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1.
Am J Epidemiol ; 193(1): 47-57, 2024 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-37579305

RESUMO

Evidence from clinical trials and observational studies on the association between thiazide diuretics and colorectal cancer risk is conflicting. We aimed to determine whether thiazide diuretics are associated with an increased colorectal cancer risk compared with dihydropyridine calcium channel blockers (dCCBs). A population-based, new-user cohort was assembled using the UK Clinical Practice Research Datalink. Between 1990-2018, we compared thiazide diuretic initiators with dCCB initiators and estimated hazard ratios (HR) with 95% confidence intervals (CIs) of colorectal cancer using Cox proportional hazard models. Models were weighted using standardized morbidity ratio weights generated from calendar time-specific propensity scores. The cohort included 377,760 thiazide diuretic initiators and 364,300 dCCB initiators, generating 3,619,883 person-years of follow-up. Compared with dCCBs, thiazide diuretics were not associated with colorectal cancer (weighted HR = 0.97, 95% CI: 0.90, 1.04). Secondary analyses yielded similar results, although an increased risk was observed among patients with inflammatory bowel disease (weighted HR = 2.45, 95% CI: 1.13, 5.35) and potentially polyps (weighted HR = 1.46, 95% CI: 0.93, 2.30). Compared with dCCBs, thiazide diuretics were not associated with an overall increased colorectal cancer risk. While these findings provide some reassurance, research is needed to corroborate the elevated risks observed among patients with inflammatory bowel disease and history of polyps.


Assuntos
Neoplasias Colorretais , Hipertensão , Doenças Inflamatórias Intestinais , Humanos , Inibidores de Simportadores de Cloreto de Sódio/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Estudos de Coortes , Doenças Inflamatórias Intestinais/induzido quimicamente , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/tratamento farmacológico , Neoplasias Colorretais/epidemiologia , Diuréticos/efeitos adversos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia
2.
J Am Heart Assoc ; 11(24): e026789, 2022 12 20.
Artigo em Inglês | MEDLINE | ID: mdl-36515246

RESUMO

Background Recent studies have reported that dihydropyridine calcium channel blockers (dCCBs) may increase the risk of pancreatic cancer, but these studies had methodological limitations. We thus aimed to determine whether dCCBs are associated with an increased risk of pancreatic cancer compared with thiazide diuretics, a clinically relevant comparator. Methods and Results We conducted a new user, active comparator, population-based cohort study using the UK Clinical Practice Research Datalink. We identified new users of dCCBs and new users of thiazide diuretics between 1990 and 2018, with follow-up until 2019. Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% CIs for pancreatic cancer, comparing dCCBs with thiazide diuretics. Models were weighted using standardized morbidity ratio weights based on calendar time-specific propensity scores. We also conducted secondary analyses by cumulative duration of use, time since initiation, and individual drugs and assessed for the presence of effect modification by age, sex, smoking status, body mass index, history of chronic pancreatitis, and diabetes. The cohort included 344 480 initiators of dCCBs and 357 968 initiators of thiazide diuretics, generating 3 360 745 person-years of follow-up. After a median follow-up of 4.5 years, the weighted incidence rate per 100 000 person-years was 37.2 (95% CI, 34.1-40.4) for dCCBs and 39.4 (95% CI, 36.1-42.9) for thiazide diuretics. Overall, dCCBs were not associated with an increased risk of pancreatic cancer (weighted HR, 0.93; 95% CI, 0.80-1.09). Similar results were observed in secondary analyses. Conclusions In this large, population-based cohort study, dCCBs were not associated with an increased risk of pancreatic cancer compared with thiazide diuretics. These findings provide reassurance regarding the long-term pancreatic cancer safety of these drugs.


Assuntos
Di-Hidropiridinas , Hipertensão , Neoplasias Pancreáticas , Humanos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Inibidores de Simportadores de Cloreto de Sódio/efeitos adversos , Estudos de Coortes , Neoplasias Pancreáticas/induzido quimicamente , Neoplasias Pancreáticas/epidemiologia , Neoplasias Pancreáticas/complicações , Di-Hidropiridinas/uso terapêutico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipertensão/induzido quimicamente
3.
BMJ Open ; 12(6): e057510, 2022 06 10.
Artigo em Inglês | MEDLINE | ID: mdl-35688595

RESUMO

OBJECTIVES: To describe the prescribing trends of antihypertensive drugs in primary care patients and assess the trajectory of antihypertensive drug prescriptions, from first-line to third-line, in patients with hypertension according to changes to the United Kingdom (UK) hypertension management guidelines. DESIGN: Population-based cohort study. SETTING AND PARTICIPANTS: We used the UK Clinical Practice Research Datalink, an electronic primary care database representative of the UK population. Between 1988 and 2018, we identified all adult patients with at least one prescription for a thiazide diuretic, angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blocker, beta-blocker or calcium channel blocker (CCB). PRIMARY AND SECONDARY OUTCOME MEASURES: We estimated the period prevalence of patients with antihypertensive drug prescriptions for each calendar year over a 31-year period. Treatment trajectory was assessed by identifying patients with hypertension newly initiating an antihypertensive drug, and treatment changes were defined by a switch or add-on of a new class. This cohort was stratified before and after 2007, the year following important changes to UK hypertension management guidelines. RESULTS: The cohort included 2 709 241 patients. The prevalence of primary care patients with antihypertensive drug prescriptions increased from 7.8% (1988) to 21.9% (2018) and was observed for all major classes except thiazide diuretics. Patients with hypertension initiated thiazide diuretics (36.8%) and beta-blockers (23.6%) as first-line drugs before 2007, and ACE inhibitors (39.9%) and CCBs (31.8%) after 2007. After 2007, 17.3% were not prescribed guideline-recommended first-line agents. Overall, patients were prescribed a median of 2 classes (IQR 1-2) after first-line treatment. CONCLUSION: Nearly one-quarter of primary care patients were prescribed antihypertensive drugs by the end of the study period. Most patients with hypertension initiated guideline-recommended first-line agents. Not all patients, particularly females, were prescribed recommended agents however, potentially leading to suboptimal cardiovascular outcomes. Future research should aim to better understand the implication of this finding.


Assuntos
Anti-Hipertensivos , Hipertensão , Antagonistas Adrenérgicos beta/uso terapêutico , Adulto , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bloqueadores dos Canais de Cálcio/uso terapêutico , Estudos de Coortes , Feminino , Humanos , Hipertensão/induzido quimicamente , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Atenção Primária à Saúde , Inibidores de Simportadores de Cloreto de Sódio/uso terapêutico
4.
Mult Scler ; 28(9): 1467-1480, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35387508

RESUMO

BACKGROUND: With many disease-modifying therapies currently approved for the management of multiple sclerosis, there is a growing need to evaluate the comparative effectiveness and safety of those therapies from real-world data sources. Propensity score methods have recently gained popularity in multiple sclerosis research to generate real-world evidence. Recent evidence suggests, however, that the conduct and reporting of propensity score analyses are often suboptimal in multiple sclerosis studies. OBJECTIVES: To provide practical guidance to clinicians and researchers on the use of propensity score methods within the context of multiple sclerosis research. METHODS: We summarize recommendations on the use of propensity score matching and weighting based on the current methodological literature, and provide examples of good practice. RESULTS: Step-by-step recommendations are presented, starting with covariate selection and propensity score estimation, followed by guidance on the assessment of covariate balance and implementation of propensity score matching and weighting. Finally, we focus on treatment effect estimation and sensitivity analyses. CONCLUSION: This comprehensive set of recommendations highlights key elements that require careful attention when using propensity score methods.


Assuntos
Esclerose Múltipla , Humanos , Esclerose Múltipla/terapia , Pontuação de Propensão
5.
Mult Scler ; 28(9): 1317-1323, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-33179573

RESUMO

BACKGROUND: Propensity score (PS) analyses are increasingly used in multiple sclerosis (MS) research, largely owing to the greater availability of large observational cohorts and registry databases. OBJECTIVE: To evaluate the use and quality of reporting of PS methods in the recent MS literature. METHODS: We searched the PubMed database for articles published between January 2013 and July 2019. We restricted the search to comparative effectiveness studies of two disease-modifying therapies. RESULTS: Thirty-nine studies were included in the review, with most studies (62%) published within the past 3 years. All studies reported the list of covariates used for the PS model, but only 21% of studies mentioned how those covariates were selected. Most studies used PS matching (72%), followed by PS adjustment (18%), weighting (15%), and stratification (3%), with some overlap. Most studies using matching or weighting reported checking post-PS covariate imbalance (91%), although about 45% of these studies relied on p values from various statistical tests. Only 25% of studies using matching reported calculating robust standard errors for the PS analyses. CONCLUSIONS: The quality of reporting of PS methods in the MS literature is sub-optimal in general, and in some cases, inappropriate methods are used.


Assuntos
Esclerose Múltipla , Humanos , Esclerose Múltipla/epidemiologia , Esclerose Múltipla/terapia , Pontuação de Propensão
6.
Drug Saf ; 45(1): 65-74, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34714528

RESUMO

INTRODUCTION: There are conflicting reports on the effects of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) on acute pancreatitis incidence. OBJECTIVE: The aim was to determine whether use of ACE inhibitors and ARBs is associated with the incidence of acute pancreatitis, compared with use of dihydropyridine calcium channel blockers (dCCBs). METHODS: We assembled two population-based, new-user, active comparator cohorts using the United Kingdom Clinical Practice Research Datalink linked to the Hospital Episode Statistics repository and Office for National Statistics from 1998 to 2018, with follow-up until 2019. The first cohort included 304,083 ACE inhibitor initiators and 194,431 dCCB initiators. The second cohort included 29,160 ARB initiators and 203,610 dCCB initiators. Cox proportional hazards models were fit to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of acute pancreatitis, comparing ACE inhibitors and ARBs, separately, with dCCBs. Models were weighted using standardized mortality ratio weights generated from calendar time-specific propensity scores. RESULTS: ACE inhibitors were associated with an increased risk of acute pancreatitis, compared with dCCBs (64.3 vs 45.2 per 100,000 person-years, respectively; HR 1.45, 95% CI 1.15-1.83). The number needed to harm after 2 and 5 years of use was 2438 and 1019, respectively. In contrast, ARBs were not associated with an increased risk of acute pancreatitis, compared with dCCBs (40.1 vs 47.6 per 100,000 person-years, respectively; HR 0.88, 95% CI 0.60-1.31). CONCLUSIONS: ACE inhibitors were associated with a modest increased risk of acute pancreatitis compared with dCCBs. This association should be balanced with the known clinical benefits of ACE inhibitors in hypertension management. In contrast, no association was observed with ARBs.


Assuntos
Antagonistas de Receptores de Angiotensina , Pancreatite , Doença Aguda , Antagonistas de Receptores de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Bloqueadores dos Canais de Cálcio/efeitos adversos , Estudos de Coortes , Humanos , Pancreatite/induzido quimicamente , Pancreatite/tratamento farmacológico , Pancreatite/epidemiologia , Sistema Renina-Angiotensina
7.
CMAJ Open ; 9(2): E607-E612, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34088731

RESUMO

BACKGROUND: Although there are concerns that inadequate breast positioning in mammographic examinations may lead to cancers being missed, few studies have examined the quality of breast positioning, especially in the Canadian context. Our objective was to assess the quality of breast positioning in mammographic examinations in a Quebec-wide representative sample of technologists. METHODS: This quality improvement study was part of a professional inspection launched by the Ordre des technologues en imagerie médicale, en radio-oncologie et en électrophysiologie médicale du Québec among its members. The inspection was conducted between May and July 2017 on a proportionate stratified random sample of all active technologists certified in mammography in Quebec. Each technologist provided images from 15 consecutive mammographic examinations they performed in the previous 6 months. The quality of positioning was then evaluated by senior technologists using a quality assessment tool specifically developed for this inspection. A technologist was deemed to have failed the professional inspection when at least 7 of the 15 mammographic examinations were scored as critical failures. Proportions were calculated accounting for sampling weights and correction for finite population. RESULTS: Among the 520 technologists certified in mammography in Quebec, 76 technologists (14.6%) were randomly selected for the professional inspection and contributed images from 1127 mammographic examinations. Thirty-eight technologists (weighted percentage 50.3%, 95% confidence interval [CI] 37.6% to 63.0%) failed the professional inspection. Overall, 492 mammographic examinations (43.7%, 95% CI 38.6% to 48.8%) had at least 1 image scored as a critical failure. INTERPRETATION: Half of the technologists performing mammographic examinations in Quebec who participated in this study failed the inspection, and a substantial proportion of their mammographic examinations demonstrated critical failures in breast positioning. Overall, our findings are concordant with those of previous studies and highlight the need for additional investigations assessing the quality of breast positioning in mammographic examinations in other jurisdictions.


Assuntos
Doenças Mamárias , Mamografia , Posicionamento do Paciente/métodos , Doenças Mamárias/diagnóstico , Doenças Mamárias/epidemiologia , Competência Clínica , Feminino , Humanos , Mamografia/métodos , Mamografia/normas , Mamografia/estatística & dados numéricos , Programas de Rastreamento/métodos , Pessoal de Laboratório Médico/normas , Pessoa de Meia-Idade , Avaliação das Necessidades , Melhoria de Qualidade/organização & administração , Quebeque/epidemiologia , Tecnologia Radiológica/educação , Tecnologia Radiológica/normas
8.
Drug Saf ; 44(2): 245-254, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33104975

RESUMO

INTRODUCTION: There are concerns that hydrochlorothiazide may increase the risk of incident nonmelanoma (cutaneous squamous cell carcinoma [cSCC], basal cell carcinoma [BCC]) and melanoma skin cancer, with regulatory agencies and societies calling for additional studies. METHODS: We conducted a propensity score-matched population-based cohort study using the United Kingdom Clinical Practice Research Datalink. A total of 20,513 new users of hydrochlorothiazide were propensity score matched, in a 1:1 ratio, to new users of other thiazide diuretics between January 1, 1988 and March 31, 2018, with follow-up until March 31, 2019. Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) for cSCC, BCC, and melanoma, comparing use of hydrochlorothiazide with use of other thiazide diuretics overall, by cumulative duration of use, and cumulative dose. RESULTS: After an 8.6-year median follow-up, hydrochlorothiazide was associated with an increased risk of cSCC (HR 1.50, 95% CI 1.06-2.11). HRs increased with cumulative duration of use, with evidence of an association after 5-10 years (HR 2.10, 95% CI 1.20-3.67) and highest after > 10 years (HR 3.70, 95% CI 1.77-7.73). Similarly, HRs increased with cumulative dose, with higher estimates for ≥ 100,000 mg (HR 4.96, 95% CI 2.51-9.81). In contrast, hydrochlorothiazide was not associated with an increased risk of BCC (HR 1.01, 95% CI 0.91-1.13) or melanoma (HR 0.82, 95% CI 0.63-1.08), with no evidence of duration- or dose-response relationships. CONCLUSIONS: Use of hydrochlorothiazide was associated with an increased risk of cSCC and with evidence of a duration- and dose-response relationship. In contrast, no association was observed for BCC or melanoma.


Assuntos
Hidroclorotiazida , Melanoma , Neoplasias Cutâneas , Estudos de Coortes , Humanos , Hidroclorotiazida/efeitos adversos , Melanoma/induzido quimicamente , Melanoma/epidemiologia , Medição de Risco , Neoplasias Cutâneas/induzido quimicamente , Neoplasias Cutâneas/epidemiologia , Inibidores de Simportadores de Cloreto de Sódio/efeitos adversos
9.
Front Med (Lausanne) ; 7: 591580, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33224966

RESUMO

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder that may be treated with non-ablative light-based devices; however, no systematic reviews on the topic exist to date. We conducted a systematic review and meta-analysis to determine efficacy of non-ablative light-based devices in treating HS. Specifically, a systematic review was conducted using MEDLINE, EMBASE, Web of Science and CINAHL. We analyzed the use of non-ablative light-based devices in the treatment of HS. At least two investigators performed title/abstract review and data extraction. Meta-analysis was conducted using comprehensive meta-analysis software. 5 RCTs and 11 case reports/series were included (n = 211 unique patients). No observational studies were found. For Nd:YAG laser, meta-analysis of 3 RCTs reported improvement in modified HS Lesion Area and Severity Index (HS-LASI) when compared to control subjects. In addition, three case reports/series reported HS-LASI, Physician Global Assessment (PGA) scores and number-of-lesion improvements in treated patients. For intense pulsed light (IPL), two RCTs reported HS-LASI and Dermatology Life Quality Index (DLQI) score improvements. For Alexandrite laser, one case report showed lesion improvement. In conclusion, meta-analysis of Nd:YAG laser in HS patients suggests significant improvement in HS-LASI scores. For IPL, evidence is limited, but suggests improvement in HS-LASI and DLQI scores. For Alexandrite laser, evidence precludes conclusions. Given small sample sizes and inconsistent reporting scales, larger RCTs are required to better determine the efficacy of these modalities in treating HS.

10.
BMJ Open ; 10(8): e036961, 2020 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-32847911

RESUMO

BACKGROUND: Propensity score (PS) methods are frequently used in cardiovascular clinical research. Previous evaluations revealed poor reporting of PS methods, however a comprehensive and current evaluation of PS use and reporting is lacking. The objectives of the present survey were to (1) evaluate the quality of PS methods in cardiovascular publications, (2) summarise PS methods and (3) propose key reporting elements for PS publications. METHODS: A PubMed search for cardiovascular PS articles published between 2010 and 2017 in high-impact general medical (top five by impact factor) and cardiovascular (top three by impact factor) journals was performed. Articles were evaluated for the reporting of PS techniques and methods. Data extraction elements were identified from the PS literature and extraction forms were pilot tested. RESULTS: Of the 306 PS articles identified, most were published in Journal of the American College of Cardiology (29%; n=88), and Circulation (27%, n=81), followed by European Heart Journal (15%; n=47). PS matching was performed most often, followed by direct adjustment, inverse probability of treatment weighting and stratification. Most studies (77%; n=193) selected variables to include in the PS model a priori. A total of 38% (n=116) of studies did not report standardised mean differences, but instead relied on hypothesis testing. For matching, 92% (n=193) of articles presented the balance of covariates. Overall, interpretations of the effect estimates corresponded to the PS method conducted or described in 49% (n=150) of the reviewed articles. DISCUSSION: Although PS methods are frequently used in high-impact medical journals, reporting of methodological details has been inconsistent. Improved reporting of PS results is warranted and these proposals should aid both researchers and consumers in the presentation and interpretation of PS methods.


Assuntos
Projetos de Pesquisa , Relatório de Pesquisa , Estudos Transversais , Humanos , Pontuação de Propensão , Publicações
11.
Urol Oncol ; 38(11): 816-825, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32654949

RESUMO

BACKGROUND: Recent interest has been geared towards the potential therapeutic and chemopreventive benefit of androgen deprivation therapy (ADT) for bladder cancer. As a result, several observational studies have investigated this potential association. Given the important side effects associated with ADT treatment, understanding the methodological strengths and weaknesses of the current evidence is warranted. OBJECTIVES: The objective of this systematic review was to examine the heterogeneity of the current observational studies on the association between ADT and bladder cancer by assessing the methodological strengths and limitations of these studies. MATERIAL AND METHODS: We systematically searched Medline, EMBASE, Healthstar, Cochrane Library Online, Science Citation Index, and Dissertation Abstracts Online, from inception to August 2019 to identify all observational studies investigating the association between ADT and bladder cancer. We assessed overall study quality using the ROBINS-I tool and evaluated the presence of other key pharmacoepidemiologic biases. RESULTS: Overall, our systematic review included 7 observational studies. Five studies reported a decreased risk of bladder cancer with ADT use, 1 study reported no association, and 1 study reported an increased risk. All studies had time-related biases, did not consider a lag period, and had potential residual confounding. Moreover, 1 study had potential detection bias, 6 included prevalent users, 3 had inadequate follow-up durations, 6 had exposure misclassification, and 5 used an inappropriate comparator. CONCLUSION: Taken together, future methodologically-rigorous studies addressing the limitations underlined in this systematic review are needed to evaluate the important potential association between ADT and bladder cancer.


Assuntos
Antagonistas de Androgênios/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Neoplasias da Bexiga Urinária/prevenção & controle , Humanos , Masculino , Estudos Observacionais como Assunto , Medição de Risco , Neoplasias da Bexiga Urinária/epidemiologia
12.
Br J Clin Pharmacol ; 86(11): 2266-2273, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32352592

RESUMO

AIMS: Previous studies suggest that the use of low-dose aspirin before a colorectal cancer (CRC) diagnosis may be associated with a decreased risk of CRC progression. Data supporting this association, however, have been inconsistent. We evaluate whether the use of prediagnostic low-dose aspirin is associated with a lower risk of metastases and all-cause mortality in CRC patients. METHODS: Using a large Italian population-based primary care database, we identified a cohort of 7478 patients newly diagnosed with nonmetastatic CRC between 2000 and 2013. Use of prediagnostic low-dose aspirin was compared with no use of low-dose aspirin. Cox proportional hazards models were used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) of incident metastasis and of all-cause mortality associated with prediagnostic low-dose aspirin use, both overall and by duration of use. RESULTS: There were 314 incident metastatic events and 2189 deaths during a mean follow-up time of 4.4 and 4.7 years, respectively. Overall prediagnostic use of low-dose aspirin was not associated with a decreased risk of incident metastasis (HR 0.88; 95% CI 0.63-1.22) or all-cause mortality (HR 1.09; 95% CI 0.96-1.22) in CRC patients. Cumulative duration of aspirin use was not associated with a decreased risk of incident metastasis (P-trend = .22) or all-cause mortality (P-trend = .38). These findings remained consistent in sensitivity analyses. CONCLUSION: In this real-world, population-based study, the prediagnostic use of low-dose aspirin was not associated with a decreased risk of incident metastasis or all-cause mortality in CRC patients.


Assuntos
Neoplasias Colorretais , Aspirina , Estudos de Coortes , Neoplasias Colorretais/diagnóstico , Humanos , Modelos de Riscos Proporcionais , Risco
14.
Diabetes Care ; 42(8): 1496-1503, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31182489

RESUMO

OBJECTIVE: There are uncertainties regarding the association between dipeptidyl peptidase 4 (DPP-4) inhibitors and bullous pemphigoid (BP), a potentially severe autoimmune skin disease. Thus, we conducted a population-based study to determine whether use of DPP-4 inhibitors, when compared with other second- to third-line antidiabetic drugs, is associated with an increased risk of BP in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Using the U.K. Clinical Practice Research Datalink, we conducted a cohort study among 168,774 patients initiating antidiabetic drugs between January 2007 and March 2018. Using time-dependent Cox proportional hazards models, we estimated adjusted hazard ratios (HRs) with 95% CIs of incident BP associated with current use of DPP-4 inhibitors, compared with current use of other second- to third-line antidiabetic drugs. We also conducted a propensity score-matched analysis to assess the impact of residual confounding. RESULTS: During 711,311 person-years of follow-up, 150 patients were newly diagnosed with BP (crude incidence rate, 21.1 per 100,000 person-years). Current use of DPP-4 inhibitors was associated with an increased risk of BP (47.3 vs. 20.0 per 100,000 person-years; HR 2.21 [95% CI 1.45-3.38]). HRs gradually increased with longer durations of use, reaching a peak after 20 months (HR 3.60 [95% CI 2.11-6.16]). Similar results were obtained in the propensity score-matched analysis (HR 2.40 [95% CI 1.13-4.66]). CONCLUSIONS: In this large population-based study, use of DPP-4 inhibitors was associated with an at least doubling of the risk of BP in patients with type 2 diabetes, albeit the absolute risk was low.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Hipoglicemiantes/efeitos adversos , Penfigoide Bolhoso/induzido quimicamente , Idoso , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Modelos de Riscos Proporcionais , Fatores de Risco
15.
Int J Radiat Oncol Biol Phys ; 98(3): 521-529, 2017 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-28258891

RESUMO

PURPOSE: To describe the outcomes of peer review across all 14 cancer centers in Ontario. METHODS AND MATERIALS: We identified all peer-reviewed, curative treatment plans delivered in Ontario within a 3-month study period from 2013 to 2014 using a provincial cancer treatment database and collected additional data on the peer-review outcomes. RESULTS: Considerable variation was found in the proportion of peer-reviewed plans across the centers (average 70.2%, range 40.8%-99.2%). During the study period, 5561 curative plans underwent peer review. Of those, 184 plans (3.3%) had changes recommended. Of the 184 plans, the changes were major (defined as requiring repeat planning or having a major effect on planning or clinical outcomes, or both) in 40.2% and minor in 47.8%. For the remaining 12.0%, data were missing. The proportions of recommended changes varied among disease sites (0.0%-7.0%). The disease sites with the most recommended changes to treatment plans after peer review and with the greatest potential for benefit were the esophagus (7.0%), uterus (6.7%), upper limb (6.3%), cervix and lower limb (both 6.0%), head and neck and bilateral lung (both 5.9%), right supraclavicular lymph nodes (5.7%), rectum (5.3%), and spine (5.0%). Although the heart is an organ at risk in left-sided breast treatment plans, the proportions of recommended changes did not significantly differ between the left breast treatment plans (3.0%, 95% confidence interval 2.0%-4.5%) and right breast treatment plans (2.4%, 95% confidence interval 1.5%-3.8%). The recommended changes were more frequently made when peer review occurred before radiation therapy (3.8%) than during treatment (1.4%-2.8%; P=.0048). The proportion of plans with recommended changes was not significantly associated with patient volume (P=.23), peer-review performance (P=.36), or center academic status (P=.75). CONCLUSIONS: Peer review of treatment plans directly affects the quality of care by identifying important clinical and planning changes. Provincial strategies are underway to optimize its conduct in radiation oncology.


Assuntos
Institutos de Câncer/normas , Neoplasias/radioterapia , Revisão por Pares/normas , Melhoria de Qualidade , Planejamento da Radioterapia Assistida por Computador/normas , Institutos de Câncer/estatística & dados numéricos , Estudos Transversais , Feminino , Hospitais com Alto Volume de Atendimentos/normas , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Hospitais com Baixo Volume de Atendimentos/normas , Hospitais com Baixo Volume de Atendimentos/estatística & dados numéricos , Humanos , Masculino , Ontário , Órgãos em Risco , Garantia da Qualidade dos Cuidados de Saúde , Radioterapia (Especialidade)/normas , Radioterapia (Especialidade)/estatística & dados numéricos , Radioterapia/normas , Dosagem Radioterapêutica , Planejamento da Radioterapia Assistida por Computador/estatística & dados numéricos , Fatores de Tempo , Resultado do Tratamento
16.
Qual Life Res ; 26(6): 1427-1437, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28168602

RESUMO

PURPOSE: This study assessed the uptake of the CONsolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO) statement; determined if use of CONSORT-PRO was associated with more complete reporting of PRO endpoints in randomised controlled trials (RCTs) and identified the extent to which high-impact journals publishing RCTs with PRO endpoints endorse CONSORT-PRO. METHODS: CONSORT-PRO citations were identified by systematically searching Medline, EMBASE and Google from 2013 (year CONSORT-PRO released) to 17 December 2015. RCTs that cited CONSORT-PRO (cases) were compared to a comparable control sample of RCTs in terms of adherence to CONSORT-PRO using t tests. General linear models assessed the relationship between CONSORT-PRO score and key, pre-specified variables. The 100 highest-impact journals that published RCTs with PRO endpoints (2014-2015) were identified via a systematic Medline search. Instructions for authors were reviewed to determine whether journals endorsed CONSORT-PRO. RESULTS: Total CONSORT-PRO scores ranged from 47 to 100% for cases and 25-96% for controls. Cases had significantly higher total CONSORT-PRO scores compared to controls: t = 2.64, p = 0.01. 'Citing CONSORT-PRO', 'journal endorsing CONSORT-PRO' and 'dedicated PRO paper' were significant predictors of higher CONSORT-PRO adherence score: R 2 = 0.48, p < 0.001. 11/100 top-ranked journals endorsed CONSORT-PRO in their instructions to authors, seven of these journals published RCTs included as cases in this study. CONCLUSION: This study demonstrated improved PRO reporting associated with journal endorsement and author use of the CONSORT-PRO extension. Despite growing awareness, more work is needed to promote appropriate use of CONSORT-PRO to improve completeness of reporting; in particular, stronger journal endorsement of CONSORT-PRO.


Assuntos
Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Determinação de Ponto Final/métodos , Determinação de Ponto Final/normas , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
17.
Pract Radiat Oncol ; 6(5): 342-351, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27025163

RESUMO

PURPOSE: Peer review (PR) of treatment plans has been recognized internationally as a key component of quality care in radiation oncology programs (ROPs). We conducted a survey of Canadian ROPs to describe current PR practices and identify barriers/facilitators to PR optimization. METHODS AND MATERIALS: A 42-item e-survey was sent to all Canadian ROPs (n = 44). Survey development was guided by expert consensus, literature review, and existing guidelines. One multidisciplinary response per ROP was requested. RESULTS: Response rate was 100.0% (44/44). All ROPs (100.0%) reported conducting some PR and rated its importance as 7/10 or higher (10 = extremely important). One-half of ROPs (52.3%) peer-reviewed >80% of curative treatment plans. ROPs reported performing PR "always/almost always" pretreatment (38.6%) or before 25% of radiation therapy delivery (52.3%). The majority of ROPs reported recommending major plan changes in <5% of plans (88.6%) and documenting findings in the medical record (58.1%). Barriers to PR were radiation oncologist availability (34.1%) and time constraints (27.3%). Facilitators included development of PR standards (97.7%) and education/support (90.9%). CONCLUSIONS: The ROPs perceive PR as highly important, but substantial variation in the extent, timing, and documentation of PR exists. The understanding of current PR activities, barriers, and facilitators will inform the development of initiatives to optimize PR in radiation oncology.


Assuntos
Radioterapia (Especialidade)/normas , Canadá , Humanos , Revisão por Pares , Inquéritos e Questionários
18.
Patient Educ Couns ; 99(4): 483-490, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26603445

RESUMO

UNLABELLED: Patient-reported outcomes (PROs) report patients' assessments of the impact of a health condition and its treatment, and can promote patient-centered care. OBJECTIVES: To address the effectiveness of graphic display of PRO data in clinical practice by reviewing existing literature, and current recommendations, regarding graphic presentations of PROs. METHODS: We performed an integrated literature review to identify themes and emerging principles guiding effective graphic display of PRO data. The findings were placed in the context of the literature informing graphical presentation of other clinical data. RESULTS: Although a large body of literature informs graphical presentation of clinical data, only nine empirical studies addressed presentation of PROs. Four major themes emerged: many patients and most clinicians can accurately interpret some PRO graphs; interpretation accuracy, personal preference, and perceived level of understanding are sometimes discordant; patient age and education may predict PRO graph comprehension; patients tend to prefer simpler graphs than do clinicians. CONCLUSIONS: Little empirical research specifically addresses graphic representation of PRO data. A single format may not work optimally for both clinicians and patients. PRACTICE IMPLICATIONS: Patients and clinicians may or may not comprehend PRO data when graphically presented. Further research to determine best practices for presenting PROs optimally is needed.


Assuntos
Apresentação de Dados , Avaliação de Resultados da Assistência ao Paciente , Assistência Centrada no Paciente , Compreensão , Humanos
19.
Qual Life Res ; 24(6): 1317-25, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25432885

RESUMO

PURPOSE: Although health-related quality of life (HRQL) is increasingly assessed in randomized controlled trials (RCTs), HRQL findings are not always incorporated into clinical decision making. We examined the current perspectives of oncologists on the use of HRQL findings from RCTs, and variation of these perspectives between countries and specialties. METHODS: A cross-sectional e-survey of oncologist members of the NCIC Clinical Trials Group, the United Kingdom National Cancer Research Institute Clinical Studies Groups, and the Australia/New Zealand cancer clinical trials network was conducted. Respondents reported their perceptions of the usefulness of RCT HRQL outcomes for informing practice, their use of HRQL findings in practice, barriers/facilitators to this use, and preferences for HRQL data presentation in RCT publications. Chi-square tests compared responses between countries and specialties. RESULTS: A total of 396 oncologists participated (estimated response rate: 30%). The most frequently reported specialties were medical (46%) and radiation (37%) oncology. HRQL findings from RCTs were reported as useful (73%), but were infrequently used to guide clinical decisions with patients. Perceived barriers were lack of time (67%) and understanding (57%), and concerns about generalizability of results (68%). Identified facilitators included joint publication of HRQL/clinical outcomes (96%) and summary of clinical implications of HRQL findings in RCT publications (76%). Use of HRQL findings, perceived barriers/facilitators, and presentation preferences did not differ by country or specialty. CONCLUSIONS: Oncologists support HRQL findings from RCTs, but perceive important barriers to their use in clinical decision making, regardless of country or specialty. Combined, clear reporting of HRQL/clinical data may facilitate their clinical application.


Assuntos
Tomada de Decisão Clínica , Conhecimentos, Atitudes e Prática em Saúde , Neoplasias/terapia , Qualidade de Vida , Austrália , Pesquisa Biomédica , Estudos Transversais , Feminino , Humanos , Masculino , Nova Zelândia , Médicos , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários , Tempo , Reino Unido
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