Dataset Information

Perceptions and practices regarding the process of obtaining informed consent from surgical patients at a tertiary care hospital.

ABSTRACT:

Background

Proper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.

Methods

A cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was performed by using SPSS version 23.

Results

Out of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).

Conclusion

The patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.

SUBMITTER: Arshad MA

PROVIDER: S-EPMC8767235 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:We examined the process of obtaining informed consent (IC) for clinical research purposes in long-term care facilities (LTCFs) in Rhode Island (RI), USA. We assessed factors that were associated with resident ability to consent, such as Brief Interview for Mental Status scores. We used a self-administered questionnaire to further understand the effect of LTCF staff evaluation of ability to consent on residents' autonomy and control over their medical decision making.Observational clinical studyLong-term care setting.LTCF personnel provided us with residents' names, as well as their professional assessment of resident ability to consent. We used Brief Interview for Mental Status (BIMS) scores to assess the cognitive capacity of all residents to assess, and compare it to the assessment provided by LTCF personnel. A logistic regression analysis was performed to determine the relationship between LTCF assessment of resident ability to consent and BIMS score or confirmed diagnosis of dementia as seen from residents' medical charts. A self-administered questionnaire was filled out by the personnel of 10 LTCFs across RI, USA.LTCF personnel in 9 out of 10 recruited facilities reported that their assessment of resident ability to consent was based on subjective assessment of the resident as alert and oriented. There was a statistically significant relationship between the LTCF assessment of resident ability to consent and previously diagnosed dementia (OR: 0.211, 95% CI 0.107-0.415). Therefore, as BIMS scores increased, the likelihood that the resident would be deemed able to consent by LTCF personnel also increased. Furthermore, there was a statistically significant relationship between LTCF assessment of resident ability to consent and BIMS scores (OR: 1.430, 95% CI 1.274-1.605).There is no standard on obtaining IC for research studies conducted in LTCFs. We recommend that standardizing the process of obtaining IC in LTCFs can enhance the ability to perform research with LTCF residents.

Project description:BackgroundThe requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients.MethodsThis was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification.ResultsOverall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent.ConclusionsAs in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general notification, b) data from the US have shown that most patients who prefer written consent are willing to forego it if obtaining written consent makes the trial too difficult to be conducted; and c) 2016 CIOMS guidelines endorse waivers of consent when the trial fulfills specific conditions. Surveys in other EU countries are needed to assess what patients believe towards pRCTs. If similar results to that reported in this study are found, it is foreseeable that with educational efforts, general notification could be an acceptable and widespread approach to the conduct of low-risk pRCTs.

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