Cancer expert doubts claims about prostate cancer trial

Cole, Andrew

doi:10.1136/bmj.a979

Cited by 223 publications

(59 citation statements)

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“…Interventions aimed at improving quality of care and access to services are also often ethically and politically challenging to withhold from a proportion of participant clusters (or to withdraw the intervention as would occur in a cross-over design) [23]. In addition, because of logistical and financial constraints, the researchers determined that the planned intervention could only be implemented in stages.…”

Section: Methodsmentioning

confidence: 99%

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Chavane

Merialdi

Betrán

et al. 2014

BMC Health Serv Res

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BackgroundAntenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country.MethodsThis is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions.DiscussionThere is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country’s health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘habits’ will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain ma...

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Section: Methodsmentioning

confidence: 99%

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Chavane

Merialdi

Betrán

et al. 2014

BMC Health Serv Res

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“…Processes needed to successfully implement knowledge into clinical practice, namely: problem clarification; identifying the determinants of the knowledge-action gap; selecting, tailoring, implementing, and evaluating knowledge translation interventions; and determining strategies for ensuring sustained knowledge use are included. Second, we will use the UK Medical Research Council Complex Interventions Framework [15,16], which provides an iterative phased approach to the development and evaluation of complex (such as knowledge translation) interventions. This framework states that the development and evaluation of complex interventions should follow a sequential approach:…”

Section: Introductionmentioning

confidence: 99%

Design, implementation, and evaluation of a knowledge translation intervention to increase organ donation after cardiocirculatory death in Canada: a study protocol

et al. 2014

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BackgroundA shortage of transplantable organs is a global problem. There are two types of organ donation: living and deceased. Deceased organ donation can occur following neurological determination of death (NDD) or cardiocirculatory death. Donation after cardiocirculatory death (DCD) accounts for the largest increments in deceased organ donation worldwide. Variations in the use of DCD exist, however, within Canada and worldwide. Reasons for these discrepancies are largely unknown. The purpose of this study is to develop, implement, and evaluate a theory-based knowledge translation intervention to provide practical guidance about how to increase the numbers of DCD organ donors without reducing the numbers of standard NDD donors.MethodsWe will use a mixed method three-step approach. In step one, we will conduct semi-structured interviews, informed by the Theoretical Domains Framework, to identify and describe stakeholders’ beliefs and attitudes about DCD and their perceptions of the multi-level factors that influence DCD. We will identify: determinants of the evidence-practice gap; specific behavioural changes and/or process changes needed to increase DCD; specific group(s) of clinicians or organizations (e.g., provincial donor organizations) in need of behaviour change; and specific targets for interventions. In step two, using the principles of intervention mapping, we will develop a theory-based knowledge translation intervention that encompasses behavior change techniques to overcome the identified barriers and enhance the enablers to DCD. In step three, we will roll out the intervention in hospitals across the 10 Canadian provinces and evaluate its effectiveness using a multiple interrupted time series design.DiscussionWe will adopt a behavioural approach to define and test novel, theory-based, and ethically-acceptable knowledge translation strategies to increase the numbers of available DCD organ donors in Canada. If successful, this study will ultimately lead to more transplantations, reducing patient morbidity and mortality at a population-level.

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“…The nested study drew on guidance [5] and reviews [16] of methods for embedding a qualitative process study within a clinical trial. A qualitative design has origins in social research and typically entails a more emergent, flexible and inductive approach in contrast to trial methodology.…”

Section: Methodsmentioning

confidence: 99%

“…Decision aids are a complex intervention with several interacting components, entailing complex behaviours and a range of effects [5]. In view of their complexity, a degree of flexibility in their implementation is inevitable.…”

Section: Introductionmentioning

confidence: 99%

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Investigating active ingredients in a complex intervention: a nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes

Brown

Bradley

et al. 2014

BMC Res Notes

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BackgroundRandomised trials provide evidence that patient decision aids improve outcomes with respect to patient knowledge, involvement and satisfaction in decision making. It is less clear how these complex interventions are implemented within patient-clinician interactions and which components are active for improving decision processes. To investigate the experiences of using a diabetes treatment decision aid and to explore how components within a complex intervention influenced the decision making process.MethodsA pragmatic mixed methods study nested within the PANDAs cluster randomised trial of a patient decision aid. Themes inductively derived from interviews and observation of consultations with further triangulation with results of decision quality and involvement measurements and case analyses.ResultsThe decision aid intervention was employed flexibly within the consultation with both the patient and clinician active in marshalling elements. The decision aid improved processing and organization of information needed for decision making within the consultation interaction. It also improved decision quality by preparing the patient for active involvement within the clinical consultation.ConclusionThe intervention was acceptable, flexible and readily implemented in primary care consultations. The decision aid was effective in facilitating cognitive processing. The intervention also facilitated rehearsal in preparation for active roles in a shared decision process.Trial registrationTrials Register Number: ISRCTN14842077. Date registered: 24.06.2010.

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Cancer expert doubts claims about prostate cancer trial

Cited by 223 publications

References 0 publications

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Design, implementation, and evaluation of a knowledge translation intervention to increase organ donation after cardiocirculatory death in Canada: a study protocol

Investigating active ingredients in a complex intervention: a nested study within the Patient and Decision Aids (PANDAs) randomised controlled trial for people with type 2 diabetes

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