Reporting Outcomes and Outcome Measures in Digital Replantation: A Systematic Review.
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ABSTRACT:
SUBMITTER: Moltaji S
PROVIDER: S-EPMC7735551 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:There is no international consensus on the use of perioperative thromboprophylaxis in digital replantation. Suboptimal perioperative management may lead to replant failure, which compromises extremity function, worsens psychosocial outcomes for patients, and incurs significant cost. This systematic review evaluates and compares the efficacy and safety of perioperative antithrombotic protocols used in digital replantation.MethodsA Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)--compliant prospectively registered (PROSPERO, CRD42018108695) systematic review was conducted. Cochrane Central Register of Controlled Trials, Medline, EMBASE, and Scopus were searched up until December 2019. Articles were assessed for eligibility in duplicate by 2 independent reviewers. All comparative studies that examined the use of perioperative thromboprophylaxis in digital replantation were eligible for inclusion.ResultsCollectively, 1,025 studies were identified of which 7 met full inclusion criteria reporting data from 635 patients (908 digital replants, 86% men, average age 37.3 years). Laceration was the most commonly reported mechanism of injury (68%), with 33% of replantation occurring in Tamai zone III. Fourteen distinct perioperative protocols were identified. One study reported significantly higher digital survival with continuous heparin infusion versus bolus heparin. Five studies demonstrated a significantly higher incidence of complications among patients treated with systemic heparin.ConclusionsThe clinical efficacy and safety of perioperative antithrombotic therapy following digital replantation remains equivocal. The perceived benefits of improved digital survival must be tempered against the adverse systemic side effects of antithrombotic and anticoagulant therapies until further prospectively collected data sets become available.
| S-EPMC7605889 | biostudies-literature
Project description:In the early period of replantation surgery, the emphasis was on digit survival. Subsequently, with better microsurgical techniques and instrumentation, the focus has shifted to function and in recent years to consideration of cost-effectiveness. Despite over 40 years of effort in refining digital replantation surgery, a rigorous evaluation of the outcomes of digital replantation has not been performed. This is because of the many confounding variables that influence outcome comparisons. These variables include the mechanism of injury (guillotine, crush, avulsion), the injury itself (total, near total, subtotal, partial amputation), and the surgical procedure (replantation, revascularization). In addition, the traditional outcome measures (two-point discrimination, range of motion, grip strength, or the ability to return to work) are reported inconsistently and vary widely among publications. All these factors make meaningful comparison of outcomes difficult. The recent emphasis on outcome research and cost-effectiveness necessitates a rethinking in the way we report outcomes of digital replantation. In this article, the authors summarize the challenges in assessing outcomes of digital replantation and explain the need to measure outcomes using rigorous clinical research designs that incorporate cost-effectiveness studies in the research protocol.
| S-EPMC3842343 | biostudies-other
Project description:Study questionWhich outcomes and outcome measures are reported in interventional trials evaluating the treatment of adenomyosis?Summary answerWe identified 38 studies, reporting on 203 outcomes using 133 outcome measures.What is known alreadyHeterogeneity in outcome evaluation and reporting has been demonstrated for several gynaecological conditions and in fertility studies. In adenomyosis, previous systematic reviews have failed to perform a quantitative analysis for central outcomes, due to variations in outcome reporting and measuring.Study design size durationA systematic search of Embase, Medline and Cochrane Register of Controlled Trials (CENTRAL) was performed with a timeframe from 1950 until February 2021, following the preferred reporting items for systematic reviews and meta-analysis (PRISMA).Participants/materials setting methodsStudies reporting on any uterus-sparing intervention to treat adenomyosis, both prospective and retrospective, were eligible for inclusion. Inclusion criteria were a clear definition of diagnostic criteria for adenomyosis and the modality used to make the diagnosis, a clear description of the intervention, a follow-up time of ≥6 months, a study population of n ≥ 20, a follow-up rate of at least 80%, and English language. The population included premenopausal women with adenomyosis. Risk of bias was assessed using the Evidence Project risk of bias tool.Main results and the role of chanceWe included 38 studies (6 randomized controlled trials and 32 cohort studies), including 5175 participants with adenomyosis. The studies described 10 interventions and reported on 203 outcomes, including 43 classified as harms, in 29 predefined domains. Dysmenorrhoea (reported in 82%), heavy menstrual bleeding (HMB) (in 79%) and uterine volume (in 71%) were the most common outcomes. Fourteen different outcome measures were used for dysmenorrhoea and 17 for HMB. Quality of life was reported in 9 (24%) studies, patient satisfaction with treatment in 1 (3%). A clear primary outcome was stated in only 18%.Limitations reasons for cautionThis review includes studies with a high risk of bias.Wider implications of the findingsShortcomings in the definition and choice of outcomes and outcome measures limit the value of the conducted research. The development and implementation of a core outcome set (COS) for interventional studies in adenomyosis could improve research quality. This review suggests a lack of patient-centred research in adenomyosis and people with adenomyosis should be involved in the development and implementation of the COS.Study funding/competing interestsNo funds specifically for this work were received. T.T. receives fees from General Electrics for lectures on ultrasound independently of this project.Trial registration numberThis review is registered with the International Prospective Register of Systematic Reviews (PROSPERO; registration number CRD42020177466) and the Core Outcome Measures in Effectiveness Trials (COMET) initiative (registration number 1649).
| S-EPMC8398753 | biostudies-literature
Project description:Background and objectiveDigital replantation for traumatic amputation has become the standard of care with advances in microsurgical techniques and technology. While digital replantation has progressed significantly, there are still gaps in knowledge in many aspects. Some of the controversial topics in digital replantation include the indications and contraindications, anesthesia, number of vessel anastomoses, mechanism of injury, role of vein graft, distal fingertip replantation, and postoperative management. This article is a narrative review that discusses these controversies and current issues pertaining to digital replantation.MethodsPubMed, Web of Science, and Google scholar were searched using keywords relating to "digit replantation", "amputation", and "digital replant" with the following terms: "indications", "contraindications", "anaesthesia", "survival", "vessels", "mechanism of injury", "vein graft", "outcome", and "thrombophylaxis". Relevant articles pertaining to digital replantation and deemed by the authors as current or controversial were included.Key content and findingsThe reported survival rates of digital replantation are high. With the advancement of microsurgical techniques and technology, the boundaries of digital replantation continue to be pushed. Various methods have been described recently to improve the success rates of difficult replants, such as strategies for venous outflow and vein grafting. However, there are still aspects of digital replantation that remain unanswered, such as the number of veins to anastomose and the thromboprophylaxis regime.ConclusionsThe review delves into controversial aspects of digital replantation, including contraindications, anesthesia, and postoperative management. Indications and contraindications will continue to evolve alongside advancements in microsurgical techniques and anesthesia. It highlights key factors influencing survival rates, such as the number of repaired vessels and the mechanism of injury. Finally, the review consolidates strategies for managing challenging digital replantations.
| S-EPMC11304438 | biostudies-literature
Project description:Therapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated the oncological safety of TM but reporting of critically important outcomes, such as quality of life, aesthetic and functional outcomes, are limited, piecemeal or inconsistent. This systematic review aimed to identify all outcomes reported in clinical studies of TM to facilitate development of a core outcome set. Medline, EMBASE, CINAHL and Web of Science were searched from inception to 5 August 2020. Included studies reported clinical outcomes following TM for adult women. Two authors screened articles independently for eligibility. Data were extracted regarding the outcome definition and classification type (for example, oncological, quality of life, etc.), time of outcome reporting and measurement tools. Of 5709 de-duplicated records, 148 were included in the narrative synthesis. The majority of studies (n = 102, 68.9 per cent) reported measures of survival and/or recurrence; approximately three-quarters (n = 75, 73.5 per cent) had less than 5 years follow-up. Aesthetic outcome was reported in half of studies (n = 75, 50.7 per cent) using mainly subjective, non-validated measurement tools. The time point at which aesthetic assessment was conducted was highly variable, and only defined in 48 (64.0 per cent) studies and none included a preoperative baseline for comparison. Few studies reported quality of life (n = 30, 20.3 per cent), functional outcomes (n = 5, 3.4 per cent) or resource use (n = 28, 18.9 per cent). Given the oncological equivalence of TM and mastectomy, treatment decisions are often driven by aesthetic and functional outcomes, which are infrequently and inconsistently reported with non-validated measurement tools.
| S-EPMC8665419 | biostudies-literature
Project description:BackgroundThe World Health Organization claimed that measuring outcomes is necessary to understand the benefits of assistive technology (AT) and create evidence-based policies and systems to ensure universal access to it. In clinical practice, there is an increasing need for standardized methods to track AT interventions using outcome assessments.ObjectiveThis review provides an overview of the available outcome measures that can be used at the follow-up stage of any AT intervention and integrated into daily clinical or service practice.MethodsWe systematically searched for original manuscripts regarding available and used AT outcome measures by searching for titles and abstracts in the PubMed, Scopus, and Web of Science databases up to March 2023.ResultsWe analyzed 955 articles, of which 50 (5.2%) were included in the review. Within these, 53 instruments have been mentioned and used to provide an AT outcome assessment. The most widely used tool is the Quebec User Evaluation of Satisfaction with Assistive Technology, followed by the Psychosocial Impact of Assistive Technology Scale. Moreover, the identified measures addressed 8 AT outcome domains: functional efficacy, satisfaction, psychosocial impact, caregiver burden, quality of life, participation, confidence, and usability. The AT category Assistive products for activities and participation relating to personal mobility and transportation was the most involved in the reviewed articles.ConclusionsAmong the 53 cited instruments, only 17 (32%) scales were designed to evaluate specifically assistive devices. Moreover, 64% (34/53) of the instruments were only mentioned once to denote poor uniformity and concordance in the instruments to be used, limiting the possibility of comparing the results of studies. This work could represent a good guide for promoting the use of validated AT outcome measures in clinical practice that can be helpful to AT assessment teams in their everyday activities and the improvement of clinical practice.
| S-EPMC10687703 | biostudies-literature
Project description:Developing drugs for rare diseases is challenging, and the precision and objectivity of outcome measures is critical to this process. In recent years, a number of technologies have increasingly been used for remote monitoring of patient health. We report a systematic literature review that aims to summarize the current state of progress with regard to the use of digital outcome measures for real-life motor function assessment of patients with rare neurological diseases. Our search of published literature identified 3826 records, of which 139 were included across 27 different diseases. This review shows that use of digital outcome measures for motor function outside a clinical setting is feasible and employed in a broad range of diseases, although we found few outcome measures that have been robustly validated and adopted as endpoints in clinical trials. Future research should focus on validation of devices, variables, and algorithms to allow for regulatory qualification and widespread adoption.
| S-EPMC10398976 | biostudies-literature
Project description:IntroductionTherapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated oncological safety of TM, but poor and inconsistent reporting of quality-of-life, aesthetic and functional outcomes, often with non-validated measurement tools. Moreover, there is a paucity of patient-reported outcome measures. Standardisation of outcome reporting is required to enable study results to be compared and combined, for example, through core outcome set (COS) development. This systematic review aims to comprehensively describe the outcomes reported in clinical studies of TM, their respective outcome measures and the time points at which they were evaluated. The overall objective is to facilitate the development of a COS for TM.Methods and analysisA systematic review of clinical studies evaluating outcomes following TM will be completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following electronic databases have been searched from inception to 5 August 2020: Ovid MEDLINE, Embase, CINAHL and Web of Science. Primary outcomes will include the number of reported outcomes of various types (clinical, aesthetic, functional, quality-of-life and cost-effectiveness), whether these are patient-reported or clinician-reported, how outcomes are defined and the outcome measurement tool(s) used. The time point(s) at which outcomes were measured will be a secondary outcome. No studies will be excluded on the basis of methodological quality in order to generate a comprehensive list of reported outcomes and outcome measures; hence, risk of bias assessment is not required. The data will be described narratively. This protocol has been reported in line with PRISMA-Protocols.Ethics and disseminationThis study does not involve human or animal participants, hence ethical approval is not required. The findings will be published in a peer-reviewed journal and presented at relevant conferences.Prospero registration numberCRD42020200365.
| S-EPMC8211071 | biostudies-literature
Project description:BACKGROUND:The development of clinical guidelines for the surgical management of gastric cancer should be based on robust evidence from well-designed trials. Being able to reliably compare and combine the outcomes of these trials is a key factor in this process. OBJECTIVES:To examine variation in outcome reporting by surgical trials for gastric cancer and to identify outcomes for prioritisation in an international consensus study to develop a core outcome set in this field. DATA SOURCES:Systematic literature searches (Evidence Based Medicine, MEDLINE, EMBASE, CINAHL, ClinicalTrials.gov and WHO ICTRP) and a review of study protocols of randomised controlled trials, published between 1996 and 2016. INTERVENTION:Therapeutic surgical interventions for gastric cancer. Outcomes were listed verbatim, categorised into groups (outcome themes) and examined for definitions and measurement instruments. RESULTS:Of 1919 abstracts screened, 32 trials (9073 participants) were identified. A total of 749 outcomes were reported of which 96 (13%) were accompanied by an attempted definition. No single outcome was reported by all trials. 'Adverse events' was the most frequently reported 'outcome theme' in which 240 unique terms were described. 12 trials (38%) classified complications according to severity, with 5 (16%) using a formal classification system (Clavien-Dindo or Accordion scale). Of 27 trials which described 'short-term' mortality, 15 (47%) used one of five different definitions. 6 out of the 32 trials (19%) described 'patient-reported outcomes'. CONCLUSION:Reporting of outcomes in gastric cancer surgery trials is inconsistent. A consensus approach to develop a minimum set of well-defined, standardised outcomes to be used by all future trials examining therapeutic surgical interventions for gastric cancer is needed. This should consider the views of all key stakeholders, including patients.
| S-EPMC6196805 | biostudies-other
Project description:BackgroundDigital clinical measures collected via various digital sensing technologies such as smartphones, smartwatches, wearables, ingestibles, and implantables are increasingly used by individuals and clinicians to capture health outcomes or behavioral and physiological characteristics of individuals. Although academia is taking an active role in evaluating digital sensing products, academic contributions to advancing the safe, effective, ethical, and equitable use of digital clinical measures are poorly characterized.ObjectiveWe performed a systematic review to characterize the nature of academic research on digital clinical measures and to compare and contrast the types of sensors used and the sources of funding support for specific subareas of this research.MethodsWe conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles reporting US-led academic research on digital clinical measures between January 2019 and February 2021. We screened each publication against specific inclusion and exclusion criteria. We then identified and categorized research studies based on the types of academic research, sensors used, and funding sources. Finally, we compared and contrasted the funding support for these specific subareas of research and sensor types.ResultsThe search retrieved 4240 articles of interest. Following the screening, 295 articles remained for data extraction and categorization. The top five research subareas included operations research (research analysis; n=225, 76%), analytical validation (n=173, 59%), usability and utility (data visualization; n=123, 42%), verification (n=93, 32%), and clinical validation (n=83, 28%). The three most underrepresented areas of research into digital clinical measures were ethics (n=0, 0%), security (n=1, 0.5%), and data rights and governance (n=1, 0.5%). Movement and activity trackers were the most commonly studied sensor type, and physiological (mechanical) sensors were the least frequently studied. We found that government agencies are providing the most funding for research on digital clinical measures (n=192, 65%), followed by independent foundations (n=109, 37%) and industries (n=56, 19%), with the remaining 12% (n=36) of these studies completely unfunded.ConclusionsSpecific subareas of academic research related to digital clinical measures are not keeping pace with the rapid expansion and adoption of digital sensing products. An integrated and coordinated effort is required across academia, academic partners, and academic funders to establish the field of digital clinical measures as an evidence-based field worthy of our trust.
| S-EPMC8482196 | biostudies-literature