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1.
Blood Press ; 32(1): 2281316, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-38010821

RESUMO

PURPOSE: Hypertension significantly contributes to cardiovascular diseases and premature deaths. Effective treatment is crucial to reduce cardiovascular risks, but poor adherence to antihypertensive drugs is a major issue. Numerous studies attempted to investigate interventions for identifying non-adherence, but often failed to address the issue effectively. The RHYME-RCT trial sought to bridge this gap by measuring non-adherence by determining antihypertensive drug concentrations in blood through a dried blood spot (DBS) method in patients with resistant hypertension. This measurement was followed by personalized feedback to improve adherence. During the course of this trial several challenges emerged, including selection bias, the gatekeeper role of physicians, the Hawthorne effect and the role of randomization. AIM: This communication aims to inform fellow researchers and clinicians of challenges that can arise when conducting clinical trials to improve adherence and offer insights for refining study designs to avoid these issues in forthcoming adherence studies.


Purpose: High blood pressure is a serious problem that can lead to heart and kidney problems and early deaths. Treating high blood pressure is therefore crucial. Initially, lifestyle changes are recommended, but if they don't work, medications are needed. However, taking these drugs daily can be challenging, and many patients miss doses which is called non-adherence. Despite numerous studies, a perfect solution hasn't been found to solve non-adherence to blood pressure lowering drugs.In the RHYME-RCT study, researchers aimed to improve drug adherence in patients with resistant hypertension. They monitored drug intake by measuring drug concentrations in the blood alongside 24-hour blood pressure monitoring. These data allowed healthcare providers to offer personalized advice to patients. The study encountered some important challenges in its design, including selection bias, where some participants shouldn't have been included or excluded in the study, and the Hawthorne effect, where patients changed their behavior because they knew they were being observed.Aim: This message is to inform fellow scientists and doctors about issues that can arise when conducting clinical trials to improve adherence and to encourage the exchange of ideas between scientists to improve future studies on medication adherence, which is essential for managing conditions like high blood pressure.


Assuntos
Doenças Cardiovasculares , Hipertensão , Humanos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/farmacologia , Hipertensão/tratamento farmacológico , Resultado do Tratamento , Pressão Sanguínea
2.
Acta Neurochir Suppl ; 130: 207-216, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37548741

RESUMO

Measure something, and it gets better-this is what is called as the Hawthorne effect (also known as the observer effect). The Hawthorne factory experiments in 1920s were remarkable industrial data collection and analysis exercises that lead to Edwards Deming's quality revolution. The Harvard Medical Practice Study (1991), Leape's "Error in Medicine" (1994), and the Bristol pediatric cardiac report (2001) are among many documents that have revealed the huge gap between best practices and actual medical practice. Alarmed by the poor standards of quality at the most respected institutions, the medical fraternity therefore began visiting facilities in different fields and observing their quality assessment processes. The next leap for neurosurgery is to realize that it is unacceptable to treat patients with no regard for the standard of clinical outcomes. The traditional neurosurgery residency training has long ignored the most important issues of self-assessment, reappraisal, relearning, and measurement of skill and surgical outcomes. However, the experience taken from disparate fields, especially cardiac surgery, may encourage research and progress in measurement and improvement of quality in neurosurgery. Like cardiac surgeons, neurosurgeons must examine and analyze the results of their interventions. The concept of quality measurement is the most important single advance we can make in neurosurgery practice. Meticulous and precise measurement of outcomes will allow future progress of our specialty.


Assuntos
Neurocirurgia , Humanos , Criança , Neurocirurgia/educação , Procedimentos Neurocirúrgicos/educação , Coleta de Dados/métodos , Neurocirurgiões , Modificador do Efeito Epidemiológico
3.
BMC Infect Dis ; 21(1): 420, 2021 May 04.
Artigo em Inglês | MEDLINE | ID: mdl-33947338

RESUMO

BACKGROUND: The Hawthorne Effect is the change in behaviour by subjects due to their awareness of being observed and is evident in both research and clinical settings as a result of various forms of observation. When the Hawthorne effect exists, it is short-lived, and likely leads to increased productivity, compliance, or adherence to standard protocols. This study is a qualitative component of an ongoing multicentre study, examining the role of Incisional Negative Pressure Wound Therapy after vascular surgery (INVIPS Trial). Here we examine the factors that influence hygiene and the role of the Hawthorne effect on the adherence of healthcare professionals to standard hygiene precautions. METHODS: This is a qualitative interview study, investigating how healthcare professionals perceive the observation regarding hygiene routines and their compliance with them. Seven semi-structured focus group interviews were conducted, each interview included a different staff category and one individual interview with a nurse from the Department for Communicable Disease Control. Additionally, a structured questionnaire interview was performed with environmental services staff. The results were analysed based on the inductive qualitative content analysis approach. RESULTS: The analysis revealed four themes and 12 subthemes. Communication and hindering hierarchy were found to be crucial. Healthcare professionals sought more personal and direct feedback. All participants believed that there were routines that should be adhered to but did not know where to find information on them. Staff in the operating theatre were most meticulous in adhering to standard hygiene precautions. The need to give observers a clear mandate and support their work was identified. The staff had different opinions concerning the patient's awareness of the importance of hygiene following surgery. The INVIPS Trial had mediated the Hawthorne effect. CONCLUSION: The results of this study indicate that the themes identified, encompassing communication, behaviour, rules and routines, and work environment, influence the adherence of healthcare professionals to standard precautions to a considerable extent of which many factors could be mediated by a Hawthorne effect. It is important that managers within the healthcare system put into place an improved and sustainable hygiene care to reduce the rate of surgical site infections after vascular surgery.


Assuntos
Modificador do Efeito Epidemiológico , Pessoal de Saúde , Controle de Infecções/métodos , Procedimentos Cirúrgicos Vasculares , Fidelidade a Diretrizes/estatística & dados numéricos , Humanos , Higiene
4.
J Am Acad Dermatol ; 82(1): 45-53, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31150716

RESUMO

BACKGROUND: Hidradenitis suppurativa (HS) is characterized by recurrent, painful nodules in flexural areas. OBJECTIVE: The objective of this study was to explore the placebo response in HS randomized clinical trials and to compare it briefly with the placebo response in psoriasis and atopic dermatitis. METHODS: A Cochrane Review on interventions in HS was used as a starting point, and a systematic review was then undertaken by using the PubMed database, yielding 7 HS randomized clinical trials for inclusion in this study. RESULTS: This review demonstrates that there is a robust placebo response in HS that is most marked in physical signs but also marked in pain responses. LIMITATIONS: Multiple outcome measures utilized in these studies and reporting bias limited this review. CONCLUSION: This large placebo response has implications for clinical trial design. This knowledge can also help deliver improved clinical care by forming the basis of nonpharmacologic treatments and help optimize current medication use to maximize the placebo effect.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Produtos Biológicos/administração & dosagem , Hidradenite Supurativa/tratamento farmacológico , Placebos/administração & dosagem , Qualidade de Vida , Adulto , Feminino , Hidradenite Supurativa/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco
5.
Support Care Cancer ; 28(12): 5751-5761, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32206970

RESUMO

PURPOSE: Patients are commonly enrolled into clinical trials. It has been reported that these patients may have better outcomes than those not enrolled into the study. The reasoning from these improvements could be attributable to closer follow-up, better patient adherence, more health aware patients have, or reaction to observation such as the Hawthorne effect. METHODS: Three hundred forty-six patients were approached for a prospective skin toxicity study in adjuvant breast cancer radiotherapy (RT) but declined participation between January 2018 and July 2019 (non-trial group). They were retrospectively reviewed and patient, treatment and RT-related characteristics, as well as the occurrence of skin reactions, and the usage of topical treatments were collected. This was compared with a comparison cohort of 349 patients who were enrolled into a previously conducted prospective study (trial group). RESULTS: More patients in the trial group had conventional RT (CFRT) versus hypofractionated RT (HFRT). Data was further stratified and there was no significant difference in moist desquamation, topical antibiotic usage, dressing application, home care use, topical corticoid steroid use, and oral analgesic use. There was a significantly lower pain score in the group compared with the non-trial group in both HFRT and CFRT (OR = 0.091 and OR = 0.348, p < 0.0001). CONCLUSION: Our results demonstrated no differences other than pain between the trial group and non-trial group. Therefore, in this cohort, patients enrolled into an observational trial while undergoing adjuvant breast RT demonstrated similar experiences of skin reactions. There are challenges to assessing differences between these groups, as confounding is likely. Therefore, it is recommended for future studies to additionally assess the impact of study participation on outcomes such as quality of life, quality of care received, and/or anxiety levels.


Assuntos
Qualidade de Vida/psicologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
6.
Acta Anaesthesiol Scand ; 64(5): 602-612, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31889306

RESUMO

BACKGROUND: Perioperative blood loss is a major contributor to morbidity and mortality in cardiac surgery. Plasma fibrinogen levels play an essential role in hemostasis and deplete quickly during hemorrhage. The objective of this study was to determine whether prophylactic fibrinogen concentrate administration lowers overall blood product transfusion requirements in high-risk cardiac surgery in patients with low fibrinogen plasma levels. METHODS: The study was performed in a prospective, randomized, and double-blinded design. The investigation included 62 patients undergoing elective, high-risk cardiac surgery. After weaning from cardiopulmonary bypass and reversal of heparin patients received either fibrinogen concentrate or placebo. The primary outcome variable was overall blood product usage 24 hours after intervention. RESULTS: The fibrinogen group received numerically fewer total units of blood products than the placebo group, but the difference was not statistically or clinically significant (for groups n = 27; n = 29 and 19 vs 37 units, respectively, P = .908). The overall transfusion rate in both groups was significantly lower than the institutional average suggested (fibrinogen group 26%, placebo group 28%). The fibrinogen group showed significantly higher fibrinogen levels (2.38 vs 1.83 g/L (end of surgery), P < .001; 3.33 vs 2.68 g/L (12 hours after intervention), P = .003) and improved viscoelastic coagulation parameters (FIBTEM MCF, 27 vs 23 mm, P = .022). CONCLUSION: This randomized, controlled trial demonstrates that point-of-care guided and prophylactic treatment with fibrinogen concentrate does not reduce transfusion of blood products in a setting of unexpectedly low transfusion rate as tested in this cohort, but may improve coagulation parameters in the setting of high-risk cardiac surgery.


Assuntos
Perda Sanguínea Cirúrgica/prevenção & controle , Procedimentos Cirúrgicos Cardíacos , Coagulantes/administração & dosagem , Fibrinogênio/administração & dosagem , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Risco
7.
Ann Fam Med ; 17(6): 554-560, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31712294

RESUMO

Most primary care researchers lack a practical approach for including field observations in their studies, even though observations can offer important qualitative insights and provide a mechanism for documenting behaviors, events, and unexpected occurrences. We present an overview of unstructured field observations as a qualitative research method for analyzing material surroundings and social interactions. We then detail a practical approach to collecting and recording observational data through a "3 Cs" template of content, context, and concepts. To demonstrate how this method works in practice, we provide an example of a completed template and discuss the analytical approach used during a study on informed consent for research participation in the primary care setting of Qatar.


Assuntos
Coleta de Dados/métodos , Observação/métodos , Atenção Primária à Saúde/métodos , Pesquisa Qualitativa , Humanos , Consentimento Livre e Esclarecido , Projetos de Pesquisa
8.
BMC Pregnancy Childbirth ; 19(1): 101, 2019 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-30922258

RESUMO

BACKGROUND: Clinical team training has been advocated as a means to improve delivery care, and failed extractions is a suggested variable for clinical audit in instrumental vaginal delivery. Other activities may also have intended or unintended effects on care processes or outcomes. METHODS: We retrospectively observed 1074 mid and low vacuum extraction deliveries during three time periods (prevalence periods): Baseline (period 0), implemented team training (period 1 and 2) and monitoring of traction force during vacuum extraction (period 2). Our primary outcome was failed extraction followed by emergency cesarean section or obstetric forceps delivery. RESULTS: The prevalence proportion (relative risk) of failed extraction decreased significantly after implementation of team training, from 19% (period 0) to 8 % (period 1), corresponding to a relative risk of 0.48 [0.26-0.87]. The secondary procedural outcome complicated delivery (duration > 15 min or number of pulls > 6, or cup detachment > 1) was decreased in period 2 compared to period 1, RR 0.42 [0.23-0.76]. Secondary clinical (neonatal) outcome were not affected. CONCLUSION: Clinically based educational efforts and increased monitoring improved procedural outcome without improving neonatal outcome. The study design has inherent limitations in making causal inference.


Assuntos
Parto Obstétrico/estatística & dados numéricos , Implementação de Plano de Saúde , Capacitação em Serviço/estatística & dados numéricos , Recursos Humanos em Hospital/educação , Vácuo-Extração/educação , Adulto , Feminino , Hospitais , Humanos , Gravidez , Estudos Retrospectivos , Vácuo-Extração/efeitos adversos , Vácuo-Extração/estatística & dados numéricos
9.
BMC Infect Dis ; 18(1): 369, 2018 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-30081843

RESUMO

BACKGROUND: Observation and feedback are core strategies of hand hygiene (HH) improvement. Direct overt observation is currently the gold standard method. Observation bias, also known as the Hawthorne effect, is a major disadvantage of this method. Our aim was to examine the variation of the Hawthorne effect on HH observation in different healthcare groups and settings. METHODS: A prospective cohort study was performed in a tertiary teaching hospital during a 15-month period. Up to 38 overt observers (82% nurses) and 93 covert observers (81% medical students) participated in HH observation. The HH events observed overtly were matched for occupation, department, observation time, and location with those observed covertly. The data of matched pairs were then analysed to detect possible Hawthorne effects on different variables. RESULTS: A total of 31,522 HH opportunities were observed (4581 overtly, 26,941 covertly). There were 3047 matched pairs after 1:1 matching of overt and covert observations. The overall HH compliance was higher with overt observation than with covert observation (78% vs. 55%, p < 0.001). The Hawthorne effect was nearly three times larger in nurses (30 percentage points) than in physicians (11 percentage points) and was significantly greater in outpatient clinics (41 percentage points) than in intensive care units (11 percentage points). The magnitude of the Hawthorne effect varied among healthcare worker occupations and observation locations (p values both < 0.001) but not among departments, observation times, or HH indications. CONCLUSIONS: Heterogeneity in the Hawthorne effect may influence the interpretation of overt observations and prevent the correct identification of target populations with poor HH compliance. Therefore, directly observed HH compliance may not be an adequate performance indicator for infection control.


Assuntos
Modificador do Efeito Epidemiológico , Higiene das Mãos/organização & administração , Controle de Infecções/métodos , Estudos de Coortes , Fidelidade a Diretrizes , Higiene das Mãos/estatística & dados numéricos , Hospitais de Ensino , Humanos , Unidades de Terapia Intensiva , Enfermeiras e Enfermeiros , Ambulatório Hospitalar , Médicos , Estudos Prospectivos , Estudantes de Medicina , Taiwan
10.
Nord J Psychiatry ; 72(6): 442-446, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30744517

RESUMO

BACKGROUND: The Hawthorne effect on clinical studies in Parkinson's disease has not been thoroughly investigated. Evidently the Hawthorne effect may have impact on study outcomes acting as a 'pre-placebo' effect in the recruitment phase, hence before inclusion. AIM: The aim of this study was to discuss the Hawthorne effect in relation to clinical and self-reported outcome measures in a randomized clinical study in the recruitment phase and during the study. METHODS: Data from 97 participants with Parkinson's disease treated with Transcranial Pulsed Electromagnetic Fields were applied, randomized to an active (n = 49) or a placebo treated group (n = 48). The participants received one home treatment session, for eight consecutive weeks. Outcome measures were the Unified Parkinson's Disease Rating Scale, The 39-item Parkinson's Disease Questionnaire and the WHO-5. RESULTS: No difference in treatment effect between the two groups was found pertaining the Unified Parkinson's Disease Rating Scale. No difference in treatment effect between the two groups was found pertaining the 39-item Parkinson's Disease Questionnaire, apart from the dimension mobility. No difference in treatment effect between the two groups was found pertaining the WHO-5 scale. CONCLUSIONS: The Hawthorne effect may have caused a 'pre-placebo' effect on the outcome measures even before obtaining baseline outcomes measures. This study may have been particularly prone to a Hawthorne effect due to the intense contact with the participants before and during the study. Moreover, the Hawthorne effect should not be viewed upon as a single entity but rather as entities affecting outcome measures throughout the full study period.


Assuntos
Modificador do Efeito Epidemiológico , Doença de Parkinson/terapia , Estimulação Magnética Transcraniana/métodos , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Avaliação de Resultados em Cuidados de Saúde , Índice de Gravidade de Doença
11.
Nord J Psychiatry ; 72(5): 367-373, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-29714082

RESUMO

INTRODUCTION: Measurement-based care (MBC) transfers the scientific principle from controlled clinical trials to the daily routine treatment to improve the care of patients with anxiety and depression. AIM: Within the pharmacopsychometric triangle in which the domain of desired clinical effect of treatment is balanced against the domain of undesired treatment side effects in terms of the domain of restored well-being. The relevance of these domains both in the controlled clinical trials and in the MBC trials will be tested. METHODS: The MBC trials are compared with the controlled clinical trials focusing on the health domains of symptoms reduction (anxiety/depression), side effects of treatment, self-reported quality of life and social functioning. RESULTS: The amount of MBC trials was found rather sparse but information emerged demonstrating that the full clinician-rated Hamilton Depression Scale (HAM-D17) was sufficient for the identification of patients being in need of treatment and the HAM-D6 subscale was valid as outcome measure. From the patient-reported domains, the full Symptom Checklist (SCL-90), the 10-item anxiety/depression subscale (SCL-10) was found valid as symptom outcome. From the full Patient Reported Inventory of Side-Effects (PRISE), a subscale including Clinician Action of Response (CAR) for side effects to antidepressants was found valid (PRISE-CAR), as was the World Health Organization subscale (WHO-5) for the measure of quality of life. CONCLUSION: The pharmacopsychometric triangle is also important in the MBC trials for improving the care of patients with anxiety and depression. However, the amount of MBC trials is still rather sparse.


Assuntos
Transtornos de Ansiedade/diagnóstico , Transtornos de Ansiedade/psicologia , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/psicologia , Avaliação de Resultados em Cuidados de Saúde/métodos , Assistência ao Paciente/métodos , Antidepressivos/uso terapêutico , Transtornos de Ansiedade/tratamento farmacológico , Ensaios Clínicos como Assunto/métodos , Transtorno Depressivo/tratamento farmacológico , Feminino , Humanos , Masculino , Qualidade de Vida/psicologia
12.
Int Wound J ; 15(6): 1010-1024, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30136375

RESUMO

The Hawthorne Effect (HE) is considered a methodological artefact in research, although its definition and influence on research outcomes lack consensus. This review explored how this term has been mentioned and discussed in the area of wound research. A scoping review was conducted on ProQuest Central, Scopus, EbscoHost, and online databases of indexed wound journals using the methodological framework by Arksey and Malley. A review protocol was applied to detail key terms, truncation and Boolean operators, and inclusion and exclusion criteria. Search findings were reported using PRISMA guidelines. A total of 38 articles reporting primary evidence were identified. Three themes emerged from the review: wound researchers' awareness of HE, the acknowledgement of the existence or otherwise of HE, and the mentioning of HE in passing. These results reflect a lack of attention to and understanding and awareness of the HE in the area of wound research. It is suggested that the HE receives more attention as a methodological concern, and its potential influence is considered and mitigated when planning future studies. Recommendations are provided to minimise the impact of the HE on the rigour of the research and confidence afforded to research findings.


Assuntos
Pesquisa Biomédica/métodos , Interpretação Estatística de Dados , Variações Dependentes do Observador , Cicatrização/fisiologia , Humanos
13.
Malar J ; 16(1): 12, 2017 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-28049477

RESUMO

BACKGROUND: Long-lasting insecticidal nets (LLINs) are ineffective malaria transmission prevention tools if they are unused. Discomfort due to heat is the most commonly reported reason for not using nets, but this problem is largely unaddressed. With increasing rural electrification and the dropping price of solar power, fans could improve comfort inside nets and be affordable to populations in malaria endemic areas. Here, results are presented from a pilot randomized controlled cross-over study testing the effect of fans on LLIN use. METHODS: Eighty-three households from two rural communities in Greater Accra, Ghana, randomized into three groups, participated in a 10-month cross-over trial. After a screening survey to identify eligible households, all households received new LLINs. BÍ»kͻͻ net fan systems (one fan per member) were given to households in Group 1 and water filters were given to households in Group 2. At mid-point, Group 1 and 2 crossed over interventions. Households in Group 1 and 2 participated in fortnightly surveys on households' practices related to nets, fans and water filters, while households in Group 3 were surveyed only at screening, mid-point and study end. Entomological and weather data were collected throughout the study. Analysis took both 'per protocol' (PP) and 'intention to treat' (ITT) approaches. The mid- and end-point survey data from Group 1 and 2 were analysed using Firth logistic regressions. Fortnightly survey data from all groups were analysed using logistic regressions with random effects. RESULTS: Provision of fans to households appeared to increase net use in this study. Although the increase in net use explained by fans was not significant in the primary analyses (ITT odds ratio 3.24, p > 0.01; PP odds ratio = 1.17, p > 0.01), it was significant in secondary PP analysis (odds ratio = 1.95, p < 0.01). Net use was high at screening and even higher after provision of new LLINs and with follow up. Fan use was 90-100% depending on the fortnightly visit. CONCLUSIONS: This pilot study could not provide definitive evidence that fans increase net use. A larger study with additional statistical power is needed to assess this association across communities with diverse environmental and socio-demographic characteristics.


Assuntos
Ar Condicionado/instrumentação , Ar Condicionado/métodos , Mosquiteiros Tratados com Inseticida/estatística & dados numéricos , Controle de Mosquitos/instrumentação , Controle de Mosquitos/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos Cross-Over , Características da Família , Feminino , Gana , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , População Rural , Adulto Jovem
14.
AJR Am J Roentgenol ; 208(3): W101-W109, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28075621

RESUMO

OBJECTIVE: The purpose of this article is to introduce the reader to basic concepts of quality and safety in radiology. CONCLUSION: Concepts are introduced that are keys to identifying, understanding, and utilizing certain quality tools with the aim of making process improvements. Challenges, opportunities, and change drivers can be mapped from the radiology quality perspective. Best practices, informatics, and benchmarks can profoundly affect the outcome of the quality improvement initiative we all aim to achieve.


Assuntos
Segurança do Paciente/normas , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Radiologia/normas , Estados Unidos
15.
BMC Health Serv Res ; 17(1): 79, 2017 01 25.
Artigo em Inglês | MEDLINE | ID: mdl-28122612

RESUMO

BACKGROUND: Evidence suggests that the process of taking part in health research can improve participants' health, independent of any intended intervention. However, no research has yet explored whether these effects differ across socioeconomic groups. If the effect of mere participation in health research also has a social gradient this could increase health inequalities and bias research results. This study used the Born in Bradford family cohort (BIB) to explore whether simply taking part in BIB had improved participants' health and, if so, whether this effect was mediated by socioeconomic status. METHODS: Survey data on self-reported health behaviours were collected between 2007 and 2010 as part of BIB. These were augmented by clinical data on birth weight. Pregnant women on their second pregnancy, joining BIB for the first time formed the control group. Their health was compared to women on their second pregnancy who had both pregnancies within the study, who formed the exposed group. In order to limit the inherent bias in a non-randomised study, propensity score analysis was used, matching on age, ethnicity, education and date of questionnaire. The results were then compared according to mothers' education. RESULTS: Of six outcomes tested, only alcohol consumption showed a statistically significant reduction with exposure to BIB (OR: 0.35, 95% CIs 0.13, 0.92). Although effect estimates were larger for women with higher education compared to lower education, these effects were not statistically significant. CONCLUSIONS: Despite one significant finding, these results overall are insufficient to conclude that simply taking part in BIB affected participants' health. We recommend that socioeconomic status is considered in future studies testing effects of research participation, and that randomised studies with larger sample sizes are conducted.


Assuntos
Estudos de Coortes , Comportamentos Relacionados com a Saúde , Disparidades nos Níveis de Saúde , Gravidez , Classe Social , Adulto , Modificador do Efeito Epidemiológico , Feminino , Humanos , Pontuação de Propensão , Inquéritos e Questionários
16.
Heliyon ; 10(4): e25730, 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38380050

RESUMO

This paper used a multi-period DID model with panel data from 283 Chinese cities between 2006 and 2019 to investigate the emission reduction effects and mechanisms of China's carbon trading scheme. The research revealed that China's Carbon Emissions Trading Scheme not only stimulated businesses to reduce emissions as a market-based environmental regulation policy but also influenced local governments' governance objectives. As a result, the Hawthorne effect inevitably manifested during the experimental period of China's Carbon Emissions Trading Scheme. Further analysis indicated that China's CETS encouraged local authorities to take a more proactive stance towards the balance between environmental preservation and economic growth, aiming to achieve a mutually beneficial outcome. Based on the political stance of local governments, they are likely to simultaneously increase their focus on both economic growth and environmental protection. However, when faced with the conflict between economic advancement and environmental safeguarding, pilot regions prioritized ecological conservation in their practical steps, leading to a modest decline in economic growth. In other words, the government's high-profile announcements may not always manifest in actual deeds. In practice, local authorities tend to allocate more administrative resources to areas highly prioritized by the central government. Furthermore, the extended analysis reveals that China's CETS has resulted in a reduction in social welfare due to a shift in governance priorities influenced by political incentives. Therefore, fine-tuning the performance evaluation mechanism, preventing any bias towards the target preferences of local authorities, and guaranteeing the successful operation of the market mechanism are imperative to achieve truly low-cost and sustainable emissions reductions objectives for CETS.

17.
Front Sports Act Living ; 5: 1236870, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37614413

RESUMO

Background: Device-based measurement in physical activity surveillance is increasing, but research design choices could increase the risk of self-selection bias and reactive behaviour. The aim of this study is to compare the self-reported physical activity profiles of four different samples: participants in a large national survey, participants in a telephone-based survey of non-responders, participants in the large national survey who accepted the invitation to device-based measuring, and the same sample during the week of monitoring. Methods: In October 2020, 163,133 Danish adults participated in a national survey and of those 39,480 signed up for device-based measurements. A balanced random sample (n = 3,750) was invited to wear an accelerometer of whom 1,525 accepted the invitation. Additionally, a short telephone-based survey on 829 non-responders to the national survey was conducted. Sociodemographic characteristics and self-reported weekly frequencies of physical activity across four domains are compared. Results: The participants in the national survey were older, more often female, and more often not working. Participants in the telephone-based survey were younger, more often doing unskilled work, and were more often active at home and at work. The participants in the device-based sample were more often active during transport and leisure in the national survey, and participants categorized in the most active category increased during the week of monitoring from 29.0% to 60.7% and from 58.5% to 81.7% for active transport and leisure activities, respectively. Conclusion: Recruiting a population representative sample for device-based measurement of physical activity is challenging, and there is a substantial risk of sample selection bias and measurement reactivity. Further research in this area is needed if device-based measures should be considered for population physical activity surveillance.

18.
Am J Infect Control ; 51(9): 1028-1033, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-36603809

RESUMO

BACKGROUND: The purpose of this study was to determine whether use of a video camera surveillance system for hand hygiene (HH) monitoring, video-based education, and feedback could improve the HH compliance in a neonatal intensive care unit (NICU). METHODS AND MATERIALS: This was an interventional before-after trial conducted in a level-III NICU between July 2019 and June 2020. HH compliance was measured using randomly selected video-camera footage in the baseline, intervention, and maintenance periods. After the baseline, an intervention consisting of feedback and education with video scenarios was implemented. The primary outcome was change in HH compliance. The compliance rates were analyzed as an interrupted time series (ITS) with a segmented regression model adjusted for autocorrelation for each study period. RESULTS: We identified a total of 8335 HH indications. There were non significant increases in the total compliance rate (9.0%, 95% CI -2% to 20%) at the time of intervention and in the compliance rate after intervention (0.26%, 95% CI -0.31% to 0.84%) per day. The hand hygiene compliance before patient contact significantly increased (19.8%, 95% CI, 4.8%-34.8%). Incorrect glove use improved non-significantly with the intervention (-3.4%, 95% CI -13.4% to 6.7%). CONCLUSION: In this study of HH monitoring using video-camera footage combined with an intervention including feedback and education, there were inconsistent improvements in HH compliance. However, these improvements were not sustained in the long term. Frequent feedback and education may be required to sustain high compliance.


Assuntos
Infecção Hospitalar , Higiene das Mãos , Humanos , Recém-Nascido , Infecção Hospitalar/prevenção & controle , Retroalimentação , Fidelidade a Diretrizes , Higiene das Mãos/métodos , Pessoal de Saúde/educação , Controle de Infecções/métodos , Unidades de Terapia Intensiva Neonatal
19.
J Biomech ; 152: 111555, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37030040

RESUMO

The Hawthorne effect is a change in behavior resulting from awareness of being observed or evaluated. This study aimed to determine whether awareness of being evaluated or presence of an observer influence gait. Twenty-one young women were asked to walk in three conditions. In the first condition (unawareness of evaluation; UE), participants were aware that it was a practice trial, and there was no observer. In the second condition (awareness of evaluation; AE), participants were aware that their gait was being evaluated. The third condition (AE + researcher observation; RO) was similar to the second condition except that an additional researcher observed the participant' gait. The spatiotemporal, kinematic, ground reaction forces, and ratio index (symmetry of both lower limbs) were compared among the three conditions. A higher ratio index indicated a relative increase in the value on left versus right. Gait speed (P = 0.012) and stride length (right and left; P = 0.006 and 0.007, respectively) were significantly increased in the AE + RO than in UE. Range of motion of the right hip and left ankle was significantly greater in AE than in UE (P = 0.039 and 0.012, respectively). The ratio index of ground reaction force during push-off was significantly higher in AE and AE + RO conditions than in UE (P < 0.001 and P = 0.004, respectively). The Hawthorne effect (awareness of being evaluated or presence of an observer) potentially influences gait. Thus, factors that influence gait analysis should be considered when evaluating normal gait.


Assuntos
Marcha , Extremidade Inferior , Feminino , Humanos , Fenômenos Biomecânicos , Modificador do Efeito Epidemiológico , Velocidade de Caminhada
20.
EClinicalMedicine ; 54: 101685, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36193169

RESUMO

Background: There is a growing number of trials examining the effectiveness of pharmacotherapies for obesity, however, little is known about placebo and nocebo effect in these trials. Hence, we sought to examine the effect of placebo in obesity trials, to better understand the potential factors affecting clinical endpoints in them. Methods: Medline, Embase, and Cochrane CENTRAL were searched for articles examining weight-loss RCTs examining patients with overweight or obesity in placebo-controlled arms from inception till 25 June 2022. This paper was registered online with PROSPERO (CRD42022302482). A single arm meta-analysis of proportions was used to estimate the primary outcomes, ≥5%, ≥10%, and ≥15% total weight loss - and the adverse effects that patients experienced during the trial. A meta-analysis of means was used to estimate the pooled mean differences of the secondary outcomes including, body weight measurements, lipid levels, glycemic indices, and blood pressure over time. Findings: A total of 63 papers involving 20,454 patients and 69 trials were included. The proportion of patients that had ≥5%, ≥10%, and ≥15% weight loss was 20·4% (CI:16·1% to 25·0%), 8·3% (CI:6·1% to 10·9%), and 6·2% (CI:3·8% to 9·7%), respectively. Analysis by duration of trials showed stepwise increase in proportion of patients with ≥5% and ≥10% weight loss with increasing duration of study. Analysis of secondary outcomes found modest improvement in all analyses. The pooled average rate of overall AEs, serious AEs, and discontinuation was 73·7% (CI:68·0% to 79·0%), 3·4% (CI:2·4% to 4·5%), and 5·2% (CI:4·0% to 6·5%), respectively. In psychiatric complications, the pooled rates of anxiety and depression were 2·7% (CI:1·8% to 3·7%) and 2·5 (CI:1·7% to 3·3%). Interpretation: Our meta-analysis of placebo-treated participants in weight-loss RCTs indicate a significant placebo and nocebo effect. These findings are important to quantify their effect and may inform the design of future RCTs. Funding: This research did not receive additional support from organizations beyond the authors' academic institutions.

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