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Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

Por: Jaspers · N. E. M. · Visseren · F. L. J. · van der Graaf · Y. · Smulders · Y. M. · Damman · O. C. · Brouwers · C. · Rutten · G. E. H. M. · Dorresteijn · J. A. N.
Objective

To determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.

Design

Hypothesis-blinded, three-armed randomised controlled trial

Setting and participants

303 statin users with stable CVD enrolled in a cohort

Intervention

Participants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).

Outcome

Primary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).

Results

Decisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.

Conclusion

In patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.

Trial registration

NTR6227/NL6080.

Long-term weight loss success and the health behaviours of adults in the USA: findings from a nationally representative cross-sectional study

Por: Shuval · K. · Marroquin · E. M. · Li · Q. · Knell · G. · Pettee Gabriel · K. · Drope · J. · Yaroch · A. L. · Chartier · K. G. · Fennis · B. M. · Qadan · M.
Objective

To describe the relationship between long-term weight loss (LTWL) success and lifestyle behaviours among US adults.

Design

Serial cross-sectional data from National Health and Nutrition Examination Survey cycles 2007–2014.

Setting and participants

Population-based nationally representative sample. The analytic sample included 3040 adults aged 20–64 years who tried to lose weight in the past year.

Measures

Participants were grouped into five LTWL categories (

Results

Individuals in the 15%–19.9% LTWL group differed significantly from the reference group (

Conclusion

Among a national sample of adults, a higher level of LTWL success does not necessarily equate to healthy weight loss behaviours. Future research should attempt to design interventions aimed at facilitating weight loss success while encouraging healthy lifestyle behaviours.

National cross-sectional survey of 1.14 million NHS staff SARS-CoV-2 serology tests: a comparison of NHS staff with regional community seroconversion rates

Por: Coltart · C. E. M. · Wells · D. · Sutherland · E. · Fowler · A.
Objectives

An initial report of findings from 1.14 million SARS CoV-2 serology tests in National Health Service (NHS) staff to compare NHS staff seroconversion with community seroconversion rates at a regional level.

Design

A national cross-sectional survey.

Setting

A SARS-CoV-2 antibody testing programme offered across all NHS Trusts.

Participants

1.14 million NHS staff.

Intervention

SARS-CoV-2 antibody testing.

Primary and secondary outcome measures

SARS-CoV-2 antibody testing was used to estimate the seroprevalence of SARS-CoV-2 in NHS staff by region, compared with community seroprevalence as determined by the COVID-19 Infection Survey (Office for National Statistics). We also explored seroprevalence trends by regional COVID-19 activity, using regional death rates as a proxy for COVID-19 ‘activity’.

Results

1 146 310 tests were undertaken on NHS staff between 26 May and 31 August 2020. 186 897 NHS tests were positive giving a seroconversion rate of 16.3% (95% CI 16.2% to 16.4%), in contrast to the national community seroconversion rate of 5.9% (95% CI 5.3% to 6.6%). There was significant geographical regional variation, which mirrored the trends seen in community prevalence rates. NHS staff were infected at a higher rate than the general population (OR 3.1, 95% CI 2.8 to 3.5). NHS seroconversion by regional death rate suggested a trend towards higher seroconversion rates in the areas with higher COVID-19 ‘activity’.

Conclusions

This is the first cross-sectional survey assessing the risk of COVID-19 disease in healthcare workers at a national level. It is the largest study of its kind. It suggests that NHS staff have a significantly higher rate of COVID-19 seroconversion compared with the general population in England, with regional variation across the country which matches the background population prevalence trends. There was also a trend towards higher seroconversion rates in areas which had experienced high COVID-19 clinical activity. This work has global significance in terms of the value of such a testing programme and contributing to the understanding of healthcare worker seroconversion at a national level.

Decision aids for female BRCA mutation carriers: a scoping review protocol

Por: McGarrigle · S. A. · Prizeman · G. · Spillane · C. · Byrne · N. · Drury · A. · Mockler · D. · Connolly · E. M. · Brady · A.-M. · Hanhauser · Y. P.
Introduction

Women who inherit a pathogenic mutation in Breast Cancer Susceptibility Genes 1 or 2 (BRCA1 or BRCA2) are at substantially higher risk of developing breast and ovarian cancer than the average woman. Several cancer risk management strategies exist to address this increased risk. Decisions about which risk management strategies to choose are complex, personal and multifactorial for these women. This scoping review will map evidence relevant to cancer risk management decision making in BRCA mutation carriers without a personal history of cancer. The objective is to identify and describe the features of patient decision aids that have been developed for BRCA mutation carriers. This information may be beneficial for designing new decision aids or adapting existing decision aids to support decision making in this population.

Methods and analysis

This scoping review will be conducted according to the Joanna Briggs Institute’s scoping review methodological framework. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist will be used for guidance. Studies on decision aids for women with a BRCA mutation who are unaffected by breast or ovarian cancer will be considered for inclusion. Five electronic databases will be searched (MEDLINE, EMBASE, Cochrane Library, CINAHL, Web of Science) with no restrictions applied for language or publication date. Studies for inclusion will be selected independently by two review authors. Data will be extracted using a predefined data extraction form. Findings will be presented in tabular form. A narrative description of the evidence will complement the tabulated results.

Ethics and dissemination

Ethical approval for conducting this scoping review is not required as this study will involve secondary analysis of existing literature. Findings will be published in a peer-reviewed journal and presented at relevant conferences.

The Cedar Project: exploring the role of colonial harms and childhood maltreatment on HIV and hepatitis C infection in a cohort study involving young Indigenous people who use drugs in two Canadian cities

Por: Pearce · M. E. · Jongbloed · K. · Pooyak · S. · Christian · W. M. · Teegee · M. G. M. · Caron · N. R. · Thomas · V. · Henderson · E. · Zamar · D. · Yoshida · E. M. · Schechter · M. T. · Spittal · P. M.
Objectives

This study examined associations between childhood maltreatment, colonial harms and sex/drug-related risks for HIV and hepatitis C virus (HCV) infection among young Indigenous people who use drugs.

Design

The Cedar Project is a cohort involving young Indigenous people who use drugs in British Columbia (BC), Canada. Indigenous collaborators, collectively known as the Cedar Project Partnership, govern the entire research process.

Setting

Vancouver is a large city on the traditional territory of the Coast Salish peoples. Prince George is a mid-sized city, on the traditional territory of Lheidli T’enneh First Nation.

Participants

420 participants completed the Childhood Trauma Questionnaire and returned for follow-up from 2003 to 2016.

Primary/secondary outcome measures

Primary outcomes were HIV and HCV infection over the study period. Secondary outcomes included sex and substance use-related risks.

Results

Prevalence of childhood maltreatment was 92.6% experienced any maltreatment; 73.4% experienced emotional abuse; 62.6% experienced physical abuse; 60.3% experienced sexual abuse; 69.5% experienced emotional neglect and 79.1% experienced physical neglect. We observed significant associations between childhood maltreatment and apprehensions into residential schools and foster care. All maltreatment types were associated with higher odds of sex/substance use-related risks; sexual abuse was associated with higher odds of HCV infection (adjusted OR: 1.67; 95% CI 1.05 to 2.66; p=0.031).

Conclusions

Findings reflect high prevalence of childhood maltreatment and their associations with HIV/HCV risk and HCV infection. Public health prevention and treatment initiatives must be trauma informed and culturally safe to support healing, health, and well-being.

Nurses and Midwives as Global Partners to Achieve the Sustainable Development Goals in the Anthropocene

Abstract

Purpose

To highlight ongoing and emergent roles of nurses and midwives in advancing the United Nations 17 Sustainable Development Goals by 2030 at the intersection of social and economic inequity, the climate crisis, interprofessional partnership building, and the rising status and visibility of the professions worldwide.

Design

Discussion paper.

Methods

Literature review.

Findings

Realizing the Sustainable Development Goals will require all nurses and midwives to leverage their roles and responsibility as advocates, leaders, clinicians, scholars, and full partners with multidisciplinary actors and sectors across health systems.

Conclusions

Making measurable progress toward the Sustainable Development Goals is critical to human survival, as well as the survival of the planet. Nurses and midwives play an integral part of this agenda at local and global levels.

Clinical Relevance

Nurses and midwives can integrate the targets of the Sustainable Development Goals into their everyday clinical work in various contexts and settings. With increased attention to social justice, environmental health, and partnership building, they can achieve exemplary clinical outcomes directly while contributing to the United Nations 2030 Agenda on a global scale and raising the profile of their professions.

Postoperative healing in the diabetic foot is impacted by discharge destination

Abstract

The aim of this study was to evaluate the impact of discharge destination on diabetes-related limb salvage surgery outcomes post-hospitalisation. This was a single-centre, observational, descriptive study of 175 subjects with diabetes who underwent limb salvage surgery of a minor foot amputation or wide incision and debridement for an acutely infected diabetic foot ulcer (DFU). Comparisons were made between subjects discharged home vs a skilled nursing facility (SNF) for 12 months postoperatively. Univariate, multivariate, and time-to-event analyses were performed. The SNF discharge group (n = 40) had worse outcomes with longer healing time (P = .022), more rehospitalisations requiring a podiatry consult (P = .009), increase of subsequent ipsilateral major lower-extremity amputation (P = .028), and a higher mortality rate (P = .012) within the 12-month postoperative period. There was no significant difference between the cohorts in surgically cleared osteomyelitis (P = .8434). The Charlson Comorbidity Index values for those discharged home and those in a short-term nursing facility were similar (P = .3819; home =5.33 ± 2.84 vs SNF =5.75 ± 2.06). The planned discharge destination after limb salvage surgery among people with an acutely infected DFU should be an added risk factor for healing outcomes. Patients discharged to SNFs experience additional morbidity and mortality compared with patients discharged home post-hospitalisation.

Assessment of a recombinant protein from <i>Leishmania infantum</i> as a novel tool for Visceral Leishmaniasis (VL) diagnosis in VL/HIV co-infection cases

by Rhaíssa E. M. Ramos, Wagner J. T. Santos, Franklin B. Magalhães, George T. N. Diniz, Carlos H. N. Costa, Osvaldo P. de Melo Neto, Zulma M. Medeiros, Christian R. S. Reis

Visceral Leishmaniasis and HIV-AIDS coinfection (VL/HIV) is considered a life-threatening pathology when undiagnosed and untreated, due to the immunosuppression caused by both diseases. Serological tests largely used for the VL diagnosis include the direct agglutination test (DAT), ELISA and immunochromatographic (ICT) assays. For VL diagnosis in HIV infections, different studies have shown that the use of the DAT assay facilitates the VL diagnosis in co-infected patients, since the performance of the most widely used ELISA and ICT tests, based on the recombinant protein rK39, are much less efficient in HIV co-infections. In this scenario, alternative recombinant antigens may help the development of new serological diagnostic methods which may improve the VL diagnosis for the co-infection cases. This work aimed to evaluate the use of the recombinant Lci2 antigen, related to, but antigenically more diverse than rK39, for VL diagnosis in co-infected sera through ELISA assays. A direct comparison between recombinant Lci2 and rK39 was thus carried out. The two proteins were first tested using indirect ELISA with sera from VL afflicted individuals and healthy controls, with similar performances. They were then tested with two different sets of VL/HIV co-infected cases and a significant drop in performance, for one of these groups, was observed for rK39 (32% sensitivity), but not for Lci2 (98% sensitivity). In fact, an almost perfect agreement (Kappa: 0.93) between the Lci2 ELISA and DAT was observed for the coinfected VL/HIV patients. Lci2 then has the potential to be used as a new tool for the VL diagnosis of VL/HIV co-infections.

Clinical debriefing: A concept analysis

Abstract

Aims and objectives

The purpose of this paper is to enhance nursing and collaborative practice by presenting a concept analysis of clinical debriefing and introducing an operational definition.

Background

Debriefing has taken many forms, using a variety of approaches. Variations and inconsistencies in clinical debriefing, and its related terms, still exist in the clinical setting.

Design

Concept analysis.

Methods

Walker and Avant's eight‐step approach to concept analysis.

Results

The defining attributes of clinical debriefing identified in this analysis are described as the five E’s: educated/experienced facilitator, environment, education, evaluation and emotions. Antecedents identified in this analysis include the critical event, the desire or need to review such an event and the organizational awareness to execute clinical debriefs. The consequences of clinical debriefings are primarily advantageous and positively impact involved nurses, healthcare teams, patients and organizations. Empirical referents of clinical debriefing are complex and multifactorial. The productivity of a clinical debrief can be enhanced through a series of proposed questions. Together, the defining attributes, antecedents and consequences shape a proposed operational definition of clinical debriefing.

Conclusion

Clinical debriefing is a valuable tool within healthcare organizations. Debriefing can be a holistic, interprofessional, collaborative experience when all five defining attributes are present. Further investigation is required to standardise debriefing practices in clinical settings.

Relevance to clinical practice

A concept analysis on clinical debriefing promotes uniformity of debriefing practices, reflective practice among nurses and healthcare teams, and contributes to nursing science by creating a platform for the development of practice standards, research and theory development.

Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial: a qualitative study based on the theoretical domains framework

Por: Lawrie · L. · Duncan · E. M. · Dunsmore · J. · Newlands · R. · Gillies · K.
Objectives

To identify barriers and enablers to participant retention in trials requiring questionnaire return using the theoretical domains framework (TDF).

Study design and setting

We identified and subsequently invited participants who did not return at least one questionnaire during their participation in a clinical trial for one-to-one semi-structured telephone interviews. We used a behavioural framework (TDF) to explore whether any of the behavioural domains (eg, beliefs about consequences, emotion) affected questionnaire return. Thereafter, we generated a series of belief statements which summarised the content of participants’ main responses and coded these under separate themes.

Participants

We distributed invites to 279 eligible individuals and subsequently interviewed 9 participants who took part in the C-Gall trial. The C-Gall trial required participants to complete five postal questionnaires during their participation.

Results

Nine participants were interviewed. We developed 7 overarching themes which were relevant for returning postal questionnaires and identified both barriers and enablers from 11 core domains: knowledge; beliefs about consequences; environmental context and resources; reinforcement; emotion; beliefs about capabilities; behavioural regulation; social professional role and identity; skills; intentions and goals. Relevant content coded under these salient domains were categorised into seven key themes: unclear expectations of trial participation, personal attributes for questionnaire return, commitment to returning questionnaires given other priorities, sources of support in returning the questionnaires, individual preferences for presentation mode and timing of the questionnaires, internal and external strategies to encourage questionnaire return and the significance of questionnaire non-return.

Conclusion

We demonstrate how a behavioural approach may be useful for clinical trials associated with significant participation burden (e.g. trials that require multiple questionnaire responses), acting as the essential groundwork for the development of appropriate evidence-based solutions to combat retention issues.

Trial registration number

55215960; Pre-results.

Effects of the COVID-19 pandemic on the sexual and mental health of adolescent and adult men who have sex with men and transgender women participating in two PrEP cohort studies in Brazil: COBra study protocol

Por: Ferraz · D. · Dourado · I. · Zucchi · E. M. · Mabire · X. · Magno · L. · Grangeiro · A. D. · Couto · M. T. · Ferguson · L. · Westin · M. · Alves dos Santos · L. · Preau · M.
Introduction

The COVID-19 pandemic and its control measures have impacted health and healthcare provision in various levels. Physical distancing measures, for instance, may affect sexual health, impacting access to HIV prevention supplies and changing sexual behaviour, as well as mental health, increasing feelings of unsafety and weakening community support ties. These effects can be worsened among socially marginalised groups, such as men who have sex with men (MSM) and transgender women (TGW). Brazil is among the countries most affected by COVID-19 in the world, where control measures have been inconsistently implemented. We aim to investigate the effects of the COVID-19 pandemic on the sexual and mental health of adolescent and adult MSM and TGW in Brazil.

Methods

Convergent mixed-method prospective cohort study, nested in two ongoing HIV pre-exposure prophylaxis (PrEP) cohorts in Brazil, named PrEP1519 and Combina. Participants will be invited to answer, at baseline and after 6 months, a questionnaire about the effects of the COVID-19 pandemic on sexual behaviour, HIV prevention and mental health. Data on HIV infection and sexually transmitted infections (STI) will be collected as part of routine follow-up from the cohorts. Main outcome measures (HIV infection, STI and depression symptoms) will be observed within 12 months after baseline. Sample size is estimated at 426 participants. Complementarily, 50 participants will be invited to in-depth interviews through video calls or interactive voice response, and 20 will be invited to chronicle their lives during the pandemic through digital diaries. Triangulation will be done across qualitative methods and with the quantitative data.

Ethics and dissemination

The study was approved by Research Ethics Committees from the Brazilian Universities coordinating the study. Findings will be published in scientific journals and presented at meetings. Informative flyers will be elaborated to communicate study findings to participants and key stakeholders.

Feasibility of continuous monitoring of vital signs in surgical patients on a general ward: an observational cohort study

Por: Leenen · J. P. L. · Dijkman · E. M. · van Dijk · J. D. · van Westreenen · H. L. · Kalkman · C. · Schoonhoven · L. · Patijn · G. A.
Objective

To determine feasibility, in terms of acceptability and system fidelity, of continuous vital signs monitoring in abdominal surgery patients on a general ward.

Design

Observational cohort study.

Setting

Tertiary teaching hospital.

Participants

Postoperative abdominal surgical patients (n=30) and nurses (n=23).

Interventions

Patients were continuously monitored with the SensiumVitals wearable device until discharge in addition to usual care, which is intermittent Modified Early Warning Score measurements. Heart rate, respiratory rate and axillary temperature were monitored every 2 min. Values and trends were visualised and alerts sent to the nurses.

Outcomes

System fidelity was measured by analysis of the monitoring data. Acceptability by patients and nurses was assessed using questionnaires.

Results

Thirty patients were monitored for a median duration of 81 hours (IQR 47–143) per patient, resulting in 115 217 measurements per parameter. In total, 19% (n=21 311) of heart rate, 51% (n=59 184) of respiratory rate and 9% of temperature measurements showed artefacts (n=10 269). The system algorithm sent 972 alerts (median alert rate of 4.5 per patient per day), of which 90.3% (n=878) were system alerts and 9.7% (n=94) were vital sign alerts. 35% (n=33) of vital sign alerts were true positives. 93% (n=25) of patients rated the patch as comfortable, 67% (n=18) felt safer and 89% (n=24) would like to wear it next time in the hospital. Nurses were neutral about usefulness, with a median score of 3.5 (IQR 3.1–4) on a 7-point Likert scale, ease of use 3.7 (IQR 3.2–4.8) and satisfaction 3.7 (IQR 3.2–4.8), but agreed on ease of learning at 5.0 (IQR 4.0–5.8). Neutral scores were mostly related to the perceived limited fidelity of the system.

Conclusions

Continuous monitoring of vital signs with a wearable device was well accepted by patients. Nurses’ ratings were highly variable, resulting in on average neutral attitude towards remote monitoring. Our results suggest it is feasible to monitor vital signs continuously on general wards, although acceptability of the device among nurses needs further improvement.

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally--Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study

Por: Kumaran · K. · Krishnaveni · G. V. · Suryanarayana · K. G. · Prasad · M. P. · Belavendra · A. · Atkinson · S. · Balasubramaniam · R. · Bandsma · R. H. J. · Bhutta · Z. A. · Chandak · G. R. · Comelli · E. M. · Davidge · S. T. · Dennis · C.-L. · Hammond · G. L. · Jha · P. · Joseph · K.
Introduction

The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.

Methods and analysis

The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.

The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.

An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.

Ethics and dissemination

The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.

Trial registration number

ISRCTN20161479, CTRI/2020/12/030134; Pre-results.

Effects of mechanical interventions in the management of knee osteoarthritis: protocol for an OA Trial Bank systematic review and individual participant data meta-analysis

Por: Macri · E. M. · Callaghan · M. · van Middelkoop · M. · Hattle · M. · Bierma-Zeinstra · S. M. A.
Introduction

Knee osteoarthritis (OA) is a prevalent and disabling musculoskeletal condition. Biomechanical factors may play a key role in the aetiology of knee OA, therefore, a broad class of interventions involves the application or wear of devices designed to mechanically support knees with OA. These include gait aids, bracing, taping, orthotics and footwear. The literature regarding efficacy of mechanical interventions has been conflicting or inconclusive, and this may be because certain subgroups with knee OA respond better to mechanical interventions. Our primary aim is to identify subgroups with knee OA who respond favourably to mechanical interventions.

Methods and analysis

We will conduct a systematic review to identify randomised clinical trials of any mechanical intervention for the treatment of knee OA. We will invite lead authors of eligible studies to share individual participant data (IPD). We will perform an IPD meta-analysis for each type of mechanical intervention to evaluate efficacy, with our main outcome being pain. Where IPD are not available, this will be achieved using aggregate data. We will then evaluate five potential treatment effect modifiers using a two-stage approach. If data permit, we will also evaluate whether biomechanics mediate the effects of mechanical interventions on pain in knee OA.

Ethics and dissemination

No new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publication in peer-reviewed journals and summaries posted on websites serving the public and clinicians.

PROSPERO registration number

CRD42020155466.

Development and psychometric evaluation of a Positive Health measurement scale: a factor analysis study based on a Dutch population

Objectives

The My Positive Health (MPH) dialogue tool is increasingly adopted by healthcare professionals in the Netherlands as well as abroad to support people in their health. Given this trend, the need arises to measure effects of interventions on the Positive Health dimensions. However, the dialogue tool was not developed for this purpose. Therefore, this study aims to work towards a suitable measurement scale using the MPH dialogue tool as starting point.

Design

A cross-sectional study design.

Participants and settings

A total of 708 respondents, who were all members of the municipal health service panel in the eastern part of the Netherlands, completed the MPH dialogue tool.

Methods

The factor structure of the MPH dialogue tool was explored through exploratory factor analysis using maximum likelihood extraction. Next, the fit of the extracted factor structure was tested through confirmatory factor analysis. Reliability and discriminant validity of both a new model and the MPH scales were assessed through Cronbach’s alpha tests.

Results

Similar to the MPH dialogue tool, the extracted 17-item model has a six-factor structure but named differently, comprising the factors physical fitness, mental functions, future perspectives, contentment, social relations and health management. The reliability tests suggest good to very good reliability of the aimed measurement tool and MPH model (Cronbach’s alpha values ranging from, respectively, 0.820 to 0.920 and 0.882 to 0.933). The measurement model shows acceptable discriminant validity, whereas the MPH model suggests overlap between domains.

Conclusion

The results suggest that the current MPH dialogue tool seems reliable as a dialogue, but it is not suitable as a measurement scale. We therefore propose a 17-item model with improved, acceptable psychometric properties which can serve as a basis for further development of a measurement scale.

Critical appraisal and issues regarding generalisability of comparative effectiveness studies of NOACs in atrial fibrillation and their relation to clinical trial data: a systematic review

Por: Bunge · E. M. · van Hout · B. · Haas · S. · Spentzouris · G. · Cohen · A.
Objective

To critically appraise the published comparative effectiveness studies on non-vitamin K antagonist oral anticoagulants (NOACs) in non-valvular atrial fibrillation (NVAF). Results were compared with expectations formulated on the basis of trial results with specific attention to the patient years in each study.

Methods

All studies that compared the effectiveness or safety between at least two NOACs in patients with NVAF were eligible. We performed a systematic literature review in Medline and EMbase to investigate the way comparisons between NOACs were made, search date 23 April 2019. Critical appraisal of the studies was done using among others ISPOR Good Research Practices for comparative effectiveness research.

Results

We included 39 studies in which direct comparison between at least two NOACs were made. Almost all studies concerned patient registries, pharmacy or prescription databases and/or health insurance database studies using a cohort design. Corrections for differences in patient characteristics was applied in all but two studies. Eighteen studies matched using propensity scores (PS), 8 studies weighted patients based on the inverse probability of treatment, 1 study used PS stratification and 10 studies applied a proportional hazards model. These studies have some important limitations regarding unmeasured confounders and channelling bias, even though the larger part of the studies were well conducted technically. On the basis of trial results, expected differences are small and a naïve analysis suggests trials with between 7200 and 56 500 patients are needed to confirm the observed differences in bleedings and between 51 800 and 7 994 300 to confirm differences in efficacy.

Discussion

Comparisons regarding effectiveness and safety between NOACs on the basis of observational data, even after correction for baseline characteristics, may not be reliable due to unmeasured confounders, channelling bias and insufficient sample size. These limitations should be kept in mind when results of these studies are used to decide on ranking NOAC treatment options.

Influence of prior comorbidities and chronic medications use on the risk of COVID-19 in adults: a population-based cohort study in Tarragona, Spain

Objective

To investigate possible relationships between pre-existing medical conditions (including common comorbidities and chronic medications) and risk for suffering COVID-19 disease in middle-aged and older adults.

Design

Population-based retrospective cohort study.

Setting

Twelve primary care centres (PCCs) in Tarragona (Spain).

Participants

79 083 people (77 676 community-dwelling and 1407 nursing-home residents), who were all individuals aged >50 years affiliated to the 12 participating PCCs.

Outcomes

Baseline cohort characteristics (age, sex, vaccinations, comorbidities and chronic medications) were established at study start (1st. March 2020) and primary outcome was time to COVID-19 confirmed by PCR among cohort members throughout the epidemic period (from 1st. March 2020 to 23rd. May 2020). Risk for suffering COVID-19 was evaluated by Cox regression, estimating multivariable HRs adjusted for age, sex, comorbidities and medications use.

Results

During the study period, 2324 cohort members were PCR-tested, with 1944 negative and 380 positive results, which means an incidence of 480.5 PCR-confirmed COVID-19 cases per 100 000 persons-period. Assessing the total study cohort, only age (HR 1.02; 95% CI 1.01 to 1.03; p=0.002), nursing-home residence (HR 21.83; 95% CI 16.66 to 28.61; p

Conclusion

Age, nursing-home residence and multiple comorbidities appear predisposing for COVID-19. Conversely, receiving ACE inhibitors, antihistamine and influenza vaccination could be protective, which should be closely investigated in further studies specifically focused on these concerns.

Phase I/II study protocol to assess safety and efficacy of adoptive cell therapy with anti-PD-1 plus low-dose pegylated-interferon-alpha in patients with metastatic melanoma refractory to standard of care treatments: the ACTME trial

Por: van der Kooij · M. K. · Verdegaal · E. M. E. · Visser · M. · de Bruin · L. · van der Minne · C. E. · Meij · P. M. · Roozen · I. C. F. M. · Jonker · M. A. · van den Bosch · S. · Liefers · G.-J. · Speetjens · F. M. · van der Burg · S. H. · Kapiteijn · E.
Introduction

Treatment with anti-PD-1 immunotherapy does not lead to long-lasting clinical responses in approximately 60% of patients with metastatic melanoma. These refractory patients, however, can still respond to treatment with tumour infiltrating lymphocytes (TIL) and interferon-alpha (IFNa). A combination of TIL, pegylated-interferon-alpha (PEG-IFNa) and anti-PD-1 is expected to provide a safe, feasible and effective therapy for patients with metastatic melanoma, who are refractory to standard of care treatment options.

Methods and analysis

Patients are treated in two phases. In phase I, the safety of the combination TIL and anti-PD-1 is assessed (cohort 1) according to CTCAE 4.03 criteria. Subsequently, the safety of cotreatment with PEG-IFNa is tested in cohort 2. The efficacy will be evaluated in the second phase of the trial. Efficacy is evaluated according to RECIST 1.1 and immune-related response criteria. Clinical and immunological parameters will be evaluated for their relation with clinical responsiveness.

Ethics and dissemination

Ethical approval of the trial was obtained from the Central Committee on Research Involving Human Subjects in the Netherlands. The trial results will be shared with the scientific community at (inter)national conferences and by publication in a peer-reviewed journal.

Trial registration number

NCT03638375; Pre-results.

Evaluating the impact of the Bolsa Familia conditional cash transfer program on premature cardiovascular and all-cause mortality using the 100 million Brazilian cohort: a natural experiment study protocol

Por: Pescarini · J. M. · Craig · P. · Allik · M. · Amorim · L. · Ali · S. · Smeeth · L. · Barreto · M. L. · Leyland · A. H. · Aquino · E. M. L. · Katikireddi · S. V.
Introduction

Brazil’s Bolsa Familia Program (BFP) is the world’s largest conditional cash transfer scheme. We shall use a large cohort of applicants for different social programmes to evaluate the effect of BFP receipt on premature all-cause and cardiovascular mortality.

Methods and analysis

We will identify BFP recipients and non-recipients among new applicants from 2004 to 2015 in the 100 Million Brazilian Cohort, a database of 114 million individuals containing sociodemographic and mortality information of applicants to any Brazilian social programme. For individuals applying from 2011, when we have better recorded income data, we shall compare premature (age 30–69) cardiovascular and all-cause mortality among BFP recipients and non-recipients using regression discontinuity design (RDD) with household monthly per capita income as the forcing variable. Effects will be estimated using survival models accounting for individuals follow-up. To test the sensitivity of our findings, we will estimate models with different bandwidths, include potential confounders as covariates in the survival models, and restrict our data to locations with the most reliable data. In addition, we will estimate the effect of BFP on studied outcomes using propensity score risk-set matching, separately for individuals that applied ≤2010 and >2011, allowing comparability with RDD. Analyses will be stratified by geographical region, gender, race/ethnicity and socioeconomic position. We will investigate differential impacts of BFP and the presence of effect modification for a combination of characteristics, including gender and race/ethnicity.

Ethics and dissemination

The study was approved by the ethics committees of Oswaldo Cruz Foundation and the University of Glasgow College of Medicine and Veterinary Life Sciences. The deidentified dataset will be provided to researchers, and data analysis will be performed in a safe computational environment without internet access. Study findings will be published in high quality peer-reviewed research articles. The published results will be disseminated in the social media and to policy-makers.

Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study

Por: Boudewijns · E. A. · Claessens · D. · Joore · M. · Keijsers · L. C. E. M. · van Schayck · O. C. P. · Winkens · B. · Gidding-Slok · A. H. M.
Introduction

The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure.

Methods and analysis

The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients’ activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models.

Ethics and dissemination

Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences.

Trial registration number

ClinicalTrials.gov Registry (NCT04127383).

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