"Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

Background: The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods: Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results: This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions: A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required

Patients’ and practice nurses’ perceptions of depression in patients with type 2 diabetes and/or coronary heart disease screened for subthreshold depression

Background Comorbid depression is common in patients with type 2 diabetes (DM2) and/or coronary heart disease (CHD) and is associated with poor quality of life and adverse health outcomes. However, little is known about patients’ and practice nurses’ (PNs) perceptions of depression. Tailoring care to these perceptions may affect depression detection and patient engagement with treatment and prevention programs. This study aimed to explore patients’ and PNs’ perceptions of depression in patients with DM2/CHD screened for subthreshold depression. Methods A qualitative study was conducted as part of a Dutch stepped-care prevention project. Using a purposive sampling strategy, data were collected through semi-structured interviews with 15 patients and 9 PNs. After consent, all interviews were recorded, transcribed verbatim and analyzed independently by two researchers with Atlas.ti.5.7.1 software. The patient and PN datasets were inspected for commonalities using a constant comparative method, from which a final thematic framework was generated. Results Main themes were: illness perception, need for care and causes of depression. Patients generally considered themselves at least mildly depressed, but perceived severity levels were not always congruent with Patient Health Questionnaire 9 scores at inclusion. Initially recognizing or naming their mental state as a (subthreshold) depression was difficult for some. Having trouble sleeping was frequently experienced as the most burdensome symptom. Most experienced a need for care; psycho-educational advice and talking therapy were preferred. Perceived symptom severity corresponded with perceived need for care, but did not necessarily match help-seeking behaviour. Main named barriers to help-seeking were experienced stigma and lack of awareness of depression and mental health care possibilities. PNs frequently perceived patients as not depressed and with minimal need for specific care except for attention. Participants pointed to a mix of causes of depression, most related to negative life events and circumstances and perceived indirect links with DM2/CHD. Conclusion Data of the interviewed patients and PNs suggest that they have different perceptions about (subthreshold) depressive illness and the need for care, although views on its causes seem to overlap more

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

The Changing Landscape for Stroke\ua0Prevention in AF: Findings From the GLORIA-AF Registry Phase 2

Background GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non\u2013vitamin K antagonist oral anticoagulant (NOAC), became available. Objectives This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1. Methods During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients\u2019 baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics. Results Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHA2DS2-VASc [Congestive heart failure, Hypertension, Age  6575 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score  652; 86.1%); 13.9% had moderate risk (CHA2DS2-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment. Conclusions The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701

Associations between the home food environment and obesity-promoting eating behaviors in adolescence

Objective: This study examines relationships between multiple aspects of the home food environment and obesity-promoting characteristics of 12- to 13-year-old adolescents\u27 diets, specifically frequency of consumption of high-energy fluids, sweet snacks, savory snacks, and take-out foods.Research Methods: This was a cross-sectional study including 347 adolescents 12 to 13 years of age and their parents. Data were collected via self-completed surveys. The adolescents\u27 diets were assessed using a Food Frequency Questionnaire derived from existing age-appropriate National Nutrition Survey data. An extensive range of domains within the home food environment were assessed. Bivariate linear regression analyses were run split by gender. Forced entry multiple linear regression analyses (adjusting for all variables significant in bivariate analyses as well as for maternal education) were also performed, stratified by the sex of the child.Results: The influence of mothers, either as models for eating behaviors or as the providers of food, was pervasive. Mothers\u27 intake of high-energy fluids (p = 0.003), sweet snacks (p = 0.010), savory snacks (p = 0.008), and take-out food (p = 0.007) was positively associated with boys\u27 intake of all these foods. In addition, mothers\u27 intake of high-energy fluids was positively associated with daughters\u27 consumption of these drinks (p = 0.025). Furthermore, availability of unhealthy foods at home was positively associated with girls\u27 sweet snack (p = 0.001), girls\u27 savory snack (p &lt; 0.001), boys\u27 savory snack (p = 0.002), and, in the bivariate analyses, girls\u27 high-energy fluid consumption (p = 0.002).Discussion: This study of home food environment influences on adolescent diet highlights the pervasive influence of mothers in determining adolescents\u27 obesity-promoting eating, providing direction for obesity prevention strategies and future research.<br /

As necessidades e os desejos na formação discursiva do marketing: base consistente ou retórica legitimadora?

Neste artigo realizamos uma análise crítica da gênese histórica da área de marketing até sua constituição atual, com um foco principal: verificar se as necessidades e os desejos dos clientes são base consistente da formação histórica, discursiva, do marketing ou, apenas, retórica legitimadora para a atuação da área. Adotamos uma orientação filosófico-epistemológica baseada na teoria do discurso proposta por Michel Foucault, que nos permitiu constatar que a centralidade das necessidades e dos desejos dos clientes no discurso contemporâneo do marketing é resultado de uma série de transformações e disputas históricas pela hegemonia de uma determinada idéia ou ponto de vista, mas sempre ancorada em condições socioeconômicas, ambientais, favoráveis às transformações ocorridas. Em outras palavras, concluímos que as transformações discursivas, constituintes da área, foram o resultado de um processo produzido social e historicamente, tendo ocorrido muito mais como um resultado de mudanças na economia e no mundo empresarial do que como uma espécie de "vocação" natural do marketing