Decision aids for people considering taking part in clinical trials

Peer reviewed

Opiniões sobre a visita de enfermagem em unidades de cirurgia: tradução, adaptação e validação de questionários

Enquadramento: Apesar da visita de enfermagem ou passagem de turno junto dos doentes garantir a continuidade dos cuidados de enfermagem, origina diversas questões éticas. Objetivos: Traduzir, adaptar e validar 2 questionários de colheita de dados sobre a visita de enfermagem em unidades cirúrgicas para a cultura portuguesa; identificar a opinião dos doentes e dos enfermeiros sobre a visita de enfermagem. Metodologia: Tradução, retroversão e adaptação dos questionários aplicados em 7 unidades cirúrgicas de um hospital central em Portugal de 22/08/2008 a 28/06/2009. A amostragem não probabilística acidental foi constituída por 137 enfermeiros e 96 doentes. Resultados: A visita de enfermagem promove a relação empática e de ajuda; a observação do doente e o planeamento de cuidados, no entanto é necessário clarificar o seu objetivo; incentivar à participação e ao envolvimento dos doentes; utilizar um discurso compreensível e garantir a privacidade da informação. Conclusão: Os questionários revelaram-se fidedignos e válidos na identificação das opiniões dos doentes e dos enfermeiros sobre a visita de enfermagem nas unidades de cirurgia em estudo.Background: Although bedside nursing handover ensures the continuity of nursing care, it raises several ethical issues. Objectives: To translate, adapt and validate 2 data collection questionnaires about bedside nursing handover in surgical units into Portuguese, and identify the patients and nurses’ opinions about bedside nursing handover. Methodology: Translation, back-translation and adaptation of the questionnaires in 7 surgical units of a central hospital in Portugal between 22/08/2008 and 28/06/2009. The non- -probability sampling consisted of 137 nurses and 96 patients. Results: Bedside nursing handover promotes an empathic and helping relationship, patient observation and care planning; however, it is necessary to clarify its purpose, encourage patient participation and engagement, use clear information, and ensure information privacy. Conclusion: The questionnaires proved to be reliable and valid to identify the patients and nurses’ opinions about bedside nursing handover in the surgical units under analysis.

Women’s involvement in clinical trials: historical perspective and future implications

The importance of considering the differences between the male and female sex in clinical decision-making is crucial. However, it has been acknowledged in recent decades that clinical trials have not always adequately enrolled women or analyzed sex-specific differences in the data. As these deficiencies have hindered the progress of understanding women’s response to medications, agencies in the United States have worked towards the inclusion of women in clinical trials and appropriate analysis of sex-specific data from clinical trials. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue.

Opiniões sobre a visita de enfermagem em unidades de cirurgia: tradução, adaptação e validação de questionários

Enquadramento: Apesar da visita de enfermagem ou passagem de turno junto dos doentes garantir a continuidade dos cuidados de enfermagem, origina diversas questões éticas. Objetivos: Traduzir, adaptar e validar 2 questionários de colheita de dados sobre a visita de enfermagem em unidades cirúrgicas para a cultura portuguesa; identificar a opinião dos doentes e dos enfermeiros sobre a visita de enfermagem. Metodologia: Tradução, retroversão e adaptação dos questionários aplicados em 7 unidades cirúrgicas de um hospital central em Portugal de 22/08/2008 a 28/06/2009. A amostragem não probabilística acidental foi constituída por 137 enfermeiros e 96 doentes. Resultados: A visita de enfermagem promove a relação empática e de ajuda; a observação do doente e o planeamento de cuidados, no entanto é necessário clarificar o seu objetivo; incentivar à participação e ao envolvimento dos doentes; utilizar um discurso compreensível e garantir a privacidade da informação. Conclusão: Os questionários revelaram-se fidedignos e válidos na identificação das opiniões dos doentes e dos enfermeiros sobre a visita de enfermagem nas unidades de cirurgia em estudo.Background: Although bedside nursing handover ensures the continuity of nursing care, it raises several ethical issues. Objectives: To translate, adapt and validate 2 data collection questionnaires about bedside nursing handover in surgical units into Portuguese, and identify the patients and nurses’ opinions about bedside nursing handover. Methodology: Translation, back-translation and adaptation of the questionnaires in 7 surgical units of a central hospital in Portugal between 22/08/2008 and 28/06/2009. The non- -probability sampling consisted of 137 nurses and 96 patients. Results: Bedside nursing handover promotes an empathic and helping relationship, patient observation and care planning; however, it is necessary to clarify its purpose, encourage patient participation and engagement, use clear information, and ensure information privacy. Conclusion: The questionnaires proved to be reliable and valid to identify the patients and nurses’ opinions about bedside nursing handover in the surgical units under analysis.

Chronic disease self-management in Aboriginal communities : towards a sustainable program of care in rural communities

The Chronic Disease Self-Management (CDSM) strategy for Aboriginal patients on Eyre Peninsula, South Australia, was designed to develop and trial new program tools and processes for goal setting, behaviour change and self-management for Aboriginal people with diabetes. The project was established as a one-year demonstration project to test and trial a range of CDSM processes and procedures within Aboriginal communities and not as a formal research project. Over a one-year period, 60 Aboriginal people with type-2 diabetes in two remote regional centres participated in the pilot program. This represents around 25% of the known Aboriginal diabetic population in these sites. The project included training for four Aboriginal Health Workers in goal setting and self-management strategies in preparation for them to run the program. Patients completed a Diabetes Assessment Tool, a Quality of Life Questionnaire (SF12), the Work and Social Adjustment Scale (WASAS) at 0, 6 and 12 months. The evaluation tools were assessed and revised by consumers and health professionals during the trial to determine the most functional and acceptable processes for Aboriginal patients. Some limited biomedical data were also recorded although this was not the principal purpose of the project. Initial results from the COAG coordinated care trial in Eyre suggest that goal setting and monitoring processes, when modified to be culturally inclusive of Aboriginal people, can be effective strategies for improving self-management skills and health-related behaviours of patients with chronic illness. The CDSM pilot study in Aboriginal communities has led to further refinement of the tools and processes used in chronic illness self-management programs for Aboriginal people and to greater acceptance of these processes in the communities involved. Participation in a diabetes self-management program run by Aboriginal Health Workers assists patients to identify and understand their health problems and develop condition management goals and patient-centred solutions that can lead to improved health and wellbeing for participants. While the development of self-management tools and strategies led to some early indications of improvements in patient participation and resultant health outcomes, the pilot program and the refinement of new assessment tools used to assist this process has been the significant outcome of the project. The CDSM process described here is a valuable strategy for educating and supporting people with chronic conditions and in gaining their participation in programs designed to improve the way they manage their illness. Such work, and the subsequent health outcome research planned for rural regions, will contribute to the development of more comprehensive CDSM programs for Aboriginal communities generally.

End-of-life care in a cardiology department: have we improved?

nd-of-life care is not usually a priority in cardiology departments. We sought to evaluate the changes in end-of-life care after the introduction of a do-not-resuscitate (DNR) order protocol. Retrospective analysis of all deaths in a cardiology department in two periods, before and after the introduction of the protocol. Comparison of demographic characteristics, use of DNR orders, and end-of-life care issues between both periods, according to the presence in the second period of the new DNR sheet (Group A), a conventional DNR order (Group B) or the absence of any DNR order (Group C). The number of deaths was similar in both periods (n = 198 vs. n = 197). The rate of patients dying with a DNR order increased significantly (57.1% vs. 68.5%; P = 0.02). Only 4% of patients in both periods were aware of the decision taken about cardiopulmonary resuscitation. Patients in Group A received the DNR order one day earlier, and 24.5% received it within the first 24 h of admission (vs. 2.6% in the first period; P < 0.001). All patients in Group A with an implantable cardioverter defibrillator (ICD) had shock therapies deactivated (vs. 25.0% in the first period; P = 0.02). The introduction of a DNR order protocol may improve end-of-life care in cardiac patients by increasing the use and shortening the time of registration of DNR orders. It may also contribute to increase ICD deactivation in patients with these orders in place. However, the introduction of the sheet in late stages of the disease failed to improve patient participation.

Factors limiting participation in arthritis self-management programmes : an exploration of barriers and patient preferences within a randomized controlled trial

Objective. To improve understanding of barriers to participation in community-based arthritis self-management programmes and patient preferences for self-management education.

Methods. Individuals with hip or knee OA referred to orthopaedic surgeons or rheumatologists at six public and private hospitals in Victoria, Australia, were recruited for a randomized controlled trial (RCT) of the Stanford Arthritis Self-Management Programme (ASMP). As part of the study design, potential participants were asked during the screening and recruitment process about reasons for being unable to attend the course, reasons for not participating in the study and individual preferences for course scheduling.

Results. Of 1125 individuals assessed, 216 (19%) were unable to attend six ASMP sessions. This was commonly due to physical limitations, including illness, restricted mobility and pain (22%), difficulty getting to or from courses (22%), work commitments (22%), the time commitment required (17%) and family roles (12%). Among those who did not want to participate in the study (n = 258), the overwhelming reason was disinterest (74%). Specific preferences for course scheduling were frequent, confirming the practical challenges faced in organizing courses for the RCT.

Conclusion. Incorporating patients from public and private settings, this study has elicited new insights into barriers to ASMP participation. Many people with hip or knee OA have limited capacity and motivation to attend community-based group programmes. Future self-management programmes and research should include more accessible options for those who cannot attend group-based programmes.

Motivation and frustration in cardiology trial participation: The patient perspective

OBJECTIVE: The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration.METHODS: Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period.RESULTS: Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment.CONCLUSIONS: Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

Motivation and frustration in cardiology trial participation: the patient perspective

OBJECTIVE: The participation of humans in clinical cardiology trials remains essential, but little is known regarding participant perceptions of such studies. We examined the factors that motivated participation in such studies, as well as those that led to participant frustration. METHODS: Patients who had participated in hypertension and coronary arterial disease (phases II, III, and IV) clinical trials were invited to answer a questionnaire. They were divided into two groups: Group I, which included participants in placebo-controlled clinical trials after randomization, and Group II, which included participants in clinical trials in which the tested treatment was compared to another drug after randomization and in which a placebo was used in the washout period. RESULTS: Eighty patients (47 patients in Group I and 33 patients in Group II) with different socio-demographic characteristics were interviewed. Approximately 60% of the patients were motivated to participate in the trial with the expectation of personal benefit. Nine participants (11.2%) expressed the desire to withdraw, which was due to their perception of risk during the testing in the clinical trial (Group I) and to the necessity of repeated returns to the institution (Group II). However, the patients did not withdraw due to fear of termination of hospital treatment. CONCLUSIONS: Although this study had a small patient sample, the possibility of receiving a benefit from the new tested treatment was consistently reported as a motivation to participate in the trials.

Repeat participation in colorectal cancer screening utilizing fecal occult blood testing : a community-based project in a rural setting

Background and Aim: To investigate participation in a second round of colorectal cancer screening using a fecal occult blood test (FOBT) in an Australian rural community, and to assess the demographic characteristics and individual perspectives associated with repeat screening. ---------- Methods: Potential participants from round 1 (50–74 years of age) were sent an intervention package and asked to return a completed FOBT (n = 3406). Doctors of participants testing positive referred to colonoscopy as appropriate. Following screening, 119 participants completed qualitative telephone interviews. Multivariable logistic regression models evaluated the association between round-2 participation and other variables.---------- Results: Round-2 participation was 34.7%; the strongest predictor was participation in round 1. Repeat participants were more likely to be female; inconsistent screeners were more likely to be younger (aged 50–59 years). The proportion of positive FOBT was 12.7%, that of colonoscopy compliance was 98.6%, and the positive predictive value for cancer or adenoma of advanced pathology was 23.9%. Reasons for participation included testing as a precautionary measure or having family history/friends with colorectal cancer; reasons for non-participation included apathy or doctors’ advice against screening.---------- Conclusion: Participation was relatively low and consistent across rounds. Unless suitable strategies are identified to overcome behavioral trends and/or to screen out ineligible participants, little change in overall participation rates can be expected across rounds.

Spatial modelling of population health screening : the role of accessibility in predicting expected patient flows

This paper describes a generalised linear mixed model (GLMM) approach for understanding spatial patterns of participation in population health screening, in the presence of multiple screening facilities. The models presented have dual focus, namely the prediction of expected patient flows from regions to services and relative rates of participation by region- service combination, with both outputs having meaningful implications for the monitoring of current service uptake and provision. The novelty of this paper lies with the former focus, and an approach for distributing expected participation by region based on proximity to services is proposed. The modelling of relative rates of participation is achieved through the combination of different random effects, as a means of assigning excess participation to different sources. The methodology is applied to participation data collected from a government-funded mammography program in Brisbane, Australia.

Identifying belief targets to increase bone marrow registry participation among students who have never donated blood

New members on bone marrow registries worldwide are needed to allow sufficient diversity in the donor pool to meet patient needs. We used the theory of planned behaviour belief-basis and surveyed students who had not donated blood previously (i.e. non-donors) (N = 150) about the behavioural, normative, and control beliefs informing their intentions to join the Australian Bone Marrow Donor Registry. Key beliefs predicting non-donors’ intentions included: viewing bone marrow donation as an invasion of the body (β = −.35), normative support from parents (β = .40), anticipating pain/side effects from giving blood (β = −.27), and lack of knowledge about how to register (β  = −.30). Few non-donors endorsed these beliefs, suggesting they are ideal targets for change in strategies encouraging bone marrow donor registration.

Radiographer commenting of trauma radiographs : a survey of the benefits, barriers and enablers to participation in an Australian healthcare setting

Introduction Radiographer abnormality detection systems that highlight abnormalities on trauma radiographs (‘red dot’ system) have been operating for more than 30 years. Recently, a number of pitfalls have been identified. These limitations initiated the evolution of a radiographer commenting system, whereby a radiographer provides a brief description of abnormalities identified in emergency healthcare settings. This study investigated radiographers' participation in abnormality detection systems, their perceptions of benefits, barriers and enablers to radiographer commenting, and perceptions of potential radiographer image interpretation services for emergency settings. Methods A cross-sectional survey was implemented. Participants included radiographers from four metropolitan hospitals in Queensland, Australia. Conventional descriptive statistics, histograms and thematic analysis were undertaken. Results Seventy-three surveys were completed and included in the analysis (68% response rate); 30 (41%) of respondents reported participating in abnormality detection in 20% or less of examinations, and 26(36%) reported participating in 80% or more of examinations. Five overarching perceived benefits of radiographer commenting were identified: assisting multidisciplinary teams, patient care, radiographer ability, professional benefits and quality of imaging. Frequently reported perceived barriers included ‘difficulty accessing image interpretation education’, ‘lack of time’ and ‘low confidence in interpreting radiographs’. Perceived enablers included ‘access to image interpretation education’ and ‘support from radiologist colleagues’. Conclusions A range of factors are likely to contribute to the successful implementation of radiographer commenting in addition to abnormality detection in emergency settings. Effective image interpretation education amenable to completion by radiographers would likely prove valuable in preparing radiographers for participation in abnormality detection and commenting systems in emergency settings.

Patient decision aids in routine maternity care: Benefits, barriers, and new opportunities

Background and aim Participation in decision-making, supported by comprehensive and quality information provision, is increasingly emphasised as a priority for women in maternity care. Patient decision aids are tools that can offer women greater access to information and guidance to participate in maternity care decision-making. Relative to their evaluation in controlled settings, the implementation of patient decision aids in routine maternity care has received little attention and our understanding of which approaches may be effective is limited. This paper critically discusses the application of patient decision aids in routine maternity care and explores viable solutions for promoting their successful uptake. Discussion A range of patient decision aids have been developed for use within maternity care, and controlled trials have highlighted their positive impact on the decision-making process for women. Nevertheless, evidence of successful patient decision aid implementation in real world health care settings is lacking due to practical and ideological barriers that exist. Patient-directed social marketing campaigns are a relatively novel approach to patient decision aid delivery that may facilitate their adoption in maternity care, at least in the short-term, by overcoming common implementation barriers. Social marketing may also be particularly well suited to maternity care, given the unique characteristics of this health context. Conclusions The potential of social marketing campaigns to facilitate patient decision aid adoption in maternity care highlights the need for pragmatic trials to evaluate their effectiveness. Identifying which sub-groups of women are more or less likely to respond to these strategies will further direct implementation.