The effect of antimalarials on the safety and persistence of treatment with biologic agents or Janus kinase inhibitors in rheumatoid arthritis.

OBJECTIVES: To test the association of use of antimalarials with the overall safety of treatment in RA patients receiving one or multiple courses of biologic (b)DMARDs or a Janus kinase inhibitor (JAKi). METHODS: BiobadaBrasil is a multicentric registry-based cohort study of Brazilian patients with rheumatic diseases starting their first bDMARD or JAKi. The present analysis includes RA patients recruited from January 2009 to October 2019, followed up over one or multiple (up to six) courses of treatment (latest date, 19 November 2019). The primary outcome was the incidence of serious adverse events (SAEs). Total and system-specific adverse events (AEs) and treatment interruption served as secondary outcomes. Negative binomial regression with generalized estimating equations (to estimate multivariate incidence rate ratios, mIRR) and frailty Cox proportional hazards models were used for statistical analyses. RESULTS: The number of patients enrolled was 1316 (2335 treatment courses, 6711 patient-years [PY]; 1254.5 PY on antimalarials). The overall incidence of SAEs was 9.2/100 PY. Antimalarials were associated with reduced risk of SAEs (mIRR: 0.49; 95% CI: 0.36, 0.68; P < 0.001), total AEs (0.68; 95% CI: 0.56, 0.81; P < 0.001), serious infections (0.53; 95% CI: 0.34, 0.84; P = 0.007) and total hepatic AEs (0.21; 95% CI: 0.05, 0.85; P = 0.028). Antimalarials were also related to better survival of treatment course (P = 0.003). There was no significant increase in the risk of cardiovascular AEs. CONCLUSION: Among RA patients on treatment with bDMARDs or JAKi, concomitant use of antimalarials was associated with reduced the incidence of serious and total AEs and with longer treatment course survival.

The negative impact of the COVID-19 pandemic on breast cancer care in Brazil: a time series study in regions with different human development indices.

BACKGROUND: The impact of the COVID-19 pandemic on breast cancer care across Brazilian regions with varying Human Development Index (HDI) levels remains unclear. This study evaluates the pandemic's effects on screening mammograms, tumor staging at diagnosis, and treatment initiation in the Brazilian Public Health System between 2017 and 2022, focusing on regions with different HDI levels. METHODS: This ecological time series study uses an inflection point regression model and monthly percentage change (MPC) to analyze an open-access Brazilian Public Healthcare System dataset. The study focuses on trends and variations in these variables among women aged 50-69 in three state groups classified by HDI: Group A (very high), Group B (medium), and Group C (high). RESULTS: The average monthly rate of screening mammograms was highest in Group A (10.70) and lowest in Group B (8.38). At the onset of the COVID-19 pandemic, screening rates dropped significantly, with the most significant decline in Group B (58.6% decrease) and the smallest in Group A (45.7% decrease), lasting for three months. Subsequently, this variable recovered until December 2022 but was insufficient to restore the total series MPC to pre-pandemic levels. Group B had the lowest average rate of early-stage (0-II) diagnoses (2.88), while Group C had the highest (3.68). Early-stage diagnoses declined in the first three months of the pandemic, followed by a partial recovery that was insufficient to restore the pre-pandemic MPC levels. The proportion of advanced-stage diagnoses was highest in Group B (49.02%) and lowest in Group A (45.97%). The pandemic maintained the upward trend of advanced-stage (III-IV) diagnoses across all groups in the total time series. The average proportion of treatments initiated after 60 days of diagnosis was above 60% across all groups, with Group B at 64.50%. This variable began to rise 3 to 4 months after the pandemic and continued increasing until December 2022, with a greater intensity than the pre-pandemic period across all groups. CONCLUSION: The COVID-19 pandemic reduced breast cancer screening and early diagnosis in Brazil, leading to more advanced cases and treatment delays across all regions, with varying impacts according to regional HDI levels.

The negative impact of the COVID-19 pandemic on breast cancer tackle in Brazil's public and private healthcare system: time series study between 2014 and 2022.

BACKGROUND: The COVID-19 pandemic has overwhelmed the healthcare systems of many countries and negatively impacted the care of other diseases. OBJECTIVE: To evaluate the trend of screening mammograms, oncological breast surgeries, and breast cancer hospitalizations in Brazil's public and private healthcare system between 2014 and 2022. METHOD: This ecological time series study uses the inflection point regression model and semester percentage change (SPC). We use the open-access dataset of the different healthcare systems in Brazil. We analyzed the trend of the variables in the pre-pandemic and the effect of the pandemic on the total time series. RESULTS: In 2020, compared to 2019, the decrease in screening mammograms, oncological breast surgeries, and breast cancer hospitalization was - 41.44%, -23.13%, and - 10.52% (public health system) and - 29.49%, -18.96%, and - 15.35% (private healthcare system). In the public healthcare system, the pandemic has enhanced the decreasing trend of mammograms (SPC - 1.6% before and - 3.4% after), has reverted the stationary trend of oncological breast surgeries to decreasing (SPC - 1.0%), has slowed the increasing trend of breast cancer hospitalization (SPC 1.8% before and 0.9% after). In the private healthcare system, the pandemic has reverted the stationary trend of mammograms to decreasing (SPC - 1.0%), has slowed the increasing trend of breast cancer surgeries (SPC 2.3% before and 0.8% after), has reverted the growing trend of breast cancer hospitalization (SPC 3.9%) to stationary. CONCLUSION: During the COVID-19 pandemic, there was an increase in inequalities between healthcare systems, especially in breast cancer screening.

The New Coronavirus Pandemic and the Trend of Breast Cancer Diagnosis according to Age-Group: Total and Interrupted Time Series Study.

OBJECTIVE: There is a lack of studies evaluating the COVID-19 pandemic effect on breast cancer detection according to age-group. This study aimed to assess the pandemic impact on the trend of mammograms, breast biopsies, and breast cancer stage at diagnosis according to age-group. METHODS: This was an ecological time series study by inflection point regression model. We used data from women aged between 30 and 49, 50 and 69, and 70 years or more available in an open-access dataset of the Brazilian public healthcare system (2017-2021). We analyzed the trend of the variables in the pre-pandemic and the pandemic effect on the total time series. RESULTS: The decreasing or stationary trend of mammograms in the pre-pandemic has changed to a decreasing trend in the total time series in all age-groups. Before the pandemic, the increasing trend of breast biopsies has changed to stationary in the total time series in all age-groups. The increasing trend of tumors at stages 0 to II in the pre-pandemic has changed to decreasing or stationary in the total time series. Finally, the increasing trend of tumors at stage III or IV remained increasing in the total time series in all age-groups. CONCLUSION: The pandemic has changed the stationary or increasing trend to a decreasing or stationary trend of mammograms, breast biopsies, and tumors at stages 0 to II but has not influenced the increasing trend of tumors at stages III and IV in all age-groups.

Impact of COVID-19 pandemic on patients with rheumatic diseases in Latin America.

The objective of our study was to describe knowledge, attitudes and practices of Latin-American rheumatology patients regarding management and follow-up of their disease during COVID-19 pandemic. A cross-sectional observational study was conducted using a digital anonymous survey. Rheumatic patients ≥ 18 years from non-English-speaking PANLAR countries were included. Our survey included 3502 rheumatic patients living in more than 19 Latin-American countries. Median age of patients was 45.8(36-55) years and the majority (88.9%) was female. Most frequently self-reported disease was rheumatoid arthritis (48.4%). At least one anti-rheumatic treatment was suspended by 23.4% of patients. Fear of contracting SARS-Cov2 (27.7%) and economic issues (25%) were the most common reasons for drug discontinuation. Self-rated disease activity increased from 30 (7-50) to 45 (10-70) points during the pandemic. Communication with their rheumatologist during the pandemic was required by 55.6% of patients, mainly by telephone calls (50.2%) and social network messages (47.8%). An adequate knowledge about COVID-19 was observed in 43% of patients. Patients with rheumatic diseases in Latin America were negatively affected by the COVID-19 pandemic. An increase in self-rated disease activity, a reduction in medication adherence, and hurdles for medical follow-up were reported. Teleconsultation was perceived as a valid alternative to in-person visits during the pandemic.

The trend and direct costs of screening and chemotherapy treatment of breast cancer in the new coronavirus pandemic: total and interrupted time series study.

BACKGROUND: The COVID-19 pandemic has overloaded the healthcare systems of many countries and reduced the population's access to treatment and prevention of other diseases. This study aims to assess whether the COVID-19 pandemic has negatively interfered with the trend and the direct costs of screening and chemotherapy treatment of breast cancer in a public and universal healthcare system. METHOD: This was an ecological time series study using an open database of a public and universal health system from 2017 to 2021. RESULTS: In 2020, there was a 41% reduction in the coverage rate of breast cancer screening in women aged 50 to 69 years (about 1 million mammograms missed). The total direct cost of breast cancer screening reduced proportionally to the number of tests (BRL 67 million). On the other hand, the cost of chemotherapy treatment was higher in 2020, both in advanced (BRL 465 million) and localized (BRL 113 million) diseases. In the time series, mammograms' trend and direct costs changed from stationary to decreasing after the COVID-19 pandemic. The trend of direct costs with chemotherapy treatment for the advanced disease has been increasing and has not changed after the COVID-19 pandemic. On the other hand, in the case of localized disease, there was a trend toward reducing direct costs after the pandemic. CONCLUSION: After COVID-19, there was a downward trend in breast cancer screening and its direct costs, an upward trend in chemotherapy costs for advanced disease, and a downward trend in chemotherapy costs for localized disease.

Assessing the process and outcome of the development of practice guidelines and recommendations: PANELVIEW instrument development.

BACKGROUND: Guideline recommendations may be affected by flaws in the process, inappropriate panel member selection or conduct, conflicts of interest and other factors. To our knowledge, no validated tool exists to evaluate guideline development from the perspective of those directly involved in the process. Our objective was to develop and validate a universal tool, the PANELVIEW instrument, to assess guideline processes, methods and outcomes from the perspective of the participating guideline panellists and group members. METHODS: We performed a systematic literature search and surveys of guideline groups (identified through contacting international organizations and convenience sampling of working panels) to inform item generation. Subsequent groups of guideline methodologists and panellists reviewed items for face validity and missing items. We used surveys, interviews and expert review for item reduction and phrasing. For reliability assessment and feedback, we tested the PANELVIEW tool in 8 international guideline groups. RESULTS: We surveyed 62 members from 13 guideline panels, contacted 19 organizations and reviewed 20 source documents to generate items. Fifty-three additional key informants provided feedback about phrasing of the items and response options. We reduced the number of items from 95 to 34 across domains that included administration, training, conflict of interest, group dynamics, chairing, evidence synthesis, formulating recommendations and publication. The tool takes about 10 minutes to complete and showed acceptable measurement properties. INTERPRETATION: The PANELVIEW instrument fills a gap by enabling guideline organizations to involve clinicians, patients and other participants in evaluating their guideline processes. The tool can inform quality improvement of existing or new guideline programs, focusing on insight into and transparency of the guideline development process, methods and outcomes.

Clinical practice guidelines in Brazil - developing a national programme.

In Brazil, governmental and non-governmental organisations develop practice guidelines (PGs) in order to optimise patient care. Although important improvements have been made over the past years, many of these documents still lack transparency and methodological rigour. In order to conduct a critical analysis and define future steps in PG development in Brazil, we carried out a structured assessment of strengths, weaknesses, opportunities and threats (SWOT analysis) for the development of a national guideline programme. Participants consisted of academia, methodologists, medical societies and healthcare system representatives. In summary, the PG development process has improved in Brazil and current investments in methodological research and capacity-building are ongoing. Despite the centralised processes for public PGs, standardised procedures for their development are not well established and human resources are insufficient in number and capacity to develop the amount of trustworthy documents needed. Brazil's capacity could be strengthened and initial efforts have been made such as the adoption of standards proposed by world-renowned institutions in PG development and enhancement of the involvement of key stakeholders. Further steps involve the alignment between health technology assessment and PG processes for synergy and the development of a national network to promote the interaction between groups involved in the development of PGs. The lessons learned from this paper could be used to foster debate on guideline development, especially for countries facing similar threats on this topic.

Development of rapid guidelines: 3. GIN-McMaster Guideline Development Checklist extension for rapid recommendations.

BACKGROUND: Practice guidelines require a substantial investment of resources and time, often taking between 1 and 3 years from conceptualisation to publication. However, urgent situations require the development of recommendations in a shorter timeframe. In this third and final article in the series exploring challenges and solutions in developing rapid guidelines (RGs), we propose guiding principles for the development of RGs. METHODS: We utilised the Guideline International Network-McMaster Guideline Development Checklist (GDC) as a starting point for elements to consider during RG development. We built on those elements using the findings from a systematic review of guideline manuals, a survey of international organisations conducting RGs, and interviews of guideline developers within WHO. We reviewed initial findings and developed an intermediate list of elements, as well as narrative guidance. We then invited experts to validate the intermediate list, reviewing for placement, brevity and redundancy. We used this iterative process and group consensus to determine the final elements for RG development guidance. RESULTS: Our work identified 21 principles within the topics of the Guideline International Network-McMaster GDC to guide the planning and development of RGs. Principles fell within 15 of the 18 checklist topics, highlighting strategies to streamline and expedite the guideline development process. CONCLUSIONS: We defined principles to guide the development of RGs, while maintaining a standardised, rigorous and transparent process. These principles will serve as guidance for guideline developers responding to urgent situations such as public health urgencies. Integration of these principles within currently disseminated guideline development standards will facilitate the use of those tools in situations necessitating RG recommendations.

Development of rapid guidelines: 2. A qualitative study with WHO guideline developers.

BACKGROUND: Situations such as public health emergencies and outbreaks necessitate the development and publication of high-quality recommendations within a condensed timeframe. For example, WHO has produced examples of and guidance for the development of rapid guidelines (RGs). However, more information is needed to understand the experiences and perceptions of guideline developers. This is the second of a series of three articles addressing methodological issues around RGs. This study describes the perceptions and experiences of guideline developers at WHO about RGs. METHODS: We conducted interviews consisting of open- and closed-ended questions with guideline developers at WHO. Our analysis described the definition and rationale of RGs, the differences from regular guidelines with regard to timelines from topic definition until publication, barriers to identifying the evidence and the lack of a standard methodology to develop RGs. RESULTS: We interviewed 10 participants, the majority of whom were comfortable with the current WHO definition of RGs. Most stated that the rationale for developing RGs should be in response to new evidence about efficacy, cost-effectiveness or safety. Respondents differed with regards to the amount of time RGs should take. While the majority of participants agreed that guidelines should be based on a systematic review, this step in the process was considered the most time and resource intensive. Challenges for developing RGs included limited personnel and financial resources as well as the lack of evidence. Facilitators, in turn, that may improve RG development include additional financial and personnel resources as well as the use of virtual meetings. CONCLUSIONS: While our study suggests a strong need and rationale for the development of RGs, standardisation of timelines and guidance on panel composition, peer-review process, conduct of meetings and sources of permissible evidence require further research.

Development of rapid guidelines: 1. Systematic survey of current practices and methods.

BACKGROUND: Guidelines in the healthcare field generally should contain evidence-based recommendations to inform healthcare decisions. Guidelines often require 2 years or more to develop, but certain circumstances necessitate the development of rapid guidelines (RGs) in a short period of time. Upholding methodological rigor while meeting the reduced development timeframe presents a challenge for developing RGs. Our objective was to review current practices and standards for the development of RGs. This is the first of a series of three articles addressing methodological issues around RGs. METHODS: We conducted a systematic survey of methods manuals and published RGs to identify reasons for the development of RGs. Data sources included existing guideline manuals, published RGs, Trip Medical Database, MEDLINE, EMBASE and communication with guideline developers until February 2018. RESULTS: We identified 46 guidelines that used a shortened timeframe for their development. Nomenclature describing RGs varied across organisations, wherein the United States Centers for Disease Control and Prevention produced 'Interim Guidelines', the National Institute for Health and Care Excellence in the United Kingdom developed 'Short Clinical Guidelines', and WHO provided 'Rapid Advice'. The rationale for RGs included response to emergencies, rapid increases in cases of a condition or disease severity, or new evidence regarding treatment. In general, the methods to assess the quality of evidence, the consensus process and the management of the conflict of interest were not always clear. While we identified another 11 RGs from other institutions, there was no reference to timeframe and reasons for conducting a RG. The three organisations mentioned above provide guidance for the development of RGs. CONCLUSIONS: There is a lack of standardised nomenclature and definitions regarding RGs and there is inconsistency in the methods described in manuals and in RG. It is therefore important that all RGs provide a detailed and transparent description of their methods in order for readers and end-users to be able to assess their quality and validate their findings.

Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision.

BACKGROUND: Allergic rhinitis (AR) affects 10% to 40% of the population. It reduces quality of life and school and work performance and is a frequent reason for office visits in general practice. Medical costs are large, but avoidable costs associated with lost work productivity are even larger than those incurred by asthma. New evidence has accumulated since the last revision of the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines in 2010, prompting its update. OBJECTIVE: We sought to provide a targeted update of the ARIA guidelines. METHODS: The ARIA guideline panel identified new clinical questions and selected questions requiring an update. We performed systematic reviews of health effects and the evidence about patients' values and preferences and resource requirements (up to June 2016). We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence-to-decision frameworks to develop recommendations. RESULTS: The 2016 revision of the ARIA guidelines provides both updated and new recommendations about the pharmacologic treatment of AR. Specifically, it addresses the relative merits of using oral H1-antihistamines, intranasal H1-antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists either alone or in combination. The ARIA guideline panel provides specific recommendations for the choice of treatment and the rationale for the choice and discusses specific considerations that clinicians and patients might want to review to choose the management most appropriate for an individual patient. CONCLUSIONS: Appropriate treatment of AR might improve patients' quality of life and school and work productivity. ARIA recommendations support patients, their caregivers, and health care providers in choosing the optimal treatment.

Brazilian urban population norms derived from the health-related quality of life SF-6D.

OBJECTIVE: This study describes the utility scores of the SF-6D, standardized for the Brazilian urban population. METHODS: Five thousand individuals, over the age of 15, were assessed in the five regions of the country, in 16 capitals. The sample consisted of representative quotas of the Brazilian population. The selection of households was random. Face-to-face approach was applied in the household interviews. The SF-6D questionnaire was used to assess the measure of utility. Sociodemographics, household income and work status were also evaluated. RESULTS: The mean score of utility assessed by the SF-6D for the study population was 0.82 (015). The scores were lower for females (0.79), and as age increases, the utility scores progressively decrease. Individuals who reported health problems affecting their work activities presented the lowest scores (0.64). CONCLUSIONS: This study describes the utility scores using the SF-6D, standardized for the Brazilian urban population. These values will be useful for understanding the impact of interventions on health and quality of life in the population, assisting decision-making in the health sector.

Perceptions of the population regarding generic drugs in Brazil: a nationwide survey.

BACKGROUND: Generic drugs (GDs) offer a way to reduce health spending without sacrificing quality. Despite this, there are doubts as to their acceptance by the population. This work aims to assess perceptions of GDs among the Brazilian population. METHODS: We conducted a national household survey face-to-face between April and May 2013, with 5000 individuals aged over 15 years. The questions explored socioeconomic and demographic characteristics, the use of GDs, and perceptions about GDs as compared to brand drugs (BDs). The chi-square test was used to examine the associations between the perceptions and the characteristics of the population. RESULTS: Of the 5000 participants, 51.3% were women, 40.2% were white, 48.6% were between 15 and 34 years of age, and 52.3% had income of less than two minimum wages (US$627.78). In terms of the use of GDs, 44.6% of the participants were taking or had taken GDs in the past three months, with the highest figures among the elderly (61.1%) and female (49.2%) populations. Regarding perceptions, 30.4% of the respondents considered GDs less effective than BDs; provided the same price, 59% would prefer BD, and 45.8% agreed that physicians prefer to prescribe GDs. The most negative perceptions about GDs were observed among lower income, elderly and nonwhite populations. CONCLUSION: The findings provide a better understanding of Brazilians' perceptions regarding GDs. This should be considered when formulating healthcare policies aiming at improving access to effective and quality drugs, and reduction of health costs.

Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.

BACKGROUND: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. METHODS: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. RESULTS: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. INTERPRETATION: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.

The Impact of COVID-19 on Granted Disability Insurances and Related Costs for Workers With Cancer: A Time Series Study in Brazil.

OBJECTIVES: To assess the impact of the COVID-19 pandemic on disability insurance grants and related costs for workers with cancer. METHODS: This ecological time series study uses the inflection point regression model and the federal government's open-access dataset. We analyze the annual grant and cost rates of cancer-related disability insurance in Brazil (2010-2021). RESULTS: In 2020, the number of disability insurance grants due to malignant neoplasms decreased by 62.26%, and the total annual cost decreased by 62.94% compared to those in 2019. All illnesses and injuries were reduced by 2.56% and 20.02%, respectively. Between 2010 and 2021, the COVID-19 pandemic has reversed the increasing trend in annual disability insurance granted due to cancer and its associated expenses to a stable trend. CONCLUSION: The COVID-19 pandemic has harmed the provision of disability insurance for workers with cancer.

Translation, transcultural adaptation into Brazilian Portuguese and concurrent validity of the rheumatoid arthritis assessment scale (RAKAS-13/Brazil).

BACKGROUND: Knowledge of patients about Rheumatoid Arthritis (RA) is a necessary aspect to better approach self-management support in a patient-centered manner. The research instrument known as the Rheumatoid Arthritis Knowledge Assessment Scale (RAKAS), consisting of 13 items, is simple, reliable and reproducible, and can be applied in both clinical practice and research protocols. OBJECTIVE: This study aimed to translate and culturally adapt the RAKAS vocabulary into Brazilian Portuguese and to evaluate its concurrent validity. METHODS: The RAKAS was translated into Brazilian Portuguese and administered to 52 elderly women with RA recruited between May 2021 and May 2022. Concurrent validity was assessed using the Spearman's correlation coefficient between RAKAS and Patient Knowledge Questionnaire (PKQ). RESULTS: The participants considered RAKAS-13/BRAZIL easy to understand and did not report any doubts in answering the final version. Concurrent validity of the RAKAS-13/BRAZIL was low compared to the PKQ (ρ = 0.283, p = 0.038). CONCLUSION: The Brazilian Portuguese version of the RAKAS (RAKAS-13/BRASIL) proved to be a questionnaire that was easy and quick to administer to assess patient knowledge about Rheumatoid Arthritis, despite its low correlation with the PKQ in the present study.

Risk factors for osteoporotic hip fracture among community-dwelling older adults: a real-world evidence study.

BACKGROUND: Hip fractures in the older adults lead to increased morbidity and mortality. Although a low bone mineral density is considered the leading risk factor, it is essential to recognize other factors that could affect the risk of hip fractures. This study aims to evaluate the contribution of clinical characteristics, patient-reported outcomes, and muscle and aerobic capacity for hip fractures in community-dwelling older adults. METHODS: This is a retrospective cohort study with real world-data from subjects ≥ 60 years old attending an outpatient clinic in Minas Gerais, Brazil, from May 1, 2019, to August 22, 2022. Data about clinical characteristics (multimorbidity, medications of long-term use, sedative and or tricyclic medications, number of falls), patient-reported outcomes (self-perception of health, self-report of difficulty walking, self-report of vision problems, and self-report of falls) and muscle and aerobic capacity (calf circumference, body mass index, and gait speed) were retrieved from an electronic health record. The association of each potential risk factor and hip fracture was investigated by a multivariable logistic regression analysis adjusted for age and sex. RESULTS: A total of 7,836 older adults were included with a median age of 80 years (IQR 72-86) and 5,702 (72.7%) were female. Hip fractures occurred in 121 (1.54%) patients. Multimorbidity was associated with an increased risk of hip fracture (OR = 1.12, 95%CI 1.06-1.18) and each episode of fall increased the chance of hip fracture by 1.7-fold (OR = 1.69, 95%CI 1.52-1.80). Patient-reported outcomes associated with increased fracture risk were regular or poor self-perception of health (OR = 1.59, 95%CI 1.06-2.37), self-report of walking difficulty (OR = 3.06, 95%CI 1.93-4.84), and self-report of falls (OR = 2.23, 95%CI 1.47-3.40). Body mass index and calf circumference were inversely associated with hip fractures (OR = 0.91, 95%CI 0.87-0.96 and OR = 0.93, 95%CI 0.88-0.97, respectively), while slow gait speed increased the chance of hip fractures by almost two-fold (OR = 1.80, 95%CI 1.22-2.66). CONCLUSION: Our study reinforces the importance of identified risk factors for hip fracture in community-dwelling older adults beyond bone mineral density and available fracture risk assessment tools. Data obtained in primary care can help physicians, other health professionals, and public health policies to identify patients at increased risk of hip fractures.

Developing a provisional definition of flare in patients with established gout.

OBJECTIVE: Various nonvalidated criteria for disease flare have been used in studies of gout. Our objective was to develop empirical definitions for a gout flare from patient-reported features. METHODS: Possible elements for flare criteria were previously reported. Data were collected from 210 gout patients at 8 international sites to evaluate potential gout flare criteria against the gold standard of an expert rheumatologist definition. Flare definitions based on the presence of the number of criteria independently associated with the flare and classification and regression tree approaches were developed. RESULTS: The mean ± SD age of the study participants was 56.2 ± 15 years, 207 of them (98%) were men, and 54 of them (26%) had flares of gout. The presence of any patient-reported warm joint, any patient-reported swollen joint, patient-reported pain at rest score of >3 (0-10 scale), and patient-reported flare were independently associated with the study gold standard. The greatest discriminating power was noted for the presence of 3 or more of the above 4 criteria (sensitivity 91% and specificity 82%). Requiring all 4 criteria provided the highest specificity (96%) and positive predictive value (85%). A classification tree identified pain at rest with a score of >3, followed by patient self-reported flare, as the rule associated with the gold standard (sensitivity 83% and specificity 90%). CONCLUSION: We propose definitions for a disease flare based on self-reported items in patients previously diagnosed as having gout. Patient-reported flare, joint pain at rest, warm joints, and swollen joints were most strongly associated with presence of a gout flare. These provisional definitions will next be validated in clinical trials.

The Negative Impact of the New Coronavirus Pandemic on the Trend of Breast Biopsies and Their Direct Costs: Interrupted Time Series Analysis.

OBJECTIVES: The overload of health services because of the COVID-19 pandemic has reduced the population's access to treatment and prevention of other diseases. This study aimed to identify whether there was a change in the trend of breast biopsies and their direct costs during the COVID-19 pandemic in a developing country's public and universal healthcare system. METHODS: This was an ecological time series study of mammograms and breast biopsies in women aged 30 years or older from an open-access data set of the Public Health System of Brazil from 2017 to July 2021. RESULTS: In 2020, there was a reduction of -40.9% in mammograms and -7.9% in breast biopsies compared with the prepandemic period. From 2017 to 2020, there was an increase in the breast biopsies ratio per mammogram (1.37%-2.55%), the percentage of Breast Imaging-Reporting and Data System (BI-RADS) IV and V mammograms (0.79%-1.14%), and the annual direct cost of breast biopsies (Brazilian Real 3 477 410.00 to Brazilian Real 7 334 910.00). In the time series, the negative impact of the pandemic was lower on BI-RADS IV to V mammograms than on BI-RADS 0 to III. There was an association between the trend of breast biopsies and BI-RADS IV to V mammography. CONCLUSIONS: The COVID-19 pandemic harmed the increasing trend of breast biopsies, their total direct costs, BI-RADS 0 to III and IV to V mammograms, observed in the prepandemic period. Furthermore, there was a tendency to screen women at a higher risk for breast cancer during the pandemic.