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Patient experiences with a smartwatch 1L-ECG versus traditional Holter monitoring for ambulatory cardiac rhythm monitoring: a qualitative study

Por: Karregat · E. P. M. · Vooijs · P. · Wierda · E. · Harskamp · R. · Lucassen · W. · Himmelreich · J. C. L. · Moll van Charante · E. P.
Objective

To explore patients’ experiences and perspectives on using a direct-to-consumer smartwatch with single-lead electrocardiography (1L-ECG) for ambulatory rhythm diagnostics in primary care.

Design

Qualitative study using semi-structured interviews and thematic analysis.

Setting

Primary care patients referred for ambulatory rhythm monitoring in a diagnostic centre.

Participant

Eighteen adults with paroxysmal palpitations, of whom nine were female patients (50%), aged 32–85 (median 66) years.

Intervention

Participants simultaneously wore a smartwatch with 1L-ECG capability (Withings ScanWatch) and a conventional Holter monitor for 7 days.

Outcome measures

Patient experiences and perceived barriers and facilitators to smartwatch use for rhythm monitoring, reported after the monitoring period.

Results

Patients found the smartwatch more user-friendly and feasible than the Holter monitor. Difficulties included uncertainty about when to initiate recordings, challenges capturing brief episodes and anxiety triggered by automated algorithm outputs. Participants emphasised the importance of accessible healthcare support for interpretation and reassurance.

Conclusions

This study shows that smartwatch-based 1L-ECG monitoring is feasible and acceptable for ambulatory rhythm diagnostics in primary care. Prior to routine implementation, it is crucial to address the identified challenges: particularly anxiety related to algorithm results, uncertainty about when to record and accessible clinician support.

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of Sao Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB ProCura)

Por: Rosa · C. D. · Ferrazoli · L. · dos Santos · D. P. · Pedace · C. · Soler-Camargo · N. C. · Silva-Pereira · T. T. · Brandao · A. P. · Bollela · V. R. · Cruz · A. L. G. · Feliciano · C. S. · Ferreira · P. R. A. · Jorge · E. P. · de Miranda · S. S. · de Oliveira · R. S. · Oliveira · M.
Introduction

Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.

Methods and analysis

We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.

Ethics and dissemination

Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.

Trial registration number

U1111-1308-4669.

Photobiomodulation for postoperative pain relief following conventional periapical surgery: a randomised controlled study protocol

Por: Cirisola · R. W. C. · Moya · L. E. P. · Olazabal · M. V. G. · Wagmann · D. A. A. · Suarez · G. P. · Wince · C. · Bruno · M. L. H. · Salaberry · D. R. · Sobral · A. P. T. · Longo · P. L. · Motta · L. J. · Bussadori · S. K. · Duran · C. C. G. · Fernandes · K. P. S. · Mesquita-Ferrari
Introduction

Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.

Methods and analysis

A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p

Ethics and dissemination

The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.

Trial registration number

NCT05935306.

Frequency of reported abuse, stigma and discrimination during facility-based childbirth among migrant mothers and their suggestions for improvement: a mixed method WHO standards-based multicentre study in Italy

Por: Mariani · I. · Covi · B. · Valente · E. P. · Lazzara · G. · Not · S. · Casetta · G. · Manfrida · M. M. · Bua · J. · Piazza · M. · Zanetti · A. · Moretti · V. · Giornelli · R. · Battistin · S. · Miani · M. P. · Pecci · L. · Pizzocchero · E. · Fabiani · C. · Michelutti · A. · Pertner · V. · Sa
Objectives

This study aims at documenting the frequency of reported abuse, stigma and discrimination and exploring the perspectives for improving the quality of maternal-newborn care (QMNC) of migrant mothers’ reporting abuse, stigma or discrimination.

Design

Mixed methods multicentre cross-sectional study.

Setting

All maternal facilities (tertiary and secondary levels of care, n=9) from Friuli-Venezia Giulia region, Northeast Italy, between November 2019 and January 2022 in Northeast Italy.

Participants

874 migrant and 3968 non-migrant women answering a validated WHO Standard-based questionnaire after birth.

Outcome measures

Frequency of reported abuse, stigma and discrimination during facility-based childbirth was calculated and compared with those of non-migrant mothers. Thematic analysis was conducted on eight open questions, using WHO Standards as a framework for the analysis.

Results

Among migrant women, 84 (9.6%) reported some type of abuse, stigma and discrimination, a frequency similar to non-migrant women (9.8%, p=0.880). The most frequently reported was verbal abuse (87.7%), followed by stigma and discrimination (15.1%). Most women (86.9%) provided at least one comment, with a frequency comparable to non-migrant women (p=0.076). Among a total of 327 comments, 104 (31.8%) were practical suggestions for improving QMNC. Experience of care was the domain with the highest frequency both of negative (64.9% of negative comments) and positive comments (51.7% of positive comments) and with the highest frequency of suggestions for improving QMNC (52.9% of suggestions). Overall, suggestions mainly focused on strengthening healthcare professionals’ communication skills, allowing companionship during childbirth, increasing healthcare professionals’ availability and timely support.

Discussions

This study shows that both migrant and non-migrant mothers are exposed to abuse, stigma and discrimination during childbirth, and that both are willing to provide practical suggestions, which should be used for planning actions to improve QMNC.

Assessing health system preparedness from trends and time delays in the management of myocardial infarctions during the COVID-19 pandemic in India: a multicentre retrospective cohort study

Por: Menon · J. C. · MS · A. · S · H. · Janakiram · C. · James · A. · Sreedevi · A. · Menon · G. R. · John · D. · Cherian · J. J. · V · V. · Abhaichand · R. K. · Punnoose · E. P. · BS · A. · Abraham · M. · Thomas · P. · Pedada · C. · Govindan · U. · Mohan · B. · Pisharody · S. · Devasia · T. · Seba
Objectives

This study aimed to analyse the number of myocardial infarction (MI) admissions during the COVID-19 lockdown periods of 2020 and 2021 (March 15th to June 15th) and compare them with corresponding pre-pandemic period in 2019. The study also evaluated changes in critical treatment intervals: onset to door (O2D), door to balloon (D2B) and door to needle (D2N) and assessed 30-day clinical outcomes. This study examined MI care trends in India during the COVID-19 lockdown period, irrespective of patients’ COVID-19 infection status.

Design

Multicentre retrospective cohort study

Setting

Twenty-three public and private hospitals across multiple Indian states, all with 24/7 interventional cardiology facilities.

Participants

All adults (>18 years) admitted with acute myocardial infarction between March 15 and June 15 in 2019 (pre-pandemic), 2020 (first lockdown) and 2021 (second lockdown). A total of 3614 cases were analysed after excluding duplicates and incomplete data.

Primary outcomes

Number of MI admissions, median O2D, D2B and D2N times.

Secondary outcomes

30-day outcomes including death, reinfarction and revascularisation.

Results

MI admissions dropped from 4470 in year 2019 to 2131 (2020) and 1483 (2021). The median O2D increased from 200 min (IQR 115–428) pre-COVID-19 to 390 min (IQR 165–796) in 2020 and 304 min (IQR 135–780) in 2021. The median D2B time reduced from 225 min (IQR 120–420) in 2019 to 100 min (IQR 53–510) in 2020 and 130 min (IQR 60–704) in 2021. Similarly, D2N time decreased from 240 min (IQR 120–840) to 35 min (IQR 25–69) and 45 min (IQR 24–75), respectively. The 30-day outcome of death, reinfarction and revascularisation was 4.25% in 2020 and 5.1% in 2021, comparable to 5.8% reported in the Acute Coronary Syndrome Quality Improvement in Kerala study.

Conclusion

Despite the expansion of catheterisation facilities across India, the country continues to fall short of achieving international benchmarks for optimal MI care.

Impact of abnormal ambulatory ECG findings when screening for atrial fibrillation in primary care: a qualitative study among participants of the PATCH-AF trial

Por: Brik · T. · Niekel · M. S. · Bak · M. A. R. · Himmelreich · J. C. L. · Harskamp · R. E. · Moll van Charante · E. P.
Background and aim

European cardiovascular guidelines recommend systematic atrial fibrillation (AF) screening in community-dwelling high-risk patients. However, little is known about the impact of abnormal screening findings, including AF and non-AF incidental findings on the target population. This gap highlights the need to assess both the benefits and potential harms from patients’ perspectives to fully understand the impact of AF screening. Therefore, the aim of this study is to explore patients’ experiences with AF screening among those who received abnormal findings from ambulatory ECG monitoring.

Design

We conducted a qualitative study using semistructured interviews, analysed thematically. Participants in the PATCH-AF trial, based in Amsterdam primary care, were purposively sampled based on their screening results (AF or non-AF incidental findings), sex and socioeconomic status.

Results

We achieved data saturation after conducting 16 interviews (6 with interviewees diagnosed with AF and 10 with non-AF incidental findings). Participants had a median age of 76 (73–79) years, and 56% were male. Their experiences, whether positive or negative, fluctuated throughout the screening process and depended on their initial motivations for participation in AF screening (seeking extra health checks, finding explanations for pre-existing symptoms or contributing to medical research), expectations and perceived benefits from clarification, diagnostic workup or treatment. Influencing factors included the type of finding (AF or non-AF incidental finding), healthcare provider communication and individual characteristics such as age, socioeconomic status and medical history.

Conclusion

This qualitative study highlights both positive and negative AF screening experiences from the patients’ perspective. It underscores how patients’ motivations and expectations for participation, the type of ambulatory ECG finding and communication and follow-up by healthcare providers shape their overall experiences. Healthcare providers should be aware of these factors to optimise screening consultations. Clear guidelines on communicating abnormal ambulatory ECG findings, especially incidental findings, are warranted.

Trial registeration number

The Netherlands Trial Register (NTR) number NL9656.

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