Medical Rehabilitation: Guidelines to Advance the Field With High-Impact Clinical Trials

The purpose of this Special Communication is to summarize guidelines and recommendations stemming from an expert panel convened by the National Institutes of Health, National Center for Medical Rehabilitation Research (NCMRR) for a workshop entitled The Future of Medical Rehabilitation Clinical Trials, held September 29-30, 2016, at the NCMRR offices in Bethesda, Maryland. The ultimate goal of both the workshop and this summary is to offer guidance on clinical trials design and operations to the medical rehabilitation research community, with the intent of maximizing the effect of future trials.     

Key Characteristics of Rehabilitation Quality Improvement Publications: Scoping Review From 2010 to 2016

Objective

To characterize the peer-reviewed quality improvement (QI) literature in rehabilitation.

How willing are dentists to treat young children?: A survey of dentists affiliated with Medicaid managed care in New York City, 2010

BackgroundDespite recommendations for children to have a dental visit by the age of 1 year, access to dental care for young children, including children enrolled in Medicaid, remains limited. The authors conducted a survey to assess the availability of dentists to see young children enrolled in Medicaid managed care (MMC) in New York City (NYC), to determine barriers to the provision of dental care to young children and, within the context of MMC, to identify strategies to facilitate the delivery of dental care to children.MethodsThe authors mailed a survey to assess the provision of dental services to young children and perceived barriers and facilitators to 2,311 general dentists (GDs) and 140 pediatric dentists (PDs) affiliated with NYC MMC. A total of 1,127 surveys (46 percent) were received. The authors analyzed the responses according to provider type, youngest aged child seen, provider’s ability to see additional children and practice location. The authors compared responses by using the χ² test.ResultsFewer than one-half (47 percent) of GDs saw children aged 0 through 2 years. Provider type, years in practice and percentage of Medicaid-insured patients were associated significantly (P χ .005) with youngest age of child seen. Among respondents seeing children aged 0 through 2 years, PDs were significantly more likely to provide preventive therapy (P = .004) and restorative treatment (P χ .001). Additional training and access to consulting PDs were identified by GDs as potential facilitators to seeing young children.ConclusionA high proportion of NYC GDs affiliated with MMC do not see young children.Practice ImplicationsNinety-four percent of NYC MMC– affiliated dentists are GDs, but 53 percent of GD respondents did not see children aged 0 through 2 years in their practices. Improving access to dental care for young children requires changes in GDs’ practices, possibly by means of additional training and access to consulting PDs.     

Chemomechanical caries removal in children: an operator's and pediatric patients' responses

BACKGROUND: This study investigated an operator's and pediatric patients' responses to chemo-mechanical caries removal (CMCR) versus the traditional method (TM) of caries removal using a handpiece and a round bur when treating dentinal-depth occlusal lesions with minimal enamel access in primary molars. METHODS: Data were collected from 50 children at baseline and before, during and after caries removal using CMCR or TM. The subjects in the CMCR group were on average younger than the subjects in the TM group and had more deep lesions. RESULTS: The operator rated CMCR as needing more clinical and technical effort and more total effort than TM. He was less satisfied with CMCR than with TM. Subjects in the CMCR group perceived the time needed for treatment as significantly longer than did the subjects in the TM group. Fear of the dentist decreased in subjects in the TM group from before to after the operative appointment, while it increased in subjects in the CMCR group. CONCLUSIONS: The authors found no direct advantage in using CMCR over using TM. CLINICAL IMPLICATIONS: CMCR cannot be recommended as an alternative to TM when treating dentinal depth occlusal lesions with minimal access in primary molars.     

Evaluation of HbA1c on the Roche COBAS Integra 800 closed tube system

OBJECTIVES: Evaluate a new whole blood (WB) HbA1c immunoassay and system with closed tube sampling (CTS) capability. DESIGN AND METHODS: Compare the Tina-quant Haemoglobin A1c Gen.2 (A1C-2) application on the COBAS INTEGRA 800 (I800) and new I800 dedicated system with CTS capability to current Integra applications and a HbA1c method accurate with common haemoglobin (Hb) variants. RESULTS: CVs were < or =1.7%. Mean bias against National Glycohaemoglobin Standardization Program (NGSP) samples was 0.3 HbA1c %. Compared to the Hitachi Tina-quant(R) [a] HbA1c II (HbA1c II) assay (accurate with common Hb variants), mean bias was 0.04% and 0.21% HbA1c at 6% and 9%, respectively, with Hb AS variants; and -0.01% and 0.26% HbA1c at 6% and 9%, respectively, with Hb AC variants. CONCLUSIONS: The Integra A1C-2 application is precise, accurate against NGSP-assigned samples and the Hb variants tested; and, the I800 dedicated system with CTS capability offers increased throughput and reduced sample handling.     

Qualitative cross-cultural exploration of vaginal bleeding/spotting symptoms and impacts associated with hormone therapy in post-menopausal women to inform the development of new patient-reported measurement tools

Objectives

To understand the vaginal bleeding/spotting experiences of postmenopausal (PM) women taking estrogen plus progestin therapies (EPT) and develop measures to assess these symptoms and their impact on women's daily lives in four countries.

Design

(1) Concept elicitation interviews were conducted with PM women in the US (n = 14), Italy (n = 15), Mexico (n = 15) and China (n = 15) to explore vaginal bleeding/spotting symptoms associated with EPT. The Post-Menopausal Bleeding Questionnaire (PMBQ) was also debriefed to evaluate understanding and comprehensiveness. (2) Based on concept elicitation, a single item electronic daily diary was developed and the PMBQ modified to form a 12-item impact measure. (3) The measures were pilot-tested and then cognitively debriefed with US women receiving EPT. All qualitative data was subject to thematic analysis.

Main outcome measures

The Vaginal Bleeding/Spotting Daily Diary, (VBS-DD) and Post-Menopausal Bleeding Impact Questionnaire (PMBIQ) were developed in this study.

Results

Concept elicitation identified vaginal bleeding and spotting as important symptoms for women taking EPT, impacting their emotional wellbeing, social life, ability to move freely, clothing and sexual activity. Based on pilot testing and cognitive debriefing, women demonstrated good understanding of the VBS-DD and the PMBQ was reduced to 10 items due to conceptual redundancy.

Conclusions

Women taking EPT in the US, China, Mexico and Italy reported vaginal bleeding/spotting symptoms that have a detrimental impact on their quality of life. Two new measures were developed to assess the severity and impact of vaginal bleeding/spotting specific to EPT. This work highlights the need for EPT-related symptoms to be a part of treatment decision-making.