Dataset Information

Does written informed consent adequately inform surgical patients? A cross sectional study.

ABSTRACT:

Background

Informed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.

Methods

Adult postsurgical patients in nine general hospitals of Italy's Campania Region were interviewed via a structured questionnaire between the second and seventh day after the surgery at the end of the first surgical follow up visit. Physicians who were independent from the surgical team administered the questionnaire.

Results

The written IC form was given to 84.5% of those interviewed. All recipients of the form signed it, either personally or through a delegate; however, 13.9% did not know/remember having done so; 51.8% said that they read it thoroughly. Of those who reported to have read it, 90.9% judged it to be clear. Of those receiving the written consent form, 52.0% had gotten it the day before the surgery at the earliest 41.1% received it some hours or immediately before the procedure. The written IC form was explained to 65.6% of the patients, and 93.9% of them received further oral information that deemed understandable. Most attention was given to the diagnosis and the type of surgical procedure, which was communicated respectively to 92.8 and 88.2% of the patients. Almost one in two patients believed that the information provided some emotional relief, while 23.2% experienced increased anxiety. Younger patients (age???60) and patients with higher levels of education were more likely to read the written IC form.

Conclusions

The written IC form is not sufficient in assuring patients and making them fully aware of choices they made for their health; pre-operative information that was delivered orally better served the patients' needs. To improve the quality of communication we suggest enhancing physicians' communication skills and for them to use structured conversation to ensure that individuals are completely informed before undergoing their procedures.

SUBMITTER: Agozzino E

PROVIDER: S-EPMC6323683 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Does written informed consent adequately inform surgical patients? A cross sectional study.

Agozzino Erminia E Borrelli Sharon S Cancellieri Mariagrazia M Carfora Fabiola Michela FM Di Lorenzo Teresa T Attena Francesco F

BMC medical ethics 20190107 1

<h4>Background</h4>Informed consent (IC) is an essential step in helping patients be aware of consequences of their treatment decisions. With surgery, it is vitally important for patients to understand the risks and benefits of the procedure and decide accordingly. We explored whether a written IC form was provided to patients; whether they read and signed it; whether they communicated orally with the physician; whether these communications influenced patient decisions.<h4>Methods</h4>Adult post ...[more]

PMID: 30616673

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Project description:BackgroundInformed consent is a process that needs time and effort to satisfy patients' desires. Patient dissatisfaction on preoperative informed consent process may be caused by multiple factors of clinical practice. This study aimed to assess patients' satisfaction and associated factors of informed consent process among elective surgical patients.MethodsA cross-sectional study was conducted on 404 postoperative patients who signed the informed consent for elective surgery. A systematic sampling technique was applied to select the study participants. Modified Leiden perioperative patient satisfaction tool was adapted to assess patients' satisfaction with preoperative informed consent process. Data were entered in to Epi-data version 4.20 and exported to SPSS version 20 for analysis. Bivariate and multivariable logistic regression was computed to identify independent variables associated with patient satisfaction towards preoperative informed consent process. A p-value of less than 0.05 was used to declare the statistical significance.ResultsThe overall satisfaction of patients with preoperative informed consent process was 70.3%. Multivariable logistic regression analysis revealed that, being male (AOR: 4.75, 95% CI: 2.47-9.16), primary school (AOR: 8.42, 95% CI: 4.74-7.55), secondary school (AOR: 2.17, 95% CI: 5.74-8.62), rural residence (AOR: 1.8, 95% CI: 2.1-3.9) and received general anesthesia (AOR: 2.92, 95% CI: 1.62-5.26) were significantly associated with patients' satisfaction with the informed consent process.ConclusionThe overall patients' satisfaction on preoperative informed consent process was relatively low. Being male, low level of education, living in rural area, and receiving general anesthesia were significantly associated with patients' satisfaction on informed consent process. Surgeons and anesthesia professionals need to work more to improving the satisfaction of patients with preoperative informed consent process. Researchers are expected to do periodic assessment of patients' level of satisfaction and factors affecting satisfaction.

Project description:OBJECTIVE:To determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents. DESIGN:Retrospective observational study of informed consent documents. SETTING:25 US hospitals, diverse in size and geographical region. COHORT:Among Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital. PRIMARY OUTCOME:The outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0-20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback. RESULTS:Among 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality. CONCLUSION:All hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital's informed consent documents can serve as a first step in driving attention to gaps in quality.

Project description:BackgroundInformed consent (IC) is a healthcare standard emphasizing the meaning of human dignity as clarified in the Universal Declaration of Human Rights. Data about IC practices in Egypt is insufficient. This study aimed to assess the Egyptian patients'/guardians' experiences about IC and their expectations about its practices' purposes in general and according to the type of the healthcare facility.MethodsSelf-administered questionnaire was carried out for 1092 participants who had undergone or were scheduled to a procedure requiring an IC at three studied types for Egyptian health care facilities. Ten statements were ranked twice by the participants to reflect their perception of IC purpose as per what is currently practiced and what they believe should be practiced.ResultsIC implementation varies significantly (p<0.05) across the health care facilities in Egypt. The percentage of its implementation at the non-governmental facilities, governmental facilities, and university hospital was 85.9%, 77.8%, and 63.8 respectively. The first three ranked purposes of the current IC practices were: "Helping patient/guardian decide (64.9%)", "Documenting patient's/guardian's decision (59.3%)", and "Having shared decision (57.3%)". The perceived purposes of IC to be practiced were: "Informing the patient/guardian (68.4%)", "Making sure patient/guardian understand (65.3%)" and "Documenting patients/guardians decisions (65.1%)". "Being a meaningless routine" was reported by the majority to be ranked as a low purpose for IC current and preferred practices.ConclusionThe practice of IC is common within the Egyptian medical community. Participants believe that information disclosure "Making sure patients understand" has to help in IC decision making and its main purpose. However, unfortunately, this is not perceived as a current purpose of IC. There was consensus agreement that documenting the patient's/guardian's decision and informing the patient/guardian are perceived as both important current and preferred purposes for IC practices.

Project description:IntroductionInformed consent is the process whereby a patient makes a voluntary decision about their medical and surgical care with knowledge of the benefits and potential risks. Poor informed consent processes may increase potential for medical errors and malpractice. Little is known of the knowledge of surgical informed consent with regard to their surgical treatment in Ethiopia. Therefore, this study aimed to assess the knowledge of surgical informed consent and associated factors among patients who underwent obstetric and gynecologic surgery at Jimma Medical Center, Jimma, Ethiopia.Methods and materialsAn institution-based cross-sectional study was conducted from April 1 to May 30, 2020, among 404 women undergo obstetric and gynecologic surgery at Jimma Medical Center. Data were collected through a face-to-face interview using a structured questionnaire. The collected data were coded, entered into Epi data version 3.1, and analyzed using SPSS version 25. Bivariate and multivariate regression analyses were performed to determine the association between an outcome variable and an independent variable. Tables, pie-charts, and texts were used to report the result.ResultsOf 404 patients sampled, only 372 women were agreed and participated in the study and gave response rate of 92.1%. The respondent satisfaction level (AOR 1.823 (95%CI 1.061-3.134)) and patient to provider relationship (AOR 0.472 (CI 1.217-3.697)) were associated with knowledge of surgical informed consent.ConclusionThe overall level of knowledge regarding informed consent for surgerywas significantly lower than that of other national and international figures. Patient satisfaction and patientto provider relationships were associated with knowledge of surgical informed consent. Adequate information should provide before surgery to improve patients' knowledge regarding surgical informed consent and to improve the consent process to make it better suited to fit the needs of all patients.

Project description:AimsPragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US.MethodsThe study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. The primary outcome measures were respondents' personal preference and hypothetical recommendation to a research ethics committee regarding the use of written informed consent vs. the alternatives.ResultsA total of 2008 adults sampled from a probability-based online panel responded to the web-based survey conducted in May 2016 (response rate: 61%). Overall, 77% of respondents endorsed written consent. In both scenarios, the alternative of general notification received significantly more support (28.7-37.1%) than the alternative of verbal consent (12.7-14.0%) (P = 0.001). Forty per cent of respondents preferred and/or recommended general notification rather than written consent.ConclusionsThe results suggested that, rather than attempting to waive written consent, current pRCTs should focus on developing ways to implement written consent that provide sufficient information without undermining recruitment or increasing selection bias. The finding that around 40% of respondents endorsed general notification over written consent raises the possibility that, with educational efforts, the majority of Spaniards might accept general notification for low-risk pRCTs.

Project description:Universal salt iodization is the most cost-effective, safe and sustainable strategy to eliminate iodine deficiency disorders. However, little is known about the availability of adequately iodized salt in the northwestern part of Ethiopia. Thus, the aim of this study was to assess the availability of adequately iodized salt at the household level and associated factors in Dabat District, northwest Ethiopia.A community-based cross-sectional study was conducted from February 21 to March 31, 2016. We included 705 households in the study. A stratified multistage followed by simple random sampling technique was employed to select households. The level of salt iodine content was determined using the rapid field test kit. Accordingly, the value of <15 parts per million (PPM) and ≥15 PPM with the corresponding color chart on the rapid test kit were used to classify the level of iodine content in the sampled salt. A multivariable binary logistic regression model was fitted to identify factors associated with the availability of adequately iodized salt. Adjusted Odds Ratio (AOR) with the corresponding 95% Confidence Interval (CI) was calculated to show the strength of association.This study indicated that about 33.2% [95% CI: 29.6, 36.7%] of households had adequately iodized salt. Urban residence (AOR = 2.15, 95% CI: 1.23, 3.76), use of packed salt (AOR = 2.23, 95% CI: 1.01, 4.89), and good respondents' knowledge on iodized salt use (AOR = 1.49, 95% CI: 1.08, 2.08) were positively associated with the availability of adequately iodized salt. However, longer distance to buy salt was inversely related with availability of adequately iodized salt (AOR = 0.68, 95% CI: 0.48, 0.99).The availability of iodized salt is well under the WHO recommendation in Dabat District in spite of the fact that Ethiopia has been implementing universal salt iodization since the last five years. Therefore, intensifying strategies targeting to enhance community awareness on the benefit and handling practice of iodized salt is essential to improve availability of iodized salt. In addition, the focus needs to be on improving accessibility of iodized salt.

Dataset Information

Does written informed consent adequately inform surgical patients? A cross sectional study.

Background

Methods

Results

Conclusions

Publications

Does written informed consent adequately inform surgical patients? A cross sectional study.

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