Contraceptive Methods--side effects
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AIMS: Community-based pharmacists are an important stakeholder in providing continuing care for chronic multi-morbid patients, and their role is steadily expanding. The aim of this study is to examine the literature exploring community-based pharmacist-initiated and/or -led deprescribing and to evaluate the impact on the success of deprescribing and clinical outcomes. METHODS: Library and clinical trials databases were searched from inception to March 2020. Studies were included if they explored deprescribing in adults, by community-based pharmacists and were available in English. Two reviewers extracted data independently using a pre-agreed data extraction template. Meta-analysis was not performed due to heterogeneity of study designs, types of intervention and outcomes. RESULTS: A total of 24 studies were included in the review. Results were grouped based on intervention method into four categories: educational interventions; interventions involving medication review, consultation or therapy management; pre-defined pharmacist-led deprescribing interventions; and pharmacist-led collaborative interventions. All types of interventions resulted in greater discontinuation of medications in comparison to usual care. Educational interventions reported financial benefits as well. Medication review by community-based pharmacist can lead to successful deprescribing of high-risk medication, but do not affect the risk or rate of falls, rate of hospitalisations, mortality or quality of life. Pharmacist-led medication review, in patients with mental illness, resulting in deprescribing improves anticholinergic side effects, memory and quality of life. Pre-defined pharmacist-led deprescribing did not reduce healthcare resource consumptions but can contribute to financial savings. Short follow-up periods prevent evaluation of long-term sustainability of deprescribing interventions. CONCLUSION: This systematic review suggests community-based pharmacists can lead deprescribing interventions and that they are valuable partners in deprescribing collaborations, providing necessary monitoring throughout tapering and post-follow-up to ensure the success of an intervention.
- MeSH
- depreskripce * MeSH
- dospělí MeSH
- farmaceuti * MeSH
- kvalita života MeSH
- lidé MeSH
- poskytování zdravotní péče MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- systematický přehled MeSH
Od 60. let minulého století hraje hormonální antikoncepce důležitou roli v životě spousty mladých žen. I přesto, že správně indikovaná antikoncepce přispívá jak tělesnému, tak duševnímu zdraví žen a je pro mnoho z nich výbornou ochranou před neplánovaným těhotenstvím, je některými odmítána pro obavy, které ne vždy nalézají oporu v dnešní medicíně založené na důkazech. I hormonální antikoncepce má své nežádoucí účinky, a proto je nutná racionální diskuze s lékařem, aby bylo každé ženě umožněno učinit informované rozhodnutí o výběru ochrany před neplánovaným těhotenstvím.
Since the 1960s, hormonal contraception has played an important role in the lives of many young women. Despite the fact that properly indicated contraception contributes to both the physical and mental health of women and for many of them is an excellent protection against unplanned pregnancy, it is rejected by some because of concerns that are not always supported by today's evidence-based medicine. Even hormonal contraceptives have side effects a rational discussion with doctor is necessary to allow each woman to make an informed decision about her choice of protection from unplanned pregnancy.
Oral contraceptive pills (OCPs) have some strong advantages over more traditional types of contraception, including their consistently high contraceptive effect as well as multiple additional positive side effects. OCPs went through decades of intense pharmaceutical development and current formulas are well optimized - however, a handful of their negative side effects remain, including some that affect cardiovascular system, for example higher risk of hypertension, venous thromboembolism and increased arterial stiffness. The gold standard for arterial stiffness assessment is currently applanation tonometry, a method that relies on arterial pulse wave velocity measurement (PWV). Another possible method for arterial stiffness measurement is the use of the VaSera device, which measures cardio-ankle vascular index (CAVI). The aim of this study was to discover the effect of OCPs use on selected cardiovascular parameters related to arterial stiffness. We measured these cardiovascular parameters in the OCPs using group (OCP) and in the control group (CTRL) using applanation tonometer Sphygmocor and the VaSera device. Comparison of the data from both groups showed us significantly increased diastolic blood pressure (DBP) and carotid-radial pulse wave velocity (crPWV) as well as significantly lower subendocardial viability index (SVI) in the OCP. These results imply a negative effect of hormonal contraceptives on the cardiovascular system with most of the negative changes affecting the peripheral arteries. Despite this evidence supporting the hypothesis of OCPs having a negative effect on cardiovascular health, further research is necessary.
- MeSH
- analýza pulzové vlny * MeSH
- arteriae carotides MeSH
- arteriální tlak MeSH
- hormonální antikoncepce * škodlivé účinky MeSH
- krevní tlak fyziologie MeSH
- lidé MeSH
- mladiství MeSH
- pilotní projekty MeSH
- tuhost cévní stěny * fyziologie MeSH
- Check Tag
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
- MeSH
- COVID-19 komplikace terapie MeSH
- délka pobytu MeSH
- dexamethason aplikace a dávkování MeSH
- glukokortikoidy aplikace a dávkování MeSH
- hodnocení ekvivalence jako téma MeSH
- klinické zkoušky, fáze II jako téma MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- progrese nemoci MeSH
- randomizované kontrolované studie jako téma MeSH
- SARS-CoV-2 MeSH
- syndrom dechové tísně etiologie terapie MeSH
- umělé dýchání * MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- protokol klinické studie MeSH
Purpose: The contraceptive pill is an effective and safe method of preventing pregnancy. The progestins used for contraception either are components of a combined hormonal contraceptive (tablets, patches or vaginal rings) or are used alone in progestin-only formulations. Progestin-only contraceptives are available as daily oral preparations, subcutaneous or intramuscular injectables (every 1-3 months), subdermal implants (every 3-5 years) and intrauterine systems (every 3-5 years). Long-acting progestins are highly effective in typical use and have a very low risk profile and few contraindications.Material and Methods: A new progestin-only, oestrogen-free contraceptive, drospirenone, in a dosage of 4 mg/day in a 24/4 regimen, has received regulatory approval in the USA and the EU. The molecule has antigonadotropic, antimineralocorticoid, antiestrogenic and antiandrogenic properties.Results: The regimen was chosen to improve the bleeding profile; maintain plasma oestradiol levels at those of the early follicular phase, to avoid hypoestrogenism; and preserve efficacy even with a missed pill, as drospirenone has a half-life of 30-34 h.Conclusions: Clinical studies have shown good efficacy, very low cardiovascular side effects and a favourable bleeding pattern, as well as maintenance of ovulation inhibition after scheduled 24 h delays in pill intake.
BACKGROUND: Men in sub-Saharan Africa are less likely than women to get tested for HIV, less likely to present for treatment, less likely to be maintained in treatment, more likely to have detectable viral load, more likely to transmit HIV with unprotected intercourse, and more likely to progress to AIDS and die sooner from HIV. The ultimate objective of this research is to provide evidence-based strategies to improve HIV testing and treatment of HIV-infected men. METHODS: This study is being conducted in the Greater Edendale Area and Vulindlela region in KwaZulu-Natal, South Africa. It is a two-stage design of a cluster-randomized trial and an individual randomized trial to test how structural and individual-level interventions address the demand-side factors that affect HIV testing and treatment for hard-to reach, high-risk men. It combines male-focused mobilization, community-based mobile HIV testing services, and a small incentive to determine if the strategies singly and in combination can result in more men diagnosed with HIV, and more men linked to and maintained in care with undetectable viral load. DISCUSSION: A priority for sub-Sahara Africa is developing and evaluating novel and cost-effective strategies for identifying hard-to-reach groups such as men, linking them to HIV testing and care services, and maintaining them in care to the point of viral suppression. We propose a combination prevention intervention that addresses men's individual, interpersonal, and structural barriers to testing and care. This includes male-led mobilization to encourage uptake of testing and treatment, male-focused testing venues, male-only counselors, developing counseling models that are flexible and responsive to men, and strategies for adhering to clinic visits without missing work and navigating the healthcare system. By thoughtfully combining male-focused mobilization, and testing and addressing some of the barriers to male engagement with health facilities, this study hopes to add to the growing evidence base about how to reach, test, link, and maintain a hard-to-reach group such as men in HIV treatment and care services. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03794245. Registered on 4 January 2019.
- MeSH
- adherence a compliance při léčbě * MeSH
- ELISA MeSH
- HIV infekce diagnóza farmakoterapie epidemiologie virologie MeSH
- HIV imunologie MeSH
- lidé MeSH
- následné studie MeSH
- plošný screening MeSH
- poradenství MeSH
- poskytování zdravotní péče metody MeSH
- prevalence MeSH
- sexuální faktory MeSH
- virová nálož MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Jihoafrická republika MeSH
- MeSH
- dospělí MeSH
- kontraceptiva orální hormonální * škodlivé účinky terapeutické užití MeSH
- kouření cigaret epidemiologie škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- nežádoucí účinky léčiv epidemiologie etiologie MeSH
- pilotní projekty MeSH
- primární prevence statistika a číselné údaje trendy MeSH
- průzkumy a dotazníky MeSH
- rezistence k aktivovanému proteinu C diagnóza epidemiologie komplikace MeSH
- rizikové faktory MeSH
- žilní tromboembolie epidemiologie etiologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- ženské pohlaví MeSH
Cíl studie: Cílem studie bylo srovnání dvou skupin žen, které podstoupily umělé ukončení těhotenství farmakologickou (faUUT) a chirurgickou instrumentální (inUUT) metodou do 49. dne amenorey. Typ studie: Prospektivní klinická studie. Název a sídlo pracoviště: Gynekologicko-porodnická klinika 1. LF UK a Nemocnice Na Bulovce, Praha. Metodika: Od srpna 2014 do července 2017 bylo na našem pracovišti provedeno celkem 838 umělých ukončení těhotenství do 49. dne amenorey. Celkem 474 žen podstoupilo faUUT a u 364 žen bylo provedeno inUUT. Srovnávali jsme anamnestické, sociodemografické a zdravotní charakteristiky subjektů a hodnotili jsme účinnost, vyžádané medicínské zásahy, spotřebu léků, množství a typ komplikací v obou skupinách. Výsledky: Ženy, které podstoupily faUUT, byly méně často po porodu (40,9 % vs. 75,0 %; p < 0,001), ale častěji byly po UUT (27,8 % vs. 19,5 %; p = 0,003). Celkový počet ambulantních návštěv byl signifikantně odlišný mezi oběma skupinami v mediánu (4 vs. 1; p < 0,001) i v průměru (3,8 vs. 1,2; p < 0,001). Spotřeba uterotonik byla výrazně vyšší ve skupině s faUUT (25,7 % vs. 8,2 %; p < 0,001). Na druhou stranu použití antibiotik bylo podobné v obou skupinách (3,2 % vs. 4,4 %; p < 0,17). Chirurgická intervence (revisio cavi uteri instrumentalis, RCUI) byla provedena u 7,4 % případů po faUUT a u 3,0 % ve skupině po inUUT (p < 0,001). Selhání faUUT bylo zjištěno ve dvou (0,4 %) případech. Závěr: Komplikace a další sledované parametry byly mezi oběma skupinami odlišné. Farmakologické ukončení těhotenství je bezpečná metoda s několika potenciálními život neohrožujícími komplikacemi.
Objective: The aim of this study was to compare two cohorts of subjects who underwent termination of pregnancy up to 49 days of amenorrhoea by medical (pharmacological) termination (faUUT) and surgical instrumental termination of pregnancy (inUUT). Design: Prospective clinical study. Setting: Department of Gynecology and Obstetrics, Charles University in Prague, 1st Faculty of Medicine, Hospital Na Bulovce. Methods: From August 2014 to July 2017, a total of 838 terminations of pregnancy up to 49 days of amenorrhoea were performed at our department. Altogether 474 of subjects underwent faUUT and inUUT was performed in 364 of women. We compared the anamnestic, sociodemographic, and health characteristics of women and we evaluated the efficacy, required medical interventions, medication use, the number and characteristics of complications in both groups. Results: Women who underwent faUUT, were fewer with previous delivery (40.9% vs. 75.0%; p < 0.001), but they had more often previous artificial termination of pregnancy (27.8% vs. 19.5%; p = 0.003). The total number of outpatient visits was significant different between both cohorts, both in median (4 vs 1; p < 0.001) and arithmetic mean (3.8 vs. 1.2; p < 0.001). The usage of uterotonics was much higher in faUUT group (25.7% vs. 8.2%; p < 0.001). On the other side, the antibiotic use was similar in both groups (3.2% vs. 4.4%; p < 0.17). The surgical intervention (revisio cavi uteri instrumentalis, RCUI) required after termination of pregnancy was performed in 7.4% of faUUT cases and in 3.0% of inUUT group (p < 0.001). The failure of faUUT was found in 2 (0.4%) subjects. Conclusion: The complications and other followed parameters were various between both groups. Medical termination of pregnancy is a safe method with some potential non life-threatening complications.
- Klíčová slova
- farmakologické ukončení těhotenství, chirurgické ukončení těhotenství,
- MeSH
- abortiva škodlivé účinky terapeutické užití MeSH
- dospělí MeSH
- indukovaný potrat * metody MeSH
- klinická studie jako téma MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- pooperační komplikace MeSH
- první trimestr těhotenství MeSH
- těhotenství MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- práce podpořená grantem MeSH
Senioři v zařízení sociálních služeb jsou v důsledku problematické dostupnosti zdravotní péče ohroženi nadužíváním léků a dalšími polékovými problémy. Potvrdila to šetření týmu klinických farmaceutů v šesti domovech pro seniory. Ukazuje to na nutnost řešit tuto situaci koncepčně a systémově v celé České republice.
Seniors in social care facilities are threatened by overmedication and other drug related problems due to problematic access to healthcare. This was confirmed by a survey of a team of clinical pharmacists at six nursing homes for the elderly. It shows the need to solve this situation conceptually and systemically throughout the Czech Republic.
Background: The availability of various oral contraceptive (OC) pill formulations with different hormone compositions suggests that there is potential to align a particular product with an individual user's needs and preferences. To explore this concept further, a survey was conducted of current users of OCs to define and confirm areas of specific needs, and to gain insight into their views and preferences for OC formulations. Methods: During November and December 2015, women users (n=615) of OCs in five Central and Eastern European countries were surveyed in face-to-face interviews conducted by experienced interviewers. The survey questionnaire comprised 34 questions about the use of and specific needs for OCs. Results: Four basic needs of women taking OCs were identified: reliable contraception, reversibility of contraception, no effect on body weight and safety. Overall, 85% of surveyed women indicated that prevention of pregnancy was the main reason for taking OCs. Weight gain was the side effect of greatest concern with OC use (46% spontaneous answer; 65% aided answer). Independent behavioural segmentation analysis identified four groups - Solved Cycle Problems (46% of participants), Low Hormone Content (22%), Lifestyle (17%) and Beauty (14%) - which characterised the women according to needs and preferences beyond the basic needs of OCs. Each group had unique features and distinct preferences for different formulations of OCs. Conclusions: Aligning product advantages with specific individual needs may enhance users' overall experience with OCs as a contraceptive option.
- Publikační typ
- časopisecké články MeSH