Outcomes and outcome measures reported in clinical studies of therapeutic mammaplasty: a systematic review protocol.
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ABSTRACT: Introduction
Therapeutic 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 analysis
A 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 dissemination
This 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 number
CRD42020200365.
SUBMITTER: Lee A
PROVIDER: S-EPMC8211071 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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:BACKGROUND:Patients with cystic fibrosis (CF) can struggle with burdensome symptoms and treatment regimens that negatively affect every aspect of their life. As physiological parameters can fail to capture these complications, the assessment of health-related quality of life (HRQOL) has gained prominence. HRQOL can be measured using standardized patient questionnaires called patient-reported outcome measures (PROMs). The Australian Cystic Fibrosis Data Registry (ACFDR) collects clinical data on adult and pediatric patients with CF. The incorporation of PROMs into the ACFDR would enable monitoring of HRQOL trends, benchmarking of HRQOL outcomes, and support of HRQOL research in CF. OBJECTIVE:Prior to incorporation of a PROM in the ACFDR, this systematic review was planned to evaluate whether any suitable PROMs are currently being used for CF. METHODS:This systematic review will be conducted in compliance with the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. MEDLINE, EMBASE, Scopus, CINAHL (Cumulative Index of Nursing and Allied Health Literature), PsycINFO, and Cochrane Library databases were searched for articles published between January 2009 and February 2019 on the use of PROMs to measure HRQOL in adult and pediatric patients with CF. Study designs such as observational studies, reviews and validation studies were included. Studies describing randomized controlled trials, dissertations, books, guideline statements, and abstracts were excluded. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) risk of bias checklist was used to assess the methodological quality of included studies. A descriptive synthesis of the results will be undertaken in line with the outcomes of this study. RESULTS:As of July 2019, the search has been conducted and 4530 records were screened. After two phases of screening, 97 studies were included in the final review and subjected to data extraction. Reviewers are currently in the process of critical appraisal. CONCLUSIONS:This review will identify any PROM(s) that may be used to measure HRQOL in the ACFDR. TRIAL REGISTRATION:PROSPERO International Prospective Register of Systematic Reviews CRD42019126931; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=126931.
| S-EPMC7240448 | biostudies-literature
Project description: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.
| S-EPMC8663685 | biostudies-literature
Project description:BackgroundPatient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care.AimsTo identify suitably validated PROMs for asthma and examine their potential for use in clinical settings.MethodsWe systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs.ResultsWe identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child's caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments.ConclusionsWe identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes.
| S-EPMC4373322 | biostudies-literature
Project description:PurposeInformal caregivers provide invaluable help and support to people with cancer. As treatments extend survival and the potential burdens on carers increase, there is a need to assess the impact of the role. This systematic review identified instruments that measure the impact of caregiving, evaluated their psychometric performance specifically in cancer and appraised the content.MethodsA two-stage search strategy was employed to: (1) identify instruments that measure the impact of caregiving, and (2) run individual searches on each measure to identify publications evaluating psychometric performance in the target population. Searches were conducted in MEDLINE, EMBASE, CINAHL and PsycINFO and restricted to English for instrument used and article language. Psychometric performance was evaluated for content and construct validity, internal consistency, test-retest reliability, precision, responsiveness and acceptability. Individual scale items were extracted and systematically categorised into conceptual domains.ResultsTen papers were included reporting on the psychometric properties of eight measures. Although construct validity and internal consistency were most frequently evaluated, no study comprehensively evaluated all relevant properties. Few studies met our inclusion criteria so it was not possible to consider the psychometric performance of the measures across a group of studies. Content analysis resulted in 16 domains with 5 overarching themes: lifestyle disruption; well-being; health of the caregiver; managing the situation and relationships.ConclusionsFew measures of caregiver impact have been subject to psychometric evaluation in cancer caregivers. Those that have do not capture well changes in roles and responsibilities within the family and career, indicating the need for a new instrument.
| S-EPMC4945691 | biostudies-literature
Project description:ObjectiveDegenerative cervical myelopathy [DCM] is a disabling and increasingly prevalent group of diseases. Heterogeneous reporting of trial outcomes limits effective inter-study comparison and optimisation of treatment. This is recognised in many fields of healthcare research. The present study aims to assess the heterogeneity of outcome reporting in DCM as the premise for the development of a standardised reporting set.MethodsA systematic review of MEDLINE and EMBASE databases, registered with PROSPERO (CRD42015025497) was conducted in accordance with PRISMA guidelines. Full text articles in English, with >50 patients (prospective) or >200 patients (retrospective), reporting outcomes of DCM were eligible.Results108 studies, assessing 23,876 patients, conducted world-wide, were identified. Reported outcome themes included function (reported by 97, 90% of studies), complications (reported by 56, 52% of studies), quality of life (reported by 31, 29% of studies), pain (reported by 29, 27% of studies) and imaging (reported by 59, 55% of studies). Only 7 (6%) studies considered all of domains in a single publication. All domains showed variability in reporting.ConclusionsSignificant heterogeneity exists in the reporting of outcomes in DCM. The development of a consensus minimum dataset will facilitate future research synthesis.
| S-EPMC4970758 | biostudies-literature
Project description:AimTo identify and appraise the quality of studies that primarily assessed the measurement properties of English language versions of multidimensional patient-reported outcome measures (PROMs) when evaluated with children with neurodisability, and to summarize this evidence.MethodMEDLINE, Embase, PsycINFO, CINAHL, AMED, and the National Health Service Economic Evaluation Database were searched. The methodological quality of the papers was assessed using the COnsensus-based Standards for selection of health Measurement INstruments checklist. Evidence of content validity, construct validity, internal consistency, test-retest reliability, proxy reliability, responsiveness, and precision was extracted and judged against standardized reference criteria.ResultsWe identified 48 studies of mostly fair to good methodological quality: 37 papers for seven generic PROMs (CHIP, CHQ, CQoL, KIDSCREEN, PedsQL, SLSS, and YQOL), seven papers for two chronic-generic PROMs (DISABKIDS and Neuro-QOL), and four papers for three preference-based measures (HUI, EQ-5D-Y, and CHSCS-PS).InterpretationOn the basis of this appraisal, the DISABKIDS appears to have more supportive evidence in samples of children with neurodisability. The overall lack of evidence for responsiveness and measurement error is a concern when using these instruments to measure change, or to interpret the findings of studies in which these PROMs have been used to assess change.
| S-EPMC5031226 | biostudies-literature
Project description:BackgroundHyperhidrosis is a chronic skin condition that impairs the patient's quality of life (QoL). There are several patient-reported outcome measures (PROMs) for patients affected by hyperhidrosis available; however an evidence-based assessment of their quality has not been undertaken so far.ObjectiveIn our systematic review, we aim to identify all existing PROMs that were developed and/or validated for measuring patient-reported outcomes in patients with hyperhidrosis and assess their measurement properties in a transparent and structured way to give a recommendation for future clinical research.Methods/designOur systematic review aims to contain all PROMs developed and/or validated for patients with hyperhidrosis. We will perform a highly sensitive, systematic literature search including the databases MEDLINE (Ovid), EMBASE (Ovid), and Science Citation Index Expanded and Social Sciences Citation Index (Web of Science). Especially studies which evaluate, describe, or compare measurement properties of PROMs for patients with hyperhidrosis will be considered as eligible. Two independent reviewers will judge the eligibility of the studies found in the literature search. The study and PROM characteristics will be summarized in evidence tables. The methodological quality of each study will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Risk of Bias checklist. We will apply predefined and consensus-based quality criteria for good measurement properties. Subsequently, the quality of the evidence will be graded. Furthermore, aspects on interpretability and feasibility will be described. A final recommendation will be given.DiscussionIn our systematic review, we aim to provide a comprehensive description of the quality of all existing PROMs for patients with hyperhidrosis. The assessment of measurement properties, interpretability, and feasibility will serve as a guidance regarding the selection of PROMs for future clinical hyperhidrosis trials.Systematic review registrationPROSPERO CRD42020170247.
| S-EPMC8171028 | biostudies-literature
Project description:BackgroundThe management of diabetes is complex. There is growing recognition of the use of patient-reported outcome measures (PROMs) as a standardized method of obtaining an outlook on patients' functional status and well-being. However, no systematic reviews have summarized the studies that investigate the measurement properties of diabetes PROMs.ObjectiveOur aims were to conduct a systematic review of studies investigating the measurement properties of diabetes PROMs by evaluating the methodological quality and overall level of evidence of these PROMs and to categorize them based on the outcome measures assessed.MethodsThis study was guided by the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines. Relevant articles were retrieved from the Embase, PubMed, and PsychINFO databases. The PROMs were evaluated with the COSMIN (COnsensus-based Standards for the selection of health Measurement Instruments) guidelines.ResultsA total of 363 articles evaluating the measurement properties of PROMs for diabetes in the adult population were identified, of which 238 unique PROMs from 248 studies reported in 209 articles were validated in the type 2 diabetes population. PROMs with at least a moderate level of evidence for ≥5 of 9 measurement properties include the Chinese version of the Personal Diabetes Questionnaire (C-PDQ), Diabetes Self-Management Instrument Short Form (DSMI-20), and Insulin Treatment Appraisal Scale in Hong Kong primary care patients (C-ITAS-HK), of which the C-PDQ has a "sufficient (+)" rating for >4 measurement properties. A total of 43 PROMs meet the COSMIN guidelines for recommendation for use.ConclusionsThis study identified and synthesized evidence for the measurement properties of 238 unique PROMs for patients with type 2 diabetes and categorized the PROMs according to their outcome measures. These findings may assist clinicians and researchers in selecting appropriate high-quality PROMs for clinical practice and research.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020180978; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020180978.
| S-EPMC8398743 | biostudies-literature
Project description:IntroductionIn the UK, it is estimated that a disabling hearing loss (HL) affects 1 in 6 people. HL has functional, economic and social-emotional consequences for affected individuals. Intervention for HL focuses on improving access to the auditory signal using hearing aids or cochlear implants. However, even if sounds are audible and speech is understood, individuals with HL often report increased effort when listening.Listening effort (LE) may be measured using self-reported measures such as patient-reported outcome measures (PROMs). PROMs are validated questionnaires completed by patients to measure their perceptions of their own functional status and well-being. When selecting a PROM for use in research or clinical practice, it is necessary to appraise the evidence of a PROM's acceptability to patients, validity, responsiveness and reliability.Methods and analysisA systematic review of studies evaluating the measurement properties of PROMs available to measure LE in HL will be undertaken. MEDLINE, EMBASE, CINAHL, PsychINFO and Web of Science will be searched electronically. Reference lists of included studies, key journals and the grey literature will be hand-searched to identify further studies for inclusion. Two reviewers will independently complete title, abstract and full-text screening to determine study eligibility. Data on the characteristics of each study and each PROM will be extracted. Methodological quality of the included studies will be appraised using the COnsensus-based Standards for the selection of health Measurement INstruments, the quality of included PROMs appraised and the credibility of the evidence assessed. A narrative synthesis will summarise extracted data.Ethics and disseminationEthical permission is not required, as this study uses data from published research. Dissemination will be through publication in peer-reviewed journals, conference presentations and the lead author's doctoral dissertation. Findings may inform the selection of PROMs used to measure LE in HL.
| S-EPMC5734199 | biostudies-literature