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1.
Clin Endocrinol (Oxf) ; 99(3): 328-334, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-36710430

RESUMO

OBJECTIVE: The ACR-TIRADS system for stratifying thyroid nodule malignancy risk has been widely promoted and implemented. We audited its introduction at a large public hospital in Auckland, New Zealand. DESIGN: Audit of outcomes following thyroid nodule fine needle aspiration (FNA) before/after ACR-TIRADS. PATIENTS: Individuals undergoing thyroid FNA 2017-2019. MEASUREMENTS: From medical records, we obtained details from the pre-FNA ultrasound (nodule size, TIRADS points/levels, radiologist recommendation for FNA), Bethesda (B) cytology classification, histology and post-FNA follow-up. RESULTS: Four hundred and twenty-two individuals had 564 FNAs, 163 had surgery and 54 (13%) had cancer in the primary nodule. 37/54 (69%) cancers were papillary thyroid carcinoma (median size 25 mm, 87% ≥10 mm, 61% ≥20 mm). Following ACR-TIRADS introduction, FNA recommendations increased greater than twofold, FNAs performed by 71%-83%, and the monthly rate of FNAs and operations by 60% and 40%, respectively. However, the proportion of cancers/FNA remained similar (9.9% post-TIRADS vs. 8.7% pre-TIRADS). The proportions of FNA results remained stable for B2-B4 categories, but doubled (11% vs. 5%) for B5-B6: 15 FNAs were needed to identify an additional B5/B6 lesion. TIRADS-5 nodules had a higher proportion of B5/B6 (20%) and a lower proportion of B2 (30%) than TIRADS-3 (2%, 57%, respectively) and TIRADS-4 (9%, 56%) nodules. About 5 additional cancers/year were diagnosed, but they were more often small (49% vs. 8% <2 cm, 17% vs. 0% <1 cm). CONCLUSION: ACR-TIRADS introduction increased workload (FNAs and operations), without increasing the proportion of cancers/FNA. It led to a few more cancers being diagnosed, but many were small and of uncertain clinical significance.


Assuntos
Neoplasias da Glândula Tireoide , Nódulo da Glândula Tireoide , Humanos , Nódulo da Glândula Tireoide/diagnóstico , Neoplasias da Glândula Tireoide/patologia , Carga de Trabalho , Estudos Retrospectivos , Ultrassonografia/métodos
2.
Clin Endocrinol (Oxf) ; 96(6): 907-913, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-34913500

RESUMO

OBJECTIVE: To assess diversity of gender and geographical location of institutional affiliation among invited speakers at major international endocrinology conferences. DESIGN AND METHODS: Descriptive study of characteristics of invited speakers at eight general and discipline-specific endocrinology conferences held annually in Europe and North America 2013-2019. Main outcomes were gender, geographical location of institutional affiliation and frequency of repeat presentations among invited speakers. RESULTS: Of 2375 invited speakers who gave 3522 presentations, 843 (35.5%) were women. Five hundred and ninety-four (25.0%) speakers gave >1 presentation at any conference. The proportion of women speakers declined as the number of presentations per speaker increased. Of speakers giving two and seven presentations, respectively, 36.0% and 20.0% were women. 52.9% of speakers were from institutions in North America, and 25.6% from institutions in Western Europe. Fewer than 5% of speakers were from institutions in each of Eastern Europe, Asia, South America, Africa and Oceania. The proportions of speakers who were women and from each geographical area were unchanged over 7 years. Up to one in three speakers gave >1 presentation at an individual conference (range 9.9%-32.2%). CONCLUSIONS: Women and speakers from institutions outside of North America and Western Europe are underrepresented among invited speakers at major international endocrinology conferences. Longitudinal data indicate no change in either speaker characteristic over the time period examined. These underrepresentations are more marked among speakers who give repeat presentations.


Assuntos
Endocrinologia , Médicas , África , Ásia , Europa (Continente) , Feminino , Humanos , Masculino
3.
Clin Endocrinol (Oxf) ; 95(1): 74-83, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33866594

RESUMO

OBJECTIVE: Prolonged severe vitamin D deficiency can cause osteomalacia, but the 25-hydroxyvitamin D (25OHD) concentration below which this occurs is unknown. We investigated the prevalence of biochemical osteomalacia in adults with a measurement of 25OHD. DESIGN, MEASUREMENT, AND PATIENTS: 25OHD results between 1/1/2009 and 15/6/2020 were obtained from the regional laboratory database, together with measurements of serum calcium, parathyroid hormone (PTH) and alkaline phosphatase (ALP) within 6 months of the index 25OHD. We defined biochemical osteomalacia as all 3 of: albumin-adjusted serum calcium (aCa)<2.0 mmol/L, PTH>7.3 pmol/L and ALP>150 IU/L. Possible osteomalacia was 2/3 criteria with the other test not done. 25OHD measurements associated with significant renal impairment, elevated hepatic transaminases or hypercalcaemia were excluded. RESULTS: 110,046 25OHD measurements were identified over the 11.5 years period. After removal of ineligible measurements, 42,171 25OHD measurements from 32,386 individuals with at least 2 of aCa, PTH and ALP were included in analyses. Median 25OHD was 63 nmol/L; 8% were <25 nmol/L, and 33% were <50 nmol/L. Five index 25OHD measurements met the definition of biochemical osteomalacia, and another 11 were possible osteomalacia. After reviewing available clinical records for these 16 episodes, we classified 9 cases as osteomalacia and 7 as other diagnoses. Thus, the prevalence of biochemical osteomalacia was 0.02% (9/42,171) for 25OHD measurements and 0.23% (8/3432) for 25OHD<25 nmol/L. All cases of osteomalacia with 25OHD measurements prior to supplementation had 25OHD≤18 nmol/L. CONCLUSION: The prevalence of biochemical osteomalacia is very low, even in individuals with 25OHD<25 nmol/L.


Assuntos
Osteomalacia , Deficiência de Vitamina D , Adulto , Humanos , Osteomalacia/epidemiologia , Hormônio Paratireóideo , Prevalência , Vitamina D , Deficiência de Vitamina D/complicações , Deficiência de Vitamina D/epidemiologia
5.
Sci Eng Ethics ; 26(4): 2069-2096, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-31673984

RESUMO

Authorship transgressions, duplicate data reporting and reporting/data errors compromise the integrity of biomedical publications. Using a standardized template, we raised concerns with journals about each of these characteristics in 33 pairs of publications originating from 15 preclinical (animal) trials reported by a group of researchers. The outcomes of interest were journal responses, including time to acknowledgement of concerns, time to decision, content of decision letter, and disposition of publications at 1 year. Authorship transgressions affected 27/36 (75%) publications. The median proportion of duplicate data within pairs of publications was 45% (interquartile range 29-57). Data/reporting discrepancies [median 3 (1-5)] were present in 28/33 (85%) pairs. Journals acknowledged receipt of concerns for 53% and 94% of publications by 1 month and 9 months, respectively. After 1 year, journals had communicated decisions for 16/36 (44%) publications. None of the decision letters specifically addressed each of the concerns raised. Decisions were no action, correction and retraction for 9, 3 and 4 publications, respectively: the amounts of duplicate data reporting and data/reporting discrepancies were similar irrespective of journal decision. Authorship transgressions affected 6/9 (67%) publications for which no action was decided. Journal responses to concerns about duplicate publication, authorship transgressions, and data/reporting discrepancies were slow, opaque and inconsistent.


Assuntos
Autoria , Pesquisa Biomédica , Animais , Editoração
6.
Calcif Tissue Int ; 105(4): 423-429, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31250043

RESUMO

INTRODUCTION: Most prospective studies of bone mineral density (BMD) in HIV-infected cohorts taking antiretroviral therapy (ART) have been of short duration, typically < 3 years. Such studies have reported short-term stable or increasing BMD. We assessed whether this BMD stability persists for > 10 years in middle-aged and older men established on ART. METHODS: A 12-year, prospective, longitudinal study in 44 HIV-infected men treated with ART who had measurements of BMD at the lumbar spine, proximal femur and total body at baseline, 2, 6 and 12 years. RESULTS: At baseline, the mean age of participants was 49 years, the mean duration of HIV infection was 8 years, and the mean duration of ART was 50 months. After 12 years, BMD increased by 6.9% (95% CI 3.4 to 10.3) at the lumbar spine, and remained stable (range of BMD change: - 0.6% to 0.0%) at the total hip, femoral neck and total body. Only two individuals had a decrease of > 10% in BMD at any site during follow-up and both decreases in BMD were explained by co-morbid illnesses. CONCLUSIONS: BMD remained stable over 12 years in middle-aged and older HIV-infected men treated with ART. Monitoring BMD in men established on ART who do not have risk factors for BMD loss is not necessary.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Densidade Óssea/efeitos dos fármacos , Infecções por HIV/tratamento farmacológico , Osteoporose/tratamento farmacológico , Adulto , Idoso , Feminino , Infecções por HIV/complicações , Humanos , Vértebras Lombares/cirurgia , Masculino , Pessoa de Meia-Idade , Osteoporose/complicações , Estudos Prospectivos , Fatores de Risco
8.
Calcif Tissue Int ; 102(1): 73-84, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29018897

RESUMO

INTRODUCTION: Numerous observational studies have reported that serum urate concentration positively correlates with bone density and reduced risk of fractures. The aim of this study was to examine whether soluble urate directly influences bone remodelling. METHODS: In laboratory studies, the in vitro effects of soluble urate were examined in osteoclast, osteoblast and osteocyte assays at a range of urate concentrations consistent with those typically observed in humans (up to 0.70 mmol/L). The clinical relevance of the in vitro assay findings was assessed using serial procollagen-1 N-terminal propeptide (P1NP) and Month 12 bone density data from a randomised controlled trial of allopurinol dose escalation in people with gout. RESULTS: Addition of urate in the RAW264.7 cell osteoclastogenesis assay led to small increases in osteoclast formation (ANOVA p = 0.018), but no significant difference in bone resorption. No significant effects on osteoclast number or activity were observed in primary cell osteoclastogenesis or resorption assays. Addition of urate did not alter viability or function in MC3T3-E1 pre-osteoblast, primary human osteoblast, or MLO-Y4 osteocyte assays. In the clinical trial analysis, reducing serum urate over a 12 month period by allopurinol dose escalation did not lead to significant changes in P1NP or differences in bone mineral density. CONCLUSION: Addition of soluble urate at physiological concentrations does not influence bone remodelling in vitro. These data, together with clinical trial data showing no effect of urate-lowering on P1NP or bone density, do not support a direct role for urate in influencing bone remodelling.


Assuntos
Remodelação Óssea/efeitos dos fármacos , Osteoclastos/efeitos dos fármacos , Osteócitos/efeitos dos fármacos , Ácido Úrico/farmacologia , Remodelação Óssea/fisiologia , Reabsorção Óssea/metabolismo , Osso e Ossos/efeitos dos fármacos , Osso e Ossos/metabolismo , Diferenciação Celular/efeitos dos fármacos , Humanos , Osteoclastos/metabolismo , Osteócitos/metabolismo , Osteogênese/efeitos dos fármacos
9.
BMC Med Res Methodol ; 18(1): 103, 2018 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-30305046

RESUMO

BACKGROUND: Research waste is estimated to be very common, but assessments of its prevalence and scope are rare. As an example, we assessed research waste in clinical research on calcium intake (assessing study design and endpoint type) and vitamin D supplementation (assessing endpoint type). METHODS: We examined 404 randomised controlled trials (RCTs) and observational studies of calcium intake (diet or supplements) and bone mineral density (BMD) or fracture, and 547 RCTs of vitamin D supplements, and assessed the proportion of studies that used surrogate or clinical endpoints. For studies with BMD or fracture as an endpoint, we estimated when the 'tipping' point occurred indicating the need for RCTs with fracture as an endpoint (based on cumulative meta-analyses of BMD RCTs, and chronological review of observational studies), and whether each study published at least 5y after the tipping point was novel, added new clinical knowledge or was research waste. RESULTS: Observational studies of calcium intake and BMD or fracture outnumbered RCTs by 3.3-4.5 times. For both calcium intake and vitamin D supplements, studies using surrogate endpoints outnumbered studies using clinical endpoints by 1.6-3 times. Of 41 RCT publications of calcium intake and BMD or fracture published at least 5y after the tipping point in 1994, we considered that 19 (46%) lacked novelty, another 13 (32%) added no new clinical knowledge, and 30 (73%) were research waste. Of 204 observational study publications of calcium intake and BMD or fracture, 197 (96%) lacked novelty, another 5 (2%) added no new clinical knowledge, and 202 (99%) were research waste. Of 39 RCTs of vitamin D supplementation and BMD or fracture published at least 5y after the tipping point in 1999, 14 (36%) lacked novelty, another 13 (33%) added no new clinical knowledge, and 27 (69%) were research waste. CONCLUSIONS: A high proportion of studies of calcium intake since 2000 (95%) and trials of vitamin D supplements since 2005 (69%) on BMD or fracture represent research waste.


Assuntos
Densidade Óssea/efeitos dos fármacos , Cálcio/administração & dosagem , Suplementos Nutricionais , Resíduos de Serviços de Saúde/estatística & dados numéricos , Vitamina D/administração & dosagem , Adulto , Determinação de Ponto Final , Fraturas Ósseas/prevenção & controle , Humanos , Resíduos de Serviços de Saúde/economia , Resíduos de Serviços de Saúde/prevenção & controle , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Vitaminas/administração & dosagem
10.
BMC Med Res Methodol ; 18(1): 101, 2018 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-30285729

RESUMO

BACKGROUND: Research waste can occur when trials are conducted in the wrong populations. Vitamin D deficient populations are most likely to benefit from vitamin D supplementation. We investigated waste attributable to randomised controlled trials (RCTs) of supplementation in populations that were not vitamin D deficient. METHODS: In December 2015, we searched Pubmed, recent systematic reviews, and three trial registries for RCTs of vitamin D with clinical endpoints in adults, and 25-hydroxvitamin D (25OHD) survey data relevant to large (N ≥ 1000) RCTs. We investigated the proportion of RCTs that studied vitamin D deficient populations, temporal trends in baseline 25OHD, and whether investigators in large RCTs considered relevant 25OHD survey data or systematic reviews in their trial justifications. RESULTS: Of 137 RCTs of vitamin D with clinical endpoints, 118 (86%) reported baseline mean/median 25OHD, which was < 25, 25-49, 50-74, and ≥ 75 nmol/L in 12 (10%), 62 (53%), 36 (31%), and 8 (7%) RCTs, respectively. In 70% of RCTs, baseline 25OHD was > 40 nmol/L. Baseline 25OHD increased over time. Before 2006, 38%, 62%, 0% and 0% of RCTs had baseline 25OHD < 25, 25-49, 50-74, and ≥ 75 nmol/L respectively; in 2011-15, the respective proportions were 9%, 49%, 37%, and 6%. Of 12 RCTs with baseline 25OHD < 25 nmol/L, 8 had neutral findings. Of 25 large RCTs (18 completed, 7 ongoing), 1 was undertaken in a vitamin D deficient population, 3 in vitamin D insufficient populations, and 17 had, or probably will have, baseline 25OHD > 40 nmol/L. 44% (8/18) of large completed RCTs cited relevant prior population 25OHD data, and only 3/10 (30%) relevant prior systematic reviews. CONCLUSIONS: Up to 70% of RCTs of vitamin D with clinical endpoints, 71% of large completed RCTs, and 100% of ongoing large RCTs could be considered research waste because they studied cohorts that were not vitamin D deficient.


Assuntos
Suplementos Nutricionais , Resíduos de Serviços de Saúde/estatística & dados numéricos , Deficiência de Vitamina D/tratamento farmacológico , Vitamina D/administração & dosagem , Adulto , Humanos , Resíduos de Serviços de Saúde/economia , Resíduos de Serviços de Saúde/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto , Vitaminas/administração & dosagem
13.
Ann Behav Med ; 51(6): 899-911, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28474286

RESUMO

BACKGROUND: Osteoporosis is a degenerative bone disorder that disproportionately affects older women worldwide. Raising awareness regarding osteoporosis within this demographic is significant for health promotion. Initial evidence suggests that visualisations of illness and treatment can improve illness perceptions, increase treatment motivations and even promote health behaviours. We are yet to understand whether different visualisation mediums vary in their impact on perceptions and motivations. PURPOSE: We investigated whether physical models or virtual animations had a greater impact on changing perceptions of osteoporosis and treatment motivation in an at-risk population of older women. METHODS: A total of 128 women aged 50 and over were randomly assigned to view a brief presentation about osteoporosis using either 3-D printed bone models or electronic tablet animations. Illness perceptions, medication beliefs and motivations were measured at baseline and post-presentation. Mixed ANOVAs were used to identify significant changes over time between groups. RESULTS: There were no significant interaction effects, revealing that neither medium had a greater impact on beliefs over time. Significant main effects of time revealed that from baseline to post-presentation, both mediums increased consequence beliefs, personal and treatment control, understanding of osteoporosis, motivations to take treatment if needed and medication necessity beliefs. Timeline beliefs and medication concerns decreased over time for both groups. CONCLUSIONS: Both 3-D models and animations of osteoporosis are equally effective in changing beliefs and treatment motivation in an at-risk population. Visualisation devices are brief, cost-effective, have high acceptability and have considerable clinical applicability to promote awareness and prevention.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Promoção da Saúde/métodos , Modelos Anatômicos , Osteoporose/psicologia , Osteoporose/terapia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Educação de Pacientes como Assunto/métodos , Idoso , Desenhos Animados como Assunto , Feminino , Humanos , Pessoa de Meia-Idade , Osteoporose/tratamento farmacológico , Resultado do Tratamento
14.
CMAJ ; 189(15): E553-E559, 2017 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-27993918

RESUMO

BACKGROUND: Media coverage of medical research influences the views and behaviours of clinicians, scientists and members of the public. We examined how frequently commenters in news stories about medical research have relevant expertise and have academic and financial conflicts, how often such conflicts are reported and whether there are associations between the conflicts and the disposition of the comments toward the findings of the source research. METHODS: We analyzed 104 independent comments in news stories on original clinical research published in high-impact medical journals from Jan. 1 to Mar. 31, 2013, and 21 related journal editorials. Main outcomes were prevalence of relevant academic and clinical expertise, prevalence and reporting of academic and financial conflicts of interest, and disposition of comments toward study findings. RESULTS: Only 1 in 6 news stories included independent comments. Overall, 25% of commenters and 0% of editorialists had neither relevant academic nor clinical expertise (p = 0.007). Among the 104 comments, an academic conflict of interest was present for 56 (54%), of which 25 (45%) were reported in the news stories. A financial conflict of interest was present for 33 (32%) of the comments, of which 11 (33%) were reported. When commenters' conflicts of interest were congruent with the findings of the source research, 97% and 93% of comments associated with academic and financial conflicts of interest, respectively, were favourably disposed toward the research. These values were 16% and 17%, respectively, when the conflicts of interest were not congruent with the research findings. INTERPRETATION: Independent commenters in new stories about medical research may lack relevant academic or clinical expertise. Academic or financial conflicts of interest were frequently present among independent commenters but infrequently reported, and were often associated with the disposition of comments about the source research.


Assuntos
Pesquisa Biomédica , Conflito de Interesses , Humanos , Meios de Comunicação de Massa/normas , Publicações Periódicas como Assunto/normas
15.
CMAJ ; 189(36): E1130-E1136, 2017 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-28893875

RESUMO

BACKGROUND: Intravenous zoledronate 5 mg annually reduces fracture risk, and 5 mg every 2 years prevents bone loss, but the optimal dosing regimens for these indications are uncertain. METHODS: We conducted a 3-year open-label extension of a 2-year randomized, placebo-controlled, double-blind study. Late postmenopausal women with osteopenia were assigned to receive a single baseline dose of 1 mg, 2.5 mg or 5 mg of zoledronate or placebo. The primary outcome was change in spine bone mineral density (BMD). Secondary outcomes were changes in hip BMD and serum markers of bone turnover. RESULTS: The study involved 160 women. Zoledronate increased BMD and reduced markers of bone turnover in a dose-dependent manner. After 2 years, the 1-mg, 2.5-mg and 5-mg zoledronate doses increased spine BMD over placebo by 5.0% (95% confidence interval [CI] 3.0% to 7.0%), 5.7% (95% CI 3.7% to 7.7%) and 5.7% (95% CI 3.7% to 7.6%), respectively; after 5 years, the respective increases were 2.0% (95% CI -1.1% to 5.0%), 2.2% (95% CI -1.0% to 5.4%) and 5.1% (95% CI 2.2% to 8.1%). After 2 years, the 1-mg, 2.5-mg and 5-mg zoledronate doses increased total hip BMD over placebo by 2.6% (95% CI 1.3% to 3.9%), 4.1% (95% CI 2.9% to 5.4%) and 4.7% (95% CI 3.4% to 5.9%), respectively; after 5 years, the respective increases were 1.8% (95% CI -0.1% to 3.8%), 2.8% (95% CI 0.8% to 4.8%) and 5.4% (95% CI 3.5% to 7.3%). BMD remained above baseline values for 2-3 years in the 1-mg group, 3-4 years in the 2.5-mg group and at least 5 years in the 5-mg group. INTERPRETATION: The antiresorptive activity of single zoledronate doses of 1-5 mg persist for at least 3 years in postmenopausal women with osteopenia. Clinical trials would be justified to evaluate the effects on fracture risk of less frequent or lower doses of zoledronate than are currently recommended. TRIAL REGISTRATION: www.anzctr.org.au, no. ACTRN12607000576426.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Difosfonatos/uso terapêutico , Imidazóis/uso terapêutico , Osteoporose Pós-Menopausa/tratamento farmacológico , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/administração & dosagem , Difosfonatos/administração & dosagem , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Imidazóis/administração & dosagem , Infusões Intravenosas , Pessoa de Meia-Idade , Coluna Vertebral/efeitos dos fármacos , Ácido Zoledrônico
16.
Clin Endocrinol (Oxf) ; 84(5): 687-92, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26668071

RESUMO

OBJECTIVE: Numerous guidelines advise about management of osteoporosis, but little research has been conducted on their recommendations. We analysed recommendations on management of bone health in clinical guidelines. DESIGN: We surveyed recommendations on assessment, treatment and monitoring of bone health in 78 clinical guidelines (22 primary focus osteoporosis, 56 primary focus not osteoporosis) lodged at the Agency for Health Research and Quality National Guidelines Clearinghouse between 1/1/2009 and 12/31/2014. MEASUREMENTS: Governance of guidelines; discussion of fracture risk in the target population; recommendations for assessment, treatment and monitoring of bone health. RESULTS: Only 14% of guidelines discussed fracture risk in the target population. When guidelines discussed assessment, 98% recommended bone mineral density (BMD) measurement but only 27% recommended estimation of fracture risk. When guidelines discussed treatment, 63-71% recommended calcium and/or vitamin D, while <12% recommended avoiding low body weight or smoking cessation. When guidelines discussed intervention, 53% did so on the basis of BMD measurement, and only 27% on the basis of estimated fracture risk. When guidelines discussed monitoring, >90% recommended BMD measurements, and only 3% recommended estimation of fracture risk. About 65% of guidelines that suggested a BMD monitoring interval recommended one of ≤3 years. Compared to guidelines with a primary focus on osteoporosis, guidelines whose primary focus was not osteoporosis were less likely to discuss fracture risk in the target population (2% vs 45%), recommend estimation of fracture risk (11% vs 55%) and recommend intervention on the basis of estimated fracture risk (10% vs 67%) (all P < 0·005). CONCLUSIONS: Our findings highlight a strong focus in clinical guidelines on BMD, a surrogate measure, rather than fracture risk, the clinically important outcome, particularly when bone health is not the primary focus. Addressing this issue might facilitate more rational use of resources and improve patient care.


Assuntos
Gerenciamento Clínico , Osteoporose/diagnóstico , Osteoporose/terapia , Guias de Prática Clínica como Assunto/normas , Densidade Óssea , Conservadores da Densidade Óssea/uso terapêutico , Cálcio da Dieta/uso terapêutico , Coleta de Dados/métodos , Coleta de Dados/estatística & dados numéricos , Exercício Físico , Fraturas Ósseas/complicações , Humanos , Osteoporose/etiologia , Fatores de Risco , Abandono do Hábito de Fumar , Vitamina D/uso terapêutico , Vitaminas/uso terapêutico
17.
Diabetologia ; 58(10): 2238-46, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26109213

RESUMO

AIMS/HYPOTHESIS: Thiazolidinediones (TZDs) are associated with an increased risk of fracture but the mechanism is unclear. We sought to determine the effect of TZDs on bone mineral density (BMD) and bone turnover markers. METHODS: PubMed, EMBASE and Cochrane CENTRAL databases were searched from inception until January 2015 for randomised controlled trials comparing TZDs with metformin, sulfonylureas or placebo, and those reporting changes in BMD and/or bone turnover markers. The primary outcome was percentage change in BMD from baseline and results were pooled with random effects meta-analyses. RESULTS: In all, 18 trials were included in the primary analyses and another two were included in the sensitivity analyses (n = 3,743, 50% women, mean age 56 years, median trial duration 48 weeks). TZDs decreased BMD at the lumbar spine (difference -1.1% [95% CI -1.6, -0.7]; p < 0.0001), total hip (-1.0% [-1.4, -0.6]; p < 0.0001) and forearm (-0.9% [-1.6, -0.3]; p = 0.007). There were statistically non-significant decreases in BMD at the femoral neck (-0.7% [-1.4, 0.0]; p = 0.06) and total body (-0.3% [-0.5, 0.0]; p = 0.08). Five trials (n = 450) showed no statistically significant difference in percentage change in BMD between the TZD group and controls up to 1 year following TZD withdrawal. In 14 trials, the effect of TZD treatment on turnover markers varied considerably between individual studies. CONCLUSIONS/INTERPRETATION: Treatment with TZDs results in modest bone loss that may not be reversed 1 year after cessation of treatment.


Assuntos
Densidade Óssea/efeitos dos fármacos , Remodelação Óssea/efeitos dos fármacos , Fraturas Ósseas/etiologia , Tiazolidinedionas/farmacologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tiazolidinedionas/efeitos adversos , Tiazolidinedionas/uso terapêutico
18.
Lancet ; 383(9912): 146-55, 2014 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-24119980

RESUMO

BACKGROUND: Findings from recent meta-analyses of vitamin D supplementation without co-administration of calcium have not shown fracture prevention, possibly because of insufficient power or inappropriate doses, or because the intervention was not targeted to deficient populations. Despite these data, almost half of older adults (older than 50 years) continue to use these supplements. Bone mineral density can be used to detect biologically significant effects in much smaller cohorts. We investigated whether vitamin D supplementation affects bone mineral density. METHODS: We searched Web of Science, Embase, and the Cochrane Database, from inception to July 8, 2012, for trials assessing the effects of vitamin D (D3 or D2, but not vitamin D metabolites) on bone mineral density. We included all randomised trials comparing interventions that differed only in vitamin D content, and which included adults (average age >20 years) without other metabolic bone diseases. We pooled data with a random effects meta-analysis with weighted mean differences and 95% CIs reported. To assess heterogeneity in results of individual studies, we used Cochran's Q statistic and the I(2) statistic. The primary endpoint was the percentage change in bone mineral density from baseline. FINDINGS: Of 3930 citations identified by the search strategy, 23 studies (mean duration 23·5 months, comprising 4082 participants, 92% women, average age 59 years) met the inclusion criteria. 19 studies had mainly white populations. Mean baseline serum 25-hydroxyvitamin D concentration was less than 50 nmol/L in eight studies (n=1791). In ten studies (n=2294), individuals were given vitamin D doses less than 800 IU per day. Bone mineral density was measured at one to five sites (lumbar spine, femoral neck, total hip, trochanter, total body, or forearm) in each study, so 70 tests of statistical significance were done across the studies. There were six findings of significant benefit, two of significant detriment, and the rest were non-significant. Only one study showed benefit at more than one site. Results of our meta-analysis showed a small benefit at the femoral neck (weighted mean difference 0·8%, 95% CI 0·2-1·4) with heterogeneity among trials (I(2)=67%, p<0·00027). No effect at any other site was reported, including the total hip. We recorded a bias toward positive results at the femoral neck and total hip. INTERPRETATION: Continuing widespread use of vitamin D for osteoporosis prevention in community-dwelling adults without specific risk factors for vitamin D deficiency seems to be inappropriate. FUNDING: Health Research Council of New Zealand.


Assuntos
Densidade Óssea/efeitos dos fármacos , Vitamina D/farmacologia , Idoso , Colecalciferol/farmacologia , Suplementos Nutricionais , Ergocalciferóis/farmacologia , Feminino , Humanos , Masculino , Osteoporose/prevenção & controle
19.
Clin Endocrinol (Oxf) ; 82(1): 12-22, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25039381

RESUMO

Osteoporotic fractures are an important public health problem with significant individual and societal costs. In addition to the major risk factors for osteoporotic fracture, low bone mineral density (BMD), age, low body weight and history of fracture or falls, some drugs are now considered to be important secondary risk factor for bone loss and fracture, particularly amongst predisposed individuals. Currently available data are often generated from small observational clinical studies, making risk assessment and development of management guidelines difficult. In many cases, the exposed population has a low baseline risk for fracture and additional assessment and treatment may not be necessary. In this review, we focus on drugs other than glucocorticoids identified as potentially causing adverse skeletal effects, summarizing the existing evidence from preclinical and clinical studies, and suggest recommendations for patient management.


Assuntos
Densidade Óssea/efeitos dos fármacos , Fraturas Ósseas/induzido quimicamente , Osteoporose/induzido quimicamente , Humanos
20.
Pharmacoepidemiol Drug Saf ; 24(6): 592-9, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25851232

RESUMO

PURPOSE: The belief that one is especially sensitive to the actions and side effects of medicines can influence treatment adherence and side-effect reporting. In this study, we investigated the prevalence of perceived medication sensitivity in the general population and its relationship to symptom complaints, information seeking about medications, use of medical care and demographic factors. METHODS: A nationally representative sample of 1000 New Zealand residents completed the Perceived Sensitivity to Medicines scale and symptoms experienced during the previous 7 days. Demographic data and medical visits, medication use and information seeking about medicines were also collected. RESULTS: Over 20% of the general population reported being very sensitive to the effects of medication (20.2%) and that small amounts of medicines can upset their body (25.3%). Participants who reported high levels of perceived sensitivity to medicines reported significantly more symptoms (M = 9.54, SE = 0.47) than people with low (M = 5.04, SE = 0.49) or moderate (M = 5.91, SE = 0.24) levels, ps < .001. This relationship was strongest in participants who were currently taking prescription medication. Those with high perceived sensitivity also reported being more likely to seek information about medicines, and had significantly more general practitioner visits. CONCLUSIONS: Perceived sensitivity to medicines is common in the population and associated with important clinical variables including information seeking, GP visits and symptom reporting. Identifying patients with higher perceived sensitivity to medicines may improve patient care by providing the basis for targeted and personalised interventions to reduce side effects and improve adherence to medications.


Assuntos
Hipersensibilidade a Drogas/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Adesão à Medicação , Aceitação pelo Paciente de Cuidados de Saúde , Adolescente , Adulto , Qualidade de Produtos para o Consumidor , Hipersensibilidade a Drogas/psicologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia/epidemiologia , Adulto Jovem
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