OBJECTIVE: This study aimed to further clarify how the outcome domain concepts should be defined for 5 of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or a vague concept to an operationalized and measurable health-related construct, so that a suitable measurement instrument can then be identified.
METHODS: A series of 5 focus group-style semistructured discussions were conducted via a Web-based discussion forum, each open for 2 weeks and ending with a vote. The participants included 148 tinnitus experts who completed a preceding e-Delphi survey that had generated the original set of minimum standards. The participants were health care users living with tinnitus, health care professionals, clinical researchers, commercial representatives, and funders.
RESULTS: The Web discussions led to a revision of all 5 original plain language definitions that had been used in the preceding e-Delphi survey. Each revised definition was voted by 8 to 53 participants and reached the prespecified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed upon for tinnitus intrusiveness, the majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. The examples included tinnitus awareness, unpleasantness, and impact on different aspects of everyday life. Thematic analysis of the 5 Web-based discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalized and measurable health construct in each case.
CONCLUSIONS: The qualitative data gathered during the Web-based discussion forum provided an important in-depth understanding of the health concepts that had raised a debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalization of those concepts to proceed to the second stage of core outcome set development that is to identify and evaluate suitable measurement instruments. This study supports the use of Web-based peer discussion forums in defining health concepts.
OBJECTIVE: This review aims to evaluate the effectiveness of nondrug interventions in reducing OIs among patients with hematological cancers.
METHODS: The PubMed, CENTRAL (Cochrane Central Register of Controlled Trials), and Embase databases were searched on December 26, 2022, for all randomized controlled trials (RCTs). The primary endpoint was OIs. The quality of included studies was assessed by the Cochrane Risk-of-Bias tool.
RESULTS: A total of 6 studies were included in this review with 4 interventions: (1) types of mouthwash received, (2) presence of coating on central venous catheters (CVCs), (3) use of well-fitted masks, and (4) types of diet consumed. The results were presented in 8 different comparisons: (1) chlorhexidine-nystatin versus saline mouth rinse, (2) chlorhexidine versus saline mouth rinse, (3) nystatin versus saline mouth rinse, (4) chlorhexidine silver sulfadiazine-coated CVCs versus uncoated catheters, (5) well-fitted masks versus no mask, (6) amine fluoride-stannous fluoride versus sodium fluoride mouthwash, (7) low-bacterial diet versus standard hospital diet, and (8) herbal versus placebo mouthwash. No clear differences were reported in any of the outcomes examined in the first 3 comparisons. There were also no clear differences in the rate of catheter-related bloodstream infection or insertion site infection between the use of chlorhexidine silver sulfadiazine-coated CVCs versus uncoated catheters in the patients. Further, no significant differences were seen between patients who used a well-fitted mask and those without a mask in the incidence of OI. The all-cause mortality and mortality due to OI were similar between the 2 groups. There was no clear difference in all-cause mortality, although common adverse effects were reported in patients who used sodium fluoride mouthwash compared with those using amine fluoride-stannous fluoride mouthwash. There was no evidence of any difference in the incidence of possible invasive aspergillosis or candidemia between patients who consumed a low-bacterial diet and a standard diet. For the last comparison, no significant difference was seen between patients who received herbal and placebo mouthwash.
CONCLUSIONS: Very limited evidence was available to measure the effectiveness of nondrug interventions in hematological cancers. The effectiveness of the interventions included in this review needs to be evaluated further in high-quality RCTs in a dedicated setting among patients with hematological malignancies.
TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42020169186; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=169186.
OBJECTIVE: We aimed to determine the prevalence of various cancers in NAFLD patients and the association between NAFLD and cancer.
METHODS: We searched PubMed, ProQuest, Scopus, and Web of Science from database inception to March 2022 to identify eligible studies reporting the prevalence of NAFLD and the risk of incident cancers among adult individuals (aged ≥18 years). Data from selected studies were extracted, and meta-analysis was performed using random effects models to obtain the pooled prevalence with the 95% CI. The quality of the evidence was assessed with the Newcastle-Ottawa Scale.
RESULTS: We identified 11 studies that met our inclusion criteria, involving 222,523 adults and 3 types of cancer: hepatocellular carcinoma (HCC), breast cancer, and other types of extrahepatic cancer. The overall pooled prevalence of NAFLD and cancer was 26% (95% CI 16%-35%), while 25% of people had NAFLD and HCC (95% CI 7%-42%). NAFLD and breast cancer had the highest prevalence out of the 3 forms of cancer at 30% (95% CI 14%-45%), while the pooled prevalence for NAFLD and other cancers was 21% (95% CI 12%-31%).
CONCLUSIONS: The review suggests that people with NAFLD may be at an increased risk of cancer that might not affect not only the liver but also other organs, such as the breast and bile duct. The findings serve as important evidence for policymakers to evaluate and recommend measures to reduce the prevalence of NAFLD through lifestyle and environmental preventive approaches.
TRIAL REGISTRATION: PROSPERO CRD42022321946; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=321946.