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Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).

ABSTRACT: AIM:Six Phase III randomized trials have determined the effectiveness of chemoradiotherapy as primary treatment for anal squamous cell carcinoma (ASCC), but outcomes reported in these trials varied widely, hindering evidence synthesis. To improve reporting in all future trials, we aim to develop a core outcomes set (COS). As the first stage of COS development, we undertook a systematic review to summarize the outcomes reported in studies evaluating chemoradiotherapy for ASCC. METHOD:Systematic literature searches identified studies evaluating radiotherapy or chemoradiotherapy for ASCC. Outcomes and accompanying definitions were extracted verbatim and categorized into domains. RESULTS:From 5170 abstracts, we identified 95 eligible studies, reporting 1192 outcomes and 533 unique terms. We collapsed these terms into 86 standardized outcomes and five domains: survival; disease activity; life impact [including quality of life (QoL)]; delivery of care; and toxicity. The most commonly reported domains were survival and disease activity, reported in 74 (86%) and 54 (62%) studies, respectively. No outcome was reported in every publication. Over half (43/86) of the standardized outcome terms were reported in fewer than five studies, and 21 (25%) were reported in a single study only. There was wide variation in definitions of disease-free survival, colostomy-free survival and progression-free survival (PFS). Anal continence was reported in only 35 (41%) studies. CONCLUSION:Outcomes reported in studies evaluating chemoradiotherapy for ASCC were heterogenous and definitions varied widely. Outcomes likely to be important to patients, such as ano-rectal function, toxicity and QoL, have been neglected. A COS for future trials will address these issues.

SUBMITTER: Fish R

PROVIDER: S-EPMC5969105 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).

Fish R R Sanders C C Ryan N N der Veer S Van SV Renehan A G AG Williamson P R PR

Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland 20180417 5

<h4>Aim</h4>Six Phase III randomized trials have determined the effectiveness of chemoradiotherapy as primary treatment for anal squamous cell carcinoma (ASCC), but outcomes reported in these trials varied widely, hindering evidence synthesis. To improve reporting in all future trials, we aim to develop a core outcomes set (COS). As the first stage of COS development, we undertook a systematic review to summarize the outcomes reported in studies evaluating chemoradiotherapy for ASCC.<h4>Method</ ...[more]

PMID: 29566456

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Project description:IntroductionThe incidence of anal squamous cell carcinoma (ASCC) has increased threefold in the last 30 years. Initial treatment is chemoradiotherapy, associated with short-term and long-term side effects. Future therapy innovations aim to reduce morbidity in treatment of early tumours while maintaining treatment efficacy, and to escalate treatment intensity in locally advanced tumours with acceptable quality of life (QoL). However, all phase III randomised controlled trials to-date have utilised different primary outcomes, which hinders evidence synthesis and presents challenges to the selection of optimal outcomes in future trials. No trial comprehensively assessed long-term side effects and QoL, suggesting outcomes reflecting issues important to patients are under-represented. This project aims to determine the priority outcomes for all stakeholders and reach agreement on a standardised core set of outcomes to be measured and reported on in all future ASCC trials.Methods and analysisA systematic review will identify all outcomes reported in trials and observational studies of chemoradiotherapy as primary treatment for ASCC. Outcomes of importance to patients will be identified through patient interviews. The long list of outcomes generated from the systematic review and interviews will be used to create a two-round Delphi process, including key stakeholders (patients and healthcare professionals). The results of the Delphi will be discussed at a face-to-face consensus meeting. Discussion will focus on outcomes that did not achieve consensus through the Delphi process and conclude with anonymous voting to ratify the final core outcome set (COS).Ethics and disseminationThe final COS will feed directly into the PersonaLising Anal cancer radioTherapy dOse (PLATO) national anal cancer trials and the Association of coloproctologists of Great Britain and Ireland (ACPGBI) supported national anal cancer database. Utilisation of the COS will increase the relevance of research output to all stakeholders and increase the capacity for data synthesis between trials. This study has ethical approval and is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative.Trial registration numberPROSPERO registration ID: CRD42016036540.

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.

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).

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Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).

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Systematic review of outcome measures following chemoradiotherapy for the treatment of anal cancer (CORMAC).

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