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Ku-gaa-gii pimitizi-win, the COVID-19 cohort study of people experiencing homelessness in Toronto, Canada: a study protocol

Por: Richard · L. · Nisenbaum · R. · Liu · M. · McGeer · A. · Mishra · S. · Gingras · A.-C. · Gommerman · J. L. · Sniderman · R. · Pedersen · C. · Spandier · O. · Jenkinson · J. I. R. · Baral · S. · Mejia-Lancheros · C. · Agarwal · A. · Jamal · A. J. · Ostrowski · M. · Dhalla · I. · Stewart
Introduction

Initial reports suggest people experiencing homelessness (PEH) are at high risk for SARS-CoV-2 infection and associated morbidity and mortality. However, there have been few longitudinal evaluations of the spread and impact of COVID-19 among PEH. This study will estimate the prevalence and incidence of COVID-19 infections in a cohort of PEH followed prospectively in Toronto, Canada. It will also examine associations between individual-level and shelter-level characteristics with COVID-19 infection, adverse health outcomes related to infection and vaccination. Finally, the data will be used to develop and parameterise a mathematical model to characterise SARS-CoV-2 transmission dynamics, and the transmission impact of interventions serving PEH.

Design, methods and analysis

Ku-gaa-gii pimitizi-win will follow a random sample of PEH from across Toronto (Canada) for 12 months. 736 participants were enrolled between June and September 2021, and will be followed up at 3-month intervals. At each interval, specimens (saliva, capillary blood) will be collected to determine active SARS-CoV-2 infection and serologic evidence of past infection and/or vaccination, and a detailed survey will gather self-reported information, including a detailed housing history. To examine the association between individual-level and shelter-level characteristics on COVID-19-related infection, adverse outcomes, and vaccination, shelter and healthcare administrative data will be linked to participant study data. Healthcare administrative data will also be used to examine long-term (up to 5 years) COVID-19-related outcomes among participants.

Ethics and dissemination

Ethical approval was obtained from the Unity Health Toronto and University of Toronto Health Sciences Research Ethics Boards (# 20-272). Ku-gaa-gii pimitizi-win was designed in collaboration with community and service provider partners and people having lived experience of homelessness. Findings will be reported to groups supporting Ku-gaa-gii pimitizi-win, Indigenous and other community partners and service providers, funding bodies, public health agencies and all levels of government to inform policy and public health programs.

Empowering interventions for people living with dementia: A European survey

Abstract

Aims

We aim to identify existing empowerment interventions for people living with dementia and to explore which used interventions and projects are considered empowering and why.

Design

This was an online survey.

Methods

We conducted an online survey between May 2018 and July 2018 amongst professionals interested in dementia care in Europe. Interventions were clustered within the ecological model for health promotion. Reasons from respondents as to why they considered interventions to be empowering were analysed and structured according to a recently developed conceptual framework of empowerment for people living with dementia.

Results

Seventy-three respondents from 23 countries together mentioned 98 interventions or projects, of which 90 were unique. Interventions focused on the (inter)personal (n = 54), organizational (n = 15), communal (n = 6) and societal (n = 15) levels. A broad range of interventions were considered empowering, but no interventions were specifically developed for, nor aimed at, empowerment. Reasons as to why respondents considered these interventions as empowering fitted the framework's domains.

Conclusion

This European survey provides insights into interventions considered empowering for people living with dementia. An important step that needs to be taken is to develop and test interventions that specifically aim to promote empowerment for people living with dementia.

Impact

Empowerment may encourage people with dementia to live the life they choose, and focus on what is possible, instead of what is no longer possible. Many interventions are considered as empowering for people living with dementia, however no interventions could be identified that were specifically developed for or aimed at empowerment. This study shows that for promoting empowerment, it is necessary to develop and test interventions that specifically aim for empowerment, do this in collaboration with relevant stakeholders, and in this way support people living with dementia to live according to their competencies, talents and wishes.

Cohort profile: the multigeneration Respiratory Health in Northern Europe, Spain and Australia (RHINESSA) cohort

Por: Svanes · C. · Johannessen · A. · Bertelsen · R. J. · Dharmage · S. · Benediktsdottir · B. · Brabäck · L. · Gislason · T. · Holm · M. · Jogi · O. · Lodge · C. J. · Malinovschi · A. · Martinez-Moratalla · J. · Oudin · A. · Sanchez-Ramos · J. L. · Timm · S. · Janson · C. · Real · F. G.
Purpose

The Respiratory Health in Northern Europe, Spain and Australia (RHINESSA) cohort was established to (1) investigate how exposures before conception and in previous generations influence health and disease, particularly allergies and respiratory health, (2) identify susceptible time windows and (3) explore underlying mechanisms. The ultimate aim is to facilitate efficient intervention strategies targeting multiple generations.

Participants

RHINESSA includes study participants of multiple generations from ten study centres in Norway (1), Denmark (1), Sweden (3), Iceland (1), Estonia (1), Spain (2) and Australia (1). The RHINESSA core cohort, adult offspring generation 3 (G3), was first investigated in 2014–17 in a questionnaire study (N=8818, age 18–53 years) and a clinical study (subsample, n=1405). Their G2 parents participated in the population-based cohorts, European Community Respiratory Heath Survey and Respiratory Health In Northern Europe, followed since the early 1990s when they were 20–44 years old, at 8–10 years intervals. Study protocols are harmonised across generations.

Findings to date

Collected data include spirometry, skin prick tests, exhaled nitric oxide, anthropometrics, bioimpedance, blood pressure; questionnaire/interview data on respiratory/general/reproductive health, indoor/outdoor environment, smoking, occupation, general characteristics and lifestyle; biobanked blood, urine, gingival fluid, skin swabs; measured specific and total IgE, DNA methylation, sex hormones and oral microbiome. Research results suggest that parental environment years before conception, in particular, father’s exposures such as smoking and overweight, may be of key importance for asthma and lung function, and that there is an important susceptibility window in male prepuberty. Statistical analyses developed to approach causal inference suggest that these associations may be causal. DNA methylation studies suggest a mechanism for transfer of father’s exposures to offspring health and disease through impact on offspring DNA methylation.

Future plans

Follow-up is planned at 5–8 years intervals, first in 2021–2023. Linkage with health registries contributes to follow-up of the cohort.

Effects of tai chi and qigong on rehabilitation after COVID-19: a protocol for systematic review and meta-analysis

Por: Zhang · Z. · Ren · J. G. · Guo · J. L. · An · L. · Li · S. · Zhang · Z. C. · Chen · Y. · Liu · H. · Lei · X.
Introduction

COVID-19 is a public health emergency of international concern, which is characterised by rapid and widespread transmission, high mortality and complications. Several studies have shown the benefits of tai chi and qigong for recovery after COVID-19; however, no meta-analysis has been reported. Therefore, the purpose of this study is to evaluate the efficacy and safety of tai chi and/or qigong on rehabilitation after COVID-19 through a systematic review and meta-analysis to provide a reference and basis for clinical application.

Methods and analysis

This study will use the Cochrane Library, PubMed, Web of Science, Embase, China Knowledge Network, China Biomedical Literature Database, Chinese Scientific Journal Database and Wanfang Database. The time period is from the inception of the database to November 2021, with no language restrictions. Searches will be conducted using the subject terms "Taichi","Qigong" and "COVID-19" plus free-text words. Articles will be screened and collected by two reviewers independently. Included studies will be assessed for quality using the Cochrane Risk of Bias Assessment Tool. Statistical analyses will be performed using the Revman V.5.3 software. The primary outcomes include 1-second forced expiratory volume and 1-second forced vital capacity, oxygen saturation, total white cell count and quality of life score. Secondary outcomes include time to remission of major symptoms, incidence of adverse events, clinical cure rate and mortality. Subgroup and sensitivity analyses will also be used to explore and interpret the heterogeneity. This protocol is written based on the guideline of the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocol.

Ethics and dissemination

Ethical approval and consent are unnecessary because no primary data will be collected. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number

CRD42021288962.

'Bringing testing closer to you: barriers and facilitators in implementing HIV self-testing among Filipino men-having-sex-with-men and transgender women in National Capital Region (NCR), Philippines - a qualitative study

Por: Dinglasan · J. L. G. · Rosadino · J. D. T. · Pagtakhan · R. G. · Cruz · D. P. · Brines · M. T. · Regencia · Z. J. G. · Baja · E. S.
Objectives

Our study identified barriers and facilitators in implementing HIV self-testing (HIVST), including the perceptions of men-having-sex-with-men (MSM) and transgender women (TGW) on HIVST. Furthermore, we explored the current knowledge, practices and potential of HIVST among the MSM and TGW populations.

Design

Qualitative in-depth key informant interviews were administered using semistructured interviews administered in both English and Filipino. Thematic analysis of the findings was done after transcribing all audio recordings.

Setting

The study was done in the National Capital Region (NCR), Philippines using online video conferencing platforms due to mobility restrictions and lockdowns caused by the COVID-19 pandemic.

Participants

All study participants were either MSM or TGW, 18–49 years old and residing/working in NCR. Exclusion criteria include biologically born female and/or currently on pre-exposure prophylaxis, antiretroviral therapy medications or an HIV-positive diagnosis.

Results

Twenty informants were interviewed, of which 75% were MSM, and most of them preferred the use of HIVST. Facilitators and barriers to the use of HIVST were grouped into three main themes: Acceptability, distribution and monitoring and tracking. Convenience and confidentiality, overcoming fears and normalisation of HIV testing services (HTS) in the country were the participants’ perceived facilitators of HIVST. In contrast, lack of privacy and maintenance of confidentiality during kit delivery were perceived as barriers in HIVST implementation. Moreover, social media was recognised as a powerful tool in promoting HIVST. The use of a welcoming tone and positive language should be taken into consideration due to the prevalent HIV stigma.

Conclusions

The identified facilitators and barriers from the study may be considered by the Philippine HTS programme implementers. The HIVST strategy may complement the current HTS. It will be very promising to involve the MSM and TGW communities and other key populations to know their HIV status by bringing testing closer to them.

Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRE

Por: Morgano · G. P. · Mbuagbaw · L. · Santesso · N. · Xie · F. · Brozek · J. L. · Siebert · U. · Bognanni · A. · Wiercioch · W. · Piggott · T. · Darzi · A. J. · Akl · E. A. · Verstijnen · I. M. · Parmelli · E. · Saz-Parkinson · Z. · Alonso-Coello · P. · Schünemann · H. J.
Introduction

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) and similar Evidence to Decision (EtD) frameworks require its users to judge how substantial the effects of interventions are on desirable and undesirable people-important health outcomes. However, decision thresholds (DTs) that could help understand the magnitude of intervention effects and serve as reference for interpretation of findings are not yet available.

The objective of this study is an approach to derive and use DTs for EtD judgments about the magnitude of health benefits and harms. We hypothesise that approximate DTs could have the ability to discriminate between the existing four categories of EtD judgments (Trivial, Small, Moderate, Large), support panels of decision-makers in their work, and promote consistency and transparency in judgments.

Methods and analysis

We will conduct a methodological randomised controlled trial to collect the data that allow deriving the DTs. We will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, we will investigate the validity of our DTs by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that our DTs approach would suggest if applied on the same guideline data.

Ethics and dissemination

The Hamilton Integrated Research Ethics Board reviewed this study as a quality improvement study and determined that it requires no further consent. Survey participants will be required to read a consent statement in order to participate in this study at the beginning of the trial. This statement reads: You are being invited to participate in a research project which aims to identify indicative DTs that could assist users of the GRADE EtD frameworks in making judgments. Your input will be used in determining these indicative thresholds. By completing this survey, you provide consent that the anonymised data collected will be used for the research study and to be summarised in aggregate in publication and electronic tools.

PROTOCOL registration number

NCT05237635.

Understanding income-related differences in distribution of child growth, behaviour and development using a cross-sectional sample of a clinical cohort study

Objectives

Children from low-income households are at an increased risk of social, behavioural and physical health problems. Prior studies have generally relied on dichotomous outcome measures. However, inequities may exist along the range of outcome distribution. Our objective was to examine differences in distribution of three child health outcomes by income categories (high vs low): body mass index (BMI), behaviour difficulties and development.

Design and setting

This was a cross-sectional study using data from a primary care-based research network with sites in three Canadian cities, and 15 practices enrolling participants.

Participants, independent variable and outcomes

The independent variable was annual household income, dichotomised at the median income for Toronto (

Results

We included data from 1628 (zBMI), 649 (SDQ) and 1405 (ITC) children. Children with lower family income had a higher risk distribution for all outcomes. For all outcomes, thecounterfactual distribution, which represented the distribution of children with lower-income who were assigned the predictor profile of the higher-income group, was more favourable than their observed distributions.

Conclusion

Comparing the distributions of child health outcomes and understanding different risk profiles for children from higher-income and lower-income groups can offer a deeper understanding of inequities in child health outcomes. These methods may offer an approach that can be implemented in larger datasets to inform future interventions.

Effects of mHealth on the psychosocial health of pregnant women and mothers: a systematic review

Por: Sakamoto · J. L. · Carandang · R. R. · Kharel · M. · Shibanuma · A. · Yarotskaya · E. · Basargina · M. · Jimba · M.
Objective

To investigate the roles of mobile health, or mHealth, in the psychosocial health of pregnant women and mothers.

Methods

A systematic search was conducted in databases and grey literature including MEDLINE, Web of Science, CINAHL, PsycINFO, PsycARTICLES, Academic Search Complete, SocINDEX, Central Register of Controlled Trials, The Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database, Health Technology Assessment, UNICEF and WHO databases. Two searches were conducted to include original research articles published in English until 15 November 2021. Several tools were used to assess the risk of bias: revised Cochrane risk of bias tool for randomised trials, Risk of Bias in Non-randomized Studies of Interventions, National Heart, Lung, and Blood Institute quality assessment tool for cohort and cross-sectional studies, Critical Appraisal Skills Program checklist for qualitative studies and Mixed Methods Appraisal Tool for mixed-methods studies. Certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation approach. Due to the high heterogeneity and variability of the included studies, data synthesis was conducted narratively.

Results

44 studies were included among 11 999 identified articles. Most studies reported mixed findings on the roles of mHealth interventions in the psychosocial health of pregnant women and mothers; mHealth improved self-management, acceptance of pregnancy/motherhood and social support, while mixed results were observed for anxiety and depressive symptoms, perceived stress, mental well-being, coping and self-efficacy. Furthermore, pregnant women and mothers from vulnerable populations benefited from the use of mHealth to improve their psychosocial health.

Conclusions

The findings suggest that mHealth has the potential to improve self-management, acceptance of pregnancy/motherhood and social support. mHealth can also be a useful tool to reach vulnerable pregnant women and mothers with barriers to health information and facilitate access to healthcare services. However, the high heterogeneity limited the certainty of evidence of these findings. Therefore, future studies should identify the context under which mHealth could be more effective.

Assessing tobacco smoke exposure in pregnancy from self-report, urinary cotinine and NNAL: a validation study using the New Hampshire Birth Cohort Study

Por: Peacock · J. L. · Palys · T. J. · Halchenko · Y. · Sayarath · V. · Takigawa · C. A. · Murphy · S. E. · Peterson · L. A. · Baker · E. R. · Karagas · M. R.
Objectives

Accurate assessment of tobacco smoke exposure is key to evaluate its effects. We sought to validate and establish cut-offs for self-reported smoking and secondhand smoke (SHS) exposure during pregnancy using urinary cotinine and 4-(methylnitrosamino)-1-(-3-pyridyl)-1-butanol (NNAL) in a large contemporary prospective study from the USA, with lower smoking prevalence than has previously been evaluated.

Design

Prospective birth cohort.

Setting

Pregnancy clinics in New Hampshire and Vermont, USA.

Participants

1396 women enrolled in the New Hampshire Birth Cohort Study with self-reported smoking, urinary cotinine, NNAL and pregnancy outcomes.

Primary and secondary outcome measures

Cut-offs for urinary cotinine and NNAL concentrations were estimated from logistic regression models using Youden’s method to predict SHS and active smoking. Cotinine and NNAL were each used as the exposure in separate multifactorial models for pregnancy outcomes.

Results

Self-reported maternal smoking was: 72% non-smokers, 5.7% ex-smokers, 6.4% SHS exposure, 6.2% currently smoked, 10% unreported. Cotinine and NNAL levels were low and highly intercorrelated (r=0.91). Geometric mean cotinine, NNAL were 0.99 ng/mL, 0.05 pmol/mL, respectively. Cotinine cut-offs for SHS, current smoking were 1.2 ng/mL and 1.8 ng/mL (area under curve (AUC) 95% CI: 0.52 (0.47 to 0.57), 0.90 (0.85 to 0.94)). NNAL cut-off for current smoking was 0.09 pmol/mL (AUC=0.82 (95% CI 0.77 to 0.87)). Using cotinine and NNAL cut-offs combined gave similar AUC to cotinine alone, 0.87 (95% CI 0.82 to 0.91). Cotinine and NNAL gave almost identical effect estimates when modelling pregnancy outcomes.

Conclusions

In this population, we observed high concordance between self-complete questionnaire smoking data and urinary cotinine and NNAL. With respect to biomarkers, either cotinine or NNAL can be used as a measure of tobacco smoke exposure overall but only cotinine can be used to detect SHS.

Impact of the COVID-19 pandemic on vaccine coverage for early childhood vaccines in Alberta, Canada: a population-based retrospective cohort study

Por: MacDonald · S. E. · Paudel · Y. R. · Kiely · M. · Rafferty · E. · Sadarangani · M. · Robinson · J. L. · Driedger · S. M. · Svenson · L. W. · on behalf of the COVImm study team
Objective

To assess the impact of the COVID-19 pandemic on early childhood vaccination coverage in Alberta, Canada.

Setting

Alberta, a western Canadian province, which has a population of 4.4 million and approximately 50 000 births annually.

Design

In this retrospective cohort study, population-based administrative health data were analysed to determine the vaccination coverage for measles-containing, pertussis-containing and rotavirus vaccines.

Primary outcome measure

We measured monthly and cumulative vaccine coverage. We assessed the absolute difference in monthly and cumulative coverage for each vaccine dose by comparing children due for vaccination in each month of 2019 and 2020, with follow-up to determine if missed doses were caught up later.

Participants

We included 114 178 children in the 2019 analysis cohort and 106 530 children in the 2020 analysis cohort.

Results

Monthly vaccination coverage in 2020 was higher than 2019 until March, when coverage significantly declined. Comparing April 2020 to 2019, coverage was 9.9% (95% CI 7.9% to 12.0%) lower for measles vaccine; 4.9% (95% CI 3.3% to 6.5%), 7.1% (95% CI 5.2% to 9.1%), 5.2% (95% CI 3.1% to 7.4%) and 8.8% (95% CI 6.6% to 10.9%) lower for first, second, third and fourth doses of pertussis-containing vaccine, respectively; and 4.0% (95% CI 2.3% to 5.7%), 7.1% (95% CI 5.1% to 9.2%) and 4.6% (95% CI 2.4% to 6.7%) lower for first, second and third doses of rotavirus vaccine, respectively. Monthly coverage improved during May to July 2020; however, some doses experienced a second decline during September to October 2020. The cumulative coverage analysis showed that the measles-containing vaccine had the largest difference in coverage at the end of follow-up.

Conclusions

Children who were due for vaccination early in the pandemic and in Fall 2020, especially those due for measles vaccination, may require additional catch-up.

Biological and clinical correlates of the patient health questionnaire-9: exploratory cross-sectional analyses of the baseline health study

Por: Califf · R. M. · Wong · C. · Doraiswamy · P. M. · Hong · D. S. · Miller · D. P. · Mega · J. L. · Baseline Study Group · Schilsky · Allen · Anderson · Anstrom · Araujo · Arges · Ardalan · Baldwin · Balu · Bashir · Bhapkar · Bigelow · Black · Blanco · Bloomfield · Borkar · Bouk · Boulw
Objectives

We assessed the relationship between the Patient Health Questionnaire-9 (PHQ-9) at intake and other measurements intended to assess biological factors, markers of disease and health status.

Design, setting and participants

We performed a cross-sectional analysis of 2365 participants from the Baseline Health Study, a prospective cohort of adults selected to represent major demographic groups in the USA. Participants underwent deep phenotyping on demographic, clinical, laboratory, functional and imaging findings.

Importance

Despite extensive research on the clinical implications of the PHQ-9, data are limited on the relationship between PHQ-9 scores and other measures of health and disease; we sought to better understand this relationship.

Interventions

None.

Main outcomes and measures

Cross-sectional measures of medical illnesses, gait, balance strength, activities of daily living, imaging and laboratory tests.

Results

Compared with lower PHQ-9 scores, higher scores were associated with female sex (46.9%–66.7%), younger participants (53.6–42.4 years) and compromised physical status (higher resting heart rates (65 vs 75 bpm), larger body mass index (26.5–30 kg/m2), greater waist circumference (91–96.5 cm)) and chronic conditions, including gastro-oesophageal reflux disease (13.2%–24.7%) and asthma (9.5%–20.4%) (p

Conclusions

Our study highlights how: (1) even subthreshold depressive symptoms (measured by PHQ-9) may be indicative of several individual- and population-level concerns that demand more attention; and (2) depression should be considered a comorbidity in common disease.

Trial registration number

NCT03154346.

How often will midwives and obstetricians experience obstetric emergencies or high-risk deliveries: a national cross-sectional study

Por: Hogh · S. · Thellesen · L. · Bergholt · T. · Rom · A. L. · Johansen · M. · Sorensen · J. L.
Objective

To estimate how often midwives, specialty trainees and doctors specialised in obstetrics and gynaecology are attending to specific obstetric emergencies or high-risk deliveries (obstetric events).

Design

A national cross-sectional study.

Setting

All hospital labour wards in Denmark.

Participants

Midwives (n=1303), specialty trainees (n=179) and doctors specialised in obstetrics and gynaecology (n=343) working in hospital labour wards (n=21) in Denmark in 2018.

Methods

Categories of obstetric events comprised of Apgar score

Outcome measures

The time interval between attending a specific obstetric event.

Results

The average time between experiencing obstetric events ranged from days to years. Emergency caesarean sections, which occur relatively frequent, were attended on average every other month by midwives, every 9 days for specialty trainees and every 17 days by specialist doctors. On average, rare events like eclampsia were experienced by midwives only every 42 years, every 6 years by specialty trainees and every 11 years by specialist doctors.

Conclusions

Some obstetric events occur extremely rarely, hindering the ability to obtain and maintain the clinical skills to manage them through clinical practice alone. By assessing the frequency of a healthcare professionals attending an obstetric emergency, our study contributes to assessing the need for supplementary educational initiatives and interventions to learn and maintain clinical skills.

Infertility-related distress and clinical targets for psychotherapy: a qualitative study

Por: Dube · L. · Nkosi-Mafutha · N. · Balsom · A. A. · Gordon · J. L.
Objectives

An estimated 30%–40% of women attending infertility tertiary care facilities experience clinically significant depression and anxiety. However, current psychological interventions for infertility are only modestly effective in this population. In this study, we aimed to identify the specific psychological components of infertility-related distress to assist in the development of a more targeted and effective therapeutic intervention. To our knowledge, this study is the first of its kind to include the views and opinions of mental health professionals who specialise in the field of infertility and the first to explore therapies currently used by mental health professionals.

Design

A qualitative approach using semistructured individual interviews and focus group interviews with women who have experience with infertility and also mental health professionals specialising in the field of infertility. Thematic analysis was used to identify patterns and themes emerging from the data.

Participants

Twenty-one women (aged 25–41 years) struggling to conceive for ≥12 months and 14 mental health professionals participated in semistructured interviews about the psychological challenges related to infertility.

Results

Five themes, each divided into subthemes, emerged from the data and these were developed into a model of infertility-related distress. These five themes are: (1) anxiety, (2) mood disturbance, (3) threat to self-esteem, identity and purpose, (4) deterioration of the couple and (5) weakened support network. In addition, therapeutic techniques used by mental health professionals were identified.

Conclusions

The results of this study suggest specific clinical targets that future interventions treating infertility-related distress should address.

Minimal clinically important difference in means in vulnerable populations: challenges and solutions

Por: Peacock · J. L. · Lo · J. · Rees · J. R. · Sauzet · O.
Introduction and motivation

Many health studies measure a continuous outcome and compare means between groups. Since means for biological data are often difficult to interpret clinically, it is common to dichotomise using a cut-point and present the ‘percentage abnormal’ alongside or in place of means. Examples include birthweight where ‘abnormal’ is defined as 140 mm Hg (high blood pressure) and lung function with varying definitions of the ‘limit of normal’. In vulnerable populations with low means, for example, birthweight in a population of preterm babies, a given difference in means between two groups will represent a larger difference in the percentage with low birthweight than in a general population of babies where most will be full term. Thus, in general, the difference in percentage of patients with abnormal values for a given difference in means varies according to the reference population’s mean value. This phenomenon leads to challenges in interpreting differences in means in vulnerable populations and in defining an outcome-specific minimal clinically important difference (MCID) in means since the proportion abnormal, which is useful in interpreting means, is not constant—it varies with the population mean. This has relevance for study power calculations and data analyses in vulnerable populations where a small observed difference in means may be difficult to interpret clinically and may be disregarded, even if associated with a relatively large difference in percentage abnormal which is clinically relevant.

Methods

To address these issues, we suggest both difference in means and difference in percentage (proportion) abnormal are considered when choosing the MCID, and that both means and percentages abnormal are reported when analysing the data.

Conclusions

We describe a distributional approach to analyse proportions classified as abnormal that avoids the usual loss of precision and power associated with dichotomisation.

Establishing best practices in cancer online support groups: protocol for a realist review

Por: Bender · J. L. · Babinski · S. · Wong · G. · Tricco · A. C. · Englesakis · M. · Cyr · A. B. · Potts · H. · Perski · O. · Esplen · M. J. · Young · C. · Wassersug · R. · Forster · V. · Papadakos · J. · Soobiah · C. · Fox · C. · Gothard-Huang · A. · Witteman · H.
Introduction

Considerable observational evidence suggests that cancer online support groups reduce feelings of isolation, depression and anxiety, enhance coping and self-management, and lead to better informed patients. Other studies indicate that cancer online support groups can increase distress. Yet no studies theorise the complex, context-dependent mechanisms by which cancer online support groups generate their—sometimes contrasting—outcomes.

Methods and analysis

Guided by an integrated knowledge translation approach and the strategy for patient-oriented research, we will conduct a realist review of cancer online support groups in partnership with stakeholders. We will follow Pawson’s five steps and existing quality standards to develop a program theory that explains how cancer online support groups work, for whom and in what circumstances. The specific research questions will be: what positive and negative outcomes have been reported on cancer online support groups? What are the mechanisms that are associated with these outcomes, in which contexts and for whom? Through a rigorous review of relevant scientific and grey literature, as well as ongoing dialogue with stakeholders, a program theory will be developed to explain who benefits from cancer online support groups and who does not, what benefits they derive (or do not), and the factors that affect these outcomes.

Ethics and dissemination

The use of secondary data for this review precludes the need for ethical approval. Dissemination will be informed by the knowledge-to-action framework and will consist of tailored knowledge products that are conceived of collaboratively with stakeholders. These will include peer-reviewed publications on how cancer online support groups can be optimised and best practice recommendations to maximise the benefits experienced by people with cancer. These traditional scientific outputs, along with their respective evidence summaries, will be amplified through strategic social media events hosted and promoted by knowledge users.

PROSPERO registration number

CRD42021250046.

A co-design study to develop supportive interventions to improve psychological and social adaptation among adults with new-onset type 1 diabetes in Denmark and the UK

Por: Due-Christensen · M. · Joensen · L. E. · Sarre · S. · Romanczuk · E. · Wad · J. L. · Forde · R. · Robert · G. · Willaing · I. · Forbes · A.
Objective

To develop supportive interventions for adults with new-onset type 1 diabetes (T1D) to facilitate positive adaptive strategies during their transition into a life with diabetes.

Design

The study used a co-design approach informed by Design Thinking to stimulate participants’ reflections on their experiences of current care and generate ideas for new supportive interventions. Visual illustrations were used to depict support needs and challenges. Initial discussions of these needs and challenges were facilitated by researchers and people with diabetes in workshops. Data comprising transcribed audio recordings of the workshop discussions and materials generated during the workshops were analysed thematically.

Settings

Specialised diabetes centres in Denmark and the United Kingdom.

Participants

Adults with new-onset T1D (n=24) and healthcare professionals (HCPs) (n=56) participated in six parallel workshops followed by four joint workshops with adults (n=29) and HCPs (n=24) together.

Results

The common solution prioritised by both adults with new-onset T1D and HCP participants was the development of an integrated model of care addressing the psychological and social elements of the diagnosis, alongside information on diabetes self-management. Participants also indicated a need to develop the organisation, provision and content of care, along with the skills HCPs need to optimally deliver that care. The co-designed interventions included three visual conversation tools that could be used flexibly in the care of adults with new-onset T1D to support physical, psychological and social adaptation to T1D.

Conclusion

This co-design study has identified the care priorities for adults who develop T1D, along with some practical conversational tools that may help guide HCPs in attending to the disruptive experience of the diagnosis and support adults in adjusting into a life with diabetes.

Treatment patterns and control of hypertension in systemic lupus erythematosus (SLE): a cross-sectional study

Por: Liu · J. L. · Pineau · C. A. · Grenier · L.-P. · Vinet · E. · Kalache · F. · Lukusa · L. · Bernatsky · S.
Objective

Hypertension (HTN) is common in systemic lupus erythematosus (SLE), representing a key risk factor for cardiovascular and renal disease. We described HTN treatment patterns in SLE, evaluated uncontrolled HTN according to Canadian and American guidelines and identified factors associated with uncontrolled HTN.

Methods

We performed a cross-sectional study, identifying all McGill Lupus Clinic registry patients with an annual visit between January 2017 and May 2019 who were taking HTN medications. We excluded those taking medications only for another indication (eg, Raynaud’s). We determined the frequency of uncontrolled HTN according to Canadian and American College of Cardiology/American Heart Association guidelines. Multivariate logistic regression (adjusted for age, sex and race/ethnicity) evaluated if uncontrolled HTN was more common with high body mass index (BMI), longer SLE duration, high disease activity, renal damage, multiple concomitant antihypertensives, prednisone and non-steroidal anti-inflammatory drugs.

Results

Of 442 patients with SLE, 108 were taking medications to treat HTN, and 38 took multiple medications concurrently. Angiotensin-receptor blockers were most common, followed by calcium channel blockers, diuretics, angiotensin-converting enzyme inhibitors and beta blockers. Among the 108 patients, 39.8% (n=43) had blood pressure (BP) >140/90 mm Hg, while 66.7% (n=72) had BP >130/80 mm Hg. In multivariate analyses, uncontrolled HTN (>130/80 mm Hg) was more likely in Caucasians (OR 2.72, 95% CI 1.12 to 6.78) and patients with higher BMI (OR 1.08, 95% CI 1.00 to 1.19). Patients with renal damage had better HTN control (OR 0.39, 95% CI 0.16 to 0.97). We could not draw definitive conclusions regarding other variables.

Conclusion

Caucasians and patients with higher BMI had more uncontrolled HTN. The negative association with renal damage is reassuring, as controlled BP is key for renal protection.

Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial

Por: Hulme · K. · Hudson · J. L. · Picariello · F. · Seaton · N. · Norton · S. · Wroe · A. · Moss-Morris · R.
Introduction

Approximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS).

Methods and analysis

A two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed.

Ethics and dissemination

The study is approved by King’s College London’s Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20–20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences.

Trial registration number

NCT04535778.

Peer-driven intervention to help patients resume CPAP therapy following discontinuation: a multicentre, randomised clinical trial with patient involvement

Por: Merle · R. · Pison · C. · Logerot · S. · Deschaux · C. · Arnol · N. · Roustit · M. · Tamisier · R. · Pepin · J. L. · Borel · J. C.
Introduction

Obstructive sleep apnoea syndrome (OSAS) is one of the most common chronic diseases. It may be associated with symptoms of excessive daytime sleepiness and neurocognitive and cardiovascular complications. First line therapy for OSAS involves home continuous positive airway pressure (CPAP), however, nearly half of patients do not adhere with this treatment over the long term. Cognitive-behavioural interventions that include health professionals and patient and public involvement are increasingly advocated in the fields of education and research. We hypothesise that a peer-driven intervention could help patients with OSAS to resume CPAP use after discontinuation.

Methods and analysis

We have designed a prospective, multicentre randomised, controlled trial that will be coconducted by health professionals, a home provider of CPAP and patients as experts or peers or participants. The primary aim is to evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation. We anticipate that 20% of patients in the intervention group will reuse CPAP as compared with 6% in control group, thus, 104 patients must be included in each group. The secondary aims are (1) to evaluate the impact of the peer-driven intervention on adherence to CPAP compared with the control group (mean adherence and percentage of nights with at least 4 hours’ use/night for 70% of nights); (2) to determine factors associated with resumption of CPAP; (3) to assess patient satisfaction with the peer-driven intervention at 6 months; (4) to evaluate the feasibility and the execution of the peer-driven intervention and peer satisfaction. Adult outpatients with an established diagnosis of severe OSA (Apnoea-Hypopnoea Index >30 events/hour) that have stopped using CPAP within 4–12 months after initiation will be recruited. The peers who will perform the intervention will be patients with OSAS treated with CPAP with good adherence (at least 4 hours/night, 70% of nights) and trained in motivational enhancement and cognitive-behavioural therapies. Trained peers will conduct three interviews within 6 months with participants.

Ethics and dissemination

Ethical approval has been obtained from the French Regional Ethics Committee CPP Ouest II-Angers, (IRB 21.02.25.68606 (2021/2025)). All participants will sign written informed consent. The results will be presented at conferences and published in peer-reviewed journals as well as public media.

Trial registration number

NCT04538274

Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol

Por: Wynne-Jones · G. · Myers · H. · Hall · A. · Littlewood · C. · Hennings · S. · Saunders · B. · Bucknall · M. · Jowett · S. · Riley · R. · Wathall · S. · Heneghan · C. · Cook · J. · Pincus · T. · Mallen · C. · Roddy · E. · Foster · N. · Beard · D. · Lewis · J. · Rees · J. L. · Higginbottom · A.
Introduction

People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals’ level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain.

Methods and analysis

The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with 15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).

Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options.

Ethics and dissemination

The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites.

Trial registration number

ISRCTN46948079.

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