Exclusion of Older Adults from Ongoing Clinical Trials on Low Back Pain: A Review of the WHO Trial Registry Database.

BACKGROUND/OBJECTIVES: The burden of low back pain (LBP) is high, especially for older adults who experience a higher number of years living with a disability. However, this population is not being well represented in clinical trials (CTs). This study analyzed the International Clinical Trial Registry Platform (ICTRP) database from the World Health Organization to verify the future trend in the participation of older adults in registered CTs on LBP. DESIGN: We performed a cross-sectional review of the ICTRP searching for prospective protocols planning interventions for LBP with registration dates from January 2015 through November 2018. From the protocols of the eligible studies, we extracted those planning to include older adults. RESULTS: A total of 167 protocols for CTs for LBP were planning to recruit participants older than 65 years. However, only five registries (2.99%; pooled sample = 169 participants) were designed to target participants specifically older than 65 years. The exclusion of older participants was not justified and imposed through an arbitrary upper-age limit in 93.6% of the protocols. Most of the protocols are from single-center studies, and a greater number are planned to be carried out in developed regions. Higher interest was in pharmacologic interventions, devices/technology, and physical rehabilitation. CONCLUSION: Older adults with LBP will continue to be underinvestigated in CTs for LBP in the near future. In general, ongoing trials are small, planned in developed regions, and proposing pharmacologic interventions to deal with LBP. J Am Geriatr Soc 67:603-608, 2019.

How do we define and measure sarcopenia? Protocol for a systematic review.

BACKGROUND: The loss of muscle mass is a natural aging consequence. A reduction of muscle mass that surpasses the physiological rate is considered the key factor responsible for the development of a geriatric syndrome called sarcopenia. However, a new understanding of the importance of muscle quality over quantity is rising; as a result, different definitions for sarcopenia has been used. Due to the negative impact on elder's health and quality of life, the number of research investigating the causes, prevalence, and management of sarcopenia is increasing, although a consensus on sarcopenia definition is still missing. This systematic review will assess observational studies reporting the presence of sarcopenia aiming to verify how sarcopenia is defined, the diagnosis criteria, and the tools used for assessment. In addition, we will investigate the influence of the definition and diagnostic tools on the prevalence rate. METHODS: Keywords related to the condition, population, and type of study will be combined to build a search strategy for each of the following databases MEDLINE, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, and Google Scholar. Two independent reviewers will analyze the retrieved papers for eligibility and the methodological quality of eligible studies. The definition of sarcopenia and diagnostic tools used in each study and the prevalence estimates will be extracted. Descriptive statistics will be used to report the definitions of sarcopenia, diagnostic tools, and whether these influence or not, the prevalence rates. DISCUSSION: Sarcopenia is receiving greater attention in geriatrics research in recent years. Therefore, it is important to investigate how this condition is defined in the literature and whether these definitions can interfere with the reported estimates devoting more efforts on the topic. The results of this study can help to determine the most used definitions of sarcopenia reported in the literature, its strengths and limitations, and open a discussion about a need for a more valid, easy, and suitable one. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015020832.

Intra- and extraoral prostheses retained by zygoma implants following resection of the upper lip and nose.

Upper lip cancers are infrequent lesions, being aggressive unless diagnosed and treated early. After the surgical resection, maxillofacial defects require special care in rehabilitation. This article describes the maxillofacial rehabilitation of an edentulous patient diagnosed with upper lip squamous cell carcinoma. The treatment consisted of a large amount of upper lip and nose tissue resection, followed by chemoradiotherapy. After the first surgical healing, zygoma implants were inserted in a two-step procedure. The maxillary and nasal prostheses were installed and fixed by a titanium framework. After 6 years follow-up, no recurrences were observed, and the patient did not develop metastases. Tissues around implants were in good health, and the prostheses remained well-fitted. The use of implant-retained prostheses improved the quality of life, and the patient was extremely satisfied with the final result. The implant-retained prostheses are well accepted by the patient, improving comfort and safety during function while recovering her esthetic apperance.

Impact of the social agendas--Agenda 21 and Healthy Cities--upon Social Determinants of Health in Brazilian municipalities: measuring the effects of diffuse social policies through the dimensions of the Millennium Development Goals.

INTRODUCTION: In order to improve the quality of life and health of the population in recent years there have been several local social agendas, like Agenda 21 and Healthy Cities. OBJECTIVES: To identify how social agendas are impacting on the living conditions and health in municipalities of the five regions of Brazil. METHODS: Through an ecological longitudinal study, the social agendas' effects on the Social Determinants of Health were measured in 105 municipalities, using indicators related to the eight dimensions of the Millennium Development Goals (MDGs). Indicators were also calculated for other 175 non-exposed municipalities. Descriptive statistics were calculated for each group of municipalities at three different moments: in the year of the agenda implementation, then 3 and 6 years later. The models were adjusted by the method of GEE to assess the effects of the agendas, time and their interaction. Nonparametric analysis of variance was used for the ordinal data with repeated measures. RESULTS: Impacts of the agendas were detected for reduction of hunger and increase of universal access to education: 'percentage of children under one year with protein/caloric undernourishment' (interaction effect: p = 0.02) and 'Age-grade distortion in the 8th grade of fundamental education' (interaction effect: p < 0.001). CONCLUSION: The comparative discussion between model results and descriptive statistics recommends, at further research, extending the period of investigation, using compound indexes, improving the methodology for the apprehension of the impacts of the diffuse social policies for development, as well as using 'mixed methodologies', integrating quantitative and qualitative tools.

[Management practices of regional referencing: a comparative study of five cases in the State of São Paulo, Brazil]. / Referenciamento regional em saúde: estudo comparado de cinco casos no Estado de São Paulo, Brasil.

OBJECTIVE: To evaluate management practices of regional referencing in the State of São Paulo, identifying the main difficulties in the process of agreement between health managers to achieve integrate health care. METHODOLOGY: 5 regions were selected (CPN-Campinas, Piracicaba-PRC, MC-Mogi das Cruzes, São José do Rio Preto-SJRP and Sao Jose dos Campos-SJC) in which were analyzed: indicators of 4 lines of care (Hypertension-HA and Diabetes Mellitus-DM, Mental Health, Oral and Women), the working tools of referencing and perceptions of regional and municipal managers on the process. RESULTS: the performance of managers regarding the scope of the universality and comprehensiveness of care was analyzed through 11 indicators, resulting in a score ranging from 0 to 5. The classification of the regions was: SJRP (4.55), CPN (2.91), SJC (2.27), PRC (2.27) and MC (1.91). The analysis of interviews with managers revealed that the formal mechanisms of listings are insufficient, and the tools for its monitoring, in metropolitan areas seems to be more difficult for agreement of references, the strengthening of spaces for negotiation between the managers was identified as a factor facilitating the process.