BACKGROUND: Choosing the most adequate measure of patient-reported outcomes (PROs) for a specific medical condition is not straightforward. This study aimed to develop a comprehensive archive of patient-reported outcome measures (PROMs), observer-reported outcome measures (ObsROMs) and caregiver-reported outcome measures (CROMs) in oncology and identify their main characteristics and target outcome domains.
METHODS: As part of the Italian PRO4All Project, we retrieved questionnaires through an extensive search of online databases. We developed a data extraction form to collect information on cancer type, questionnaire variant(s), recall period, and scoring system. We performed a content analysis of the questionnaires to assign each item a specific outcome domain according to a predefined 38-item taxonomy.
RESULTS: A total of 386 PROMs (n = 356), ObsROMs (n = 13) and CROMs (n = 17) were identified and described; of these, 358 were also analyzed in their content. 47.3 % of the instruments were cancer type-specific, 45.1 % were generic for cancer and 7.9 % were developed for the general population but also recommended in oncology. The great majority (92.2 %) were patient-reported. In 50.3 % the recall period was \"last week\". The mean number of items per questionnaire was 22.0 (range: 1-130). 7794 items were assigned an outcome domain, the most frequent being emotional functioning/wellbeing (22 %), physical functioning (15.7 %), general outcomes (10.1 %) and delivery of care (8.9 %).
CONCLUSIONS: There are a variety of patient and caregiver-reported measures in oncology. This archive can guide researchers and practitioners in selecting the most suitable measures and fostering a patient-centered approach in clinical trials, clinical practice, and regulatory activities.

Large variation exists in the monitoring of clinical outcome domains in patients with persistent spinal pain syndrome (PSPS). Furthermore, it is unclear which outcome domains are important from the PSPS patient\'s perspective. The study objectives were to identify patient-relevant outcome domains for PSPS and to establish a PSPS outcomes framework. PubMed, CINAHL, Cochrane, and EMBASE were searched to identify studies reporting views or preferences of PSPS patients on outcome domains. The Arksey and O\'Malley framework was followed to identify outcome domains. An expert panel rated the domains based on the importance for PSPS patients they have treated. A framework of relevant outcome domains was established using the selected outcome domains by the expert panel. No studies were found for PSPS type 1. Five studies with 77 PSPS type 2 patients were included for further analysis. Fourteen outcome domains were identified. An expert panel, including 27 clinical experts, reached consensus on the domains pain, daily activities, perspective of life, social participation, mobility, mood, self-reliance, and sleep. Eleven domains were included in the PSPS type 2 outcomes framework. This framework is illustrative of a more holistic perspective and should be used to improve the evaluation of care for PSPS type 2 patients. Further research is needed on the prioritization of relevant outcome domains.

BACKGROUND: Venous leg ulceration (VLU) is a chronic, recurring condition with associated pain, malodour, impaired mobility and susceptibility to infection which in turn significantly impacts an individual\'s health-related quality of life. Randomised controlled trials (RCTs) aim to determine the efficacy of interventions to improve outcomes. To be useful, these outcomes should be consistently and fully reported across RCTs. A core outcome set (COS) is an agreed-upon standardised set of outcomes which should be, at a minimum, reported in all RCTs for a given indication including that of VLU.
OBJECTIVE: To gain consensus on which outcome domains and outcomes should be considered as core and therefore included in all RCTs of interventions in VLU treatment.
METHODS: Two sequential, two round e-Delphi surveys were completed. The first gained consensus on core outcome domains and the second on core outcomes within those domains. Participants included: people with direct experience of having VLUs and their carers, healthcare professionals whose practice included VLU care and researchers within wound care (clinical, academic, industry).
RESULTS: Five outcome domains; healing, pain, quality of life, resource use and adverse events, and 11 outcomes were rated as core by participants. The patient and not the limb or ulcer was the preferred unit of analysis for reporting.
CONCLUSIONS: We recommend investigators report on all five outcome domains, regardless of the type of intervention being evaluated. Future research is needed to identify measurement methods for the 11 identified outcomes. We also recommend investigators follow the CONSORT guidelines (http://www.consort-statement.org/).

UNASSIGNED: This retrospective study was designed to analyze the prevalence and impact of associated comorbidities on fibromyalgia (FM) outcomes (functionality, pain, depression levels) for patients who participated in an intensive multicomponent clinical program in a tertiary care center.
UNASSIGNED: Participants included a sample of 411 patients diagnosed with FM at a large tertiary medical center using the 2016 ACR criteria. Patients completed an intensive 2-day cognitive behavioral treatment (CBT) program, filled out the Fibromyalgia Impact Questionnaire Revised (FIQR), the Center for Epidemiologic Studies Depression Scale (CES-D), the Pain Catastrophizing Scale (PCS), and were followed for 6 months after treatment completion. T-tests were performed to analyze differences between the presence or absence of select comorbidities for the three outcomes at follow-up. Statistically significant comorbidities (p < 0.05) were used as predictors in multivariable logistic regression models.
UNASSIGNED: The FM associated comorbidities in this cohort that had significant impact on the measured outcome domains after treatment program completed were Obesity (FIQR p = 0.024), Hypothyroidism (CES-D p = 0.023, PCS p = 0.035), Gastroesophageal reflux disease GERD (PCS p < 0.001), Osteoarthritis (CES-D p = 0.047). Interestingly, Headache, the most frequent FM associated comorbidity in this cohort (33.6%), did not have a significant impact on the outcome domains at follow-up. Obesity (18.2%) was the only FM associated comorbidity significantly impacting all three outcome domains at follow-up.
UNASSIGNED: The present study suggests that addressing obesity may significantly impact outcomes in FM patients.

UNASSIGNED: There is wide-ranging published literature around cranioplasty following traumatic brain injury (TBI) and stroke, but the heterogeneity of outcomes limits the ability for meta-analysis. Consensus on appropriate outcome measures has not been reached, and given the clinical and research interest, a core outcome set (COS) would be beneficial.
UNASSIGNED: To collate outcomes currently reported across the cranioplasty literature which will subsequently be used in developing a cranioplasty COS.
UNASSIGNED: This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. All full-text English studies with more than ten patients (prospective) or more than 20 patients (retrospective) published after 1990 examining outcomes in CP were eligible for inclusion.
UNASSIGNED: The review included 205 studies from which 202 verbatim outcomes were extracted, grouped into 52 domains, and categorised into one or more of the OMERACT 2.0 framework core area(s). The total numbers of studies that reported outcomes in the core areas are 192 (94%) pathophysiological manifestations/ 114 (56%) resource use/economic impact/ 94 (46%) life impact/mortality 20 (10%). In addition, there are 61 outcome measures used in the 205 studies across all domains.
UNASSIGNED: This study shows considerable heterogeneity in the types of outcomes used across the cranioplasty literature, demonstrating the importance and necessity of developing a COS to help standardise reporting across the literature.

Introduction: A core outcome set (COS) improves the quality of reporting in clinical trials; however, this has not been developed for clinical trials of exercise training among adults undergoing solid organ transplant. Research Question: To explore the perspectives of transplant patients and healthcare professionals on the key outcomes domains that are relevant for clinical trials of exercise in all recipients of transplanted organs. Methods: A Delphi approach was employed with 2 rounds of online questionnaires. Participants rated the importance of outcome domains using a 9-point Likert scale ranging from \"not important\" to \"very important\". A score of 7 to 9 (very important) by 70% or more participants and a score of 1 to 3 (not important) by less than 15% participants were required to keep an outcome domain from the first to the second round. Results: Thirty-six participants completed 2 rounds of questionnaires (90% response rate). After Round 1, 8 outcome domains were considered very important in the pretransplant phase; 16 in the early posttransplant; and 17 in the late posttransplant. Only 1 outcome domain, organ rejection in the early posttransplant phase, met the criteria to be considered very important after Round 2. Conclusion: Although consensus was not reached on the core outcome domains, this study provides preliminary information on which domains are higher priority for patients and professionals. Future work should consider a meeting with key stakeholders to allow for deeper discussion to reach consensus on a core outcome set.

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions.
METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting.
RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set.
CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.

UNASSIGNED: There is considerable diversity of outcome selections and methodologies for handling the multiple outcomes across all systematic reviews (SRs) of Interdisciplinary Pain Treatment (IPT) due to the complexity. This diversity presents difficulties for healthcare decision makers. Better recommendations about how to select outcomes in SRs (with or without meta-analysis) are needed to explicitly demonstrate the effectiveness of IPT.
UNASSIGNED: This overview systematically collates the reported outcomes and measurements of IPT across published SRs and identifies the methodological characteristics. Additionally, we provide some suggestions on framing the selection of outcomes and on conducting SRs of IPT.
UNASSIGNED: Three electronic databases (PubMed, Cochrane Library, and Epistemonikos) and the PROSPERO registry for ongoing SR were supplemented with hand-searching ending on 30 September 2021.
UNASSIGNED: We included 18 SRs with data on 49007 people from 356 primary randomised controlled trials (RCTs); eight were followed by meta-analysis and ten used narrative syntheses of data. For all the SRs, pain was the most common reported outcome (72%), followed by disability/functional status (61%) and working status (61%). Psychological well-being and quality of life were also reported in half of the included SR (50%). The core outcome domains according to VAPAIN, IMMPACT, and PROMIS were seldom met. The methodological quality varied from critically low to moderate according to AMSTAR2. The AMSTAR2 rating was negatively correlated to the number of outcome domains in PROMIS, and VAPAIN was positively correlated with IMMPACT and PROMIS, indicating the intercorrelations between the reported outcomes.
UNASSIGNED: This systematic overview showed wide-ranging disparity in reported outcomes and applied outcome domains in SRs evaluating IPT interventions for chronic pain conditions. The intercorrelations between the reported outcomes should be appropriately handled in future research. Some approaches are discussed as well.

OBJECTIVE: Pain after surgery has a major impact on acute and long-term recovery and quality of life, but its management is often insufficient. To enhance the quality of research and to allow for better comparability between studies, it is important to harmonize outcomes for assessing the efficacy and effectiveness of pain management interventions after surgery. As a first step in developing a core outcome set, this study aimed to systematically search for outcome domains assessed in research regarding acute pain management after sternotomy as an example of a typically painful surgical procedure.
METHODS: A systematic literature review was performed using MEDLINE, Embase, and CENTRAL. Eligibility criteria consisted of randomized controlled trials and observational trials targeting pain management after sternotomy in adults in the acute postoperative setting (≤2 weeks). After duplicate removal and title and abstract screening by 2 independent reviewers, study characteristics and outcome domains were identified, which were extracted from full texts and summarized qualitatively.
RESULTS: Of 1350 studies retrieved by database searching, 156 studies were included for full-text extraction. A total of 80 different outcome domains were identified: pain intensity, analgesic consumption, physiological function, and adverse events were the most frequent ones. Outcome domains were often not explicitly reported, and the combination of domains and assessment tools was heterogeneous. The choice of outcomes is commonly made within clinicians; patients\' perspectives are not considered.
CONCLUSIONS: The wide variety of commonly applied outcome domains, the nonexplicit wording, and the heterogeneous combination of the domains indicating treatment benefit demonstrate the need for harmonization of outcomes assessing perioperative pain management after surgery.

BACKGROUND: This systematic review aimed to identify, compare and contrast outcome domains and outcome instruments reported in studies investigating interventions that seek to restore bilateral (two-sided) and/or binaural (both ears) hearing in adults with single-sided deafness (SSD). Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
METHODS: Records were identified by searching MEDLINE, EMBASE, PubMed, CINAHL, ClinicalTrials.gov, ISRCTN, CENTRAL, WHO ICTRP and the NIHR UK clinical trials gateway. The search included records published from 1946 to March 2020. Included studies were those as follows: (a) recruiting adults aged 18 years or older diagnosed with SSD of average threshold severity worse than 70 dB HL in the worse-hearing ear and normal (or near-normal) hearing in the better-hearing ear, (b) evaluating interventions to restore bilateral and/or binaural hearing and (c) enrolling those adults in a controlled trial, before-and-after study or cross-over study. Studies that fell just short of the participant eligibility criteria were included in a separate sensitivity analysis.
RESULTS: Ninety-six studies were included (72 full inclusion, 24 sensitivity analysis). For fully included studies, 37 exclusively evaluated interventions to re-establish bilateral hearing and 29 exclusively evaluated interventions to restore binaural hearing. Overall, 520 outcome domains were identified (350 primary and 170 secondary). Speech-related outcome domains were the most common (74% of studies), followed by spatial-related domains (60% of studies). A total of 344 unique outcome instruments were reported. Speech-related outcome domains were measured by 73 different instruments and spatial-related domains by 43 different instruments. There was considerable variability in duration of follow-up, ranging from acute (baseline) testing to 10 years after the intervention. The sensitivity analysis identified no additional outcome domains.
CONCLUSIONS: This review identified large variability in the reporting of outcome domains and instruments in studies evaluating the therapeutic benefits and harms of SSD interventions. Reports frequently omitted information on what domains the study intended to assess, and on what instruments were used to measure which domains.
BACKGROUND: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): Registration Number CRD42018084274 . Registered on 13 March 2018, last revised on 7th of May 2019.