Ensayo clínico para determinar si el momento de administración del ácido tranexámico en la cirugía de prótesis total de rodilla con torniquete influye en el sangrado perioperatorio

Background and objectivesThe ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear. Our primary objective was to prove if administering it before surgical incision, instead of before releasing the tourniquet, reduces postoperative bleeding. A second objective was to determine whether a second dose reduces post-operative bleeding.Material and methodsA prospective, double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty. They were randomised into 4 groups. Tranexamic acid was administered before the surgical incision in “pre-induction groups” (1 and 2), and just before the tourniquet release in “pre-release groups” (3 and 4). Groups 2 and 4 received a second dose 3 hours post-surgery. Main outcome was postoperative bleeding (visible blood loss and calculated total bleeding). Secondary outcomes were haemoglobin variations, complications and transfusion rate.ResultsThe mean calculated total bleeding was 1563 ml (95%CI: 1445 to 1681) in preinduction groups versus 1576 ml (95%CI: 1439 to 1713) in pre-release groups (P = .9); 1579 ml (95%CI: 1452 to 1706) in single-dose groups versus 1559 ml (95%CI: 1431 to 1686) in double-dose groups (P = .82). One patient was transfused. The mean haemoglobin at discharge was 10.4 g/dl (95%CI: 10.2 to 10.7) in singledose groups versus 10.8 (95%CI: 10.6 to 11.1) in double-dose groups (P = .06).ConclusionsThere were no differences in bleeding or transfusion regarding the time of tranexamic acid administration. The second dose had not impact on outcomes.Trial registration: EudraCT 2016-000071-24.     

Predictive factors of positive online patient ratings of spine surgeons

BACKGROUND

Online physician rating websites are increasingly used by patients to evaluate their doctors. The purpose of this investigation was to evaluate factors associated with better spine surgeon ratings.

Contextualizing the lived experience of quality of life for persons with spinal cord injury: A mixed-methods application of the response shift model

Objective: The objective of this study was to gain greater insight into individuals’ quality of life (QOL) definitions, appraisals, and adaptations following spinal cord injury (SCI).

Design: A mixed-methods design, applying the Schwartz and Sprangers response shift (RS) model. RS is a cognitive process wherein, in response to a change in health status, individuals change internal standards, values, or conceptualization of QOL

Setting: Community-dwelling participants who receive medical treatment at a major Midwestern medical system and nearby Veterans’ Affairs hospital.

Participants: A purposive sample of participants with SCI (N?=?40) completed semi-structured interviews and accompanying quantitative measures.

Interventions: Not applicable.

Outcome Measures: Qualitative data were analyzed using content analysis to identify themes. Analysis of variance were performed to detect differences based on themes and QOL, well-being, and demographic and injury characteristics.

Results: Four RS themes were identified, capturing the range of participant perceptions of QOL. The themes ranged from complete RS, indicating active engagement in maintaining QOL, to awareness and comparisons redefining QOL, to a relative lack of RS. Average QOL ratings differed as a function of response shift themes. PROMIS Global Health, Anxiety, and Depression also differed as a function of RS themes.

Conclusion: The RS model contextualizes differences in QOL definitions, appraisals, and adaptations in a way standardized QOL measures alone do not.     

Exercise and Lifestyle Education program for Brazilians living with prediabetes and diabetes: A pilot randomized trial

AimsTo test the Diabetes College Brazil Study feasibility, the acceptability of study interventions and their preliminary effectiveness, and describe the study protocol modifications due to the COVID-19 pandemic.MethodsSingle-center, double-blinded pilot randomized trial with two parallel groups, Exercise and Lifestyle Education (ExLE; 12-week exercise and educational interventions) and Exercise (Ex; 12-week exercise intervention only) involving patients with prediabetes or diabetes. Feasibility (eligibility, recruitment, retention, completeness of variables measures and participation rates), acceptability (satisfaction), and preliminary effectiveness of interventions (variables: functional capacity, physical activity (PA), exercise self-efficacy, diabetes knowledge, health literacy, adherence to Mediterranean food pattern, glycated hemoglobin (HbA1c), anthropometric measures, cardiac autonomic control, depression, and quality of life (QofL)).ResultsEligibility, recruitment, retention, participation in exercise sessions, and education classes rates were 17%, 93%,82%, 76%, and 71%, respectively. Missing data in the post-intervention assessment (PA, HbA1c, cardiac autonomic control, anthropometric measures, depression, and QofL) were mainly related to research procedure modifications. The interventions were highly acceptable, and most variables improved farther in the ExLE, with moderate effect sizes for PA, diabetes knowledge, health literacy, cardiac autonomic control, and QofL.ConclusionsThe Diabetes College Brazil Study is feasible, and the ExLE may benefit Brazilians living with prediabetes and diabetes.     

Adverse events due to unnecessary radiation exposure in medical imaging reported in Finland

IntroductionAdverse events in radiology are quite rare, but they do occur. Radiation safety regulations and the law obligate organizations to report certain adverse events, harm and near misses, especially events related to patients' health and safety. The aim of this study was to describe and analyse incidents related to radiation safety issues reported in Finland.MethodsThe data were collected from incident reports documented by radiology personnel concerning notifications of abnormal events in medical imaging made to the Radiation and Nuclear Safety Authority between 2010 and 2017. During these eight years, 312 reports were submitted. Only events reported from radiology departments were included; nuclear medicine, radiotherapy and animal radiology cases were excluded. The final number of reports was 293 (94%).ResultsThe majority of the 293 approved reports were related to computed tomography (CT, 68.3%) and to X-ray examinations (27.6%). Altogether 82.9% of those irradiated were adults, most of whom were exposed to unnecessary radiation through CT (86.5%), 5.5% were children, and 4.4% pregnant women. The most common effective dose of unnecessary radiation was 1 mSv or less (89.7% of all examinations). The highest effective doses were reported in CT (from under 1 mSv–20 mSv and above). The reasons for the adverse events were incorrect identification (32%), incorrect procedure, site or side (30%); and human errors or errors of knowledge (20%).ConclusionAdverse events occurred especially in CT examinations. It is important to collect and analyse incident data, assess the harmful events, learn from them and aim to reduce adverse events.Implications for practiceThis study emphasizes the need for radiological personnel to obtain evidence-based information on adverse events and focus on training to improve patient safety.     

Percepciones y deseos sobre el parto en gestantes a término en Zamora

ObjectiveTo describe perceptions and wishes regarding childbirth in a group of full-term pregnant women in Zamora.MethodQualitative study of phenomenological character. Participants and scope of study: pregnant women (37-38 weeks), Zamora Sur and Santa Elena health centres (Zamora, Spain). Data collection: semi-structured interviews, until data saturation (16 interviews). Data analysis: analysis of thematic content.ResultsThe maternal feelings varied from joy to fear or stress. The interviewees said they did not feel capable of enduring the pain of childbirth. The needs that they felt most important were having support and accompaniment during delivery (especially of their partner) and receiving good treatment from the healthcare workers.ConclusionsThe importance and repercussion of childbirth for women are not only biological, but also largely mental, emotional and social. It is conditioned by multiple factors: maternal feelings, their ability to deal with the pain of childbirth, their needs, the changes they have made, the support they have and the health professionals who care for them.     

Wrong tooth extraction: further analysis of “never event” data

The NHS in England requires the reporting of defined “never events” that are directly related to patients’ safety. Analysis of data from 2012–2015 has been published previously in this journal. An examination of continuing data from 2015–2019 shows that “wrong tooth/teeth removed” has not reduced in frequency and it still remains a common “wrong-site surgery” event accounting for between 16% and 24% of wrong-site surgery never events and 7%–10% of all never events reported. Hospitals and community Trusts remain the main source of such reports, although some now originate from primary-care-based dental settings. Further efforts have focused on prevention, and the implementation of existing measures to reduce the risk of wrong tooth extraction, is warranted.     

Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry’s self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012–2016, we evaluate the transparency of reporting using indicators derived from industry’s European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry’s self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.