The YOU CALL-WE CALL randomized clinical trial: Impact of a multimodal support intervention after a mild stroke

Background Comparison of a multimodal intervention WE CALL (study initiated phone support/information provision) versus a passive intervention YOU CALL (participant can contact a resource person) in individuals with first mild stroke. Methods and Results This study is a single-blinded randomized clinical trial. Primary outcome includes unplanned use of health services (participant diaries) for adverse events and quality of life (Euroquol-5D, Quality of Life Index). Secondary outcomes include planned use of health services (diaries), mood (Beck Depression Inventory II), and participation (Assessment of Life Habits [LIFE-H]). Blind assessments were done at baseline, 6, and 12 months. A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time, with a significance level of 0.01. We enrolled 186 patients (WE=92; YOU=94) with a mean age of 62.5±12.5 years, and 42.5% were women. No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures (effect sizes ranged from 0.25 to 0.7). The only significant change for both groups from 6 months to 1 year (n=139) was in the social domains of the LIFE-H (increment in score, 0.4/9±1.3 [95% confidence interval, 0.1–0.7]; effect size, 0.3). Qualitatively, the WE CALL intervention was perceived as reassuring, increased insight, and problem solving while decreasing anxiety. Only 6 of 94 (6.4%) YOU CALL participants availed themselves of the intervention. Conclusions Although the 2 groups improved equally over time, WE CALL intervention was perceived as helpful, whereas YOU CALL intervention was not used.

Guaiac versus immunochemical tests: Faecal occult blood test screening for colorectal cancer in a rural community

Objective: To describe patient participation and clinical performance in a colorectal cancer (CRC) screening program utilising faecal occult blood test (FOBT). Methods: A community-based intervention was conducted in a small, rural community in north Queensland, 2000/01. One of two FOBT kits – guaiac (Hemoccult-ll) or immunochemical (Inform) – was assigned by general practice and mailed to participants (3,358 patients aged 50–74 years listed with the local practices). Results: Overall participation in FOBT screening was 36.3%. Participation was higher with the immunochemical kit than the guaiac kit (OR=1.9, 95% Cl 1.6-2.2). Women were more likely to comply with testing than men (OR=1.4, 95% Cl 1.2-1.7), and people in their 60s were less likely to participate than those 70–74 years (OR=0.8, 95% Cl 0.6-0.9). The positivity rate was higher for the immunochemical (9.5%) than the guaiac (3.9%) test (χ2=9.2, p=0.002), with positive predictive values for cancer or adenoma of advanced pathology of 37.8% (95% Cl 28.1–48.6) for !nform and 40.0% (95% Cl 16.8–68.7) for Hemoccult-ll. Colonoscopy follow-up was 94.8% with a medical complication rate of 2–3%. Conclusions: An immunochemical FOBT enhanced participation. Higher positivity rates for this kit did not translate into higher false-positive rates, and both test types resulted in a high yield of neoplasia. Implications: In addition to type of FOBT, the ultimate success of a population-based screening program for CRC using FOBT will depend on appropriate education of health professionals and the public as well as significant investment in medical infrastructure for colonoscopy follow-up.

Työkykyarviokokous moniammatillisen työryhmän päätöksentekotilanteena : Tutkimus vuorovaikutuksesta ja potilaan osallisuudesta

Work capacity assessment meeting as a decision-making situation of a multi-professional team a study on interaction and patient participation Multi-professional working has become an increasingly popular method of work in social and health care. The introduction of the viewpoints of several professionals is seen as a way to enhance the openness and quality of decision-making. However, so far relatively few study results are available on the implementation of this method in actual operations. This study examines one work method, a work capacity assessment meeting, along with medical certificates B and their enclosures written by the doctor to the patient after a meeting. After the theoretical and methodological chapter, providing background information, the study describes the structure of the meeting and the medical certificate as a constructive factor. This is followed by a discussion on the manner of assessing the various domains of the patient s functional capacity and the decision-making based on the assessed factors. Next, the study moves on to examine the effect of patient involvements on the conclusions and decisions that professionals make at the meeting. In conclusion, the study looks into how the voices of the professionals and the customer are transferred to the medical certificate. The material of the study consists of 11 meetings recorded on video, of which eight are work capacity assessment meetings and three are rehabilitation examination meetings. The first type of meeting is attended by a patient and a number of professionals, while the latter is attended only by the professionals. All the patients, whose cases are discussed in the work capacity assessment meetings, have a musculoskeletal disorder, while the rehabilitation meetings are related to patients who all also have some additional problem. The study material also consists of seven medical certificates B, written after a work capacity assessment meeting. For the most part, the material has been collected by the conversation analysis method. Moreover, also discourse analysis and a rhetorical approach were used. By using conversation analysis, it is possible to study closely how interaction is built up at the meeting and to examine how the actors implement their institutional assessment tasks in a co-operation that takes its form turn by turn. The four main findings of the study are as follows: firstly, the meeting is structured to a great extent on the basis of the medical certificate form to various phases of the meeting and the headings of the certificate are seen as communicative affordances at the meeting, directed primarily to the professionals that have assessed the patient s work capacity with various tests. The medical certificate is the ethno-method of the doctor acting as the chairman of the meeting that functions in two directions: it constructs the meeting and constitutes the task of the professionals as they produce contents for it. Secondly, the study describes the ways that are used to assess the different domains of the patient s work capacity, how they are described at the meeting and how a decision is taken when the assessment information has been saturated in the opinion of the team. Thirdly, the study brings up ways, with which the patient can influence the conclusions and decisions made by the professionals at the meeting. The study showed that the patient can affect the preconditions of his or her own future and wellbeing. Fourthly, the study describes how the wealth of expressions at the meeting is transferred to the certificate as an argumentative micro-cosmos, where the patient is classified to be recommended for rehabilitation or disability pension. An important finding is also how objective and subjective information and the voices of actors at the meeting are transferred to the statement in a strategic and intentional manner, with an orientation to the decision that will be taken at the insurance institution. The study results can be utilized in the training of professionals and in developing the operations of organisations performing the assessment of the work capacity of people suffering from musculoskeletal disorders.

Avaliação da terceirização da gestão municipal de unidades ambulatoriais de Duque de Caxias, no programa de Saúde Mental.

O trabalho tem por objeto a terceirização da gestão municipal de unidades ambulatoriais de saúde mental no segundo, terceiro e quarto distritos do município de Duque de Caxias, no Rio de Janeiro, na modalidade de organização social, entre 2009 a 2012. O marco inicial refere-se a assinatura do Termo de parceria entre a Secretaria Municipal de Saúde de Duque de Caxias (SMSDC) e uma Organização da Sociedade Civil de Interesse Público (OSCIP). O marco final refere-se a rescisão unilateral do Termo de Parceria com a OSCIP por parte da SMSDC. O objetivo geral: analisar a gestão terceirizada nos ambulatórios de saúde mental do município de Duque de Caxias no referido período na modalidade de OSCIP. Objetivos específicos: descrever as circunstâncias de implantação do processo de terceirização na gestão das unidades de saúde mental em Duque de Caxias na modalidade de OSCIP; analisar a participação da OSCIP nos ambulatórios de saúde mental no município de Duque de Caxias nos distritos de interesse do estudo; discutir as implicações do modelo de terceirização para a política de Saúde Mental em Duque de Caxias. Trata-se de abordagem quanti-qualitativa do tipo descritiva. As fontes primárias se constituíram de decretos, leis, portarias, resoluções, documentos, atas e relatórios de gestão da OSCIP e do programa de Saúde Mental de Duque de Caxias, atas do Conselho do Municipal de Caxias e atas das Conferencias Nacionais e Municipais de Saúde e de Saúde Mental. Para o processo de análise dos dados foi utilizada a analise documental e a analise estatística. Os dados quantitativos foram tabulados e analisados através de estatística simples e apresentados sob a forma de tabelas e gráficos a partir dos dados do TABNET, DATASUS, relatórios da OSCIP e do Programa de Saúde Mental de Duque de Caxias, em especial das unidades terceirizadas dos 2, 3 e 4 distritos do município. Os resultados mostraram que apesar da parceria entre a instituição terceirizada e a Secretaria Municipal de Saúde que previa aumento da produção de consultas em Saúde Mental, alcançando um mínimo 75% das consultas estimadas para psiquiatras e psicólogos, não resultou em diminuição significativa na taxa de internação psiquiátrica no período estudado, que passou de 1,19% do total de internações em 2009 para 0,77% deste total em 2012, apresentando até uma elevação para 1,26% no ano de 2010. Tal fato pode ser devido ao modelo de gestão terceirizado não estar adequado à complexidade da abordagem do paciente com transtorno mental, onde o envolvimento e a formação do profissional baseada no vínculo, na participação do paciente e a construção do seu plano terapêutico com a participação da família, são aspectos diferenciais na qualidade da assistência em saúde mental. O modelo de gestão adotado por Caxias para as Unidades estudadas não apresentou correspondência na redução efetiva da taxa de internação psiquiátrica dos pacientes residentes em Duque de Caxias.

Do diabetic veterans use the Internet? Self-reported usage, skills, and interest in using My HealtheVet Web portal.

OBJECTIVE: The Veterans Health Administration has developed My HealtheVet (MHV), a Web-based portal that links veterans to their care in the veteran affairs (VA) system. The objective of this study was to measure diabetic veterans' access to and use of the Internet, and their interest in using MHV to help manage their diabetes. MATERIALS AND METHODS: Cross-sectional mailed survey of 201 patients with type 2 diabetes and hemoglobin A(1c) > 8.0% receiving primary care at any of five primary care clinic sites affiliated with a VA tertiary care facility. Main measures included Internet usage, access, and attitudes; computer skills; interest in using the Internet; awareness of and attitudes toward MHV; demographics; and socioeconomic status. RESULTS: A majority of respondents reported having access to the Internet at home. Nearly half of all respondents had searched online for information about diabetes, including some who did not have home Internet access. More than a third obtained "some" or "a lot" of their health-related information online. Forty-one percent reported being "very interested" in using MHV to help track their home blood glucose readings, a third of whom did not have home Internet access. Factors associated with being "very interested" were as follows: having access to the Internet at home (p < 0.001), "a lot/some" trust in the Internet as a source of health information (p = 0.002), lower age (p = 0.03), and some college (p = 0.04). Neither race (p = 0.44) nor income (p = 0.25) was significantly associated with interest in MHV. CONCLUSIONS: This study found that a diverse sample of older VA patients with sub-optimally controlled diabetes had a level of familiarity with and access to the Internet comparable to an age-matched national sample. In addition, there was a high degree of interest in using the Internet to help manage their diabetes.

Risk communication in clinical trials: a cognitive experiment and a survey.

BACKGROUND: A Royal Statistical Society Working Party recently recommended that "Greater use should be made of numerical, as opposed to verbal, descriptions of risk" in first-in-man clinical trials. This echoed the view of many clinicians and psychologists about risk communication. As the clinical trial industry expands rapidly across the globe, it is important to understand risk communication in Asian countries. METHODS: We conducted a cognitive experiment about participation in a hypothetical clinical trial of a pain relief medication and a survey in cancer and arthritis patients in Singapore. In part 1 of the experiment, the patients received information about the risk of side effects in one of three formats (frequency, percentage and verbal descriptor) and in one of two sequences (from least to most severe and from most to least severe), and were asked about their willingness to participate. In part 2, the patients received information about the risk in all three formats, in the same sequence, and were again asked about their willingness to participate. A survey of preference for risk presentation methods and usage of verbal descriptors immediately followed. RESULTS: Willingness to participate and the likelihood of changing one's decision were not affected by the risk presentation methods. Most patients indicated a preference for the frequency format, but patients with primary school or no formal education were indifferent. While the patients used the verbal descriptors "very common", "common" and "very rare" in ways similar to the European Commission's Guidelines, their usage of the descriptors "uncommon" and "rare" was substantially different from the EU's. CONCLUSION: In this sample of Asian cancer and arthritis patients, risk presentation format had no impact on willingness to participate in a clinical trial. However, there is a clear preference for the frequency format. The lay use of verbal descriptors was substantially different from the EU's.

What leads Indians to participate in clinical trials? A meta-analysis of qualitative studies.

BACKGROUND: With the globalization of clinical trials, large developing nations have substantially increased their participation in multi-site studies. This participation has raised ethical concerns, among them the fear that local customs, habits and culture are not respected while asking potential participants to take part in study. This knowledge gap is particularly noticeable among Indian subjects, since despite the large number of participants, little is known regarding what factors affect their willingness to participate in clinical trials. METHODS: We conducted a meta-analysis of all studies evaluating the factors and barriers, from the perspective of potential Indian participants, contributing to their participation in clinical trials. We searched both international as well as Indian-specific bibliographic databases, including Pubmed, Cochrane, Openjgate, MedInd, Scirus and Medknow, also performing hand searches and communicating with authors to obtain additional references. We enrolled studies dealing exclusively with the participation of Indians in clinical trials. Data extraction was conducted by three researchers, with disagreement being resolved by consensus. RESULTS: Six qualitative studies and one survey were found evaluating the main themes affecting the participation of Indian subjects. Themes included Personal health benefits, Altruism, Trust in physicians, Source of extra income, Detailed knowledge, Methods for motivating participants as factors favoring, while Mistrust on trial organizations, Concerns about efficacy and safety of trials, Psychological reasons, Trial burden, Loss of confidentiality, Dependency issues, Language as the barriers. CONCLUSION: We identified factors that facilitated and barriers that have negative implications on trial participation decisions in Indian subjects. Due consideration and weightage should be assigned to these factors while planning future trials in India.

So different, yet so similar: meta-analysis and policy modeling of willingness to participate in clinical trials among Brazilians and Indians.

BACKGROUND: With the global expansion of clinical trials and the expectations of the rise of the emerging economies known as BRICs (Brazil, Russia, India and China), the understanding of factors that affect the willingness to participate in clinical trials of patients from those countries assumes a central role in the future of health research. METHODS: We conducted a systematic review and meta-analysis (SRMA) of willingness to participate in clinical trials among Brazilian patients and then we compared it with Indian patients (with results of another SRMA previously conducted by our group) through a system dynamics model. RESULTS: Five studies were included in the SRMA of Brazilian patients. Our main findings are 1) the major motivation for Brazilian patients to participate in clinical trials is altruism, 2) monetary reimbursement is the least important factor motivating Brazilian patients, 3) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects, and 4) Brazilian patients are more likely willing to participate in clinical trials than Indians. CONCLUSION: Our study provides important insights for investigators and sponsors for planning trials in Brazil (and India) in the future. Ignoring these results may lead to unnecessary fund/time spending. More studies are needed to validate our results and for better understanding of this poorly studied theme.

Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions.

BACKGROUND: Few educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. METHODS: We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in "stages." For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. RESULTS: The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals' testimonials regarding various considerations that might influence patients' and families' treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. CONCLUSIONS: This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial.

BACKGROUND: Living related kidney transplantation (LRT) is underutilized, particularly among African Americans. The effectiveness of informational and financial interventions to enhance informed decision-making among African Americans with end stage renal disease (ESRD) and improve rates of LRT is unknown. METHODS/DESIGN: We report the protocol of the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED) Study, a two-phase study utilizing qualitative and quantitative research methods to design and test the effectiveness of informational (focused on shared decision-making) and financial interventions to overcome barriers to pursuit of LRT among African American patients and their families. Study Phase I involved the evidence-based development of informational materials as well as a financial intervention to enhance African American patients' and families' proficiency in shared decision-making regarding LRT. In Study Phase 2, we are currently conducting a randomized controlled trial in which patients with new-onset ESRD receive 1) usual dialysis care by their nephrologists, 2) the informational intervention (educational video and handbook), or 3) the informational intervention in addition to the option of participating in a live kidney donor financial assistance program. The primary outcome of the randomized controlled trial will include patients' self-reported rates of consideration of LRT (including family discussions of LRT, patient-physician discussions of LRT, and identification of a LRT donor). DISCUSSION: Results from the PREPARED study will provide needed evidence on ways to enhance the decision to pursue LRT among African American patients with ESRD.

Exercise Prescription for Patients with Non-specific Chronic Low Back Pain: a Qualitative Exploration of Decision Making in Physiotherapy Practice

Background: Providing an effective exercise prescription process for patients with non-specific chronic low back pain (NSCLBP) is a challenging task. Emerging research has indicated that partnership in care and shared decision making are important for people with NSCLBP and calls for further investigation into the approaches used to prescribe exercise. Objective: To explore how shared decision making and patient partnership are addressed by physiotherapists in the process of exercise prescription for patients with NSCLBP. Design: A qualitative study using a philosophical hermeneutic approach. Methods: Eight physiotherapists were each observed on three occasions undertaking their usual clinical activities (total n=24 observations). They conducted brief interviews after each observation and a later in depth semi-structured interview. Iterative hermeneutic strategies were used to interpret the texts and identify the characteristics and processes of exercise prescription for patients with NSCLBP. Findings: The findings revealed how physiotherapy practice often resulted in unequal possibilities for patient participation which were in turn linked to the physiotherapists? assumptions about the patients, clinical orientation, cognitive and decision making processes. Three linked themes emerged: (1) I want them to exercise, (2) Which exercise? - the tension between evidence and everyday practice and (3) Compliance-orientated more than concordance based. Conclusions: This research, by focusing on a patient-centred approach, makes an important contribution to the body of evidence relating to the management of NSCLBP. It challenges physiotherapists to critically appraise their approaches to the prescription of exercise therapy in order to improve outcomes for these patients.

Readiness to participate in psychiatric research.

BACKGROUND: The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in research. Seeking patients' views about their experience in research projects may allow investigators to develop more effective recruitment and retention strategies. METHODS: A total of 100 patients consecutively admitted to a psychiatric university hospital were interviewed with respect to their willingness to participate in a study. For a different study scenario, patients were asked whether they would be ready to participate if such a study were organized in the service and to indicate their reasons for refusing or for participating. RESULTS: The general readiness to participate in a study ranged between 70% and 96%. The prospect of remuneration did not notably augment the potential consent rate. The most common and spontaneous motivation for agreeing to take part in a study was to help science progress and to allow future patients to benefit from improved diagnosis and treatment (87%). The presence or lack of a financial incentive was rarely chosen as an argument to agree (23%) or to refuse (7%) to participate. Patients relied mainly on their treating physicians when contemplating possible participation in a study (family physician [65%] and hospital physician [54%]). CONCLUSIONS: Clinicians and, in particular, treating doctors can play an important role in facilitating the recruitment process.

Faktorer som påverkar patientens delaktighet i omvårdnad – en litteraturstudie

Bakgrund: Patientens rätt att vara delaktig i planering och genomförande av sin vård betonas idag, men många patienter är mindre delaktiga än de önskar vara. Det finns många fördelar med att patienten är delaktig. Syfte: Att beskriva vilka faktorer som påverkar patientens delaktighet i omvårdnad från patientens och sjuksköterskans perspektiv inom somatisk slutenvård. Metod: Litteraturstudie baserad på 16 vetenskapliga artiklar, publicerade mellan åren 2006 och 2015. Sökning skedde i databaserna PubMed och CINAHL, samt i de funna artiklarnas referenslistor. Resultat: Fem kategorier med faktorer som påverkade patientens delaktighet i omvårdnad identifierades; kunskap, relationen mellan patienten och sjuksköterskan, sjuksköterskans förhållningssätt, patientens situation och egenskaper samt organisationen. Slutsats: Faktorerna inom de fem kategorierna utgör ett komplicerat samspel och varje patient är en unik person med egna önskemål och preferenser för delaktighet.

Engaging patients as safety partners : some considerations for ensuring a culturally and linguistically appropriate approach

Engaging patients as ‘safety partners’ with health service providers to help identify and rectify preventable adverse events in health care is being increasingly accepted in the USA, Australia, and elsewhere as a promising strategy to improve patient safety outcomes. The implications of this trend for patients and families of minority cultural and language backgrounds have not, however, been comprehensively considered. In this article, attention is given to briefly exploring the notion of patient participation in health care and the problematic transposition of the concept into patient safety discourse. The importance of recognising and responding to the critical relationship between culture, language and
patient safety outcomes, and the possible benefits and risks of engaging patients of minority ethnic backgrounds in safety partnership programs are explored. It is suggested that if patient safety engagement/partnership programs are to perform well in cross-cultural health care contexts, they need to be supported by research evidence and appropriately informed by the perspectives and experiences of patients and families/nominated carers from minority cultural and language backgrounds. They also need to be appropriately supported by culturally competent policies and practices across the entire health care system. The importance of robust internationally comparative research on this issue is highlighted.

National indicators of health literacy: ability to understand health information and to engage actively with healthcare providers - a population-based survey among Danish adults

Health literacy is a multidimensional concept covering a range of cognitive and social skills necessary for participation in health care. Knowledge of health literacy levels in general populations and how health literacy levels impacts on social health inequity is lacking. The primary aim of this study was to perform a population-based assessment of dimensions of health literacy related to understanding health information and to engaging with healthcare providers. Secondly, the aim was to examine associations between socio-economic characteristics with these dimensions of health literacy.