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1.
Eur Respir J ; 2021 Feb 11.
Artículo en Inglés | MEDLINE | ID: mdl-33574079

RESUMEN

BACKGROUND: Observational studies suggest an association between reduced lung function and risk of coronary artery disease and ischaemic stroke, independent of shared cardiovascular risk factors such as cigarette smoking. We use the latest genetic epidemiological methods to determine if impaired lung function is causally associated with an increased risk of cardiovascular disease. METHODS AND FINDINGS: Mendelian Randomisation uses genetic variants as instrumental variables to investigate causation. Preliminary analysis used two sample Mendelian Randomisation with lung function single nucleotide polymorphisms. To avoid collider bias the main analysis used single nucleotide polymorphisms for lung function identified from UKBiobank in a Multivariable Mendelian Randomisation model conditioning for height, body mass index and smoking.Multivariable Mendelian Randomisation shows strong evidence that reduced FVC causes increased risk of coronary artery disease, Odds Ratio:1·32 (1·19-1·46) per Standard Deviation. Reduced FEV1 is unlikely to be cause increased risk of coronary artery disease as evidence of its effect becomes weak after conditioning for height 1·08 (0·89, 1·30). There is weak evidence that reduced lung function increases risk of ischaemic stroke. CONCLUSION: There is strong evidence that reduced FVC is independently and causally associated with coronary artery disease. Although the mechanism remains unclear, FVC could be taken into consideration when assessing cardiovascular risk and considered a potential target for reducing cardiovascular events. FEV1 and airflow obstruction do not appear to cause increased cardiovascular events, confounding and collider bias may explain previous findings of a causal association.

3.
Thorax ; 2020 Dec 03.
Artículo en Inglés | MEDLINE | ID: mdl-33273026

RESUMEN

The longer-term consequences of SARS-CoV-2 infection are uncertain. Consecutive patients hospitalised with COVID-19 were prospectively recruited to this observational study (n=163). At 8-12 weeks postadmission, survivors were invited to a systematic clinical follow-up. Of 131 participants, 110 attended the follow-up clinic. Most (74%) had persistent symptoms (notably breathlessness and excessive fatigue) and limitations in reported physical ability. However, clinically significant abnormalities in chest radiograph, exercise tests, blood tests and spirometry were less frequent (35%), especially in patients not requiring supplementary oxygen during their acute infection (7%). Results suggest that a holistic approach focusing on rehabilitation and general well-being is paramount.

5.
BMJ Open ; 10(12): e040267, 2020 12 21.
Artículo en Inglés | MEDLINE | ID: mdl-33371025

RESUMEN

OBJECTIVES: An integrated respiratory service was commissioned in 2016 in a UK region to support patients with chronic obstructive pulmonary disease. The service brought together the respiratory department of a National Health Service hospital and a not-for-profit community provider. This paper evaluates: (1) the perceived efficacy of integrated working between the organisations from the perspective of staff and (2) the relationship between commissioning and integration of the services. DESIGN: Semistructured interviews with staff from the three organisations involved in the integrated respiratory service. Staff were purposefully sampled. The interviews were audio recorded, transcribed and analysed thematically. SETTING: Secondary care respiratory unit; community provider of respiratory care; and a clinical commissioning group. PARTICIPANTS: Nineteen interview participants: nine from the community provider; eight from the hospital and two from the clinical commissioning group. RESULTS: Staff identified lack of integration between the organisations characterised by: poor communication, lack of trust, absence of shared information technology and ineffective integrative initiatives. The commissioning process created barriers to integration including: contractual limitations which prevented pathway development, absence of agreed clinical governance arrangements and lack of recognition of community work undertaken by hospital staff. Positive working relationships were established over time as staff recognised the skills that each had to offer. CONCLUSIONS: The commissioning process underpinned the relationship between the organisations and contributed to distrust and negative perceptions of the 'other'. Commissioning an integrated service should incorporate dialogue with stakeholders as early as possible and before the contract is finalised to develop a bedrock of trust.

6.
J Health Serv Res Policy ; : 1355819620974054, 2020 Nov 23.
Artículo en Inglés | MEDLINE | ID: mdl-33225763

RESUMEN

OBJECTIVES: To investigate the effects of an admission avoidance pathway within a new integrated respiratory service on the number of Chronic Obstructive Pulmonary Disease (COPD)-related hospital admissions in England. METHODS: We used interrupted time series analysis to estimate the effects of the admission avoidance pathway on COPD hospital admissions, length of stay, and 30-day readmissions. We included all unplanned admissions with COPD as primary diagnosis using Hospital Episode Statistics, comparing the intervention region with a demographically similar control region in the two years before and one year after the implementation of the new service. RESULTS: Unplanned hospital admissions for COPD exacerbations followed a clear seasonal pattern, peaking in early winter. We found no evidence that the admission avoidance pathway influenced the rate of hospital admissions or 30-day readmissions. We found weak evidence of a trend change in length of stay following the launch of the admission avoidance pathway. CONCLUSIONS: Our study adds to the growing body of evidence that suggests that additional admission avoidance capacity alone does not lead to a measurable reduction in admissions or length of stay. Further investigation is required to understand the reasons why. A longer follow-up may be required to see some of the potential benefits.

7.
Sci Rep ; 10(1): 18950, 2020 11 03.
Artículo en Inglés | MEDLINE | ID: mdl-33144664

RESUMEN

Antimicrobial silver (Ag+) coatings on orthopaedic implants may reduce infection rates, but should not be to the detriment of regenerative cell populations, primarily mesenchymal stem/stromal cells (MSCs). We determined intramedullary silver release profiles in vivo, which were used to test relevant Ag+ concentrations on MSC function in vitro. We measured a rapid elution of Ag+ from intramedullary pins in a rat femoral implantation model, delivering a maximum potential concentration of 7.8 µM, which was below toxic levels determined for MSCs in vitro (EC50, 33 µM). Additionally, we present in vitro data of the reduced colonisation of implants by Staphylococcus aureus. MSCs exposed to Ag+ prior to/during osteogenic differentiation were not statistically affected. Notably, at clonal density, the colony-forming capacity of MSCs was significantly reduced in the presence of 10 µM Ag+, suggesting that a subpopulation of clonal MSCs was sensitive to Ag+ exposure. At a molecular level, surviving colony-forming MSCs treated with Ag+ demonstrated a significant upregulation of components of the peroxiredoxin/thioredoxin pathway and processes involved in glutathione metabolism compared to untreated controls. Inhibition of glutathione synthesis using L-buthionine sulfoxamine eliminated MSC clonogenicity in the presence of Ag+, which was rescued by exogenous glutathione.

8.
Future Healthc J ; 7(3): e85-e87, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33094265

RESUMEN

Service redevelopment has taken place across the NHS in response to the COVID-19 pandemic. At North Bristol NHS Trust, six vulnerable medical staff in non-patient facing roles set up a virtual advice service called 'Ask the Medical Reg'. This service aimed to provide senior medical support to inpatient and community teams for general medical and COVID-19-related queries. Here we outline the structure of our service and present data from the first 4 weeks of operation. We describe how the service has supported both junior doctors working within the hospital and GPs and paramedics, helping with complex decisions to prevent unnecessary admissions.

9.
Health Qual Life Outcomes ; 18(1): 336, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33036615

RESUMEN

BACKGROUND: The Severe Asthma Questionnaire (SAQ) is a health related quality of life (HRQoL) questionnaire validated for use in severe asthma. It is scored using the mean value of 16 items (SAQ score) in addition to a single item global rating of HRQoL (SAQ-global). The aim was to validate clinically relevant subscales using exploratory factor analysis (EFA). METHODS: The SAQ was completed, along with measures of asthma control and EQ5D-5L by patients attending six UK severe asthma centres. Clinical data were included in the analysis. EFA using principal axis factoring and oblimin rotation was used to achieve simple structure of data. RESULTS: 460 patients with severe asthma participated, 65% women, mean age 51 (16-83) years. A three factor solution achieved best fit and showed that the SAQ items formed three distinct but inter-correlated groups of items where items were grouped in a way that was consistent with item content. The three subscales were differentially associated with clinically relevant variables (lung function and mood). Males and females interpreted the question of night disturbance in different ways. CONCLUSIONS: This paper provides a template for best practice in the use of EFA when validating HRQoL subscales. The SAQ can be scored as three subscales with content reflecting three different constructs people with severe asthma use when making judgements about their lives. The subscale 'My Life' assesses the impact of severe asthma on different life activities, 'My Mind' assesses the perceived emotional impact and 'My Body' the impact of extra-pulmonary symptoms and side effects.

10.
Am J Orthod Dentofacial Orthop ; 158(6): 799-806, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-33010979

RESUMEN

INTRODUCTION: Patients and parents want shorter treatment times, but it is unclear whether they would compromise outcome quality to shorten treatment. The purpose of this study was to compare orthodontists' and parents' perceptions of finished occlusion and their willingness to extend treatment time to achieve improved outcomes. The effects of elapsed treatment time and patient compliance were also investigated. METHODS: Parallel surveys for orthodontists (n = 1000) and parents (n = 750) displayed simulated treatment outcomes of well-aligned teeth with occlusions in 1 mm increments from 3 mm Class III to 3 mm Class II. Participants rated their preferences on a visual analogue scale (VAS; 0-100) and specified whether they would extend treatment, and for how long, to improve the occlusion. RESULTS: Two hundred thirty-three orthodontists (23%) and 243 parents (32%) responded. Despite differences between the scores given (P < 0.0001), both groups rated Class I occlusion most acceptable (mean VAS = 93.9 and 80.7, respectively) and 3 mm Class III malocclusion least acceptable (mean VAS = 25.9 and 40.9, respectively). Parents were willing to extend treatment more often and for a greater time than orthodontists to improve results (P < 0.0001). In addition, parents were less willing to terminate treatment early (P < 0.05). Both groups perceived existing outcomes as more acceptable if the patient was noncompliant (P < 0.05), but elapsed time in treatment had no significant effect on ratings. CONCLUSIONS: For outcomes with well-aligned teeth, orthodontists and parents agreed on what the most and least acceptable occlusal relationships were. To achieve better outcomes, parents were willing to extend treatment duration more often and for a greater time than were orthodontists. In addition, parents were less willing than orthodontists to terminate treatment early.


Asunto(s)
Maloclusión de Angle Clase III , Ortodoncia , Actitud del Personal de Salud , Oclusión Dental , Humanos , Ortodoncistas , Padres
11.
12.
BMJ Open ; 10(6): e030128, 2020 06 08.
Artículo en Inglés | MEDLINE | ID: mdl-32518208

RESUMEN

OBJECTIVES: Early access to invasive coronary angiography and revascularisation for high-risk non-ST elevation myocardial infarction (NSTEMI) improves outcomes and is supported by current guidelines. We sought to determine the most effective criteria at presentation to emergency department (ED) to identify high-risk NSTEMI. SETTING: Secondary care centre northwest England with national follow-up. PARTICIPANTS: 1642 consecutive patients (median age 59, 52% male) presenting to ED with a primary symptom of chest pain in whom there is suspicion of NSTEMI. PRIMARY AND SECONDARY MEASURES: Multivariate logistic regression analysis for the prediction of all-cause death (primary) and major adverse cardiac event (MACE defined as all-cause death, unplanned coronary revascularisation and adjudicated NSTEMI (third universal definition)) (secondary measure) at 1 year. RESULTS: The incidence of adjudicated NSTEMI was 10.7%, and 1-year mortality was 6.3%. Independent predictors for all-cause death at 1 year were Global Registry of Acute Coronary Events (GRACE) >140, age (per decade increase) and high-sensitive cardiac troponin T (hs-cTnT) >50 ng/L. hs-cTnT >50 ng/L was associated with adjudicated index presentation NSTEMI in the greatest proportion of patients (61.7%). When using MACE at 12 months, as opposed to all-cause death, as an end point History, ECG, Age, Risk factors and Troponin (HEART) score ≥7 was included in the multivariate model and had better prediction of index NSTEMI than GRACE>140. Combining hs-cTnT >50 ng/L and a second independent predictor identified both a high proportion of index NSTEMI and elevated risk of all-cause death at 1 year. CONCLUSIONS: hs-cTnT >50 ng/L or HEART score ≥7 appear effective strategies to identify high-risk NSTEMI at presentation to emergency room with chest pain. Multicentre prospective studies enriched with early presenters, and with competitor high-sensitive and point-of-care troponins, are required to validate and extend these findings. TRIAL REGISTRATION NUMBER: NCT02581540.

14.
J Obstet Gynaecol ; 40(3): 308-315, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31455124

RESUMEN

Regular audit of results of prenatal screening for congenital heart disease (CHD) is crucial to ensure reliable prenatal diagnosis. We aimed to assess the accuracy of prenatal diagnosis of major CHD between 1996 and 2013. During the study period, prenatal detection of major CHD improved from 4.5% to 71.0% (p<.001). Prenatal diagnoses on 628 live born children and terminated pregnancies were compared with postnatal findings or autopsy reports. The proportion of correct diagnoses increased throughout the study period from 42.9% in 1996 and reached 88.2% in 2013 (p<.001). A total of 32 foetuses with suspected major CHD were terminated though no major CHD was found at autopsy. In these pregnancies, termination was mainly performed due to other anomalies in the foetus.Along with improved detection of major CHD, the validity of a prenatal diagnosis is increasing. No cases of misinterpreted major CHD resulted in the termination of a healthy foetus in this study.Impact statementWhat is already known on this subject? Prenatal diagnosis of isolated congenital heart disease (CHD) correlates well with lesions found during autopsy performed in terminated foetuses. Few studies have assessed the accuracy of prenatal diagnosis of major CHD in live born children, cases with associated anomalies and the time trend in validity.What the results of this study add? This study illustrates that the validity of prenatal diagnosis of major CHD is increasing. Prenatal diagnoses in terminated pregnancies as well as in live born children is high except for coarctation of the aorta and atrioventricular septal defects. Chromosomal anomalies are associated with lower accuracy of prenatal diagnosis.What the implications are of these findings for clinical practice and/or further research? Prenatal diagnosis is an accurate tool for detecting major CHD. Misinterpretation has not led to the termination of a healthy foetus; however, this study illustrates that vigilant care should be placed on the cardiac evaluation when termination is considered due to the cardiac defect.

15.
J Clin Med ; 8(12)2019 Dec 04.
Artículo en Inglés | MEDLINE | ID: mdl-31817201

RESUMEN

BACKGROUND: Xpert MTB/RIF (GX) for tuberculosis (TB) diagnosis is often located in reference laboratories, and sputum needs to be transported using a cold chain. Transport media to preserve sputum are available, but performance data under programmatic conditions are limited. METHODS: Sputum samples were collected from patients with presumptive TB in Nigeria. One sputum was transported in a cold chain, tested immediately with GX and cultured. One sputum was swabbed and stored in PrimeStore-Molecular-Transport-Medium (Primestore), and the remainder was stored in OMNIGene-sputum (Omnigene), kept for seven days and tested with GX. RESULTS: Of 248 patients, 63 were fresh-sputum culture-positive and 56 GX-positive (sensitivity 88.9%, 95% CI: 78.4-95.4%). Four of 185 culture-negative patients were GX-positive (specificity 97.8%, 94.6-99.4%). Omnigene GX and Primestore GX were positive in 56/62 (90.3%, 80.1-96.4%) and 49/62 (79.0%, 66.8-88.3%) culture-positive, respectively, and 1/185 (99.5%, 97.0-100.0%) and 3/185 (98.4%, 95.3-99.7%) were culture-negative patients. 14 Human Immunodeficiency Virus (HIV)-infected and 44 HIV-uninfected patients were culture-positive. Omnigene and Primestore detected 12/14 (85.7%, 57.2-98.2%) and 5/14 (35.7%, 12.8-64.9%) HIV-infected and 41/44 (93.2%, 81.3-98.6%) HIV-uninfected culture-positive patients. Interpretation: Omnigene stored and fresh sputum samples had similar GX results. The GX results of Primestore-stored samples were similar to those found in the fresh sputum of non-HIV infected patients, but GX-positivity was lower in HIV-infected patients. This was likely due to the lower amount of bacilli collected by the swab and transferred to PrimeStore.

16.
Int J Chron Obstruct Pulmon Dis ; 14: 1855-1866, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31686798

RESUMEN

Background: Brain damage and cardiovascular disease are extra-pulmonary manifestations of chronic obstructive pulmonary disease (COPD). Cardiovascular risk factors and smoking are contributors to neurodegeneration. This study investigates whether there is a specific, COPD-related deterioration in brain structure and function independent of cardiovascular risk factors and smoking. Materials and methods: Neuroimaging and clinical markers of brain structure (micro- and macro-) and function (cognitive function and mood) were compared between 27 stable COPD patients (age: 63.0±9.1 years, 59.3% male, forced expiratory volume in 1 second [FEV1]: 58.1±18.0% pred.) and 23 non-COPD controls with >10 pack years smoking (age: 66.6±7.5 years, 52.2% male, FEV1: 100.6±19.1% pred.). Clinical relationships and group interactions with brain structure were also tested. All statistical analyses included correction for cardiovascular risk factors, smoking, and aortic stiffness. Results: COPD patients had significantly worse cognitive function (p=0.011), lower mood (p=0.046), and greater gray matter atrophy (p=0.020). In COPD patients, lower mood was associated with markers of white matter (WM) microstructural damage (p<0.001), and lower lung function (FEV1/forced vital capacity and FEV1) with markers of both WM macro (p=0.047) and microstructural damage (p=0.028). Conclusion: COPD is associated with both structural (gray matter atrophy) and functional (worse cognitive function and mood) brain changes that cannot be explained by measures of cardiovascular risk, aortic stiffness, or smoking history alone. These results have important implications to guide the development of new interventions to prevent or delay progression of neuropsychiatric comorbidities in COPD. Relationships found between mood and microstructural abnormalities suggest that in COPD, anxiety, and depression may occur secondary to WM damage. This could be used to better understand disabling symptoms such as breathlessness, improve health status, and reduce hospital admissions.


Asunto(s)
Encefalopatías/etiología , Encéfalo , Enfermedades Cardiovasculares/etiología , Enfermedad Pulmonar Obstructiva Crónica/etiología , Fumar/efectos adversos , Afecto , Anciano , Encéfalo/diagnóstico por imagen , Encéfalo/fisiopatología , Encefalopatías/diagnóstico por imagen , Encefalopatías/fisiopatología , Encefalopatías/psicología , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/fisiopatología , Estudios de Casos y Controles , Cognición , Femenino , Volumen Espiratorio Forzado , Humanos , Pulmón/fisiopatología , Masculino , Persona de Mediana Edad , Degeneración Nerviosa , Neuroimagen/métodos , Valor Predictivo de las Pruebas , Pronóstico , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Factores de Riesgo , Rigidez Vascular , Capacidad Vital
17.
PLoS One ; 14(10): e0223297, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31581226

RESUMEN

BACKGROUND: Mild cognitive impairment is a common systemic manifestation of chronic obstructive pulmonary disease (COPD). However, its pathophysiological origins are not understood. Since, cognitive function relies on efficient communication between distributed cortical and subcortical regions, we investigated whether people with COPD have disruption in white matter connectivity. METHODS: Structural networks were constructed for 30 COPD patients (aged 54-84 years, 57% male, FEV1 52.5% pred.) and 23 controls (aged 51-81 years, 48% Male). Networks comprised 90 grey matter regions (nodes) interconnected by white mater fibre tracts traced using deterministic tractography (edges). Edges were weighted by the number of streamlines adjusted for a) streamline length and b) end-node volume. White matter connectivity was quantified using global and nodal graph metrics which characterised the networks connection density, connection strength, segregation, integration, nodal influence and small-worldness. Between-group differences in white matter connectivity and within-group associations with cognitive function and disease severity were tested. RESULTS: COPD patients' brain networks had significantly lower global connection strength (p = 0.03) and connection density (p = 0.04). There was a trend towards COPD patients having a reduction in nodal connection density and connection strength across the majority of network nodes but this only reached significance for connection density in the right superior temporal gyrus (p = 0.02) and did not survive correction for end-node volume. There were no other significant global or nodal network differences or within-group associations with disease severity or cognitive function. CONCLUSION: COPD brain networks show evidence of damage compared to controls with a reduced number and strength of connections. This loss of connectivity was not sufficient to disrupt the overall efficiency of network organisation, suggesting that it has redundant capacity that makes it resilient to damage, which may explain why cognitive dysfunction is not severe. This might also explain why no direct relationships could be found with cognitive measures. Smoking and hypertension are known to have deleterious effects on the brain. These confounding effects could not be excluded.


Asunto(s)
Disfunción Cognitiva/etiología , Disfunción Cognitiva/fisiopatología , Conectoma , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Sustancia Blanca/fisiología , Anciano , Anciano de 80 o más Años , Cognición , Disfunción Cognitiva/psicología , Imagen de Difusión Tensora , Femenino , Humanos , Procesamiento de Imagen Asistido por Computador , Masculino , Persona de Mediana Edad , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Pruebas de Función Respiratoria , Índice de Severidad de la Enfermedad , Sustancia Blanca/diagnóstico por imagen
18.
Med Humanit ; 45(3): 294-303, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31371484

RESUMEN

Health research is often bounded by disciplinary expertise. While cross-disciplinary collaborations are often forged, the analysis of data which draws on more than one discipline at the same time is underexplored. Life of Breath, a 5-year project funded by the Wellcome Trust to understand the clinical, historical and cultural phenomenology of the breath and breathlessness, brings together an interdisciplinary team, including medical humanities scholars, respiratory clinicians, medical anthropologists, medical historians, cultural theorists, artists and philosophers. While individual members of the Life of Breath team come together to share ongoing work, collaborate and learn from each other's approach, we also had the ambition to explore the feasibility of integrating our approaches in a shared response to the same piece of textual data. In this article, we present our pluralistic, interdisciplinary analysis of an excerpt from a single cognitive interview transcript with a patient with chronic obstructive pulmonary disease. We discuss the variation in the responses and interpretations of the data, why research into breathlessness may particularly benefit from an interdisciplinary approach, and the wider implications of the findings for interdisciplinary research within health and medicine.


Asunto(s)
Investigación Biomédica/métodos , Disnea , Relaciones Interprofesionales , Conducta Cooperativa , Interpretación Estadística de Datos , Humanos , Comunicación Interdisciplinaria
20.
JAMA Netw Open ; 2(7): e197242, 2019 07 03.
Artículo en Inglés | MEDLINE | ID: mdl-31322690

RESUMEN

Importance: Primary outcome change could threaten the validity of a clinical trial; however, evidence about the consequences on the reported intervention effect size is unclear. Objectives: To examine the status of randomized clinical trials whose primary outcome changed between trial registration and publication and to quantify the association of this change with the reported intervention effect size. Design, Setting, and Participants: In this cross-sectional study on the primary report of randomized clinical trials with clear prospectively registered primary outcomes, PubMed and Embase were searched for articles published between January 1, 2011, and December 31, 2015. The search was conducted in January 2016, identifying randomized clinical trials and the combination of keywords and text words related to registry. Main Outcomes and Measures: Based on the developed approach, trials were classified as having primary outcome change when there was a major discrepancy between the registered and published primary outcomes. Intervention effect was estimated or recalculated using the odds ratio (OR) for each comparison. Each component OR is structured so that an OR is less than 1 if the intervention group has a more favorable result than the control group. The ratio of ORs (ROR), which is the summary OR for trials with primary outcome change divided by those without, and its 95% CI were calculated, with a value less than 1 indicating a larger reported intervention effect size in trials with primary outcome change than those without. Results: Among 29 749 searched articles (28 810 MEDLINE and 939 Embase), 1488 articles were randomly selected for review. Of 389 trials with clear primary outcomes prospectively described in the registry (416 outcomes reported), 33.4% (130 of 389) of trials had at least 1 primary outcome change. Most (66 of 130) of the changes were either not reporting or omitting the primary outcome. In total, 338 trials (365 outcomes and 487 comparisons) were available for quantitative analysis on the reported intervention effect size bias assessment. Compared with those without primary outcome change, trials with primary outcome change showed a 16% (pooled ROR, 0.84; 95% CI, 0.73-0.96) larger reported intervention effect size. The result persisted after adjustment for potential confounders (ROR, 0.81; 95% CI, 0.71-0.93) and other sensitivity and subgroup analyses. Conclusions and Relevance: Results of this study suggest that inconsistencies between registered and published primary outcomes of clinical trials are common, and trials with primary outcome change are likely to have a larger intervention effect than those without.


Asunto(s)
Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación/estadística & datos numéricos , Estudios Transversales , Humanos , Sistema de Registros
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