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Values and preferences towards medical cannabis among people living with chronic pain: a mixed-methods systematic review

Por: Zeng · L. · Lytvyn · L. · Wang · X. · Kithulegoda · N. · Agterberg · S. · Shergill · Y. · Esfahani · M. A. · Heen · A. F. · Agoritsas · T. · Guyatt · G. H. · Busse · J. W.
Objective

To explore values and preferences towards medical cannabis among people living with chronic pain.

Design

Mixed-methods systematic review.

Data sources

We searched MEDLINE, EMBASE and PsycINFO from inception to 17 March 2020.

Study selection

Pairs of reviewers independently screened search results and included quantitative, qualitative and mixed-methods studies reporting values and preferences towards medical cannabis among people living with chronic pain.

Review methods

We analysed data using meta-narrative synthesis (quantitative findings were qualitised) and tabulated review findings according to identified themes. We used the Grading of Recommendations Assessment, Development and Evaluation approach to assess certainty of evidence.

Results

Of 1838 initial records, 15 studies proved eligible for review. High to moderate certainty evidence showed that patient’s use of medical cannabis for chronic pain was influenced by both positive (eg, support from friends and family) and negative social factors (eg, stigma surrounding cannabis use). Most patients using medical cannabis favoured products with balanced ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD), or high levels of CBD, but not high THC preparations. Many valued the effectiveness of medical cannabis for symptom management even when experiencing adverse events related to concentration, memory or fatigue. Reducing use of prescription medication was a motivating factor for use of medical cannabis, and concerns regarding addiction, losing control or acting strangely were disincentives. Out-of-pocket costs were a barrier, whereas legalisation of medical cannabis improved access and incentivised use.

Low to very low certainty evidence suggested highly variable values towards medical cannabis among people living with chronic pain. Individuals with pain related to life-limiting disease were more willing to use medical cannabis, and preferred oral over inhaled administration.

Conclusions

Our findings highlight factors that clinicians should consider when discussing medical cannabis. The variability of patients’ values and preferences emphasise the need for shared decision making when considering medical cannabis for chronic pain.

Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial: rationale and design of the THERMAC trial

Por: van de Voort · E. M. F. · Struik · G. M. · Koppert · L. B. · Moelker · A. · Debets · R. · Yo · G. · Macco · M. J. P. V. · Sinke · R. H. J. A. · Franckena · M. · Birnie · E. · Verhoef · C. · Klem · T. M. A. L.
Introduction

Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study.

Methods and analysis

The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response.

Ethics and dissemination

This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals.

Trial registration number

NL9205 (www.trialregister.nl); Pre-results.

Life or limb: an international qualitative study on decision making in sarcoma surgery during the COVID-19 pandemic

Por: Bunzli · S. · O'Brien · P. · Aston · W. · Ayerza · M. A. · Chan · L. · Cherix · S. · de las Heras · J. · Donati · D. · Eyesan · U. · Fabbri · N. · Ghert · M. · Hilton · T. · Idowu · O. K. · Imanishi · J. · Puri · A. · Rose · P. · Sabah · D. · Turcotte · R. · Weber · K. · Dowsey · M. M. · Choon
Objectives

The COVID-19 pandemic is unprecedented as a global crisis over the last century. How do specialist surgeons make decisions about patient care in these unprecedent times?

Design

Between April and May 2020, we conducted an international qualitative study. Sarcoma surgeons from diverse global settings participated in 60 min interviews exploring surgical decision making during COVID-19. Interview data were analysed using an inductive thematic analysis approach.

Setting

Participants represented public and private hospitals in 14 countries, in different phases of the first wave of the pandemic: Australia, Argentina, Canada, India, Italy, Japan, Nigeria, Singapore, Spain, South Africa, Switzerland, Turkey, UK and USA.

Participants

From 22 invited sarcoma surgeons, 18 surgeons participated. Participants had an average of 19 years experience as a sarcoma surgeon.

Results

17/18 participants described a decision they had made about patient care since the start of the pandemic that was unique to them, that is, without precedence. Common to ‘unique’ decisions about patient care was uncertainty about what was going on and what would happen in the future (theme 1: the context of uncertainty), the impact of the pandemic on resources or threat of the pandemic to overwhelm resources (theme 2: limited resources), perceived increased risk to self (theme 3: duty of care) and least-worst decision making, in which none of the options were perceived as ideal and participants settled on the least-worst option at that point in time (theme 4: least-worst decision making).

Conclusions

In the context of rapidly changing standards of justice and beneficence in patient care, traditional decision-making frameworks may no longer apply. Based on the experiences of surgeons in this study, we describe a framework of least-worst decision making. This framework gives rise to actionable strategies that can support decision making in sarcoma and other specialised fields of surgery, both during the current crisis and beyond.

Intersectional role of paternal gender-equitable attitudes and maternal empowerment in child undernutrition: a cross-sectional national study from India

Por: Sharma · A. J. · Subramanyam · M. A.
Objectives

To investigate the role of the intersection of maternal empowerment, paternal gender-equitable attitudes, and household wealth in stunting and severe stunting among underfives in India.

Design

Cross-sectional study.

Setting

Community-based setting, nationally representative household survey from India.

Participants

We used a sample of 22 867 mother–father–child triads from the fourth round of India’s National Family Health Survey (2015–2016). Our inclusion criterion was children below the age of 5 years. The exclusion criterion was a lack of information on paternal gender-equitable attitudes and maternal empowerment. Observations with missing data on any of the covariates were also excluded.

Primary outcome

Stunting and severe stunting among underfives in India.

Results

Our survey-adjusted logistic regression models revealed that even among children from poorer households, those with either an empowered mother or a father with gender-equitable attitudes versus those with none such parents, had a lower odds of stunting (adjusted OR (AOR): 0.92, 95% CI: 0.84 to 1.02) and severe stunting (AOR: 0.87, 95% CI: 0.77 to 0.98), independent of all covariates. We also found substantially lower odds of severe stunting in groups with parental concordance in a woman-friendly outlook, whether non-affluent (AOR: 0.80, 95% CI: 0.67 to 0.94) or affluent (AOR: 0.50, 95% CI: 0.38 to 0.67).

Conclusion

We argue that while women’s autonomy could reduce the risk of child undernutrition, focusing on men’s attitudes towards gender equity also holds promise for reducing undernutrition. Our findings not only underscore how patriarchy is embodied in undernourished children, but also suggest programmatic interventions to address this deep-rooted scourge in India.

Predicting hospital admissions from individual patient data (IPD): an applied example to explore key elements driving external validity

Por: Meid · A. D. · Gonzalez-Gonzalez · A. I. · Dinh · T. S. · Blom · J. · van den Akker · M. · Elders · P. · Thiem · U. · Küllenberg de Gaudry · D. · Swart · K. M. A. · Rudolf · H. · Bosch-Lenders · D. · Trampisch · H. J. · Meerpohl · J. J. · Gerlach · F. M. · Flaig · B. · Kom · G. · Sne
Objective

To explore factors that potentially impact external validation performance while developing and validating a prognostic model for hospital admissions (HAs) in complex older general practice patients.

Study design and setting

Using individual participant data from four cluster-randomised trials conducted in the Netherlands and Germany, we used logistic regression to develop a prognostic model to predict all-cause HAs within a 6-month follow-up period. A stratified intercept was used to account for heterogeneity in baseline risk between the studies. The model was validated both internally and by using internal-external cross-validation (IECV).

Results

Prior HAs, physical components of the health-related quality of life comorbidity index, and medication-related variables were used in the final model. While achieving moderate discriminatory performance, internal bootstrap validation revealed a pronounced risk of overfitting. The results of the IECV, in which calibration was highly variable even after accounting for between-study heterogeneity, agreed with this finding. Heterogeneity was equally reflected in differing baseline risk, predictor effects and absolute risk predictions.

Conclusions

Predictor effect heterogeneity and differing baseline risk can explain the limited external performance of HA prediction models. With such drivers known, model adjustments in external validation settings (eg, intercept recalibration, complete updating) can be applied more purposefully.

Trial registration number

PROSPERO id: CRD42018088129.

Variation in SARS-CoV-2 seroprevalence across districts, schools and classes: baseline measurements from a cohort of primary and secondary school children in Switzerland

Por: Ulyte · A. · Radtke · T. · Abela · I. A. · Haile · S. R. · Blankenberger · J. · Jung · R. · Capelli · C. · Berger · C. · Frei · A. · Huber · M. · Schanz · M. · Schwarzmueller · M. · Trkola · A. · Fehr · J. · Puhan · M. A. · Kriemler · S.
Objectives

To determine the variation in SARS-CoV-2 seroprevalence in school children and the relationship with self-reported symptoms.

Design

Baseline measurements of a longitudinal cohort study (Ciao Corona) from June to July 2020.

Setting

55 schools stratified by district in the canton of Zurich, Switzerland.

Participants

2585 children (1339 girls; median age: 11 years, age range: 6–16 years), attending grades 1–2, 4–5 and 7–8.

Main outcome measures

Variation in seroprevalence of SARS-CoV-2 in children across 12 cantonal districts, schools and grades, assessed using Luminex-based test of four epitopes for IgG, IgA and IgM (Antibody Coronavirus Assay,ABCORA 2.0). Clustering of cases within classes. Association of seropositivity and symptoms. Comparison with seroprevalence in adult population, assessed using Luminex-based test of IgG and IgA (Sensitive Anti-SARS-CoV-2 Spike Trimer Immunoglobulin Serological test).

Results

Overall seroprevalence was 2.8% (95% CI 1.5% to 4.1%), ranging from 1.0% to 4.5% across districts. Seroprevalence in grades 1–2 was 3.8% (95% CI 2.0% to 6.1%), in grades 4–5 was 2.4% (95% CI 1.1% to 4.2%) and in grades 7–8 was 1.5% (95% CI 0.5% to 3.0%). At least one seropositive child was present in 36 of 55 (65%) schools and in 44 (34%) of 131 classes where ≥5 children and ≥50% of children within the class were tested. 73% of children reported COVID-19-compatible symptoms since January 2020, with the same frequency in seropositive and seronegative children for all symptoms. Seroprevalence of children and adults was similar (3.2%, 95% credible interval (CrI) 1.7% to 5.0% vs 3.6%, 95% CrI 1.7% to 5.4%). The ratio of confirmed SARS-CoV-2 cumulative incidence-to-seropositive cases was 1:89 in children and 1:12 in adults.

Conclusions

SARS-CoV-2 seroprevalence was low in children and similar to that in adults by the end of June 2020. Very low ratio of diagnosed-to-seropositive children was observed. We did not detect clustering of SARS-CoV-2-seropositive children within classes, but the follow-up of this study will shed more light on transmission within schools.

Trial registration number

NCT04448717.

Play interventions for paediatric patients in hospital: a scoping review

Por: Gjaerde · L. K. · Hybschmann · J. · Dybdal · D. · Topperzer · M. K. · Schroder · M. A. · Gibson · J. L. · Ramchandani · P. · Ginsberg · E. I. · Ottesen · B. · Frandsen · T. L. · Sorensen · J. L.
Objective

Play is a non-invasive, safe and inexpensive intervention that can help paediatric patients and their families manage difficult aspects of being ill or hospitalised. Although play has existed in hospitals for decades, research on hospital play interventions is scarce. This review aimed to categorise and synthesise the last 20 years of research on hospital play interventions.

Design

Scoping review.

Data sources

PubMed, CINAHL, CENTRAL, ERIC and PsycINFO (1 January 2000– 9 September 2020).

Study selection and data extraction

We systematically searched for original peer-reviewed articles, written in English, on hospital play interventions in paediatric patients (0–18 years) in non-psychiatric settings. Two reviewers independently screened titles and abstracts, reviewed full text of relevant articles and extracted data. We thematically synthesised the data from the included studies, and a descriptive analysis, based on a developed framework, is presented.

Results

Of the 297 included articles, 78% came from high-income countries and 56% were published within the last 5 years. Play interventions were carried out across all ages by various healthcare professionals. Play interventions served different roles within four clinical contexts: A) procedures and diagnostic tests, B) patient education, C) treatment and recovery and D) adaptation. Across these contexts, play interventions were generally facilitated and purpose-oriented and had positive reported effects on pain, stress, and anxiety.

Conclusions

Play in hospitals is an emerging interdisciplinary research area with a significant potential benefit for child and family health. Future research should further describe principles for play in hospitals. High-quality studies investigating short-term and long-term effects are needed to guide when and how to best integrate play in hospitals.

Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol

Por: Motiwala · M. A. · Habib · S. · Ghafoor · R. · Irfan · S.
Introduction

Various intracanal medicaments have been used in cases of chronic apical periodontitis for appropriate disinfection of the root canal system to eliminate microbes especially from the inaccessible areas. Calcium hydroxide is the most common intracanal medicament available in various forms, but its effectiveness with or without iodoform using microbial culture is unknown. Therefore, our aim is to compare the antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of teeth presenting with chronic apical periodontitis by assessing the bacterial load reduction.

Method and analysis

60 single rooted teeth of patients with diagnosis of chronic apical periodontitis will be selected and the canals debrided chemomechanically. The patients will be randomised into two groups: Calcipex and Metapex. The first sample (S1) for bacterial culture will be taken before placement of intracanal medicament and the second sample (S2) will be taken after 7 days, before final obturation from the canal and sent to lab for culture. Colony-forming unit will be evaluated. Paired t-test will be used to assess difference between antimicrobial efficacies within the group of medicaments. Independent sample t-test will be used to assess antimicrobial efficacies between groups. Level of significance will be kept at 0.05.

Ethics and dissemination

Approval from Aga Khan University Hospital Ethical review committee is taken. Findings will be reported according to the Standard Protocol Items for Randomised Trials guidelines. Research findings will be disseminated through annual reports, peer-reviewed journals and conferences.

Trial registration number

NCT04336709.

Risk factors for mortality of adult patients with COVID-19 hospitalised in an emerging country: a cohort study

Objective

To describe mortality of in-hospital patients with COVID-19 and compare risk factors between survivors and non-survivors.

Design

Prospective cohort of adult inpatients.

Setting

Tertiary healthcare teaching hospital in Guadalajara, Mexico.

Participants

All patients with confirmed COVID-19 hospitalised from 25 March to 7 September 2020 were included. End of study: 7 November 2020.

Primary outcome measures

Patient survival analysed by the Kaplan-Meier method and comparison of factors by the log-rank test. Mortality risk factors analysed by multivariate Cox’s proportional-hazard model.

Results

One thousand ten patients included: 386 (38%) died, 618 (61%) alive at discharge and six (0.6%) remained hospitalised. There was predominance of men (63%) and high frequency of overweight–obesity (71%); hypertension (54%); diabetes (40%); and lung (9%), cardiovascular (8%) and kidney diseases (11%); all of them significantly more frequent in non-survivors. Overweight–obesity was not different between groups, but severity of disease (Manchester Triage System and quick Sequential Organ Failure Assessment) was significantly worse in non-survivors, who were also significantly older (65 vs 45 years, respectively) and had haematological, biochemical, coagulation and inflammatory biomarkers more altered than survivors. Mortality predictors were invasive mechanical ventilation (IMV; OR 3.31, p

Conclusions

Mortality in hospitalised patients with COVID-19 in this emerging country centre seemed to be higher than in developed countries. Patients displayed a high frequency of risk factors for poor outcome, but the need for IMV, ICU admission, older age, more severe disease at admission, antecedent of kidney disease and higher CRP levels significantly predicted mortality.

Current status of health systems financing and oversight for end-stage kidney disease care: a cross-sectional global survey

Por: Yeung · E. · Bello · A. · Levin · A. · Lunney · M. · Osman · M. A. · Ye · F. · Ashuntantang · G. · Bellorin-Font · E. · Benghanem Gharbi · M. · Davison · S. · Ghnaimat · M. · Harden · P. · Jha · V. · Kalantar-Zadeh · K. · Kerr · P. · Klarenbach · S. · Kovesdy · C. · Luyckx · V. · Neuen · B.
Objectives

The Global Kidney Health Atlas (GKHA) is a multinational, cross-sectional survey designed to assess the current capacity for kidney care across all world regions. The 2017 GKHA involved 125 countries and identified significant gaps in oversight, funding and infrastructure to support care for patients with kidney disease, especially in lower-middle-income countries. Here, we report results from the survey for the second iteration of the GKHA conducted in 2018, which included specific questions about health financing and oversight of end-stage kidney disease (ESKD) care worldwide.

Setting

A cross-sectional global survey.

Participants

Key stakeholders from 182 countries were invited to participate. Of those, stakeholders from 160 countries participated and were included.

Primary outcomes

Primary outcomes included cost of kidney replacement therapy (KRT), funding for dialysis and transplantation, funding for conservative kidney management, extent of universal health coverage, out-of-pocket costs for KRT, within-country variability in ESKD care delivery and oversight systems for ESKD care. Outcomes were determined from a combination of desk research and input from key stakeholders in participating countries.

Results

160 countries (covering 98% of the world’s population) responded to the survey. Economic factors were identified as the top barrier to optimal ESKD care in 99 countries (64%). Full public funding for KRT was more common than for conservative kidney management (43% vs 28%). Among countries that provided at least some public coverage for KRT, 75% covered all citizens. Within-country variation in ESKD care delivery was reported in 40% of countries. Oversight of ESKD care was present in all high-income countries but was absent in 13% of low-income, 3% of lower-middle-income, and 10% of upper-middle-income countries.

Conclusion

Significant gaps and variability exist in the public funding and oversight of ESKD care in many countries, particularly for those in low-income and lower-middle-income countries.

Study protocol: epidemiological and clinical characteristics of acute viral hepatitis in Brazilian health services

Por: Sitnik · R. · Maluf · M. M. · Oliveira · K. G. · Siqueira · R. A. · Ferreira · C. E. d. S. · Mangueira · C. L. P. · Azevedo · R. S. · Ferraz · M. L. C. G. · Correa · M. C. J. M. · Ferreira · P. R. A. · Mendes Pereira · G. F. · de Souza · F. M. A. · Pimenta · C. · Pinho · J. R. R.
Introduction

Acute viral hepatitis is a disease of great clinical importance. This study proposes actions to better characterise cases of acute hepatitis in Brazil and to provide relevant information to institutionalised health policies within the Unified Health System. Available data on acute hepatitis in Brazil need to be re-evaluated regarding the different hepatotropic agent (hepatitis A to E virus) frequencies, as well as other agents that can cause similar clinical conditions, such as Herpes Simplex Virus 1 and 2(HSV1, HSV2), Varicella Zoster Virus (VZV), Cytomegalovirus (CMV), Epstein Barr Virus (EBV), Human Herpes Virus 6 and 7 (HHV6, HHV7), arbovirus (yellow fever, dengue, chikungunya, Zika), parvovirus B19, adenovirus, parechovirus, enterovirus, HIV, leptospirosis, toxoplasmosis and syphilis, in addition to autoimmune hepatitis. In this context, the primary aim of this study is the clinical-epidemiological and molecular characterisation of acute viral hepatitis in Brazilian health services from all geographical regions of the country. The present article describes the study protocol.

Methods and analysis

This study will evaluate 2280 patients with symptoms and/or signs suggestive of acute liver disease in Brazilian health institutions in all five geographic Brazilian regions. Demographic, epidemiological and clinical data will be collected, as well as blood samples to be analysed at Hospital Israelita Albert Einstein Clinical Laboratory.

Ethics and dissemination

Ethics approval was obtained at the national research ethics committee (Conselho Nacional de Ética em Pesquisa— CONEP–CAAE 00952818.4.1001.0071) and at all participating sites. Results will be published in journals and presented at scientific meetings.

How do children and adolescents experience healthcare professionals? Scoping review and interpretive synthesis

Por: Davison · G. · Kelly · M. A. · Conn · R. · Thompson · A. · Dornan · T.
Objective

Explore children’s and adolescents’ (CADs’) lived experiences of healthcare professionals (HCPs).

Design

Scoping review methodology provided a six-step framework to, first, identify and organise existing evidence. Interpretive phenomenology provided methodological principles for, second, an interpretive synthesis of the life worlds of CADs receiving healthcare, as represented by verbatim accounts of their experiences.

Data sources

Five key databases (Ovid Medline, Embase, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus, and Web of Science), from inception through to January 2019, reference lists, and opportunistically identified publications.

Eligibility criteria

Research articles containing direct first-person quotations by CADs (aged 0–18 years inclusive) describing how they experienced HCPs.

Data extraction and synthesis

Tabulation of study characteristics, contextual information, and verbatim extraction of all ‘relevant’ (as defined above) direct quotations. Analysis of basic scope of the evidence base. The research team worked reflexively and collaboratively to interpret the qualitative data and construct a synthesis of children’s experiences. To consolidate and elaborate the interpretation, we held two focus groups with inpatient CADs in a children’s hospital.

Results

669 quotations from 99 studies described CADs’ experiences of HCPs. Favourable experiences were of forming trusting relationships and being involved in healthcare discussions and decisions; less favourable experiences were of not relating to or being unable to trust HCPs and/or being excluded from conversations about them. HCPs fostered trusting relationships by being personable, wise, sincere and relatable. HCPs made CADs feel involved by including them in conversations, explaining medical information, and listening to CADs’ wider needs and preferences.

Conclusion

These findings strengthen the case for making CADs partners in healthcare despite their youth. We propose that a criterion for high-quality child-centred healthcare should be that HCPs communicate in ways that engender trust and involvement.

Interventional treatments for chronic, axial or radicular, non-cancer, spinal pain: a protocol for a systematic review and network meta-analysis of randomised trials

Por: Wang · X. · Martin · G. · Sadeghirad · B. · Darzi · A. J. · Couban · R. J. · Florez · I. D. · Crandon · H. N. · Kum · E. · Chang · Y. · Esfahani · M. A. · Sivananthan · L. · Mehrabi · F. · Sengupta · N. K. · Rathod · P. · Morsi · R. Z. · Buckley · D. N. · Guyatt · G. H. · Rampersaud · Y.
Introduction

Chronic, non-cancer, axial or radicular spinal pain is a common condition associated with considerable socioeconomic burden. Clinicians frequently offer patients various interventional procedures for the treatment of chronic spine pain; however, the comparative effectiveness and safety of available procedures remains uncertain.

Methods

We will conduct a systematic review of randomised controlled trials that explores the effectiveness and harms of interventional procedures for the management of axial or radicular, chronic, non-cancer, spine pain. We will identify eligible studies through a systematic search of Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science from inception without language restrictions. Eligible trials will: (1) enrol primarily adult patients (≥18 years old) with axial or radicular, chronic, non-cancer, spine pain, (2) randomise patients to different, currently available, interventional procedures or to an interventional procedure and a placebo/sham procedure or usual care, and (3) measure outcomes at least 1 month after randomisation.

Pairs of reviewers will independently screen articles identified through searches and extract information and assess risk of bias of eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias. We will use frequentist random-effects network meta-analyses to assess the relative effects of interventional procedures, and five a priori hypotheses to explore between studies subgroup effects. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty in evidence for each outcome, including direct, indirect and network estimates.

Ethics and dissemination

No research ethics approval is required for this systematic review, as no confidential patient data will be used. We will disseminate our findings through publication in a peer-reviewed journal and conference presentations, and our review will support development of a BMJ Rapid Recommendations providing contextualised clinical guidance based on this body of evidence.

PROSPERO registration number

CRD42020170667.

Symptoms of common mental disorders and adherence to antiretroviral therapy among adults living with HIV in rural Zimbabwe: a cross-sectional study

Por: Haas · A. D. · Kunzekwenyika · C. · Hossmann · S. · Manzero · J. · van Dijk · J. · Manhibi · R. · Verhey · R. · Limacher · A. · von Groote · P. M. · Manda · E. · Hobbins · M. A. · Chibanda · D. · Egger · M. · IeDEA Southern Africa
Objectives

To examine the proportion of people living with HIV who screen positive for common mental disorders (CMD) and the associations between CMD and self-reported adherence to antiretroviral therapy (ART).

Setting

Sixteen government-funded health facilities in the rural Bikita district of Zimbabwe.

Design

Cross-sectional study.

Participants

HIV-positive non-pregnant adults, aged 18 years or older, who lived in Bikita district and had received ART for at least 6 months.

Outcome measures

The primary outcome was the proportion of participants screening positive for CMD defined as a Shona Symptoms Questionnaire score of 9 or greater. Secondary outcomes were the proportion of participants reporting suicidal ideation, perceptual symptoms and suboptimal ART adherence and adjusted prevalence ratios (aPR) for factors associated with CMD, suicidal ideation, perceptual symptoms and suboptimal ART adherence.

Results

Out of 3480 adults, 18.8% (95% CI 14.8% to 23.7%) screened positive for CMD, 2.7% (95% CI 1.5% to 4.7%) reported suicidal ideations, and 1.5% (95% CI 0.9% to 2.6%) reported perceptual symptoms. Positive CMD screens were more common in women (aPR 1.67, 95% CI 1.19 to 2.35) than in men and were more common in adults aged 40–49 years (aPR 1.47, 95% CI 1.16 to 1.85) or aged 50–59 years (aPR 1.51, 95% CI 1.05 to 2.17) than in those 60 years or older. Positive CMD screen was associated with suboptimal adherence (aPR 1.53; 95% CI 1.37 to 1.70).

Conclusions

A substantial proportion of people living with HIV in rural Zimbabwe are affected by CMD. There is a need to integrate mental health services and HIV programmes in rural Zimbabwe.

Trial registration number

NCT03704805.

SARS-CoV-2 seroprevalence in healthcare workers of a Swiss tertiary care centre at the end of the first wave: a cross-sectional study

Por: Meylan · S. · Dafni · U. · Lamoth · F. · Tsourti · Z. · Lobritz · M. A. · Regina · J. · Bressin · P. · Senn · L. · Grandbastien · B. · Andre · C. · Fenwick · C. · D'Acremont · V. · Croxatto · A. · Guilleret · I. · Greub · G. · Manuel · O. · Calandra · T. · Pantaleo · G. · Lazor-Blanchet · C
Objective

To assess the SARS-CoV-2 transmission in healthcare workers (HCWs) using seroprevalence as a surrogate marker of infection in our tertiary care centre according to exposure.

Design

Seroprevalence cross-sectional study.

Setting

Single centre at the end of the first COVID-19 wave in Lausanne, Switzerland.

Participants

1874 of 4074 responders randomly selected (46% response rate), stratified by work category among the 13 474 (13.9%) HCWs.

Main outcome measures

Evaluation of SARS-CoV-2 serostatus paired with a questionnaire of SARS-CoV-2 acquisition risk factors internal and external to the workplace.

Results

The overall SARS-CoV-2 seroprevalence rate among HCWs was 10.0% (95% CI 8.7% to 11.5%). HCWs with daily patient contact did not experience increased rates of seropositivity relative to those without (10.3% vs 9.6%, respectively, p=0.64). HCWs with direct contact with patients with COVID-19 or working in COVID-19 units did not experience increased seropositivity rates relative to their counterparts (10.4% vs 9.8%, p=0.69 and 10.6% vs 9.9%, p=0.69, respectively). However, specific locations of contact with patients irrespective of COVID-19 status—in patient rooms or reception areas—did correlate with increased rates of seropositivity (11.9% vs 7.5%, p=0.019 and 14.3% vs 9.2%, p=0.025, respectively). In contrast, HCWs with a suspected or proven SARS-CoV-2-infected household contact had significantly higher seropositivity rates than those without such contacts (19.0% vs 8.7%, p

Conclusions

The overall seroprevalence was 10% without significant differences in seroprevalence between HCWs exposed to patients with COVID-19 and HCWs not exposed. This suggests that, once fully in place, protective measures limited SARS-CoV-2 occupational acquisition within the hospital environment. SARS-CoV-2 seroconversion among HCWs was associated primarily with community risk factors, particularly household transmission.

Prayer as a pain intervention: protocol of a systematic review of randomised controlled trials

Por: Ferreira-Valente · A. · Jarego · M. · Queiroz-Garcia · I. · Pimenta · F. · Costa · R. M. · Day · M. A. · Pais-Ribeiro · J. · Jensen · M. P.
Background

Pain is a universal experience and the most common reason for seeking healthcare. Inadequate pain management negatively impacts numerous aspects of patient health. Multidisciplinary treatment programmes, including psychosocial interventions, are more useful for pain management than purely biomedical treatment alone. Recently, researchers showed increasing interest in understanding the role of spirituality/religiosity and spiritual/religious practices on pain experience, with engagement in religious practices, such as prayer, showing to positively impact pain experience in religious individuals. This systematic review will seek to summarise and integrate the existing findings from randomised controlled trials assessing the effects of prayer and prayer-based interventions on pain experience.

Methods

The systematic review procedures and its report will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Electronic searches in nine databases (Web of Science Core Collection, MEDLINE, SCIELO Citation Index, PubMed, Cochrane Central Register of Controlled Clinical Trial, PsycINFO, Scopus, LILACS and Open-SIGLE) will be performed to identify randomised controlled trials of prayer-based interventions. Two independent researchers will assess studies for inclusion and extract data from each paper. Risk of bias assessment will be assessed independently by two reviewers based on the Consolidated Standards of Reporting Trials statement. Qualitative synthesis of the body of research will be conducted using a narrative summary synthesis method. Meta-analysis will be limited to studies reporting on the same primary outcome. Formal searches are planned to start in June 2021. The final report is anticipated to be completed by September 2021.

Discussion

Findings will be useful to (1) understand the condition of our knowledge in this field and (2) provide evidence for prayer effectiveness in reducing pain intensity and pain-related stress and increasing pain tolerance in adults experiencing acute or chronic pain.

PROSPERO registration number

CRD42020221733.

Self-reported health and smoking status, and body mass index: a case-control comparison based on GEN SCRIP (GENetics of SChizophRenia In Pakistan) data

Por: Ayub · M. · Arsalan · A. · Khan · S.-u.-D. A. · Bajwa · S. · Hussain · F. · Umar · M. · Khizar · B. · Sibtain · M. · Butt · A. · Mukhtar-Ul-Haq · M. · Dogar · I. A. · Ansari · M. A. · Shafiq · S. · Tariq · M. · Hussain · M. I. · Nasar · A. · Mustafa · A. B. · Taj · R. · Rehman · R. U. · Rajp
Introduction

Individuals with schizophrenia are at a high risk of physical health comorbidities and premature mortality. Cardiovascular and metabolic causes are an important contributor. There are gaps in monitoring, documenting and managing these physical health comorbidities. Because of their condition, patients themselves may not be aware of these comorbidities and may not be able to follow a lifestyle that prevents and manages the complications. In many low-income and middle-income countries including Pakistan, the bulk of the burden of care for those struggling with schizophrenia falls on the families.

Objectives

To determine the rate of self-reported physical health disorders and risk factors, like body mass index (BMI) and smoking, associated with cardiovascular and metabolic disorders in cases of schizophrenia compared with a group of mentally healthy controls.

Design

A case-controlled, cross-sectional multicentre study of patients with schizophrenia in Pakistan.

Settings

Multiple data collection sites across the country for patients, that is, public and private psychiatric OPDs (out patient departments), specialised psychiatric care facilities, and psychiatric wards of teaching and district level hospitals. Healthy controls were enrolled from the community.

Participants

We report a total of 6838 participants’ data with (N 3411 (49.9%)) cases of schizophrenia compared with a group of healthy controls (N 3427 (50.1%)).

Results

BMI (OR 0.98 (CI 0.97 to 0.99), p=0.0025), and the rate of smoking is higher in patients with schizophrenia than in controls. Problems with vision (OR 0.13 (0.08 to 0.2), joint pain (OR 0.18 (0.07 to 0.44)) and high cholesterol (OR 0.13 (0.05 to 0.35)) have higher reported prevalence in controls. The cases describe more physical health disorders in the category ‘other’ (OR 4.65 (3.01 to 7.18)). This captures residual disorders not listed in the questionnaire.

Conclusions

Participants with schizophrenia in comparison with controls report more disorders. The access in the ‘other’ category may be a reflection of undiagnosed disorders.

Epidemiological trends in COVID-19 pandemic: prospective critical appraisal of observations from six countries in Europe and the USA

Por: Velicu · M. A. · Furlanetti · L. · Jung · J. · Ashkan · K.
Introduction

Europe was the epicentre of the COVID-19 pandemic in March 2020, with the highest number of cases and deaths between March and April. In May, the infection numbers registered a fall followed by a second new rise, not proportionally reflected by an increase in the number of deaths. We aimed to investigate the relationship between disease prevalence and infection fatality rate (IFR), and the number of intensive care unit (ICU) and hospital admissions over time, to develop a predictive model, as well as appraising the potential contributing factors underpinning this complex relationship.

Methods

A prospective epidemiological study using data from six countries collected between 10 March and 4 September 2020. Data on the number of daily hospital and ICU admissions with COVID-19 were gathered, and the IFR and the prevalence were calculated. Trends over time were analysed. A linear regression model was used to determine the association between the fatality rates and the number of admissions.

Findings

The prediction model confirmed the linear association between the fatality rates and the numbers of ICU and hospital admissions. The exception was during the peak of the COVID-19 pandemic when the model underestimated the fatalities indicating that a substantial number of deaths occurred outside of the hospitals. The fatality rates decreased in all countries from May until September regardless of the trends in prevalence, differences in healthcare systems or strategic variations in handling the pandemic.

Interpretation

The observed gradual reduction in COVID-19 fatality rates over time despite varying disease prevalence and public health measures across multiple countries warrants search for a biological explanation. While our understanding of this novel virus grows, hospital and ICU admission rates remain effective predictors of patient outcomes which can be used as early warning signs for escalation of public health measures.

Virtual reality-based relaxation for enhancement of perioperative well-being and quality of life: protocol for a randomised pilot trial

Por: Schrempf · M. C. · Petzold · J. Q. · Vachon · H. · Petersen · M. A. · Gutschon · J. · Wolf · S. · Sommer · F. · Murnauer · M. · Anthuber · M.
Introduction

Patients with cancer undergoing surgery often suffer from reduced quality of life and various forms of distress. Untreated distress can negatively affect coping resources as well as surgical and oncological outcomes. A virtual reality-based stress reduction intervention may increase quality of life and well-being and reduce distress in the perioperative phase for patients with cancer. This pilot trial aims to explore the feasibility of the proposed intervention, assess patient acceptability and obtain estimates of effect to provide data for sample size calculations.

Methods and analysis

Patients with colorectal cancer and liver metastasis undergoing elective surgery will be recruited for this single-centre, randomised pilot trial with a three-arm design. A total of 54 participants will be randomised at 1:1:1 ratio to one of two intervention groups or a control receiving standard treatment. Those randomised to an intervention group will either receive perioperative virtual reality-based stress reduction exercises twice daily or listen to classical music twice daily. Primary feasibility outcomes are number and proportions of participants recruited, screened, consented and randomised. Furthermore, adherence to the intervention, compliance with the completion of the quality of life questionnaires and feasibility of implementing the trial procedures will be assessed. Secondary clinical outcomes are measurements of the effectiveness of the interventions to inform sample size calculations.

Ethics and dissemination

The study protocol, the patient information and the informed consent form have been approved by the ethics committee of the Ludwigs-Maximilians-University, Munich, Germany (Reference Number: 19–915). Study findings will be submitted for publication in peer-reviewed journals.

Trial registration number

DRKS00020909.

Instruments measuring the quality of life among people living with type 2 diabetes mellitus in India: a systematic review protocol

Por: Demla · C. · Thomas · A. · Jose · J. · Joshy · A. L. · Hrishikesh · M. A. · Rajendran · A. · Parsekar · S. S.
Introduction

Type 2 diabetes mellitus affects an individual’s quality of life (QoL); and there are multiple instruments that can be used to measure QoL. The purpose of this systematic review is to identify the existing instruments that have been used to measure QoL in people living with diabetes, and to enlist the major domains (such as physical and psychological components) available in the identified instruments. Additionally, we plan to determine the psychometric properties of the identified QoL instruments using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.

Methods and analysis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guideline was followed to report this systematic review protocol. Searches will be conducted on MEDLINE (via PubMed, Web of Science), SCOPUS and CINAHL. Predetermined inclusion/exclusion criteria will be applied to the search results, to include studies with adult individuals diagnosed with type 2 diabetes mellitus, with and without complications, and exclude studies with type 1 diabetes or other clinical illness. Studies conducted outside India will be excluded. Five authors in pairs will independently screen the articles and extract the data that meets the inclusion criteria. The COSMIN criteria will be used to assess the risk of bias of included studies. Narrative synthesis will be performed to analyse the findings of the instruments.

Ethics and dissemination

Ethical permission is not applicable, as this is a systematic review. We intend to disseminate the systematic review findings through a national or international conference and publish the findings in a peer-reviewed journal.

PROSPERO registration number

CRD42020180432.

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