scholarly journals Capacity and consent to treatment – how well did we do?

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S314-S314
Author(s):  
Khui Chiang Wee ◽  
Nithya Anandan ◽  
Nguemo Angahar ◽  
Abhilash Mannam

AimsAn audit on capacity assessment and consent to treatment on inpatient visits to Atherleigh Park Hospital was performed using the Mental Health Act Code of Practice as a framework. Six standards were evaluated:1) documentation of capacity assessment in patient care records2) documentation of patients who display a lack of capacity3) completion of a Section 58 and/or 62 for detained patients4) documentation of medicines on T2/T3 form and if they match with the patient's prescription chart5) evidence of medication concordance and monitoring of adverse side effects6) patient education on medicines prescribed for themMethodInclusion criteria included patients who were detained under Sections 2, 3 and informal admissions, who were admitted for 72 hours or more, between October and December 2019. This gave a total sample size of 75. Data were collected by looking at patients’ care records and if applicable, their Section paperwork to identify any documentations related to the standards evaluated as above. Data collected were transcribed to a web link, downloaded and analysed.ResultIn standard 1), it was found that 77% of the capacity assessment and consent to treatment forms were recorded in patient care records. Of these, 100% of were completed by a medic and 99% of all sections in the form were completed. However, only 57% of patients were re-assessed when their capacity and consent changed during admission. In standards 2), 3) and 4), documentation of patients who lacked capacity, completion of a Section 58 or 62 form and charting of medications on the T2/T3 forms were fully compliant. In standards 5) and 6), 76% of medication concordance were documented in patients’ records. Only 39% of adverse effects from medications were documented but monitoring compliance was 100%. Medication counselling was done infrequently, with 47% of patients given a leaflet and 28% educated on their side effects.ConclusionAction plans were identified. Firstly, to link the capacity assessment form with patient electronic ward round notes to ensure clinicians complete it at the end of a review. In order to monitor adverse effects from medications, physical examination, blood tests and ECG are to be done following a new prescription, and to be repeated if indicated. Information leaflets on common psychiatric medications are to be made readily available for patients. The findings from this service evaluation and the actions plans were shared with doctors. A re-audit is vital to re-evaluate the hospital's compliance.

2020 ◽  
Author(s):  
Nigel Kirby ◽  
Victoria Shepherd ◽  
Jeremy Howick ◽  
Sophie Betteridge ◽  
Kerenza Hood

Abstract Background Nocebo effects (‘negative placebo’ effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). However, little is known about how information on potential side effects is provided to trial participants. In this study we aimed to increase the evidence-base in this area by identifying the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants. Methods Trials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry. Eligible studies were placebo controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK in three targeted clinical areas (cancer, musculoskeletal conditions and mental and behavioural disorders). Ongoing and recently completed (within three years) trials were included. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11. Results PILs from 33 studies were included. Most of the patient information leaflets were ranked as ‘fairly easy to read’ or ‘difficult to read’ according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33 64%). Discussion Participant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. In comparison to the adverse effects, potential benefits from the intervention and/or study were described less often and by shorter text. Participants were commonly presented with adverse effects ahead of any potential benefits.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 856.3-857
Author(s):  
G. Alvarez ◽  
A. Perez Jaen ◽  
A. Uribe Luna ◽  
M. Rexach Fumaña ◽  
L. Peries Reverter ◽  
...  

Background:Biological therapies have marked a difference in the treatment of many autoimmune conditions. As all treatments, they have their side effects although little evidence of long-term effects has been reported.Objectives:Analyze retrospectively the appearance of infections that required hospitalization and other side effects in patients treated with biological therapies over the past 10 years.Methods:Biological drugs dispensed in our center to non-cancer patients from 2008 to 2018 were reviewed. Health records were collected from our database and all statistical analyzes were performed with the SPSS program.Results:24 different biological drugs applied to 34 medical conditions; 847 treatments were dispensed over a total of 555 patients. The median age was 44 years with a mean duration of 3.6 years of treatment. The most commonly used drug were adalimumab (n = 280, 33%), infliximab (n = 119, 12%), etanercept (n = 97.13%), rituximab (n = 63, 7%), vedolizumab (n = 47, 5.5%) and omalizumab (n = 43.5%). The rest of the drugs were administered <30 times each (ustekinumab, golimumab, certolizumab, tocilizumab, secukinumab and abatacept), representing <4% of the total sample.The underlying conditions included Crohn’s Disease (n = 262, 31%), rheumatoid arthritis (n = 133, 16%), ulcerative colitis (n = 118, 14%), spondyloarthropathies (n = 86, 10%), psoriatic arthritis (n = 56, 7%), psoriasis (n = 49, 6%), asthma (n = 34, 4%), nephropathies (n = 19, 2%) and vasculitis (n = 13, 1.5%). The rest were pathologies with <10 cases.During treatment, infection requiring hospitalization occurred in 10.2% (n = 86). The most frequent focus of infection was respiratory (n = 23, 27%), abdominal (n = 19, 22%), soft tissue-bone (n = 17 cases, 20%), urinary (n = 7, 8%) and tuberculosis (n = 4, 5%). No case of hepatitis reactivation was observed. At the time of hospital admission, 46% of patients were only under biological therapy, 21% had another non-corticosteroid immunosuppressant, 17% were associated with corticosteroid, and 15% had triple therapy (corticosteroids, another immunosuppressant and the biological drug). The drugs associated with more infections were: abatacept 20%, rituximab 16% and adalimumab 13%.During the study period, 14 deaths (1.7%) were observed; being the cause cancer-related (n=5), infection (n=5), the disease itself for which was receiving biological treatment (n=2), and endocrine metabolic causes (n=2).At the end of the review, 48% of the treatments were still in use, while 52% had stopped for various reasons: 20% ineffectiveness, 12% side effects, 12% maintained complete remission. The remaining low percentage was due to death, pregnancy, or study entry.The side effects that led to a change in treatment was: non-immune hematological disorders in 4.1% (14% of tocilizumab, 7% of rituximab and 6% of vedolizumab), immune disorders in 3.8% (6% of secukinumab, 5% of tocilizumab and 4.5% of certolizumab), nervous system involvement in 2.4% (11.5% of golimumab,10% of abatacept, 5% of tocilizumab), debut or worsening of heart failure in 1.4% (9, 5% of tocilizumab, 2.5% of etanercept and 1.4% of adalimumab) and cancer-related in 0.7% (2% of infliximab, 1.7% of etanercept).Conclusion:In these 10 years of follow-up and and evaluating 847 treatments, there were 10% hospitalizations due to infections (n = 86) causing death in 5 patients. In light of these results, and pending an exhaustive statistical analysis, we did not find high frequencies of serious side effects in our series. Very little long-term evidence exists on the safety of these drugs.References:[1]Singh JA, Wells GA, Christensen R, et al. Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev. 2011;2011(2):CD008794. Published 2011 Feb 16.Disclosure of Interests:None declared.


BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S335-S335
Author(s):  
Madhumanti Mitra ◽  
Shahid Hussain ◽  
Emma Raynor ◽  
Joanna Wong ◽  
Jennifer Thom

AimsThe main aim of this audit was to look at documentation in medication charts in an acute mixed inpatient unit in South Manchester. In addition, we also looked at completion of capacity assessment and consent to treatment forms as appropriate.BackgroundSafe prescription, administration and monitoring of medication is key to effective patient care. Due to the busy nature of inpatient hospital wards, errors do unfortunately occur both with the medications, and with the recording of their administration.We will use a data collection tool to collect data as per standards described in our local GMMH policy. The medication chart will be used as the standard, as this is the current chart that is in use in the Trust.MethodData were collected from 31 medication charts for inpatients admitted in the ward between the 5/12/19 to 18/12/19. We captured data from each page of the medication chart that required a record to be made by any staff, including details of prescribing, administration and pharmacist checks. Data were recorded as either Yes/No or NA (Not Applicable). Data were then summarised and analysed using MS excel.ResultOf the 31 patients, 22 (71%) had a capacity assessment form completed and 16 (52%) had a consent to treatment form completed. From the data analysis, it was clear that there are high rates of completion for the ‘essential’ parts of all prescriptions, including medicine name, dose, route and data. ‘Route’ was only recorded for 40% of prescriptions for depot medicines. Details of the administration of a medicine by a nurse was generally well-completed. For as required medications, all information relating to administration (date, time, dose and given by) were fully completed for 100% of prescriptions. For regular prescriptions however, the administration details were not as well-completed, where date of administration was recorded in 84% of prescriptions and signature in 29% of prescriptions. Unique patient identifiers are well-recorded on Page 1 of the prescription chart, though not maintained throughout the prescription chart. Nature of reaction to an allergy or sensitivity was only recorded in 6 of the 21 patients (29%).ConclusionOverall, there were good completion rates for the mandatory parts of the prescriptions. However improvements could be made for prescriptions as well as administration and pharmacy checks. The capacity assessment and consent to treatment forms could be improved upon too. We plan to put the recommendations and re-audit in 3-6 months’ time.


BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S333-S333
Author(s):  
Emma McPhail ◽  
Ian Yanson

AimsImprove and standardise the quality of medical seclusion reviews (MSRs).Acknowledge existing good practise.Highlight areas for improvement.Improve the awareness of doctors performing MSRs of the requirements in the Mental Health Act Code of Practice (MHA CoP)BackgroundMSRs are an essential clinical tool to ensure safe and consistent patient care. Patients detained in seclusion can be at heightened risk of poor mental and physical health, in addition to being a risk to themselves and others. There is clear guidance in the MHA CoP regarding what areas require to be covered in a MSR.MethodA retrospective audit of all MSRs in September 2019 across all patients within all directorates within Rampton Hospital was undertaken. 281 inpatients were identified within Rampton Hospital, and 61 of these patients were found to have had seclusion in September 2019. A total of 439 MSRs were identified for these patients.The standard applied was the MHA CoP guidance for MSRs: 1)MSRs should be conducted in person, and should include:2)Review of physical health3)Review of psychiatric health4)Assessment of the adverse effects of medication5)Review of observations required6)Reassessment of medication prescribed7)Assessment of the patient's risk to others8)Assessment of the patient's risk of self-harm9)Assessment of the need for continuing seclusion100% compliance with targets or a reason why it was not possible was expected to be documented.ResultThe results show there is a large variation in compliance with the MHA CoP. The area with the highest compliance was the completion of reviews in person-(99.3%). The criterion with the average worst compliance was whether the need for physical observations was reviewed-(4.3%). Physical health was reviewed in 86.1% of cases, in contrast to psychiatric health at 38.3%. The adverse effects of medication and reassessment of medication prescribed were recorded in only 8.9%. The risk from the patient to others was recorded in 25.3%, whereas risk to self was recorded in 10.7%. The need for continuing seclusion was recorded in 72.7%.ConclusionThe quality of MSRs at Rampton Hospital is currently inadequate. Improvement in practice is required to meet accepted standards and ensure safe, consistent patient care. Ways to improve this are being considered, including improving the knowledge of the MHA CoP and providing a MSR template.


2019 ◽  
Vol 19 (9) ◽  
pp. 1080-1102 ◽  
Author(s):  
Ghansham S. More ◽  
Asha B. Thomas ◽  
Sohan S. Chitlange ◽  
Rabindra K. Nanda ◽  
Rahul L. Gajbhiye

Background & Objective: :Nitrogen mustard derivatives form one of the major classes of anti-cancer agents in USFDA approved drugs list. These are polyfunctional alkylating agents which are distinguished by a unique mechanism of adduct formation with DNA involving cross-linking between guanine N-7 of one strand of DNA with the other. The generated cross-linking is irreversible and leads to cell apoptosis. Hence it is of great interest to explore this class of anticancer alkylating agents.Methods::An exhaustive list of reviews, research articles, patents, books, patient information leaflets, and orange book is presented and the contents related to nitrogen mustard anti-cancer agents have been reviewed. Attempts are made to present synthesis schemes in a simplified manner. The mechanism of action of the drugs and their side effects are also systematically elaborated.Results::This review provides a platform for understanding all aspects of such drugs right from synthesis to their mechanism of action and side effects, and lists USFDA approved ANDA players among alkylating anticancer agents in the current market.Conclusion: :Perusing this article, generic scientists will be able to access literature information in this domain easily to gain insight into the nitrogen mustard alkylating agents for further ANDA development. It will help the scientific and research community to continue their pursuit for the design of newer and novel heterocyclic alkylating agents of this class in the coming future.


1985 ◽  
Vol 19 (5) ◽  
pp. 349-358 ◽  
Author(s):  
Peter W. Letendre ◽  
Douglas J. DeJong ◽  
Donald R. Miller

The use of methotrexate in rheumatoid arthritis is reviewed. Methotrexate, a folic acid antagonist, is sometimes employed in an attempt to symptomatically control patients whose disease does not respond adequately to conventional therapies. Systemic administration of 7.5–15 mg/wk in a “pulse” fashion appears to be effective without precipitating severe adverse effects. However, concern over potentially serious side effects and a lack of well-controlled clinical trials have limited its use to severe, refractory disease. Further studies are needed before its role in rheumatoid arthritis can justifiably be expanded.


Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 158
Author(s):  
Naira Delgado ◽  
Helena Bonache ◽  
Moisés Betancort ◽  
Yurena Morera ◽  
Lasana T. Harris

It is generally accepted that empathy should be the basis of patient care. However, this ideal may be unrealistic if healthcare professionals suffer adverse effects when engaging in empathy. The aim of this study is to explore the effect of inferring mental states and different components of empathy (perspective-taking; empathic concern; personal distress) in burnout dimensions (emotional exhaustion; depersonalization; personal accomplishment). A total of 184 healthcare professionals participated in the study (23% male, Mage = 44.60; SD = 10.46). We measured participants’ empathy, the inference of mental states of patients, and burnout. Correlation analyses showed that inferring mental states was positively associated with perspective-taking and with empathic concern, but uncorrelated with personal distress. Furthermore, emotional exhaustion was related to greater levels of personal distress and greater levels of inferences of mental states. Depersonalization was associated with greater levels of personal distress and lower levels of empathic concern. Personal accomplishment was associated with the inference of mental states in patients, lower levels of personal distress, and perspective-taking. These results provide a better understanding of how different components of empathy and mental state inferences may preserve or promote healthcare professionals’ burnout.


Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 742
Author(s):  
José Javier Morales-Núñez ◽  
José Francisco Muñoz-Valle ◽  
Carlos Meza-López ◽  
Lin-Fa Wang ◽  
Andrea Carolina Machado Sulbarán ◽  
...  

The main expected result of a vaccine against viruses is the ability to produce neutralizing antibodies. Currently, several vaccines against SARS-CoV-2 are being applied to prevent mortal complications, being Pfizer-BioNTech (BNT162b2) one of the first to be authorized in the USA and Mexico (11 December 2020). This study evaluated the efficacy of this vaccine on antibody production with neutralizing capacity and its side effects in healthcare workers with and without prior SARS-CoV-2 infection and in a group of unvaccinated individuals with prior COVID-19. The main findings are the production of 100% neutralizing antibodies in both groups after the second dose, well-tolerated adverse effects, the possible presence of immunosenescence, and finally, we support that a single dose of this vaccine in individuals with prior COVID-19 would be sufficient to achieve an immunization comparable to people without prior COVID-19 with a complete vaccination program (2 doses).


2018 ◽  
Vol 31 (1) ◽  
pp. 21-24 ◽  
Author(s):  
Andrea Albrecht ◽  
Theresa Penger ◽  
Michaela Marx ◽  
Karin Hirsch ◽  
Helmuth G. Dörr

AbstractBackground:Despite the fact that priming with sex steroids in prepubertal children before growth hormone (GH) provocative tests is recommended, there is an ongoing controversial discussion about the appropriate age of the children, the drug used for priming, the dose and the period between priming and the GH test. Interestingly, there is no discussion on the safety of this procedure. To date, only little data have been available on the possible side effects of priming with testosterone.Methods:We analyzed the outcome in 188 short-statured prepubertal boys who had been primed with testosterone enanthate (n=136: 50 mg; n=51: 125 mg, and accidentally one boy with 250 mg) 7 days prior to the GH test. Serum testosterone levels were measured on the day of the GH test in 99 boys.Results:Overall, only five boys developed adverse side effects. Two boys (dose 125 mg) showed severe low-flow priapism and had to undergo decompression of the corpora cavernosa. One boy suffered from self-limiting priapism and testicular pain (dose 50 mg). Two patients reported testicular pain (each dose 50 mg). The single patient with 250 mg testosterone did not show any adverse effects. The total side effect rate was 2.7%. The serum testosterone levels of the boys with side effects were not different from the testosterone levels of the boys without any side effects.Conclusions:Parents and patients should be informed about the possible side effects of priming with testosterone such as priapism and testicular pain. However, the overall side effect rate is low. We found no correlation between the outcome and the testosterone dose used and/or the level of serum testosterone.


Gut ◽  
1999 ◽  
Vol 44 (6) ◽  
pp. 886-888 ◽  
Author(s):  
P Deltenre ◽  
A Berson ◽  
P Marcellin ◽  
C Degott ◽  
M Biour ◽  
...  

BACKGROUNDTreatment of ulcerative colitis or Crohn’s disease with sulphasalazine causes several adverse effects, including hepatitis. Sulphasalazine is cleaved by colonic bacteria into 5-aminosalicylic acid and sulphapyridine. Received wisdom was that 5-aminosalicylic acid was topically active, whereas sulphapyridine was absorbed and caused immunoallergic side effects. Mesalazine, a slow release formulation of 5-aminosalicylic acid, was expected to be a safe alternative. However, several cases of acute hepatitis have been reported.CASE REPORTA 65 year old man had increased liver enzymes, anti-nuclear and anti-smooth muscle autoantibodies and IgG levels, and lesions of chronic hepatitis after 21 months of mesalazine treatment. Although liver dysfunction had been identified eight months earlier, simvastatin rather than mesalazine had been withdrawn, without any improvement. In contrast, liver enzyme and IgG levels became normal and autoantibodies disappeared after discontinuation of mesalazine administration.CONCLUSIONContrary to initial expectations, mesalazine can cause most of the sulphasalazine induced adverse effects, and hepatic side effects may be almost as frequent. When liver dysfunction occurs, mesalazine administration should be discontinued to avoid the development of chronic hepatitis and liver fibrosis.


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