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1.
J Crohns Colitis ; 18(2): 275-285, 2024 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-37706542

RESUMO

BACKGROUND: The IBD-Control Questionnaire is a simple, generic measure of patient-perceived disease control used increasingly in clinical practice and research. We aimed to address knowledge gaps in its psychometric performance, to ensure that it can be used with confidence in a variety of contexts. METHODS: We analysed 7341 responses to the IBD Registry COVID-19 survey, sent to 40 911 patients who completed an online self-assessment tool during the pandemic. Questions covered demographics, comorbidities, inflammatory bowel disease [IBD] sub-type, and IBD-Control Questionnaire and symptom scores [CD-PRO2 or UC-PRO2]. Psychometric properties of IBD-Control-8 were tested overall and within subgroups (Crohn's disease [CD], ulcerative colitis [UC] and IBD unclassified; male and female; ≤65 and >65 years; number of co-morbidities; deprivation status). RESULTS: Internal consistency was very strong overall [α: 0.84, ω: 0.89] and for each subgroup [α range: 0.81-0.85; ω: 0.86-0.90]. Construct validity was demonstrated by moderate correlation of each item with global rating [VAS] [rs range: 0.47-0.65], strong correlation between IBD-Control-8 score and VAS [rs = 0.74], moderate-to-strong with PRO2 scores [CD: rs = -0.718; UC: rs = -0.602] and significantly higher IBD-Control-8 scores for PRO2-remission vs PRO2-active, consistent across subgroups. Exploratory and confirmatory factor analyses demonstrated a two-factor model (items loading onto 'Health-related Quality of Life' [HRQoL] or 'Treatment' domains). Extensive tests for factorial invariance confirmed consistency. CONCLUSIONS: IBD-Control-8 is a psychometrically robust scale which can be used across a range of populations. It offers a quick, reliable, and valid method of assessing patient-perceived control. The construct of 'control' includes traditional HRQoL and a novel domain relating to treatment perception.


Assuntos
Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Humanos , Masculino , Feminino , Qualidade de Vida , Índice de Gravidade de Doença , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/epidemiologia , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Inquéritos e Questionários
2.
BMJ Open ; 13(11): e076955, 2023 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-37993152

RESUMO

OBJECTIVES: To examine time trends in patient characteristics, care processes and case fatality of first emergency admission for alcohol-related liver disease (ARLD) in England. DESIGN: National population-based, retrospective observational cohort study. SETTING: Clinical Practice Research Datalink population of England, 2008/2009 to 2017/2018. First emergency admissions were identified using the Liverpool ARLD algorithm. We applied survival analyses and binary logistic regression to study prognostic trends. OUTCOME MEASURES: Patient characteristics; 'recent' General Practitioner (GP) consultations and hospital admissions (preceding year); higher level care; deaths in-hospital (including certified cause) and within 365 days. Covariates were age, sex, deprivation status, coding pattern, ARLD stage, non-liver comorbidity, coding for ascites and varices. RESULTS: 17 575 first admissions (mean age: 53 years; 33% women; 32% from most deprived quintile). Almost half had codes suggesting advanced liver disease. In year before admission, only 47% of GP consulters had alcohol-related problems recorded; alcohol-specific diagnostic codes were absent in 24% of recent admission records. Overall, case fatality rate was 15% in-hospital and 34% at 1 year. Case-mix-adjusted odds of in-hospital death reduced by 6% per year (adjusted OR (aOR): 0.94; 95% CI: 0.93 to 0.96) and 4% per year at 365 days (aOR: 0.96; 95% CI: 0.95 to 0.97). Exploratory analyses suggested the possibility of regional inequalities in outcome. CONCLUSIONS: Despite improving prognosis of first admissions, we found missed opportunities for earlier recognition and intervention in primary and secondary care. In 2017/2018, one in seven were still dying during index admission, rising to one-third within a year. Nationwide efforts are needed to promote earlier detection and intervention, and to minimise avoidable mortality after first emergency presentation. Regional variation requires further investigation.


Assuntos
Transtornos Relacionados ao Uso de Álcool , Hepatopatias , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Estudos Retrospectivos , Mortalidade Hospitalar , Hospitalização , Hepatopatias/epidemiologia , Hepatopatias/terapia , Transtornos Relacionados ao Uso de Álcool/epidemiologia , Transtornos Relacionados ao Uso de Álcool/terapia , Eletrônica
3.
Frontline Gastroenterol ; 14(5): 407-414, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37581184

RESUMO

Background and aims: Healthcare quality improvement (QI) is the systematic process to continuously improve the quality of care and outcomes for patients. The landmark Inflammatory Bowel Disease (IBD) UK National Audits provided a means to measure the variation in care, highlighting the need to define the standards of excellence in IBD care. Through a consensus approach, we aimed to establish key performance indicators (KPIs), providing reliable benchmarks for IBD care delivery in UK. Methods: KPIs that measure critical aspects of a patient journey within an IBD service were identified though stakeholder meetings. A two-stage Delphi consensus was then conducted. The first involved a multidisciplinary team of IBD clinicians and patients to refine definitions and methodology. The second stage assessed feasibility and utility of the proposed QI process by surveying gastroenterology services across UK. Results: First, the four proposed KPIs were refined and included time from primary care referral to diagnosis in secondary care, time to treatment recommendation following a diagnosis, appropriate use of steroids and advanced therapies prescreening and assessment. Second, the Delphi consensus reported >85% agreement on the feasibility of local adoption of the QI process and >75% agreement on the utility of benchmarking of the KPIs. Conclusions: Through a structured approach, we propose quantifiable KPIs for benchmarking to improve and reduce the individual variation in IBD care across the UK.

4.
Health Qual Life Outcomes ; 21(1): 2, 2023 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-36639633

RESUMO

BACKGROUND: Patient-reported outcome measures (PROMs) are recommended for assessing patient-centered outcomes in inflammatory bowel disease (IBD). The main aims were to assess the level of participation in an electronic PROM (ePROM) data collection system among patients with IBD, and evaluate reliability and validity of the resulting scores. METHODS: Patients included in the IBD registry of Maccabi Healthcare Services, a state-mandated healthcare provider for over 2.6 million people in Israel, were invited to complete the IBD-Control measure and a general health item, with follow-up ePROMs at 3 and 6 months including a global rating of change item. Descriptive statistics were used to compare patient characteristics by participation rate, and assess survey completion time. Initial scores were assessed for internal consistency reliability using Cronbach's alpha. Test-retest reliability was assessed using the intraclass correlation coefficient from paired scores of patients identified as unchanged between the initial and first follow-up. Construct validity was assessed by the ability of IBD-control scores to discriminate between patient sub-groups in expected ways. Empirical validity was assessed using ePROM score correlations with laboratory markers of disease activity. Score coverage was also assessed. RESULTS: A total of 13,588 patients were invited to participate [Mean age = 49 years (SD = 17); females = 51%]. Participation rate was 31.5%. Participants compared to non-participants were slightly older, were more likely to be female, to have a history of biologic treatment, to have higher socio-economic status, and to be more experienced in the usage of the digital patient portal. Median survey completion time was approximately 1:30 min. Internal consistency and test-retest reliability were 0.86 and 0.98, respectively. Scores discriminated between patient sub-groups in clinically expected ways, with expected correlations to laboratory markers of disease activity. A notable ceiling effect was observed (> 15%) for IBD-Control scores. CONCLUSIONS: Feasibility, reliability, and validity of the ePROM system was supported for measuring the level of perceived disease control in patients diagnosed with IBD in Israel. Additional research is needed to identify ways to increase patient participation, assess clinical implications of the identified measurement ceiling of the IBD-control, and evaluate the added value of the derived scores in support of clinical decision making.


Assuntos
Doenças Inflamatórias Intestinais , Participação do Paciente , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Reprodutibilidade dos Testes , Qualidade de Vida , Doenças Inflamatórias Intestinais/terapia , Inquéritos e Questionários , Medidas de Resultados Relatados pelo Paciente
6.
Aliment Pharmacol Ther ; 57(4): 368-377, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36397658

RESUMO

BACKGROUND: Emergency admissions in England for alcohol-related liver disease (ArLD) have increased steadily for decades. Statistics based on administrative data typically focus on the ArLD-specific code as the primary diagnosis and are therefore at risk of excluding ArLD admissions defined by other coding combinations. AIM: To deploy the Liverpool ArLD Algorithm (LAA), which accounts for alternative coding patterns (e.g., ArLD secondary diagnosis with alcohol/liver-related primary diagnosis), to national and local datasets in the context of studying trends in ArLD admissions before and during the COVID-19 pandemic. METHODS: We applied the standard approach and LAA to Hospital Episode Statistics for England (2013-21). The algorithm was also deployed at 28 hospitals to discharge coding for emergency admissions during a common 7-day period in 2019 and 2020, in which eligible patient records were reviewed manually to verify the diagnosis and extract data. RESULTS: Nationally, LAA identified approximately 100% more monthly emergency admissions from 2013 to 2021 than the standard method. The annual number of ArLD-specific admissions increased by 30.4%. Of 39,667 admissions in 2020/21, only 19,949 were identified with standard approach, an estimated admission cost of £70 million in under-recorded cases. Within 28 local hospital datasets, 233 admissions were identified using the standard approach and a further 250 locally verified cases using the LAA (107% uplift). There was an 18% absolute increase in ArLD admissions in the seven-day evaluation period in 2020 versus 2019. There were no differences in disease severity or mortality, or in the proportion of admissions with decompensation of cirrhosis or alcoholic hepatitis. CONCLUSIONS: The LAA can be applied successfully to local and national datasets. It consistently identifies approximately 100% more cases than the standard coding approach. The algorithm has revealed the true extent of ArLD admissions. The pandemic has compounded a long-term rise in ArLD admissions and mortality.


Assuntos
COVID-19 , Hepatopatias , Humanos , Pandemias , COVID-19/epidemiologia , Hospitalização , Hepatopatias/diagnóstico , Hepatopatias/epidemiologia , Hospitais , Inglaterra/epidemiologia , Algoritmos
8.
J Crohns Colitis ; 16(12): 1874-1881, 2022 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-35868223

RESUMO

BACKGROUND: Patient-reported outcome measures [PROMs] are key to documenting outcomes that matter most to patients and are increasingly important to commissioners of health care seeking value. We report the first series of the ICHOM Standard Set for Inflammatory Bowel Disease [IBD]. METHODS: Patients treated for ulcerative colitis [UC] or Crohn's disease [CD] in our centre were offered enrolment into the web-based TrueColours-IBD programme. Through this programme, e-mail prompts linking to validated questionnaires were sent for symptoms, quality of life, and ICHOM IBD outcomes. RESULTS: The first 1299 consecutive patients enrolled [779 UC, 520 CD] were studied with median 270 days of follow-up (interquartile range [IQR] 116, 504). 671 [52%] were female, mean age 42 years (standard deviation [sd] 16), mean body mass index [BMI] 26 [sd 5.3]. At registration, 483 [37%] were using advanced therapies. Median adherence to fortnightly quality of life reporting and quarterly outcomes was 100% [IQR 48, 100%] and 100% [IQR 75, 100%], respectively. In the previous 12 months, prednisolone use was reported by 229 [29%] patients with UC vs 81 [16%] with CD, p <0.001; 202 [16%] for <3 months; and 108 [8%] for >3 months. An IBD-related intervention was reported by 174 [13%] patients, and 80 [6%] reported an unplanned hospital admission. There were high rates of fatigue [50%] and mood disturbance [23%]. CONCLUSIONS: Outcomes reported by patients illustrate the scale of the therapeutic deficit in current care. Proof of principle is demonstrated that PROM data can be collected continuously with little burden on health care professionals. This may become a metric for quality improvement programmes or to compare outcomes.


Assuntos
Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Humanos , Feminino , Adulto , Masculino , Qualidade de Vida , Colite Ulcerativa/diagnóstico , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/diagnóstico , Doença de Crohn/tratamento farmacológico , Doenças Inflamatórias Intestinais/terapia , Medidas de Resultados Relatados pelo Paciente , Doença Crônica
10.
BMJ Open ; 11(12): e056413, 2021 12 30.
Artigo em Inglês | MEDLINE | ID: mdl-35679143

RESUMO

OBJECTIVES: Knowledge of the extent of variation in outcome assessment for inflammatory bowel disease (IBD) in routine practice is limited. We aimed to describe and quantify variation in outcome coverage and to explore patient, clinician and practitioner factors associated with it. DESIGN: Prospective exploratory mixed-methods study. SETTING: IBD clinics at six hospitals in North West England with differing electronic health record (EHR) systems. METHODS: Mixed-methods study comprising: (a) structured observations of outcomes elicited during consultations (102 patients consulting 24 clinicians); (b) retrospective analysis of outcomes recorded in the EHR (909 consultations; 127 clinicians) and (c) semistructured interviews with the 24 observed clinicians. We determined whether specific outcome 'sets' were elicited or recorded, including: (1) a minimum set of symptom pairs ('PRO-2'); (2) symptom sets from disease activity indices and (3) a reference list of 37 symptoms, signs and impacts. Factors associated with variation were explored in univariate and multivariate binary logistic regression analyses and from clinician interviews. RESULTS: PRO-2 coverage was not invariable (elicited during 81% of observed consultations; recorded in 56% of EHR) and infrequent for complete activity indices (all domains from Harvey-Bradshaw Index: elicited, 18%; recorded, 5%). The median number of outcomes from the reference list elicited per consultation was 12 (13-fold variation) and recorded in EHR was 7 (>20-fold variation). Symptom quantification (PRO-2) seldom adhered closely to standardised descriptors and an explicit timeframe was defined rarely. PRO-2 recording in EHR was associated with a diagnosis of ulcerative colitis (OR: 2.09 (95% CI 1.15 to 3.80)) and nurse-led consultations (OR: 6.98 (95% CI 3.28 to 14.83)) and a three-way model suggested 26% of total variability lay between clinicians, 17% between patients but the remainder was unexplained. Most clinicians expressed preference for individualised health status evaluations versus standardised outcome assessments. CONCLUSIONS: There was little evidence for standardised assessment and recording of IBD outcomes and substantial intra-clinician and inter-clinician variation from one consultation to another. Nurses demonstrated a greater tendency to standardised practice.


Assuntos
Doenças Inflamatórias Intestinais , Doença Crônica , Hospitais , Humanos , Doenças Inflamatórias Intestinais/diagnóstico , Avaliação de Resultados em Cuidados de Saúde/métodos , Estudos Prospectivos , Estudos Retrospectivos
11.
Aliment Pharmacol Ther ; 52(8): 1341-1352, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32955122

RESUMO

BACKGROUND: Anti-tumour necrosis factor (TNF) agents are effective in Crohn's disease but some patients lose response and require alternative biologic therapy. There are few data on comparative effectiveness of vedolizumab and ustekinumab in this setting. AIM: To compare the effectiveness of ustekinumab and vedolizumab in anti-TNF-refractory Crohn's disease over 12 months. METHODS: Patients commencing ustekinumab or vedolizumab for anti-TNF-refractory Crohn's disease with minimum follow-up of 12 months were included. The primary outcome measure was the difference in steroid-free remission rates at end of induction (2 months) and at 12 months. We also assessed rates of clinical response and remission, treatment persistence, surgery and adverse events in both groups. We performed logistic regression analysis to assess factors associated with steroid-free remission and clinical response and remission. RESULTS: We included 85 patients commencing vedolizumab and 45 commencing ustekinumab. In an unadjusted model, rates of steroid-free and clinical remission were significantly higher among ustekinumab-treated patients. After adjusting for confounders, steroid-free remission was higher among ustekinumab-treated patients at 2 months (odds ratio, OR 2.79, 95% confidence interval, CI 1.06-7.39, P = 0.038) and 12 months (OR 2.01, 95% CI 0.89-4.56, P = 0.095). More patients treated with ustekinumab remained on therapy at the end of 12 months (84.4% vs 61.5%, P = 0.007). CONCLUSIONS: Ustekinumab appeared more effective in treating anti-TNF-refractory Crohn's disease and more patients persisted with therapy.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Doença de Crohn/tratamento farmacológico , Ustekinumab/uso terapêutico , Adulto , Anti-Inflamatórios/uso terapêutico , Terapia Biológica , Pesquisa Comparativa da Efetividade , Doença de Crohn/epidemiologia , Resistência a Medicamentos/efeitos dos fármacos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Falha de Tratamento , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Fator de Necrose Tumoral alfa/imunologia , Adulto Jovem
12.
Aliment Pharmacol Ther ; 52(1): 182-195, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32441393

RESUMO

BACKGROUND: Variations in emergency care quality for alcohol-related liver disease (ARLD) have been highlighted. AIM: To determine whether introduction of a regional quality improvement (QI) programme was associated with a reduction in potentially avoidable inpatient mortality. METHOD: Retrospective observational cohort study using hospital administrative data spanning a 1-year period before (2014/2015) and 3 years after a QI initiative at seven acute hospitals in North West England. The intervention included serial audit of a bundle of process metrics. An algorithm was developed to identify index ("first") emergency admissions for ARLD (n = 3887). We created a standardised mortality ratio (SMR) to compare relative mortality and regression models to examine risk-adjusted odds of death. RESULTS: In 2014/2015, three of seven hospitals had an SMR above the upper control limit ("outliers"). Adjusted odds of death for patients admitted to outlier hospitals was higher than non-outliers (OR 2.13, 95% CI 1.32-3.44, P = 0.002). Following the QI programme there was a step-wise reduction in outliers (none in 2017/2018). Odds of death was 67% lower in 2017/2018 compared to 2014/2015 at original outlier hospitals, but unchanged at other hospitals. Process audit performance of outliers was worse than non-outliers at baseline, but improved after intervention. CONCLUSIONS: There was a reduction in unexplained variation in hospital mortality following the QI intervention. This challenges the pessimism that is prevalent for achieving better outcomes for patients with ARLD. Notwithstanding the limitations of an uncontrolled observational study, these data provide hope that co-ordinated efforts to drive adoption of evidence-based practice can save lives.


Assuntos
Mortalidade Hospitalar , Hepatopatias Alcoólicas/mortalidade , Qualidade da Assistência à Saúde/normas , Adulto , Idoso , Serviço Hospitalar de Emergência , Inglaterra/epidemiologia , Feminino , Hospitalização , Hospitais/normas , Humanos , Hepatopatias Alcoólicas/terapia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
14.
Pharmacoeconomics ; 37(12): 1509-1523, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31372948

RESUMO

BACKGROUND AND OBJECTIVE: Regulatory approval of biosimilars often depends on extrapolating evidence from one clinical indication to all of those of the originator biologic. We aimed to develop a quantitative benefit-risk analysis to assess whether the resulting increase in the uncertainty in the clinical performance of biosimilars (i.e. risk) may be countered by their lower pricing (benefit). METHODS: A 1-year decision-analytic model was developed for the biosimilar infliximab (Inflectra®) for Crohn's disease. The perspective was that of the National Health Service in the UK and costs were valued to 2015/16. A hypothetical cohort of biologic-naïve patients with moderate-to-severe Crohn's disease was simulated through the model. Immunogenicity to infliximab was a key modifier, influencing rates of non-response and infusion reactions. Net health benefit was estimated based on quality-adjusted life-years. A range of sensitivity analyses tested the robustness of the results and explored how the biosimilar price must respond to varying immunogenicity to remain the preferred option. RESULTS: The base-case analysis predicted a positive incremental net health benefit of 0.04 (95% central range 0.00-0.09) favouring the biosimilar, based on 0.803 quality-adjusted life-years, and costs of £18,087 and £19,176 for the biosimilar and originator, respectively. Two-way sensitivity analyses suggested that if 50% of patients developed antibodies, the value-based price of £410 per vial must be lower than that of the originator (£420), but remain higher than the actual market price (£378). CONCLUSIONS: The model supports the use of Inflecta® for Crohn's disease in the UK, and provides a framework for the quantitative evaluation of biosimilars in the context of a health technology assessment. Value-based pricing using this methodology could protect health systems from the potential risks of biosimilars where they are untested in the approved populations.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Modelos Econômicos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Estudos de Coortes , Análise Custo-Benefício , Doença de Crohn/economia , Árvores de Decisões , Fármacos Gastrointestinais/administração & dosagem , Fármacos Gastrointestinais/efeitos adversos , Fármacos Gastrointestinais/economia , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Infliximab/economia , Método de Monte Carlo , Anos de Vida Ajustados por Qualidade de Vida , Medição de Risco
15.
Aliment Pharmacol Ther ; 50(2): 176-192, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31135073

RESUMO

BACKGROUND: The UK IBD Audit Programme reported improved inpatient care processes for ulcerative colitis (UC) between 2005 and 2013. There are no independent data describing national or institutional trends in patient outcomes over this period. AIM: To assess the association between the outcome of emergency admission for UC and year of treatment. METHODS: Retrospective analysis of hospital administrative data, focused on all emergency admissions to English public hospitals with a discharge diagnosis of UC. We extracted case mix factors (age, sex, co-morbidity, emergency bed days in last year, deprivation status), outcomes of index admission (death and first surgery), 30-day emergency readmissions (all-cause, and selected causes) and outcome of readmission. RESULTS: There were 765 deaths and 3837 unplanned first operations in 44 882 emergency admissions, with 5311 emergency readmissions (with a further 171 deaths and 517 first operations). Case mix adjusted odds of death for any given year were 9% lower (OR 0.91, 95% CI: 0.89-0.94), and that for emergency surgery 3% lower (OR 0.97, 95% CI: 0.95-0.98) than the preceding year. Results were robust to sensitivity analysis (admissions lasting ≥4 days). There was no reduction in odds for all-cause readmission, but rates for venous thromboembolism declined significantly. Analysis of institutional-level metrics across 136 providers showed a stepwise reduction in outliers for mortality and unplanned surgery. CONCLUSIONS: Risk of death and unplanned surgery for UC patients admitted as emergencies declined consistently, as did unexplained variation between hospitals. Risk of readmission was unchanged (over 1 in 10). Multiple factors are likely to explain these nationwide trends.


Assuntos
Colite Ulcerativa/epidemiologia , Colite Ulcerativa/terapia , Atenção à Saúde , Serviço Hospitalar de Emergência/estatística & dados numéricos , Admissão do Paciente/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Atenção à Saúde/normas , Atenção à Saúde/estatística & dados numéricos , Serviço Hospitalar de Emergência/tendências , Inglaterra/epidemiologia , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Readmissão do Paciente/estatística & dados numéricos , Melhoria de Qualidade/tendências , Estudos Retrospectivos , Adulto Jovem
16.
Aliment Pharmacol Ther ; 49(8): 978-996, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30828852

RESUMO

BACKGROUND: The suitability of disease activity indices has been challenged, with growing interest in objective measures of inflammation. AIM: To undertake a systematic review of efficacy and safety outcomes in placebo-controlled randomised controlled trials (RCTs) of patients with Crohn's disease. METHODS: MEDLINE, EMBASE, CINAHL and Cochrane Library were searched until November 2015, for RCTs of adult Crohn's disease patients treated with medical or surgical therapies. Data on efficacy and safety outcomes, end-point definitions, and measurement instruments were extracted and stratified by publication date (pre-2009 and 2009 onwards). RESULTS: One hundred and eighty-one RCTs (110 induction and 71 maintenance) were identified, including 23 850 patients. About 92.3% reported clinical efficacy endpoints. The Crohn's Disease Activity Index (CDAI) dominated, defining clinical response or remission in 63.5% of trials (35 definitions of response or remission). CDAI < 150 was the commonest endpoint, but reporting reduced between periods (46.4%-41.1%), whilst use of CDAI100 increased (16.8%-30.4%). Fistula studies most commonly reported fistula closure (9, 90.0%). Reporting of biomarker, endoscopy and histology endpoints increased overall (33.3%-40.6%, 14.4%-30.4% and 3.2%-12.5%, respectively), but were heterogeneous and rarely reported in fistula trials. Patient-reported outcome measures were reported in 41.4% of trials and safety endpoints in 35.4%. Many of the common adverse events relate to disease exacerbation or treatment failure. CONCLUSIONS: Trial endpoints vary across studies, over time and are distinct in fistula studies. Despite growth in reporting of objective measures of inflammation and in patient-reported outcome measures, there is a lack of standardisation. This confirms the need for a core outcome set for comparative effectiveness research in Crohn's disease.


Assuntos
Doença de Crohn/terapia , Adulto , Progressão da Doença , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Resultado do Tratamento
17.
J Crohns Colitis ; 12(4): 408-418, 2018 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-29216349

RESUMO

BACKGROUND AND AIMS: Success in delivering value-based healthcare involves measuring outcomes that matter most to patients. Our aim was to develop a minimum Standard Set of patient-centred outcome measures for inflammatory bowel disease [IBD], for use in different healthcare settings. METHODS: An international working group [n = 25] representing patients, patient associations, gastroenterologists, surgeons, specialist nurses, IBD registries and patient-reported outcome measure [PROM] methodologists participated in a series of teleconferences incorporating a modified Delphi process. Systematic review of existing literature, registry data, patient focus groups and open review periods were used to reach consensus on a minimum set of standard outcome measures and risk adjustment variables. Similar methodology has been used in 21 other disease areas [www.ichom.org]. RESULTS: A minimum Standard Set of outcomes was developed for patients [aged ≥16] with IBD. Outcome domains included survival and disease control [survival, disease activity/remission, colorectal cancer, anaemia], disutility of care [treatment-related complications], healthcare utilization [IBD-related admissions, emergency room visits] and patient-reported outcomes [including quality of life, nutritional status and impact of fistulae] measured at baseline and at 6 or 12 month intervals. A single PROM [IBD-Control questionnaire] was recommended in the Standard Set and minimum risk adjustment data collected at baseline and annually were included: demographics, basic clinical information and treatment factors. CONCLUSIONS: A Standard Set of outcome measures for IBD has been developed based on evidence, patient input and specialist consensus. It provides an international template for meaningful, comparable and easy-to-interpret measures as a step towards achieving value-based healthcare in IBD.


Assuntos
Neoplasias Colorretais/etiologia , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/terapia , Fístula Intestinal/etiologia , Avaliação de Resultados da Assistência ao Paciente , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anemia/etiologia , Consenso , Técnica Delphi , Progressão da Doença , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Recursos em Saúde/estatística & dados numéricos , Humanos , Comunicação Interdisciplinar , Internacionalidade , Masculino , Pessoa de Meia-Idade , Estado Nutricional , Admissão do Paciente , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Taxa de Sobrevida , Adulto Jovem
18.
J Crohns Colitis ; 11(suppl_2): S576-S585, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-27797917

RESUMO

Patient reported outcome measures [PROMs] are standardized, validated questionnaires intended for completion by patients in order to measure their perceptions of their own health condition or its treatment without interpretation of the patient's response by a clinician or anyone else. Mayo Clinic Score [MCS] or Crohn's Disease Activity Index [CDAI], most frequently used as end points in conventional clinical trials, are composite instruments that are not fully objective nor capture the impact of disease from the patient's perspective. They are difficult to apply to routine clinical practice because they are complex and time consuming. The European Medicines Agency and Food and Drug Administration are re-evaluating composite indices in clinical trials and product development guidelines. The ultimate goal is to support labelling claims to improve safety and effectiveness of medical products through PROMs allied to an objective measure of inflammation, as happens informally in clinical practice. PROMs, developed and validated according to rigorous criteria, are set to become a co-primary end point for clinical trials of therapy, together with objective measure[s] of inflammation. This will affect future trials' design and their results. To find a place in routine care, PROMs should be easy to use, acceptable to patients and healthcare teams, and able to demonstrate added value to normal practice, supporting decision-making at the level of individual patients. Ideally, the same PROMs should be used in clinical trials and practice, to avoid the current disconnect when interpreting the results of clinical trials and translating them into routine clinical practice.


Assuntos
Doenças Inflamatórias Intestinais/terapia , Medidas de Resultados Relatados pelo Paciente , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Colite Ulcerativa/terapia , Doença de Crohn/terapia , Determinação de Ponto Final , Humanos , Guias de Prática Clínica como Assunto , Inquéritos e Questionários , Resultado do Tratamento
19.
BMJ Open ; 6(1): e010100, 2016 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-26792220

RESUMO

OBJECTIVES: To identify emergency seizure admissions to hospital and their subsequent access to specialist outpatient services. DESIGN: Algorithmic analysis of anonymised routine hospital data over 7 years using specialist follow-up by 3 months as the target outcome. POPULATION: All adults resident in Merseyside and Cheshire, England. MAIN OUTCOMES: Whether, and when, access to the specialist advice that might prevent further admissions was offered. RESULTS: 1.4% of all emergency medical admissions are as a result of seizure. In the following 12 months 35% were readmitted and experienced a mean of 2.3 emergency department visits. Only 27% (48% of those already known to specialists and 13% of those not known) were offered appointments. Subsequent attendance at a specialist clinic is more likely if already known to a clinic, if aged <35 years, if female, or required a longer spell in hospital. Extrapolation from other work suggests 100,000 bed days per annum could be saved. CONCLUSIONS: Most seizure admissions are not being referred for the help that could prevent future admissions. The majority of those that are referred are not seen within an appropriate time frame. Our service structures are not providing an optimum service for people with epilepsy.


Assuntos
Hospitalização/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Convulsões/terapia , Adolescente , Adulto , Idoso , Assistência Ambulatorial/estatística & dados numéricos , Estudos de Coortes , Atenção à Saúde/normas , Serviço Hospitalar de Emergência/estatística & dados numéricos , Inglaterra , Feminino , Humanos , Assistência de Longa Duração/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Adulto Jovem
20.
Inflamm Bowel Dis ; 20(2): 265-70, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24374876

RESUMO

INTRODUCTION: Stricturing is a common complication of Crohn's disease. Endoscopic balloon dilatation (EBD) offers a valuable alternative to surgical intervention, but there are limited data on factors influencing its safety and efficacy. METHODS: A multicenter retrospective audit across 4 U.K. teaching hospitals was performed on the use of EBD for Crohn's strictures between 1998 and 2011. Demographics, smoking status, medications, C-reactive protein, endoscopic findings, and subsequent surgery at follow-up were recorded. Success of EBD was defined as symptomatic improvement without the need for surgery at follow-up. RESULTS: Seventy-nine patients (47 women; median age, 48 yr) were identified for this study. Forty-eight (61%) patients had ileocolonic anastomotic strictures, whereas the rest had de novo strictures. In total, 191 EBDs (range, 1-11; median 2) were carried out on 93 strictures (range, 1-5; median 1) over a median duration of 12 months (range, 1-84). There were no serious adverse events. Success at index EBD was 34%, with a further 43% achieving long-term benefit from additional EBDs. Eighteen (23%) patients required surgery. Time to surgery after the first EDB was 2.6 to 71.1 months (median, 12.8 mo). Longer Crohn's disease duration (P = 0.03) and high C-reactive protein (P = 0.008) were associated with an increased need for subsequent surgery. CONCLUSIONS: EBD was safe and effective in achieving long-term symptom improvement and avoidance of surgery in most patients. Prospective controlled trials are needed to evaluate the effect of other factors, including Crohn's disease phenotype, and the role of concomitant medication to identify those best suited to EBD.


Assuntos
Doenças do Colo/terapia , Colonoscopia/métodos , Doença de Crohn/complicações , Dilatação/métodos , Obstrução Intestinal/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças do Colo/epidemiologia , Doenças do Colo/etiologia , Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Feminino , Seguimentos , Humanos , Incidência , Obstrução Intestinal/epidemiologia , Obstrução Intestinal/etiologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Reino Unido/epidemiologia , Adulto Jovem
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