overall and short-lived, even following false-positive test results. Individuals with a higher risk of cancer tend to experience more symptoms of anxiety and distress during the screening process; thus, more attention to this group is recommended.
| S-EPMC8886782 | biostudies-literature
Project description:BackgroundLymphoma treatment can lead to long-term consequences such as fatigue, infertility and organ damage. In clinical trials, survival outcomes, clinical response and toxicity are extensively reported while the assessment of treatment on quality of life (QoL) and symptoms is often lacking.ObjectiveWe evaluated the use and frequency of patient-reported outcome (PRO) instruments used in randomized controlled trials (RCTs) for Hodgkin lymphoma (HL) and their consistency of reporting.MethodsMEDLINE, CENTRAL and trial registries for RCTs investigating HL were systematically searched from 01/01/2016 to 31/05/2022. Following trial selection, trial, patient characteristics and outcome data on the use of PRO measures (PROMs) and reporting of PROs using a pre-defined extraction form were extracted. To assess reporting consistency, trial registries, protocols and publications were compared.ResultsWe identified 4,222 records. Following screening, a total of 317 reports were eligible for full-text evaluation. One hundred sixty-six reports of 51 ongoing/completed trials were included, of which 41% of trials were completed and 49% were ongoing based on registry entries. Full-text or abstract were available for 33 trials. Seventy percent of trials were conducted in the newly diagnosed disease setting, the majority with advanced HL. In 32 trials with published follow-up data, the median follow-up was 5.2 years. Eighteen (35%) completed/ongoing trials had mentioned PRO assessment in registry entries, protocol or publications. Twelve trials (67%) had published results and only 6 trials (50%) reported on PROs in part with the exception of 1 trial where PROs were evaluated as secondary/exploratory outcome. The most referenced global PROM was the EORTC-QLQ-C30 (12 studies), the EQ-5D (3 studies) and the FACT-Neurotoxicity (3 studies). FACT-Lymphoma, a disease-specific PROM for non-HL was mentioned in one ongoing trial. None of the trials referenced the EORTC QLQ-HL27, another disease-specific PROM developed specifically for HL patient's QoL assessment.DiscussionsOnly one-third of RCTs in HL report PROs as an outcome and only half present the outcome in subsequent publications, showcasing the underreporting of PROs in trials. Disease-specific PROMs are underutilized in the assessment of QoL in HL patients. Guidance on the assessment of PROs is needed to inform on comprehensive outcomes important to patients.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=391552, identifier CRD42023391552.
| S-EPMC10965683 | biostudies-literature
Project description:In public health context, oncology is associated with severe negative impact on patients and on their relatives' quality of life. Over the last decades, survival has remained at 50% worldwide for some tumor locations. Patient reported outcomes (PROs) assessment and, the corresponding use in clinical practice, help establishing patient individualized profiling involving caregivers. The purpose of this systematic review was to examine critical success factors for PROs assessment in daily clinical oncology practice. Additionally, we investigated how PROs collection can change oncology perspectives for patients and caregivers. According to PRISMA guidelines, 83 studies were included in this systematic review, whether related with implementation in daily clinical practice or associated with its use in oncology. PROs assessment gathers multi-professional teams, biomedical and clinical expertise, patients, families and caregivers. Institutional involvement, first line for caregiver's adherence, team continuous formation, encompassing training and support, design of clear workflows, continuous monitoring, and data analysis are crucial for implementation. PROs measures are decisive in oncology. Several items were improved, including caregiver-patient-physician communication, patient risk groups identification, unmet problems and needs detection, disease course and treatment tracking, prognostic markers, cost-effectiveness measurement and comfort/support provision for both patients and caregivers. Routine assessment and implementation of PROs in clinical practice are a major challenge and a paradigm transformation for future.
| S-EPMC9124403 | biostudies-literature
Project description:BackgroundAtrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking.Methods and resultsWe performed a systematic review of the measurement properties of atrial fibrillation-specific health-related quality of life questionnaires. Methodological quality was assessed using the Consensus based Standards for selection of health Measurement Instruments (COSMIN) checklist, with measurement properties rated for quality against optimal criteria and levels of evidence. We screened 2,216 articles, of which eight articles describing five questionnaires were eligible for inclusion: Atrial Fibrillation 6 (AF6), Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), Atrial Fibrillation Quality of Life Questionnaire (AFQLQ), Atrial Fibrillation Quality of Life (AFQoL), and Quality of Life in Atrial Fibrillation (QLAF). Good reliability (internal consistency and test-retest reliability) was demonstrated for AF6, AFEQT, AFQLQ and AFQoL. Content, construct and criterion validity were positively rated only in AFEQT. Responsiveness was positively rated only in AFEQT, but with limited evidence. Overall, AFEQT showed strong positive evidence for 2 of 9 measurement properties, compared to one for AFQoL and none for the remaining questionnaires.InterpretationGiven the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further studies to robustly assess reliability, validity and responsiveness of AF-specific quality of life questionnaires are required. This review consolidates the current evidence for quality of life assessment in patients with atrial fibrillation and identifies priority areas for future research.
| S-EPMC5089715 | biostudies-literature