'Space to talk': a Portuguese focus group study of parents' experiences, needs and preferences in parenting support during prenatal and well-child care.

OBJECTIVE: To explore the experiences, needs and preferences of a group of parents regarding the parenting support received during prenatal and well-child care in the Portuguese National Health Service. DESIGN AND SETTING: We undertook descriptive-interpretive qualitative research running multiple focus groups in Porto, Northern Portugal. PARTICIPANTS, DATA COLLECTION AND ANALYSIS: Purposive sampling was used between April and November 2018. Focus groups were conducted with 11 parents of a 0-3 years old with well-child visits done in primary care units. Thematic analysis was performed in a broadly inductive coding strategy and findings are reported in accordance with Consolidated Criteria for Reporting Qualitative Research guidelines. RESULTS: Three main themes were identified to describe parents' experience when participating in their children's healthcare: (1) logistics/delivery matter, including accessibility, organisation and provision of healthcare activities, unit setting and available equipment; (2) prenatal and well-child care: a relational place to communicate, with parents valuing a tripartite space for the baby, the family and the parent himself, where an available and caring health provider plays a major role and (3) parenting is challenging and looks for support, based on key points for providers to watch for and ask about, carefully explained and consensual among health providers. CONCLUSION: This study provides insight into parents' needs and healthcare practices that affect the parenting experience. To meet parents' preferences, sensitive health providers should guarantee a relational place to communicate and person-centredness, accounting for the whole family system to support healthy parenting collaboratively. Future studies are warranted to further strengthen the knowledge in the field of a population-based approach for parenting support.

Parenting, child development and primary care-'Crescer em Grande!' intervention (CeG!) based on the Touchpoints approach: a cluster-randomised controlled trial protocol.

INTRODUCTION: Despite support for parenting being already recognised as a priority, there remains a paucity of evidence on how to facilitate its adoption in regular visits of maternal and child health primary care (PC). We describe the protocol for a study to assess the effect of an innovative universal Touchpoints-based intervention-'Crescer em Grande!' (CeG!) - when supporting the process of transition to parenthood and early infancy, at multiple PC units. METHODS AND ANALYSIS: A cluster-randomised trial will be conducted in 12 PC units (clusters) from the Lisbon metropolitan area, Portugal. Participants will be a minimum of three family physicians and one nurse/unit, as well as 216 expecting parents and future babies until 18 months who are using the PC services. Sites will be randomised to either the CeG! or usual care. The CeG! will consist of: (1) the integration of the Touchpoints approach in PC maternal and well-child visits, with the support of 28 leaflets for parents to file in a folder; plus (2) training for PC providers on how to perform the CeG! into existing practice. Parents will be required to fill in questionnaires at point throughout their child's 18-month, mostly online. The primary outcome will be the self-perception of parental competence (Parenting Sense of Competence Scale). Other outcomes include: family functioning, couple dynamics, mental health, well-being/quality of life, psychological experience of pregnancy, attachment, child development. Acceptability, satisfaction and feasibility of CeG! will also be obtained from providers' and parents' perspectives. Costs associated with delivering the CeG! will be calculated. Study analyses will be under the principle of intention-to-treat. ETHICS AND DISSEMINATION: Approval was obtained from the Ethics Committee of the Regional Health Administration. The results will be shared with participants and disseminated via peer-reviewed published papers, presentations at scientific and professional conferences. TRIAL REGISTRATION NUMBER: ISRCTN90692907.

Adapting the Portuguese dignity question framework for adolescents: ages 10-18.

OBJECTIVE: Dignity therapy (DT) is well established in adult populations, and it is likely that it could benefit younger people. This study aimed to adapt the adult Portuguese DT question framework for adolescents (DT-QF-Adol) (ages 10-18). METHOD: Five stages were followed: (1) the Portuguese DT-QF for adults was adapted for adolescents with the original author's collaboration, (2) an expert committee provided feedback on the adapted version, (3) an initial consensus version of the DT-QF-Adol was created, (4) expert committee consult affirmed final consensus, and (5) validation stage with a sample of 17 adolescents followed in ambulatory psychology clinic. RESULTS: DT's original author endorsed the final Portuguese DT-QF-Adol, reinforcing that it captures the fundamental dimensions of DT. There was 100% agreement on the final consensus version and defined age group (10-18 years old). Twenty adolescents were invited to participate, and 17 were included after informed consent was obtained; 53% were female. The average age was 12.7 years. The interviewed adolescents reported that the DT-QF-Adol was clear, and they did not identify any ambiguity or difficulty in answering any of the questions. They assumed that this information could positively affect the way parents and friends see and cared for them, permitting others to understand their concerns and preferences. Participants felt that the DT-QF-Adol could be a good starting point for a conversation with their loved ones. Although they did not consider vital for health professionals to access their answers, they strongly felt that the DT-QF-Adol might be essential to sick adolescents and they would recommend it to others. SIGNIFICANCE OF RESULTS: We developed a DT-QF of nine questions for Portuguese adolescents (DT-QF-Adol), coined Protocolo de Perguntas da Terapia da Dignidade para Adolescentes - 10-18 anos. This tool can potentially be considered a good addition for pediatric palliative care.

The Portuguese versions of the This Is ME Questionnaire and the Patient Dignity Question: tools for understanding and supporting personhood in clinical care.

BACKGROUND: Modern medicine can be impersonal and routinized, paying insufficient attention to issues of personhood. The Patient Dignity Question (PDQ) and This Is ME (TIME) Questionnaire are clinical tools developed with the aim of probing for personhood, reinforcing dignity and promoting health care attitudes based on looking at people for who they are and not defining them solely based on their medical condition. This study aimed to translate and validate the TIME Questionnaire and the PDQ into European Portuguese, coined as Questionário Este Sou EU (ESEU) and Pergunta da Dignidade (PD), respectively. METHODS: A three-stage research design, namely: a forward and back translation process (which included an expert committee panel), collected data on a sample of 43 non-institutionalized active elderly for the validation stage and a final expert panel consultation. Inclusion criteria: being 50 years old or older; ability to provide written informed consent; ability to read, speak and understand Portuguese. RESULTS: The original TIME authors fully endorsed the back translated version. A Portuguese version was created. Forty-three participants (response rate of 62%) were included, 53% of whom were male. The average age was 69 years old (range, 60-80 years old). The interviewed elderly strongly felt that the ESEU's summary captured their essence as a person beyond whatever health problems they might be experiencing (6.8, SD =0.48), heightened their sense of dignity (6.1, SD =1.48), considered important that health care professionals (HCPs) have access to ESEU´s summary (6.6, SD =0.73) and that this information could affect the way HCPs see and care for them (6.4, SD =0.86), rated on a Likert scale: 1 "strongly disagree"-7 "strongly agree". According to the experts' evaluations, the translated ESEU Questionnaire was clear, precise, comprehensible and captured important dimensions of personhood. CONCLUSIONS: The Questionário ESEU and the PD are clear, precise, comprehensible and well-aligned in terms of measuring aspects of personhood. This measure could add additional value to the patient-healthcare provider relationship, allowing a new perspective on how healthcare professionals perceive patients in suffering, ensuring they acknowledge not just patienthood, but critical dimensions of personhood.

Tapentadol for chronic musculoskeletal pain in adults.

BACKGROUND: Chronic musculoskeletal pain is a prevalent condition and a major cause of disability and absence from the workplace worldwide. Opioids are frequently used to treat chronic pain, although adverse effects often restrict their long-term benefits. Tapentadol is an opioid and norepinephrine re-uptake inhibitor, which may cause a lower incidence (and severity) of adverse effects compared to other strong opioids. OBJECTIVES: To determine the efficacy, safety and tolerability of tapentadol extended release for moderate-to-severe pain for at least three months for any musculoskeletal cause. SEARCH METHODS: We searched electronic databases (CENTRAL, MEDLINE, EMBASE, Web of Science) to March 2014, unrestricted by language, as well as trials registers and reference lists from retrieved studies. We contacted drug manufacturers for further information. SELECTION CRITERIA: Randomised controlled trials (RCTs) of tapentadol in people with chronic musculoskeletal pain, compared to placebo or active control. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed risk of bias of included studies and extracted data. We performed two meta-analyses for the comparisons tapentadol extended release vs. placebo, and tapentadol extended release vs. active-control (oxycodone). We used random-effects and fixed-effect models according to the presence or not of heterogeneity, respectively. Also, we performed subgroup analyses. The primary efficacy outcome was pain control assessed by change in pain intensity scores and responder's rate (at least 50% pain relief). Primary safety outcome was withdrawal rate due to adverse effects. MAIN RESULTS: Four parallel-design RCTs of moderate quality including 4094 patients with osteoarthritis or back pain, or both, met the inclusion criteria. Three trials were phase III studies with 12-weeks follow-up and the fourth trial was an open-label safety study of 52-weeks follow-up. All trials were oxycodone-controlled and three were also placebo-controlled. Two trials included patients with knee osteoarthritis, one evaluated patients with low back pain and one enrolled both. All studies reported last-observation-carried-forward (LOCF) as imputation method. We requested baseline-observation-carried-forward (BOCF) imputed analyses and any unpublished data from the manufacturer but the manufacturers denied the request. Two out of the four oxycodone-controlled studies and one out of the three placebo-controlled studies did not provided data on responder's rate. Two studies were considered to be of high risk of bias.In comparison to placebo, tapentadol was associated with a mean reduction of 0.56 points (95% confidence interval (CI) 0.92 to 0.20) in the 11-point numerical rating scale (NRS) at 12 weeks and with a 1.36 increase (95% CI 1.13 to 1.64) in the risk of responding to treatment (number needed to treat for an additional beneficial outcome (NNTB) 16; 95% CI 9 to 57, for 12-weeks). Moderate-to-high heterogeneity was found for the efficacy outcome estimates. Tapentadol was associated with a 2.7 fold increase (95% CI 2.05 to 3.52) in the risk of discontinuing treatment due to adverse effects number needed to treat for an additional harmful outcome (NNTH) 10; 95%CI 7 to 12, for 12 weeks).In comparison to oxycodone, pooled data showed a 0.24 points (95%CI 0.43 to 0.05) reduction in pain intensity from baseline in the 11-point NRS. The two studies that evaluated responder's rate showed a non-significant 1.46 increase (95% CI 0.92 to 2.32) in the risk of responding to treatment among tapentadol treated patients. Tapentadol was associated with a 50% risk reduction (95% CI 42% to 60%) of discontinuing treatment due to adverse effects (NNTB 6; 95% CI 5 to 7, for 12 weeks). Tapentadol was also associated with a 9% reduction (95% CI 4 to 15) in the overall risk of adverse effects (NNTH 18; 95% CI 12 to 35, for 12 weeks) and with a non-significant 43% reduction (95% CI 33 to 76) in the risk of serious adverse effects. Moderate to high heterogeneity was found for most efficacy (except for the primary outcome) and safety outcome estimates. Subgroup analysis showed a higher improvement with tapentadol among patients with knee osteoarthritis and among pooled results from studies of higher quality and shorter follow-up period, although there were no statistical significant differences in the effect size between these subgroups. AUTHORS' CONCLUSIONS: Tapentadol extended release is associated with a reduction in pain intensity in comparison to placebo and oxycodone. However, the clinical significance of the results is uncertain due to the following reasons: modest difference between interventions in efficacy outcomes, high heterogeneity in some comparisons and outcomes, high withdrawals rates, lack of data for the primary outcome in some studies and impossibility to use BOCF as imputation method. Tapentadol is associated with a more favourable safety profile and tolerability than oxycodone.

[Off-label prescribing: scientific analysis taking the use of bevacizumab in ophthalmology as an example]. / Prescrição off-label: análise científica tendo como exemplo a utilização de bevacizumab em oftalmologia.

Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified.

A prescrição off-label levanta problemas técnicos/científicos, profissionais e éticos específicos. No presente trabalho, procurámos realizar uma análise técnico-científica da prescrição off-label recorrendo a um exemplo atual, clinica e economicamente relevante: o caso paradigmático da utilização de bevacizumab em patologias do foro oftalmológico para as quais não tem indicação formal aprovada. Para tal realizámos uma revisão sistemática da literatura sobre a eficácia e segurança deste medicamento, assim como de ranibizumab­ o qual tem indicações oftalmológicas aprovadas, no sentido de analisar qualitativamente a evidência científica disponível sobreas duas intervenções. Este caso é exemplar para análise técnico-científica dos problemas da prescrição off-label, já que, de acordo com os resultados da revisão sistemática realizada, o uso do bevacizumab neste contexto possui, de facto, evidência científica de dimensão apreciável, incluindo ensaios clínicos head-to-head com ranibizumab. No entanto, os problemas de segurança identificados levantam a questão da utilização deste fármaco nas patologias oftalmológicas. Os diferentes agentes que participam no processo de decisão terapêutica (médicos, doentes e decisores institucionais) devem estar adequadamente informados sobre a evidência existente que suporta a prescrição off-label, a qual, por definição, deve ser sempre de caracter excecional e devidamente justificada.

Is the OSCE a feasible tool to assess competencies in undergraduate medical education?

BACKGROUND: The Objective Structured Clinical Examination (OSCE) was introduced by Harden et al. (1975) trying to answer the problems regarding the assessment of clinical competencies. Despite increasingly widespread use of OSCEs, debate continues with arguments as 'why using such a demanding format if other methods are available?' AIM: To review and synthesize evidence on technical and economic feasibility of OSCE in undergraduate medical studies. METHODS: Best Evidence Medical Education methodology was applied by two independent coders to 1083 studies identified by literature search from 1975 until the end of 2008. KEY FINDINGS: The OSCE is a feasible approach to the assessment of clinical competence for use in different cultural and geographical contexts; to assess a wide range of learning outcomes; in different specialties and disciplines; for formative and summative purposes; to assess students a curriculum or an educational intervention; in the different phases of education including the early and later years of the undergraduate curriculum; and in different health care professions. CONCLUSION: Despite being an expensive test format, evidence suggests that the use of OSCE produces reliable results. The study also suggests that one reason for the wide-scale adoption of the OSCE and the feasibility of its use in different contexts and situations is its inherent flexibility in terms of the number of students that can be assessed, the number of examiners included, the type of patients represented and the format of the examination itself, including the length of the examination, the number and duration of stations.

[Generalization of the results of clinical studies through the analysis of subgroups]. / A Generalização dos Resultados de Estudos Clínicos Através da Análise de Subgrupos.

Subgroup analysis in clinical trials are usually performed to define the potential heterogeneity of treatment effect in relation with the baseline risk, physiopathology, practical application of therapy or the under-utilization in clinical practice of effective interventions due to uncertainties of its benefit/risk ratio. When appropriately planned, subgroup analysis are a valid methodology the define benefits in subgroups of patients, thus providing good quality evidence to support clinical decision making. However, in order to be correct, subgroup analysis should be defined a priori, done in small numbers, should be fully reported and, most important, must endure statistical tests for interaction. In this paper we present an example of the treatment of post-menopausal osteoporosis, in which the benefits of an intervention (the higher the fracture risk is, the better the benefit is) with a specific agent (bazedoxifene) was only disclosed after a post-hoc analysis of the initial global trial sample.

Clinical comparability of the new antiepileptic drugs in refractory partial epilepsy: a systematic review and meta-analysis.

PURPOSE: Evaluate the clinical comparability of new antiepileptic drugs (AEDs) in partial refractory epilepsy. METHODS: Systematic review of randomized trials (RCTs) comparing a new AED (add-on treatment) with placebo or another AED. PRIMARY OUTCOMES: responder (≥50% seizure reduction) and withdrawal (tolerability) rates. Pooled estimates of odds ratios (ORs) and number needed treat/harm (NNT/NNH) taking into account baseline risk were derived by random-effects meta-analysis. Adjusted frequentist indirect comparisons between AEDs were estimated. KEY FINDINGS: Sixty-two placebo-controlled (12,902 patients) and eight head-to-head RCTs (1,370 patients) were included. Pooled ORs for responder and withdrawal rates (vs. placebo) were 3.00 [95% confidence interval (CI) 2.63-3.41] and 1.48 (1.30-1.68), respectively. Indirect comparisons of responder rate based on relative measurements of treatment effect (ORs) favored topiramate (1.52; 1.06-2.20) in comparison to all other AEDs, whereas gabapentin (0.67; 0.46-0.97) and lacosamide (0.66; 0.48-0.92) were less efficacious, without significant heterogeneity. When analyses were based on absolute estimates (NNTs), topiramate and levetiracetam were more efficacious, whereas gabapentin and tiagabine were less efficacious. Withdrawal rate was higher with oxcarbazepine (OR 1.60; 1.12-2.29) and topiramate (OR 1.68; 1.07-2.63), and lower with gabapentin (OR 0.65; 0.42-1.00) and levetiracetam (OR 0.62; 0.43-0.89). SIGNIFICANCE: The differences found are of relatively small magnitude to allow a definitive conclusion about which new AED(s) has superior effectiveness. This uncertainty probably reflects the limitations of conclusions based on indirect evidence. The process of pharmacologic clinical decision making in partial refractory epilepsy probably depends more on other aspects, such as individual patient characteristics and pharmacoeconomics, than on available controlled randomized evidence.

A comprehensive checklist for reporting the use of OSCEs.

BACKGROUND: The Objective Structured Clinical Examination (OSCE) has experienced an explosion of use which has rarely been accompanied by systematic investigations on its validity, reliability and feasibility. A systematic review of OSCE was undertaken as part of Best Evidence Medical Education at the Centre for Evidence Based Medicine of the Faculty of Medicine of the University of Lisbon. Several problems were identified with published papers relating to completeness of information presented, methodological issues or the use of terminology. AIM: To identify a need for standardization within the reporting of OSCE studies in medical education based in the first 104 papers of the aforementioned review. METHOD: Two independent reviewers coded each paper. RESULTS: The most important problem identified was the lack of information, followed by the degree of inconsistency when reporting on OSCEs (papers with missing data and papers where data was given in a way that interpretation is difficult or impossible in terms of evidence; heterogeneity in reporting, lack of a standardized vocabulary, statistical errors and lack of structure within reporting). CONCLUSIONS: The authors present a 'Comprehensive Checklist for those describing the use of OSCEs in the report of educational literature' as an attempt to encourage better report standards.

Asymptomatic carotid bruit.

Cerebrovascular events are responsible for high morbidity and mortality, and carotid atherosclerosis with vascular stenosis is a major etiological factor in cerebrovascular disease. Carotid bruit is an important marker of generalized atherosclerosis. On the basis of good quality studies, we can conclude that it indicates an increased risk of cerebrovascular events and acute myocardial infarction, with the degree of carotid stenosis and presence of ischemic heart disease as the most important predictive factors. Management can be medical (risk factor modification and antiplatelet therapy) or surgical (endarterectomy). In this review article we briefly discuss the management of asymptomatic carotid bruit based on the main studies published in the last few years addressing cardiovascular event prevention in carotid atherosclerosis.