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OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).
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Ensayos Clínicos Controlados como Asunto/métodos , Placebos , Procedimientos Quirúrgicos Operativos , HumanosRESUMEN
PURPOSE: To explore in a sample of adult cancer patients: (1) the relative influence of initiation source, information format and consultation format on preferred approach to life expectancy disclosure using a discrete choice experiment (DCE); and (2) whether patient age, cancer type and perceived prognosis were associated with preferences within the three attributes. METHODS: A DCE survey of adult solid tumour and haematological cancer patients. Participants chose between three hypothetical scenarios about life expectancy disclosure consisting of three attributes: initiation source (i.e. doctor versus patient-initiated discussion), information content (i.e. estimate presented as best-worst-typical length of life case scenario versus median survival time) and consultation format (i.e. two 20-min versus one 40-min consultation). Respondents selected their most preferred scenario within each question. RESULTS: Three hundred and two patients completed the DCE (78% consent rate). Initiation source was the most influential predictor of patient choice. More preferred a doctor deliver life expectancy information as soon as it is available rather than waiting for the patient to ask (59% vs 41% z = - 7.396, p < 0.01). More patients preferred the two 20-min rather than the one 40-min consultation format (55% vs 45%, z = 4.284, p < 0.01). Information content did not influence choice. Age, cancer type, and patient-perceived prognosis were not associated with preferences. CONCLUSION: Healthcare professionals should assess cancer patients' preferences for engaging in life expectancy discussions as soon as they have this information, and ensure patients have adequate time to consider the information they receive, seek additional information and involve others if they wish.
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Enfermedad Crítica/mortalidad , Esperanza de Vida/tendencias , Neoplasias/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Encuestas y CuestionariosRESUMEN
It is commonly assumed that a specific testing occasion (task, design, procedure, etc.) provides insights that generalize beyond that occasion. This assumption is infrequently carefully tested in data. We develop a statistically principled method to directly estimate the correlation between latent components of cognitive processing across tasks, contexts, and time. This method simultaneously estimates individual-participant parameters of a cognitive model at each testing occasion, group-level parameters representing across-participant parameter averages and variances, and across-task correlations. The approach provides a natural way to "borrow" strength across testing occasions, which can increase the precision of parameter estimates across all testing occasions. Two example applications demonstrate that the method is practical in standard designs. The examples, and a simulation study, also provide evidence about the reliability and validity of parameter estimates from the linear ballistic accumulator model. We conclude by highlighting the potential of the parameter-correlation method to provide an "assumption-light" tool for estimating the relatedness of cognitive processes across tasks, contexts, and time.
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Cognición , Simulación por Computador , Humanos , Modelos Lineales , Tiempo de Reacción , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVE: Using a vignette-style DCE in a sample of oncology patients, this study explored: (1) the relative influence of the patient's level of concern about their depression on preferences for care, (2) the relative influence of depression severity according to a mental health checklist on preferred treatment-seeking options, and (3) whether patient age and gender were associated with depression care preference. METHODS: A discrete choice experiment (DCE) survey of cancer patients was conducted. Hypothetical vignettes to elicit care preferences were created using two attributes: the cancer patient's level of concern about depression (a little or a great deal) and results of a mental health checklist (not depressed or very depressed). Three response options for care preferences were presented, including a self-directed approach, shared care approach, and clinician-directed referral approach. Participants chose their most and least preferred options. RESULTS: A total of 281 cancer patients completed the survey. There was a significant association between level of concern and the most preferred option. Those with a great deal of concern about depression preferred to receive referral from their clinician more than those with a little concern about depression. Males were significantly more likely to select a self-directed approach as their most preferred option. CONCLUSIONS: An oncology patient's level of concern about depression may influence the type of care they want to receive from their cancer doctor for depression. This finding has implications for depression screening in clinical practice.
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Depresión/psicología , Oncología Médica/métodos , Neoplasias/psicología , Educación del Paciente como Asunto/métodos , Prioridad del Paciente/psicología , Adulto , Conducta de Elección , Toma de Decisiones , Depresión/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/terapia , Derivación y Consulta/estadística & datos numéricosRESUMEN
Only 2-3% of cancer patients enrol in a trial. We surveyed patients' willingness to change clinician or treating centre, or to travel, to participate in trials, to improve trial recruitment. Of 188 respondents, 79% were willing to participate in a trial in at least one scenario. Increasing travel time, change in oncologist, private health insurance and out of pocket expenses decreased likelihood of joining a trial. Rural and regional patients, and those from lower socio-economic areas, were more willing to travel. To optimise access to trials, clinicians should refer within and between institutions.
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Actitud Frente a la Salud , Neoplasias/terapia , Participación del Paciente/psicología , Viaje , Anciano , Australia , Ensayos Clínicos como Asunto , Estudios Transversales , Femenino , Gastos en Salud , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Neoplasias/economía , Participación del Paciente/estadística & datos numéricos , Población Rural , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
PURPOSE: Cancer patients can be overwhelmed when being confronted with their diagnosis and treatment options. Such information is often provided during one consultation between the patient and treating clinician. In order to achieve optimal cancer care, there may be justification for alternative consultation styles. We assessed, in a sample of adult medical oncology patients, their preferences for (i) attending one 40-min consultation or two 20-min consultations and (ii) receiving written only or both written and online information, when making a cancer treatment decision. METHODS: This was a cross-sectional survey using a discrete choice design of 159 adult medical oncology patients presenting for their second or subsequent outpatient consultation. Participants were presented with a set of hypothetical scenarios and asked to indicate their most and least preferred scenario. The scenarios contained a caveat explaining that there would be no difference between the available treatment options in terms of when treatment would be initiated and the impact it would have on patients' life expectancy. RESULTS: One hundred forty-seven patients completed the DCE. Of these, 70% (n = 103) preferred being provided with written and online information rather than just written information. This preference was statistically significant (p < 0.01). Fifty-nine percent (n = 86) of patients preferred two 20-min consultations over one 40-min consultation when making a treatment decision. Significantly, more patients preferred two shorter consultations rather than one longer consultation when this was combined with written and online information (p < 0.01). CONCLUSION: When making a cancer treatment decision, clinicians should consider offering patients written and online information, combined with two shorter consultations.
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Toma de Decisiones , Neoplasias/psicología , Prioridad del Paciente/psicología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/terapia , Educación del Paciente como Asunto , Relaciones Médico-Paciente , Derivación y Consulta , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To explore in a sample of medical oncology outpatients and their nominated support persons (SPs): (1) the relative influence of pain, consciousness and life extension on end-of-life choices using a discrete choice experiment (DCE); (2) the extent to which SPs can predict the choices of index patients and (3) whether having a previous end-of-life discussion was associated with dyad agreement. METHODS: Adult medical oncology patients and their SPs were approached for consent to complete a survey containing a DCE. Participants chose between three unlabelled care scenarios characterised by three attributes: pain (mild, moderate or severe), consciousness (some, half or most of time) and extension of life (1, 2 or 3 weeks). Respondents selected (1) most-preferred and (2) least-preferred scenarios within each question. SPs answered the same questions but from patient's perspective. RESULTS: A total of 110 patients and 64 SPs responded overall (42 matched patient-SP dyads). For patients, pain was the most influential predictor of most- and least-preferred scenarios (z = 12.5 and z = 12.9). For SPs, pain was the only significant predictor of most and least-preferred scenarios (z = 9.7 and z = 11.5). Dyad agreement was greater for choices about least- (69%) compared to most-preferred scenarios (55%). Agreement was slightly higher for dyads reporting a previous EOL discussion (68 versus 48%; p = 0.065). CONCLUSION: Patients and SPs place significant value on avoiding severe pain when making end-of-life choices, over and above level of consciousness or life extension. People's views about end-of-life scenarios they most as well as least prefer should be sought.
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Conducta de Elección , Neoplasias/terapia , Sistemas de Apoyo Psicosocial , Calidad de la Atención de Salud , Cuidado Terminal/métodos , Cuidado Terminal/normas , Adulto , Planificación Anticipada de Atención , Anciano , Anciano de 80 o más Años , Cuidadores/psicología , Estudios Transversales , Femenino , Humanos , Masculino , Oncología Médica/métodos , Oncología Médica/normas , Persona de Mediana Edad , Neoplasias/complicaciones , Neoplasias/psicología , Encuestas y CuestionariosRESUMEN
BACKGROUND: Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial. METHODS: A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials. RESULTS: Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate. CONCLUSION: Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery.
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Ortopedia , Humanos , DolorRESUMEN
BACKGROUND & AIMS: Cholecystokinin-cholescintigraphy (CCK-CS) provides a physiologic, noninvasive, and quantitative method for assessing gallbladder contraction and calculation of a gallbladder ejection fraction (GBEF). At present, it is used most commonly to identify patients with suspected functional gallbladder disorder. However, the methodology of CCK infusion and normal values differ markedly among imaging centers. METHODS: This document represents the consensus opinion of an interdisciplinary panel that gathered to assess the current optimal method for performing CCK-CS in adults, potential uses and limitations of CCK-CS, and questions that require further investigation. RESULTS: The panel recommended the use of a single, standardized, recently described CCK-CS protocol that involves infusion of 0.02 µg/kg of sincalide over 60 minutes with a normal gallbladder ejection fraction defined as ≥38%. The panel emphasized the need for a large, multicenter, prospective clinical trial to establish the utility of CCK-CS in the diagnosis of functional gallbladder disease. Although not without controversy regarding its clinical utility, the primary indication for CCK-CS at present is the well-selected patient with suspected functional gallbladder disorder. CONCLUSIONS: Agreement was reached that the adoption of this standardized protocol is critical to improve how CCK-CS is used to direct patient care and will represent an improvement over the diverse methods currently in use by eliminating the current lack of uniformity and adding both reliability and credibility to the results.
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Colecistoquinina/metabolismo , Enfermedades de la Vesícula Biliar/diagnóstico , Vesícula Biliar/fisiopatología , Cintigrafía/métodos , Cintigrafía/normas , Adulto , HumanosRESUMEN
BackTrack is a multi-component, community-based intervention designed to build capacity amongst 14-17-year-old high risk young people. The aim of the current study seeks to explore community value and preferences for reducing youth crime and improving community safety using BackTrack in a rural setting in Armidale, New South Wales, Australia. The study design used discrete choice experiments (DCEs), designed in accordance with the 10-item checklist outlined by the International Society for Pharmacoeconomics and Outcomes Research. The DCE was pilot tested on 43 participants to test feasibility and comprehension. A revised version of the survey was subsequently completed by 282 people over a 12-day period between 30 May 2016 and 10 June 2016, representing a survey response rate of 35%. Ninety per cent of respondents were residents of Armidale, the local rural town where BackTrack was implemented. The DCE generated results that consistently demonstrated a preference for social programs to address youth crime and community safety in the Armidale area. Respondents chose BackTrack over Greater Police Presence 75% of the time with an annual benefit of Australian dollars (AUD) 150 per household, equivalent to a community benefit of AUD 2.04 million. This study estimates a strong community preference for BackTrack relative to more policing (a community willing to pay equivalent to AUD 2.04 million) highlighting the clear value of including community preferences when evaluating community-based programs for high-risk young people.
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Crimen , Policia , Adolescente , Australia , Conducta de Elección , Humanos , Nueva Gales del Sur , Encuestas y CuestionariosRESUMEN
Objective: To investigate the factors underlying willingness to participate in a hypothetical trial among patients and surgeons, to inform the design of future placebo surgery controlled trials. Background: Placebo surgery controlled trials are the gold standard for testing the efficacy of surgical procedures. However, these trials commonly fail to meet the target sample size and terminate underpowered. Methods: From October 2019 to July 2020, eligible patients were identified from the orthopedic waiting list at a single tertiary hospital and surgeons were identified from orthopedic clinics at three tertiary hospitals in Australia. Qualitative interviews explored factors underlying willingness to participate in a hypothetical trial, including understanding of trial concepts; attitudes; and trial design preferences. Data collection and analysis were conducted in parallel. Recruitment ceased when no new concepts emerged. Interview data were analyzed using reflexive thematic analysis. Results: The majority of surgeons and only a few patients indicated a willingness to participate in a placebo surgery controlled trial. Factors underlying willingness were captured in four themes: (1) Understanding and attitudes toward placebo; (2) Attitudes towards randomization/perception of equipoise; (3) Perception of risk; and (4) Ethical concerns. Conclusions: To optimize recruitment in the future, trialists may consider embedding strategies into the recruitment process that validate patients' symptoms, encourage an altruistic mindset, address surgeon biases, and involve surgeons in explaining trial concepts to patients. Trialists may also consider designing three arm trials that meet surgeons' preferences for a "low" and "high" fidelity placebo.
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OBJECTIVE: To explore the preferences of people with cancer regarding the timing and format of information provision about emotional concerns that may occur when undergoing medical procedures. METHODS: Eligible cancer survivors were mailed a survey containing discrete choice scenarios examining their timing and format preferences for information about potential emotional concerns associated with an upcoming hypothetical medical procedure. RESULTS: Of 356 eligible patients, 271 (76 %) completed the survey. Both face-to-face discussion and written materials were preferred as the mode of information delivery over access to a website. In order of descending preference, participants preferred to receive the information 1 week, 3 days and the day of the procedure. There were no differences in preferences for timing or format between subgroups based on age, gender, education and cancer type. CONCLUSION: This study has demonstrated that cancer patients prefer receiving information about emotional concerns that might be experienced as part of a medical procedure in either written or via face-to-face format, and one week before the procedure. PRACTICE IMPLICATIONS: In order to provide patient-centred care, clinicians and the healthcare system more broadly should consider patient preferences for information delivery about upcoming medical procedures. INFORMATION: preparation for medical procedures; discrete choice; oncology; patient preference; emotional response.
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Neoplasias , Prioridad del Paciente , Conducta de Elección , Emociones , Humanos , Neoplasias/terapia , Encuestas y CuestionariosRESUMEN
INTRODUCTION: In order to properly evaluate the efficacy of orthopaedic procedures, rigorous, randomised controlled sham surgery trial designs are necessary. However, randomised controlled trials (RCTs) for surgery involving a placebo are ethically debated and difficult to conduct with many failing to reach their desired sample size and power. A review of the literature on barriers and enablers to recruitment, and patient and surgeon attitudes and preferences towards sham surgery trials, will help to determine the characteristics necessary for successful recruitment. METHODS AND ANALYSIS: This review will scope the diverse literature surrounding sham surgery trials with the aim of informing a discrete choice experiment to empirically test patient and surgeon preferences for different sham surgery trial designs. The scoping review will be conducted in accordance with the methodological framework described in Arksey and O'Malley (2005) and reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols extension for Scoping Reviews. The review will be informed by a systematic search of Medline, Embase, PsycInfo, CINAHL and EconLit databases (from database inception to 21 June 2019), a Google Scholar search, and hand searching of reference lists of relevant studies or reviews. Studies or opinion pieces that involve patient, surgeon or trial characteristics, which influence the decision to participate in a trial, will be included. Study selection will be carried out independently by two authors with discrepancies resolved by consensus among three authors. Data will be charted using a standardised form, and results tabulated and narratively summarised with reference to the research questions of the review. ETHICS AND DISSEMINATION: The findings from this review will inform the design of a discrete choice experiment around willingness to participate in surgical trials, the outcomes of which can inform decision and cost-effectiveness models of sham surgery RCTs. The qualitative information from this review will also inform patient-centred outcomes research. The review will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: CRD42019133296.
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Conocimientos, Actitudes y Práctica en Salud , Pacientes/psicología , Placebos , Cirujanos/psicología , Procedimientos Quirúrgicos Operativos , Actitud del Personal de Salud , Investigación Biomédica , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Literatura de Revisión como AsuntoRESUMEN
OBJECTIVES: Pandemics pressure national governments to respond swiftly. Mitigation efforts created an imbalance between population health, capacity of the healthcare system and economic prosperity. Each pandemic arising from a new virus is unknown territory for policy makers, and there is considerable uncertainty of the appropriateness of responses and outcomes. METHODS: A qualitative approach was used to review mixed sources of data including Australian reports, official government publications, and COVID-19 data to discern robust future responses. Publicly available epidemiological and economic data were utilised to provide insight into the impact of the pandemic on Australia's healthcare system and economy. RESULTS: Policies implemented by the Australian Government to mitigate the spread of COVID-19 impacted the healthcare sector and economy. This paper incorporates lessons learned to inform optimal economic preparedness. The rationale for an economic response plan concomitant with the health pandemic plan is explored to guide Australian Government policy makers in ensuring holistic and robust solutions for future pandemics. CONCLUSIONS: In future, an Australian Economic Pandemic Response Plan will aid in health and economic system preparedness, whilst a strong Australian economy and strategic planning will ensure resilience to future pandemics.
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OBJECTIVE: Cancer patients and their support persons commonly feel overwhelmed when being confronted with their diagnosis and treatment options. We used a DCE to examine patients' and support persons' preferences for: (i) attending one 40 min consultation or two 20 min consultations when making a cancer treatment decision; and for (ii) receiving additional information in written form only or in both written and online forms. Here we focus on support persons' preferences and whether they differ from patients' preferences. RESULTS: 159 adult medical oncology patients and 64 of their support persons took part in this study. Participants were presented with a set of hypothetical scenarios and asked to indicate their most and least preferred scenario. 92% of support persons (n = 59) completed the DCE. Most preferred to receive two consultations along with written and online information (n = 30, 51%). This was the only scenario that was chosen by statistically significantly more support persons (p =0.037). The proportions of patients and support persons choosing each scenario did not differ significantly from each other (p >0.05). Our findings suggest that when making cancer treatment decisions, clinicians should consider offering patients and support persons written and online information, combined with two shorter consultations.
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Toma de Decisiones , Neoplasias/terapia , Participación del Paciente , Derivación y Consulta , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Oncología Médica , Persona de Mediana Edad , Prioridad del Paciente , Relaciones Médico-PacienteRESUMEN
BACKGROUND AND AIMS: Cholecystokinin-cholescintigraphy (CCK-CS) provides a physiologic, noninvasive, and quantitative method for assessing gallbladder contraction and calculation of a gallbladder ejection fraction (GBEF). At present, it is used most commonly to identify patients with suspected functional gallbladder disorder. However, the methodology of CCK infusion and normal values differ markedly among imaging centers. METHODS: This document represents the consensus opinion of an interdisciplinary panel that gathered to assess the current optimal method for performing CCK-CS in adults, potential uses and limitations of CCK-CS, and questions that require further investigation. RESULTS: The panel recommended the use of a single, standardized, recently described CCK-CS protocol that involves infusion of 0.02 µg/kg of sincalide over 60 minutes with a normal GBEF defined as ≥38%. The panel emphasized the need for a large, multicenter, prospective clinical trial to establish the utility of CCK-CS in the diagnosis of functional gallbladder disease. Although not without controversy regarding its clinical utility, the primary indication for CCK-CS at present is the well-selected patient with suspected functional gallbladder disorder. CONCLUSION: Agreement was reached that the adoption of this standardized protocol is critical to improve how CCK-CS is used to direct patient care and will represent an improvement over the diverse methods currently in use by eliminating the current lack of uniformity and adding both reliability and credibility to the results.