|Year : 2020 | Volume
| Issue : 1 | Page : 38-42
Differences, occasioned by an interval of 1 week, in consent information recall by daycare prostate biopsy patients
Ikenna I Nnabugwu1, Fredrick O Ugwumba1, Solomon K Anyimba2
1 Department of Surgery, College of Medicine, Enugu Campus, University of Nigeria, Enugu State, Nigeria; Department of Surgery, University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu, Nigeria
2 Department of Surgery, University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu, Nigeria
|Date of Submission||18-Jun-2019|
|Date of Decision||22-Dec-2019|
|Date of Acceptance||09-Feb-2020|
|Date of Web Publication||03-Apr-2020|
Dr. Ikenna I Nnabugwu
Department of Surgery, College of Medicine, Enugu Campus, University of Nigeria, PMB 01129, Enugu State.
Source of Support: None, Conflict of Interest: None
Objective: The objective of this study was to evaluate the extent of recall of consent information by daycare prostate biopsy patients in a low-literacy setting and to compare the extent of recall 1 week against the extent of recall 2 weeks after formal consent session. Materials and Methods: This is a cross-sectional study where consecutive patients for daycare prostate biopsy at a tertiary hospital were recruited from February to November, 2017. After giving informed consent for the study, the participants were randomized to receive formal consent session 1 week (Group A) or 2 weeks (Group B) to the planned date of procedure. Extent of recall was ascertained on the procedure day using semi-structured researcher-administered questionnaire from only participants who checked in with Generalized Anxiety Disorder 7 (GAD-7) score ≤ 9. Data were analyzed using Statistical Package for Social Sciences software, version 21.0, IBM Co., Armonk, NY, USA. Results: At 15.8%, the recall of the risks associated with the planned procedure was poorer than the recall of nature of the disease condition (75.8%), and the recall of nature of the planned procedure (54.7%). Aggregate recall on consent information was not influenced by age (P = 0.57) or formal education status (P = 0.13) of participants, and did not vary between the two groups (P = 0.53). Conclusion: Recall of consent information on risk of planned procedure is poorer than that on the nature of disease and on the nature of planned procedure. There is no evidence that aggregate recall on consent information among daycare prostate biopsy patients changes significantly in the short term (one week) irrespective of formal education status and patient age.
Keywords: Consent-information recall, daycare procedure, prostate biopsy
|How to cite this article:|
Nnabugwu II, Ugwumba FO, Anyimba SK. Differences, occasioned by an interval of 1 week, in consent information recall by daycare prostate biopsy patients. Int J Med Health Dev 2020;25:38-42
|How to cite this URL:|
Nnabugwu II, Ugwumba FO, Anyimba SK. Differences, occasioned by an interval of 1 week, in consent information recall by daycare prostate biopsy patients. Int J Med Health Dev [serial online] 2020 [cited 2020 Nov 29];25:38-42. Available from: https://www.ijmhdev.com/text.asp?2020/25/1/38/281883
| Introduction|| |
Any surgical procedure is a significant event in a patient’s life, and it is perceived to be associated with risks by all involved. Some procedures, however, are undertaken as daycare procedures based on the understanding that the patients have minimal risk of significant post-procedure morbidity.,,, Prostate biopsy is one such procedure. Informed consent process in ambulatory surgical setting akin to that in major nonambulatory surgical settings addresses all known sources of concerns for the patients in a bid to ensure optimum comprehension, allay procedure-associated anxiety, and delay the individual’s information attrition rate.,
It is known that the extent of information recalled after informed consent session depends on many factors such as cognitive ability, literacy level, nature of planned procedure, and previous experience. These influence the level of anxiety of the patients with respect to the planned procedure. The time after the consent session that the recall is required of the individual is also a factor that influences the extent of recall. This observation is as a result of the recognized phenomenon of time-dependent information attrition.
Recall of information transmitted during consent sessions for planned procedures is known to be generally low, even among patients scheduled for minor procedures. Despite these challenges, the extent of recall of consent information by the patient remains a recognized approach to assess the understanding of the indication for, the nature of, and the risks associated with the proposed treatment procedure. Therefore, to improve on consent information delivery and retention, various strategies known to increase extent of recall of consent information by patients have been deployed.,
However, irrespective of the strategy deployed, it is advocated that personalized communication, in contrast to top-down exposition, should take place between the physician and the patient to allay all anxieties and maximize patient understanding. This personalized communication approach reduces paternalism and checks against information overwhelm.,
Individuals vary with the level of anxiety shown when faced with the challenge of making a decision to give consent for a procedure. An important objective of informed consent sessions is to deliver adequate information to the patient to reduce to the minimum the contributions of the other factors, which tend to increase anxiety for the planned procedure. Learning is optimal in an atmosphere of minimal anxiety. In the same vein, anxiety is reduced in the presence of understanding.
This study sought to show the extent of recall, in the short term, of information believed to have been passed across during informed consent sessions for daycare prostate biopsy procedure, and the factors that influence it. In addition, the extent of recall 1 week after is compared against the extent of recall 2 weeks after formal consent session.
| Materials and Methods|| |
This was a survey conducted from February to November 2017, in a third tier hospital in southeast Nigeria. The target population included patients undertaking daycare prostate biopsy. To be eligible to participate in this study, the participants must be cognitively sound enough to have given their clinical history themselves and a written informed consent to participate in the study.
Each participant was randomized to receive a formal consent session 1 or 2 weeks before the scheduled prostate biopsy procedure. Before leaving the outpatient clinic on that day of formal consent session, the study participants attested that the consent session addressed all concerns regarding the planned procedure.
On the morning of the surgical procedure day, Generalized Anxiety Disorder 7 (GAD-7) questionnaire,, was administered to each study participant by a pre-tutored research assistant (RA1). Subsequently, another pre-tutored research assistant (RA2), blinded to the proceedings from RA1, administered the study consent information recall questionnaire. The study consent information recall questionnaire was designed to assess patient’s recall of the nature of the disease condition, the nature of the planned procedure, and the risks involved in the planned procedure. The questions were non-leading and open-ended. RA2 must have observed the procedure informed consent session involving the study participant 1 or 2 weeks earlier.
Responses to the questions were recorded as “uninformed,” “forgotten,” “incorrect response,” and “correct response.” The responses to the three questions from each study participant were aggregated to create an index of effective returns from informed consent session termed “aggregate returns on consent information.” This index was ranked into “good returns,” “fair returns,” and “poor returns.” Regression analysis was used to evaluate the relationship between these levels of aggregate returns on consent information and other variables. Statistical Package for Social Sciences (SPSS) software, version 20.0, was used for analysis.
| Results|| |
A total of 95 respondents scheduled for daycare prostate biopsies participated in this survey. Of which, 98.9% were Nigerians from the southeast region and within the age range of 55–82 years (mean, 68.1 ± 6.8 years). Forty-nine participants (51.6%) were randomized to Group A, whereas 46 candidates (48.4%) were randomized to Group B. All the respondents checked in no or mild anxiety using GAD-7 scale with a range of 0–9, a median of 1, and a mode of 0. Other descriptive statistics are shown in [Table 1].
|Table 1: Displays the frequency distribution of the responses from study participants|
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Matching the 1-week group (Group A) against the 2-week group (Group B) showed no significant differences in the level of formal education attained (χ2 = 1.263; P = 0.35), in the comparison of mean age (t = -0.153; P = 0.88), and in the comparison of mean GAD-7 score (t = -0.757; P = 0.45). [Table 2] compares the extent of appropriate recall of the information on nature of disease condition, nature of planned procedure, and risks involved in the planned procedure by study participants within the two groups.
|Table 2: Proportion of appropriate recall by participants within the two groups A and B|
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The calculated aggregate returns on consent shows that 22.1% of participating patients showed good returns on consent information, 43.2% showed fair returns, whereas 34.7% showed poor returns on consent information. In [Table 3], the result of ordinal regression analysis of the variables that relate to returns on consent information is shown.
|Table 3: Results of ordinal regression analysis of the studied variables as they relate to the calculated index of effective consent termed “returns on consent information”|
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| Discussion|| |
Various authors have studied the concept of patient’s recall of consent information. Consistently, the extent of recall has been documented to be low, the medicolegal implication of which is worrisome for the medical care provider. In view of this, various modalities have been incorporated into the informed consent process to enhance information delivery to and comprehension by the patient. These modalities include, but are not limited to, handing out information bills and documents, use of patient-friendly multimedia materials,, and repeat back techniques. Though some studies have documented objective improvement in the extent of recall of information by patients using these modalities, others have failed to establish the same.,,
Low socioeconomic setting is challenged by low literacy levels, less than optimal infrastructure development, poor language development (making translation of consent information to the local languages challenging), absence of social security, and rudimentary health insurance system., Handing out complementary patient information leaflets to be studied at home and the playback of patient-friendly multimedia recordings during consent proceedings are therefore of limited use.
In this study, the extent of recall of consent information given 2 weeks earlier was compared against the extent of recall of consent information given 1 week earlier among daycare prostate biopsy patients. This is in a bid to contribute response to the concern that formal consent session may need to be repeated when scheduled daycare procedure is postponed by a week.
Overall, 75.8% of the respondents were able to appropriately recall the information on the nature of diagnosis [Table 1]. This is quite impressive. On the background that 74.7% of the respondents had formal education beyond the primary level [Table 1], this proportion of respondents that appropriately recalled the nature of diagnosis would be understood. Better understanding, and hence, good recall of consent information associated with formal education and health literacy have been reported., On the contrary, just 15.8% of respondents showed appropriate recall of risks involved in the planned procedure. This is worrisome, but not peculiar to this study as Johnstone et al. also observed poor recall of risks or complications of planned procedure. This recall pattern may be because study participants shut out information on risks or complications to avoid being overwhelmed by consent information. In all, however, within the context of this study’s design and participants, only 34.7% of participants showed poor aggregate returns on consent information [Table 1]. It is encouraging to know that approximately two in every three daycare prostate biopsy patients are able to recall, within 1 or 2 weeks, more than average of the information given during consent sessions. However, these values can still be improved on through the routine use of audiovisual aids and other strategies to improve learning and through improving literacy level of the society.
There is no significant difference in the extent of recall within specific domains and in aggregate returns on consent information between the two groups [Table 2]. In this study population, a difference of 1 week has not caused a reduction in the extent of consent information recalled. Though studies have shown that there is reduction in quality and quantity of consent information recalled with increasing time interval, 1-week interval has not proven to be the significant time for such variation in the short term. This suggests that there may not be any need to repeat formal consent session for patients with suspected prostate cancer whose daycare prostate biopsy procedure is moved by 1 week to a new date.
[Table 3] shows that the aggregate returns on consent information is not influenced significantly by the age of patients (odds ratio, 0.984; 95% CI: 0.931–1.041; P = 0.57), level of formal education (odds ratio, 0.503; 95% CI: 0.206–1.224; P = 0.13), and whether the consent information was delivered 1 or 2 weeks earlier (odds ratio, 1.274; 95% CI: 0.595–2.729; P = 0.53). This is the essence of personalized informed consent sessions. When the delivery of consent information is personalized, the differences between cognitively sound patients in terms of variables, such as health literacy level, level of formal education attained, and age within adulthood, tend to even out.
| Conclusion|| |
The recall of consent information on the nature of disease condition is good enough, whereas the recall of consent information on the nature of the planned procedure is fair. The recall of consent information on risks involved in the planned procedure is quite poor. Overall, one-third of study participants showed poor aggregate returns on consent information. An interval of 1 week, in the short term, does not significantly alter aggregate returns on consent information, just as the level of formal education attained and the age of participant do not.
Clinically, it is not uncommon to postpone daycare procedures such as prostate biopsy. The findings from this study suggest that there may not be any need to repeat formal informed consent session for 1-week postponements.
We acknowledge the roles of Ekeoma Nwosu, Uko Uko, and Louis Okolie in data collection.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]