COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures

Purpose

The original COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was developed to assess the methodological quality of single studies on measurement properties of Patient-Reported Outcome Measures (PROMs). Now it is our aim to adapt the COSMIN checklist and its four-point rating system into a version exclusively for use in systematic reviews of PROMs, aiming to assess risk of bias of studies on measurement properties.

Methods

For each standard (i.e., a design requirement or preferred statistical method), it was discussed within the COSMIN steering committee if and how it should be adapted. The adapted checklist was pilot-tested to strengthen content validity in a systematic review on the quality of PROMs for patients with hand osteoarthritis.

Results

Most important changes were the reordering of the measurement properties to be assessed in a systematic review of PROMs; the deletion of standards that concerned reporting issues and standards that not necessarily lead to biased results; the integration of standards on general requirements for studies on item response theory with standards for specific measurement properties; the recommendation to the review team to specify hypotheses for construct validity and responsiveness in advance, and subsequently the removal of the standards about formulating hypotheses; and the change in the labels of the four-point rating system.

Conclusions

The COSMIN Risk of Bias checklist was developed exclusively for use in systematic reviews of PROMs to distinguish this application from other purposes of assessing the methodological quality of studies on measurement properties, such as guidance for designing or reporting a study on the measurement properties.

     

Meta-analytical review of factors involved in dentin adherence

Literature data on adherence tests of dentin-bonding systems (DBS) may differ widely, even for the same DBS. The problem of bond testing is that materials are seldom compared with a standard, and experimental conditions often vary. We sought to identify the parameters that influence this variability. Using inclusion and exclusion criteria, we conducted a meta-analytical review of 75 articles, published between 1992 and 1996 in SCI reviews, that give bond strength data for 15 dentin-bonding agents of the so-called third and fourth generations. Seventeen selected parameters were classified into four groups: Group A includes factors related to the dentin substrate (i.e., nature of teeth); group B, composite and bonding area (i.e., composite stiffness); group C, storage conditions of the bonded samples (i.e., thermocycling); and group D, test design (i.e., crosshead speed). For each report, the experimental features, the bond strength means and standard deviations, and the failure mode were extracted and tabulated. Statistical Analysis System software was used to perform Pearson correlation analysis and analysis of variance, with bond strength as the dependent variable and experimental conditions as the independent variables. The meta-analytical review highlighted the significant influence of various parameters in the different groups: origin of dentin, types of teeth, pulpal pressure, tooth storage temperature, maximum storage time of teeth, and dentin depth in group A; type and stiffness of composite and bonding area in group B; storage of bonded samples (medium, temperature, and time) in group C, and testing mode and crosshead speed in group D. A significant positive correlation was observed between the mean bond strength and the rate of cohesive failure. It can be concluded from this study that some of these parameters should be controlled by the use of a standardized protocol. Unfortunately, the substrate-related variables are more difficult to control, even though their influence is consistent.     

Cancer-promoting effect of Taiwan betel quid in hamster buccal pouch carcinogenesis

OBJECTIVE: To investigate the cancer-promoting effect of Taiwan betel quid in hamster buccal pouch carcinogenesis.
MATERIALS AND METHODS: Two hundred and fifty-two non-inbred mate adult Syrian golden hamsters were randomly divided into six groups, each containing forty-two animalS. A treatment regimen over a 14-week experimental period was employed with six animals per group being killed at seven different periods (every 2 weeks). The right buccal pouch of each animal was painted three times a week with various combinations of 7, 12-dimethylbenz[a]anthracene (DMBA), Taiwan betel quid extract, dimethyl sulfoxide (DMSO) and mineral oil.
RESULT: Both the number and size of tumors in animals concurrently treated with DMBA and betel quid were significantly higher than those in animals treated with DMBA alone in each killing period of 8, 10, 12 and 14 weekS. No visible tumors but hyperkeratosis and acanthosis were observed in pouches treated with betel quid alone for all killing periods.
CONCLUSION: Our results indicate Taiwan betel quid may be a co-carcinogen in human oral carcinogenesis, if extrapolation can be made from the current animal study.     

Acute-phase response of human hepatocytes after infection with Chlamydia pneumoniae and cytomegalovirus

BACKGROUND: There is increasing evidence that chronic inflammation plays a pivotal role in the development of atherosclerosis. Whether inflammation is the cause or consequence of vascular damage is unclear. Also, the source of inflammation is unknown, but may well be infection by Cytomegalovirus (CMV) or Chlamydia pneumoniae (C. pneumoniae). Infection of the liver by CMV or C. pneumoniae may induce a general inflammatory reaction contributing to accelerated atherogenesis. In this study we investigated the production of interleukin-6 (IL-6), fibrinogen and plasminogen activator inhibitor-1 (PAI-1) by hepatocytes after infection with CMV or C. pneumoniae. METHODS: HepG2 cell monolayers were grown to confluence in 48-well tissue culture plates. Hepatocytes were infected with 50 microL or 100 microL of suspension of CMV (10(2.70) TCID50 mL(-1)) and C. pneumoniae (10(4.75) TCID50 mL(-1)). The medium of the inoculated cells was collected every 24 h, from day 1 to day 4, for determination of IL-6, PAI-1 and fibrinogen concentrations. RESULTS: Fibrinogen production was increased significantly in a dose-dependent manner after infection with CMV (50 microL: P=0.022 and 100 microL: P<0.001) and C. pneumoniae (P=0.012). Cytomegalovirus infection resulted in an increase of IL-6 production compared with uninfected cells (P=0.048). Cytomegalovirus and C. pneumoniae infection did not result in a significantly increase of PAI-1 production by hepatocytes. CONCLUSION: We conclude that in addition to direct vascular wall infection by C. pneumoniae and CMV, virus-related development of atherosclerosis might also be initiated by chronic liver infection and subsequent production of inflammatory and procoagulant mediators released in the circulation. This may be another pathophysiological link for the observed relation between infections and the development of atherosclerosis.     

Coincidental diagnosis of tuberculous lymphadenitis: a case report

The aim of this case report was to present a case of multiple calcified tuberculous lymph nodes found on a panoramic radiograph coincidently diagnosed in an endodontic clinic. A detailed discussion on the differential diagnosis of similar such calcification found in the same region is also presented. A 14‐year‐old girl was referred to our department with the complaint of painless swelling in the left side of the lower jaw. Clinical and radiographical examinations were performed, leading to the initial diagnosis of chronic periapical abscess. The patient's medical history was re‐evaluated. Advanced imaging and excisional biopsy were performed in order to confirm the final diagnosis. Regarding the presenting signs and symptoms of bilateral carious mandibular molars, a periapical inflammatory process was considered in the provisional diagnosis. A thorough examination and investigations were suggestive of cervical tuberculous lymphadenitis (scrofula), and the patient underwent excision of the same. The clinician should consider the possibility of chronic granulomatous inflammatory lesions in the differential diagnosis of radiopaque lesions.