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1.
Ginekol Pol ; 92(2): 165-173, 2021.
Article in English | MEDLINE | ID: covidwho-1964413

ABSTRACT

The Polish Society of Colposcopy and Cervical Pathophysiology (PTKiPSM) together with the Polish Society of Gynecologists and Obstetricians (PTGiP) issued a final summary of interim guidelines for secondary cervical cancer prevention during the SARS-CoV-2 pandemic based on the analysis of the latest directional publications and the authors' own experiences. The aim of the summary is to facilitate the implementation of the most effective possible screening of cervical precancerous lesions and cervical cancer due to temporary significant limitation of screening as a consequence of the ongoing epidemiological threat. These final guidelines are taking into account the 2020 call of the World Health Organization (WHO) for global epidemiological elimination of cervical cancer. The guidelines supplement the interim guidelines of PTKiPSM and PTGiP announced in March 2020 on the possible deferral of diagnostic and therapeutic procedures in patients with abnormal screening tests results in secondary prevention of cervical cancer in current pandemic.


Subject(s)
Colposcopy , Early Detection of Cancer/methods , Mass Screening/methods , Secondary Prevention , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control , Algorithms , COVID-19/epidemiology , Female , Humans , Pandemics , Poland , Precancerous Conditions/diagnosis , Precancerous Conditions/prevention & control , Precancerous Conditions/surgery , SARS-CoV-2 , Uterine Cervical Neoplasms/surgery
2.
Trials ; 23(1): 583, 2022 Jul 22.
Article in English | MEDLINE | ID: covidwho-1957067

ABSTRACT

BACKGROUND: The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with the first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with a better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease. METHODS: Trial design: Phase IIA randomised, double-blind, 2 × 2 design, placebo-controlled, interventional trial. RANDOMISATION: Participants will be randomised 1:1 by stratification, with the following factors: gender, obesity, symptomatic or asymptomatic, current smoking status presence or absence of comorbidity, and if the participant has or has not been vaccinated. BLINDING: Participants and investigators will both be blinded to treatment allocation (double-blind). DISCUSSION: We propose to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and patients treated at the Mexican Social Security Institute (IMSS) facilities. Participants with or without symptomatic COVID-19 or who tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate. If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04918927 . Registered on June 9, 2021.


Subject(s)
COVID-19 , Amides , Antiviral Agents/adverse effects , COVID-19/drug therapy , Humans , Nitro Compounds , Pyrazines , SARS-CoV-2 , Secondary Prevention , Thiazoles , Treatment Outcome
4.
Lancet ; 399(10332): 1347-1358, 2022 04 02.
Article in English | MEDLINE | ID: covidwho-1768602

ABSTRACT

Although substantial progress has been made in the diagnosis and treatment of acute coronary syndromes, cardiovascular disease remains the leading cause of death globally, with nearly half of these deaths due to ischaemic heart disease. The broadening availability of high-sensitivity troponin assays has allowed for rapid rule-out algorithms in patients with suspected non-ST-segment elevated myocardial infarction (NSTEMI). Dual antiplatelet therapy is recommended for 12 months following an acute coronary syndrome in most patients, and additional secondary prevention measures including intensive lipid-lowering therapy (LDL-C <1·4 mmol/L), neurohormonal agents, and lifestyle modification, are crucial. The scientific evidence for diagnosis and management of acute coronary syndromes continues to evolve rapidly, including adapting to the COVID-19 pandemic, which has impacted all aspects of care. This Seminar provides a clinically relevant overview of the pathobiology, diagnosis, and management of acute coronary syndromes, and describes key scientific advances.


Subject(s)
Acute Coronary Syndrome , COVID-19 , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/therapy , Humans , Pandemics , Secondary Prevention , Troponin
5.
G Ital Cardiol (Rome) ; 23(2 Suppl 1): e3-e14, 2022 02.
Article in Italian | MEDLINE | ID: covidwho-1765602

ABSTRACT

Razionale. In Italia la pandemia COVID-19 ha determinato importanti riorganizzazioni logistiche nell'erogazione delle cure ospedaliere e di specialistica ambulatoriale. Ciò ha spinto clinici e decisori pubblico-amministrativi della Sanità ad adottare nuovi modelli organizzativi in molteplici scenari clinici. Materiali e metodi. Il registro OIBOH (Optimal Intensification therapy in a Broad Observed High risk patient population with coronary disease) è uno studio osservazionale "cross-sectional" condotto in vari centri italiani di cardiologia ambulatoriale per valutare durante la pandemia COVID-19 la capacità di identificare in breve tempo i pazienti ad altissimo rischio cardiovascolare residuo dopo un evento coronarico recente (<12 mesi). Successivamente alla valutazione clinica iniziale, venivano arruolati i pazienti ritenuti ad altissimo rischio, registrando le caratteristiche cliniche e di trattamento in una scheda di raccolta dati elettronica.Risultati. Al registro hanno partecipato 134 centri di cardiologia ambulatoriale che hanno arruolato 1428 pazienti su 3227 esaminati fra quelli che avevano avuto accesso ad una visita cardiologica durante la pandemia nel periodo ottobre 2020-marzo 2021. Il criterio di arruolamento era costituito dall'aver avuto una diagnosi di coronaropatia confermata angiograficamente negli ultimi 12 mesi, per sindrome coronarica acuta (SCA) o cronica (SCC). La SCA come evento indice era presente nel 93% dei pazienti arruolati mentre la SCC nel 7%. L'età media era 67 ± 10 anni, il 25% era di sesso femminile. Il 96.1% dei pazienti con SCA e il 67.6% dei pazienti con SCC sono stati sottoposti a rivascolarizzazione coronarica. Il 46% e 47% dei pazienti con SCA e SCC, rispettivamente, era diabetico. Oltre il 65% dei pazienti presentava una malattia coronarica multivasale. È stata osservata una importante prevalenza di arteriopatia periferica (17.5% nei pazienti con SCA e 19.6% nei pazienti con SCC). I valori di pressione arteriosa e frequenza cardiaca risultavano ben controllati (128 ± 25.2 mmHg e 65 ± 12.3 b/min nei pazienti con SCA; 127 ± 23.4 mmHg e 67 ± 13.2 b/min nei pazienti con SCC). Viceversa, è stato riportato uno scarso controllo dei livelli di colesterolemia LDL, con un valore medio di 88.8 ± 38.6 mg/dl nei pazienti con SCA e 86 ± 36.6 mg/dl nei pazienti con SCC. Solo il 16.4% dei pazienti con SCA raggiungeva i livelli raccomandati dalle attuali linee guida europee. Nonostante l'estensivo uso di statine (>90%), si è rilevato un utilizzo limitato dell'associazione statina ad alta intensità + ezetimibe (solo il 22.4% dei pazienti). Estremamente basso è stato l'utilizzo di inibitori di PCSK9 (2.5%). La duplice terapia antiaggregante piastrinica (DAPT) è risultata complessivamente ben condotta fin dalla dimissione ospedaliera. Nei pazienti in DAPT, l'inibitore P2Y12 più utilizzato è risultato il ticagrelor alla dose di 90 mg, soprattutto dopo un evento coronarico acuto (in circa l'80% dei pazienti con SCA). Nella stragrande maggioranza dei casi (>90%) i cardiologi ambulatoriali hanno posto indicazione a prosecuzione della DAPT oltre i 12 mesi con aspirina e ticagrelor 60 mg bid. Conclusioni. La gestione del paziente con coronaropatia in fase cronica stabilizzata è molto complessa. Tale complessità logistico-gestionale si è accentuata durante la pandemia COVID-19. Il registro OIBOH ha evidenziato un'ottima capacità di identificare le problematiche clinico-prognostiche delle cardiologie ambulatoriali italiane, specie nei pazienti ad altissimo rischio residuo. Rimangono importanti aree di miglioramento come uno stretto controllo della colesterolemia LDL, mentre altre raccomandazioni delle linee guida, come la prosecuzione della DAPT con ticagrelor 60 mg oltre i 12 mesi, risultano ben applicate. L'implementazione dell'assistenza con la medicina digitale e l'intelligenza artificiale potrebbe migliorare di molto la performance dei clinici.


Subject(s)
COVID-19 , Coronary Disease , Animals , Bees , Disease Outbreaks , Humans , Pandemics/prevention & control , Proprotein Convertase 9 , Registries , Secondary Prevention
6.
J Psychosoc Nurs Ment Health Serv ; 60(3): 11-14, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1732322

ABSTRACT

In 2021, drug overdose deaths exceeded 100,000 for the first time in U.S. history, mostly attributable to opioid overdoses. Medications for opioid use disorders are considered the gold standard for treatment; however, treatment initiation and adherence remain a challenge. Mindfulness-based interventions show efficacy for substance use disorders, and peer support has been shown to improve treatment outcomes. The purpose of the current study was to examine the feasibility and acceptability of the Minds and Mentors Program. Enrollment, randomization, and retention rates were 36%, 49%, and 57%, respectively. Client satisfaction scores ranged from 84.4% to 100%. Approximately 64% of participants attended 10 of 12 treatment sessions, representing treatment adherence. Qualitative analysis revealed four main domains: Permission to Be Honest and Open, Applicability for Everyday Life, Hope Restored, and Changing the Way I Think. [Journal of Psychosocial Nursing and Mental Health Services, 60(3), 11-14.].


Subject(s)
Drug Overdose , Mindfulness , Opioid-Related Disorders , Feasibility Studies , Humans , Opioid-Related Disorders/drug therapy , Secondary Prevention
7.
MEDICC Rev ; 24(1): 70-75, 2022 Jan 31.
Article in English | MEDLINE | ID: covidwho-1687931

ABSTRACT

We discuss the suitability of innate immune stimulation in acute respiratory infection post-exposure prophylaxis. The induction of innate immunity can be used to reduce susceptibility to immune-evasive pathogens (coronavirus, influenza virus, respiratory syncytial virus and rhinovirus). After the emergence of multiple SARS-CoV-2 variants, scientists are debating whether new variants could affect vaccine efficacy and how antigens could be redesigned to compensate. In addition, there is insufficient vaccine production to cover universal demand, and equitable vaccine distribution is a global challenge. Given these factors, non-specific immune stimulators may be suitable for a quick first response in the case of a suspected or early respiratory infection. Our group completed several HeberNasvac studies in healthy volunteers and patients with respiratory infections, and is currently starting large clinical trials in patients with early SARS-CoV-2 infections. This nasal formulation of hepatitis B vaccine has demonstrated its capacity to stimulate innate immunity markers (TLR3, TLR7 and TLR8 in tonsils) at the virus' entry site, in systemic compartments (HLA class II in monocytes and lymphocytes) and in the activation of dendritic cells, lymphocytes and other cell lines in vitro and ex vivo. In addition, research generated by the current pandemic may obtain results useful for treating other acute respiratory infections, which have long been main drivers of mortality among older adults and in early childhood.


Subject(s)
COVID-19 , SARS-CoV-2 , Aged , Child, Preschool , Cuba , Humans , Immunity, Innate , Post-Exposure Prophylaxis , Secondary Prevention
8.
N Engl J Med ; 386(3): 220-229, 2022 01 20.
Article in English | MEDLINE | ID: covidwho-1632249

ABSTRACT

BACKGROUND: Current therapies for recurrent Clostridioides difficile infection do not address the disrupted microbiome, which supports C. difficile spore germination into toxin-producing bacteria. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of recurrent C. difficile infection. METHODS: We conducted a phase 3, double-blind, randomized, placebo-controlled trial in which patients who had had three or more episodes of C. difficile infection (inclusive of the qualifying acute episode) received SER-109 or placebo (four capsules daily for 3 days) after standard-of-care antibiotic treatment. The primary efficacy objective was to show superiority of SER-109 as compared with placebo in reducing the risk of C. difficile infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed. RESULTS: Among the 281 patients screened, 182 were enrolled. The percentage of patients with recurrence of C. difficile infection was 12% in the SER-109 group and 40% in the placebo group (relative risk, 0.32; 95% confidence interval [CI], 0.18 to 0.58; P<0.001 for a relative risk of <1.0; P<0.001 for a relative risk of <0.833). SER-109 led to less frequent recurrence than placebo in analyses stratified according to age stratum (relative risk, 0.24 [95% CI, 0.07 to 0.78] for patients <65 years of age and 0.36 [95% CI, 0.18 to 0.72] for those ≥65 years) and antibiotic received (relative risk, 0.41 [95% CI, 0.22 to 0.79] with vancomycin and 0.09 [95% CI, 0.01 to 0.63] with fidaxomicin). Most adverse events were mild to moderate and were gastrointestinal in nature, with similar numbers in the two groups. SER-109 dose species were detected as early as week 1 and were associated with bile-acid profiles that are known to inhibit C. difficile spore germination. CONCLUSIONS: In patients with symptom resolution of C. difficile infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.).


Subject(s)
Clostridioides difficile , Clostridium Infections/therapy , Firmicutes , Aged , Anti-Bacterial Agents/adverse effects , Double-Blind Method , Feces/microbiology , Female , Gastrointestinal Tract/microbiology , Humans , Intention to Treat Analysis , Male , Microbiota/drug effects , Middle Aged , Recurrence , Secondary Prevention , Spores, Bacterial
9.
Hematology Am Soc Hematol Educ Program ; 2021(1): 76-84, 2021 12 10.
Article in English | MEDLINE | ID: covidwho-1566496

ABSTRACT

Arterial thrombotic events in younger patients without a readily apparent etiology present significant diagnostic and management challenges. We present a structured approach to diagnosis with consideration of common causes, including atherosclerosis and embolism, as well as uncommon causes, including medications and substances, vascular and anatomic abnormalities, systemic disorders, and thrombophilias. We highlight areas of management that have evolved within the past 5 years, including the use of dual-pathway inhibition in atherosclerotic disease, antithrombotic therapy selection in embolic stroke of undetermined source and left ventricular thrombus, the role of closure of patent foramen ovale for secondary stroke prevention, and the thrombotic potential of coronavirus disease 2019 infection and vaccination. We conclude with a representative case to illustrate the application of the diagnostic framework and discuss the importance of consideration of bleeding risk and patient preference in determining the appropriate management plan.


Subject(s)
Thrombosis/diagnosis , Thrombosis/therapy , Adult , Atherosclerosis/complications , Atherosclerosis/diagnosis , Atherosclerosis/therapy , COVID-19/complications , Disease Management , Embolism/complications , Embolism/diagnosis , Embolism/therapy , Female , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/diagnosis , Foramen Ovale, Patent/therapy , Humans , Secondary Prevention , Stroke/prevention & control , Thrombosis/etiology
10.
J ECT ; 37(4): 230-237, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1532626

ABSTRACT

BACKGROUND: Continuation or maintenance electroconvulsive therapy (C/M-ECT) is recommended to reduce relapse rates of patients with major depressive disorder. During the ongoing COVID-19 pandemic, ECT services have come under pressure or needed to close because of redirected resources and safety reasons. We investigated the impact of C/M-ECT discontinuation on relapse in patients with unipolar depressive disorder in Flanders, Belgium. METHODS: Between March 30 and June 18, 2020, all patients receiving C/M-ECT in 2 ECT centers were included. Continuation or maintenance electroconvulsive therapy was discontinued in 33 patients and continued in 4 patients. Relapse was defined as the need to restart ECT or the need for hospitalization. Depressive symptoms were assessed every 3 weeks using the Patient Health Questionnaire, the Clinical Global Impression Scale, and 2 additional patient-rated questions. RESULTS: Relapse in the discontinuation group was 60.6%. All 4 patients who continued ECT remained remitted. Kaplan-Meier survival analysis showed significantly shorter relapse rates for patients receiving bitemporal and/or frequent C/M-ECT (1- to 2-week intervals). Patients older than 60 years showed longer survival rates. CONCLUSIONS: Our results confirm earlier prospective and retrospective data regarding the efficacy and importance of C/M-ECT as relapse prevention. After treatment discontinuation, close monitoring of early warning signs for relapse is crucial, especially in the first few months. With the COVID-19 pandemic continuing, our data provide an indication of the necessity to ensure adequate care and access to ECT not only for the acutely ill but also for the vulnerable patients who are depending on C/M-ECT.


Subject(s)
COVID-19 , Depressive Disorder, Major/therapy , Electroconvulsive Therapy/methods , Pandemics , Adult , Age Factors , Aged , Aged, 80 and over , Belgium , Depressive Disorder, Major/etiology , Depressive Disorder, Major/psychology , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Retrospective Studies , Secondary Prevention , Survival Analysis
12.
Int J Orthop Trauma Nurs ; 43: 100899, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1442404

ABSTRACT

INTRODUCTION: Fracture Liaison Service (FLS) managed secondary fracture prevention services have been hampered during the COVID-19 pandemic. A challenging opportunity is to use pulse-echo ultrasound (P-EU) in the plaster room. The study had two objectives: can P-EU help our decision to justly avoid DXA/VFA scans in plaster treated women (50-70 years) after fracture and whether its use can encourage or nudge all plaster treated patients (>50 years) who need DXA/VFA scans. PATIENTS AND METHODS: 1307 patients (cohort: pre-COVID-19) and 1056 patients (cohort: peri-COVID-19), each of them ≥ 50 years after recent fracture, were studied. Only in women aged 50-70 years, we used a P-EU decision threshold (DI) >= 0.896 g/cm2 to rule out further analysis by means of DXA/VFA. All other plaster patients received P-EU as part of patient information. Peri-Covid-19, all performed DXA/VFA scans were counted until three months post-study closure. By then each patient still waiting for a DXA/VFA had received a scan. RESULTS: Peri-COVID-19, 69 out of 191 plaster-treated women aged 50-70 years were ruled out (36%), for plaster and not in-plaster treated women aged 50-70 years, it was 27%. Comparing all peri-to pre-COVID-19 plaster-treated women and men, a significant P-EU nudging effect was found (difference in proportions: 8.8%) P = .001. CONCLUSION: The combination of patient information and P-EU in the plaster room is effective to reduce DXA/VFA scans and allow extra patients to undergo DXA/VFA. After all, more than a quarter of 50-70 years old women in plaster did not need to be scanned.


Subject(s)
COVID-19 , Osteoporotic Fractures , Spinal Fractures , Aged , Female , Humans , Male , Middle Aged , Osteoporotic Fractures/diagnostic imaging , Osteoporotic Fractures/epidemiology , Osteoporotic Fractures/prevention & control , Pandemics , Retrospective Studies , SARS-CoV-2 , Secondary Prevention , Spinal Fractures/epidemiology
13.
N Engl J Med ; 385(12): 1067-1077, 2021 09 16.
Article in English | MEDLINE | ID: covidwho-1413249

ABSTRACT

BACKGROUND: Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain. METHODS: We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia. RESULTS: A total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76). CONCLUSIONS: Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt. (Funded by the National Health and Medical Research Council of Australia; SSaSS ClinicalTrials.gov number, NCT02092090.).


Subject(s)
Cardiovascular Diseases/prevention & control , Diet, Sodium-Restricted , Hypertension/diet therapy , Stroke/prevention & control , Aged , Cardiovascular Diseases/epidemiology , China , Diet, Sodium-Restricted/adverse effects , Female , Humans , Hyperkalemia/complications , Hypertension/complications , Hypertension/epidemiology , Male , Middle Aged , Mortality , Potassium, Dietary/adverse effects , Secondary Prevention , Stroke/epidemiology
14.
BMJ Open ; 11(9): e050259, 2021 09 06.
Article in English | MEDLINE | ID: covidwho-1394117

ABSTRACT

BACKGROUND: Substance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial. METHODS: A total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants' usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD. TRIAL REGISTRATION NUMBER: UMIN000042186.


Subject(s)
Psychotherapy, Group , Substance-Related Disorders , Cost-Benefit Analysis , Humans , Indonesia , Multicenter Studies as Topic , Quality of Life , Randomized Controlled Trials as Topic , Secondary Prevention , Substance-Related Disorders/prevention & control
19.
MMW Fortschr Med ; 163(11): 28, 2021 06.
Article in German | MEDLINE | ID: covidwho-1258277
20.
Int J Environ Res Public Health ; 18(9)2021 05 02.
Article in English | MEDLINE | ID: covidwho-1231480

ABSTRACT

This paper describes the development of the 'Brain-Fit' app, a digital secondary prevention intervention designed for use in the early phase after transient ischaemic attack (TIA) or minor stroke. The aim of the study was to explore perceptions on usability and relevance of the app in order to maximise user engagement and sustainability. Using the theory- and evidence-informed person-based approach, initial planning included a scoping review of qualitative evidence to identify barriers and facilitators to use of digital interventions in people with cardiovascular conditions and two focus groups exploring experiences and support needs of people (N = 32) with a history of TIA or minor stroke. The scoping review and focus group data were analysed thematically and findings were used to produce guiding principles, a behavioural analysis and explanatory logic model for the intervention. Optimisation included an additional focus group (N = 12) and individual think-aloud interviews (N = 8) to explore perspectives on content and usability of a prototype app. Overall, thematic analysis highlighted uncertainty about increasing physical activity and concerns that fatigue might limit participation. Realistic goals and progressive increases in activity were seen as important to improving self-confidence and personal control. The app was seen as a useful and flexible resource. Participant feedback from the optimisation phase was used to make modifications to the app to maximise engagement, including simplification of the goal setting and daily data entry sections. Further studies are required to examine efficacy and cost-effectiveness of this novel digital intervention.


Subject(s)
Ischemic Attack, Transient , Stroke Rehabilitation , Stroke , Humans , Ischemic Attack, Transient/prevention & control , Life Style , Secondary Prevention , Stroke/prevention & control
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