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Are predominantly western standards and expectations of informed consent in surgery applicable to all? A qualitative study in a tertiary care hospital in Sri Lanka.

ABSTRACT: OBJECTIVE:To identify the different perceptions on informed surgical consent in a group of Sri Lankan patients. METHODS:A qualitative study was conducted in a single surgical unit at a tertiary care hospital from January to May 2018. The protocol conformed to the Declaration of Helsinki. Patients undergoing elective major surgeries were recruited using initial purposive and later theoretical sampling. In-depth interviews were conducted in their native language based on the grounded theory. Initial codes were generated after analysing the transcripts. Constant comparative method was employed during intermediate and advanced coding. Data collection and analyses were conducted simultaneously, until the saturation of the themes. Finally, advanced coding was used for theoretical integrations. RESULTS:Thirty patients (male:female=12:18) were assessed. The mean age was 41±9 years. Sinhalese predominated (50.0%, n=15). Majority underwent thyroidectomy (36.7%, n=11). The generated theory categorises the process of obtaining informed consent in four phases: initial interaction phase, reasoning phase, convincing phase and decision-making phase. Giving consent for surgery was a dependent role between patient, family members and the surgeon, as opposed to an individual decision by the patient. Some patients abstained from asking questions from doctors since doctors were 'busy', 'short-tempered' or 'stressed out'. Some found nurses to be more approachable than doctors. Patients admitted that having a bystander while obtaining consent would relieve their stress. They needed doctors to emphasise more on postoperative lifestyle changes and preprocedure counselling at the clinic level. To educate patients about their procedure, some suggested leaflets or booklets to be distributed at the clinic before ward admission. The majority disliked watching educational videos because they were 'scared' to look at surgical dissections and blood. CONCLUSION:The informed consent process should include key elements that are non-culture specific along with elements or practices that consider the cultural norms of the society.

SUBMITTER: Samaranayake UMJE

PROVIDER: S-EPMC6347869 | biostudies-other | 2019 Jan

REPOSITORIES: biostudies-other

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Are predominantly western standards and expectations of informed consent in surgery applicable to all? A qualitative study in a tertiary care hospital in Sri Lanka.

Samaranayake Udagedara Mudiyanselage Jayami Eshana UMJE Mathangasinghe Yasith Y Banagala Anura Sarath Kumara ASK

BMJ open 20190125 1

<h4>Objective</h4>To identify the different perceptions on informed surgical consent in a group of Sri Lankan patients.<h4>Methods</h4>A qualitative study was conducted in a single surgical unit at a tertiary care hospital from January to May 2018. The protocol conformed to the Declaration of Helsinki. Patients undergoing elective major surgeries were recruited using initial purposive and later theoretical sampling. In-depth interviews were conducted in their native language based on the grounde ...[more]

PMID: 30813111

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Project description:BackgroundApproval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form.MethodsWe obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important.ResultsTwenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important.ConclusionThe number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

Project description:IntroductionTime-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.MethodsTerm infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters-empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.ResultsA total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.ConclusionDespite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.

Project description:BackgroundDiabetic retinopathy (DR) is one of the leading causes for complete loss of vision among working-aged adults around the world. The present study aims to evaluate the rate of DR and its risk factors among the adults with young-onset diabetes from a tertiary care setting in Sri Lanka.MethodsA consecutive sample of 1,007 individuals referred from multiple centers, were invited for the study. Ophthalmological evaluation was done, with dilated indirect ophthalmoscopy by an Ophthalmologist. Retinopathy was classified according to the International Clinical DR Disease Severity Scale. An interviewer-administered questionnaire was used to collect socio-demographic and anthropometric details. Seated blood pressure, Fasting Blood Glucose (FBG), HbA1c and urine microalbumin were also measured. Data were analysed using SPSSv14. A binary logistic regression analysis was performed in all patients, with 'presence of DR' as the dichotomous dependent variable and other independent covariates.ResultsSample size was 684 (response rate-67.9%), mean age was 37.1?±?5.9 years and 36.0% were males. Mean duration of diabetes was 5.2?±?4.0 years. Previous retinal screening had been done in 51.0% by a non-specialist doctor and in 41.5% by a consultant ophthalmologist. Rate of any degree of DR in the study population was 18.1% (Males 16.4%, Females 20.0%; P?=?NS). In patients with DR, majority had mild Non-Proliferative DR (NPDR) (57.2%), while 32.2% had moderate NPDR, 0.8% had severe NPDR and 9.7% had maculopathy. Mean age, duration of diabetes, systolic (SBP) and diastolic blood pressure (DBP), FBG, HbA1c and urine microalbumin levels were significantly higher amongst the patients with DR. The results of the binary logistic regression indicate that the duration of diabetes (OR:1.24), HbA1c (OR:1.19), age (OR:1.11), urine Microalbumin (OR:1.11) and DBP (OR:1.04) all were significantly associated with DR.ConclusionsIn this large multi center study, nearly one in five adults with young-onset diabetes was found to have retinopathy. Age, duration of diabetes, HbA1C and urine Microalbumin levels were significantly associated with the presence of retinopathy, while HbA1c was also a significant factor determining severity. Nearly 50% of the study population has never undergone retinal screening by an ophthalmologist, highlighting the need for well organized screening programs.

Project description:BackgroundThe leprosy services utilization by the patients at the clinic and field level should be high to achieve the target of eliminating leprosy as a public health problem in Sri Lanka. Furthermore, assessing patient and health system delay of a diagnosis and patient knowledge on disease are of equal importance to reveal the accurate picture.Methods and findingsA descriptive cross-sectional study was conducted to assess the utilization of government healthcare services by 672 adult leprosy patients in Western Province (WP). Paucibacillary patients diagnosed at least six months and above, and Multibacillary patients diagnosed at least 12 months and above were selected by consecutive sampling method. An interviewer-administered questionnaire (IAQ) was used for data collection. Clinic utilization by leprosy patients was 87.8%. The mean patient-related delay (time taken from the onset of symptoms to the encounter of a doctor/health facility for the first time) was 16.8 months and health care system delay (time taken from the date of clinic registration to start of treatment) was 21.2 days. The overall delay was 17.5 months. Services provided by the Medical Officer of Health (MOH) office for families affected with leprosy was known by 53.8% (n = 298) of patients. Majority of family contacts were examined at the hospitals (n = 299, 44%), 30.8% (n = 207) by the Public Health Inspectors (PHI) and 7% (n = 46) at the MOH offices. PHIs had visited 56.7% (n = 401) of the patient's houses and 54% (n = 363) had received health education by PHI. Mean knowledge score was 50.7 (SD = 17.9). More than half (57.9%, n = 389) of the study sample had a good or very good knowledge level.ConclusionsUtilization of clinic services was satisfactory. However, a considerable patient-related delay was found. Half of the patients were aware of available field services and a majority of contact screening was conducted at hospitals. Patient knowledge on leprosy was satisfactory.

Project description:BackgroundLeishmaniasis is a notifiable disease in Sri Lanka since 2008. Previous studies show a gap in the notification of leishmaniasis. The purpose of the present study was to determine the Knowledge, attitudes and practice of medical officers regarding leishmaniasis.MethodsA cross-sectional study was conducted in the Anuradhapura district which reported the highest case load of leishmaniasis. Medical officers from public and private health care institutes in the area filled a self-administered questionnaire in the presence of the investigators.ResultsOne hundred and eighty-eight (188) medical officers completed the questionnaire. Of them, 95.7% were aware of leishmaniasis as a parasitic infection and 84.7% correctly identified Leishmania donovani as the causative organism in Sri Lanka. From the respondents, 181 (96.8%) knew that the vector of leishmaniasis is sand fly. Cutaneous leishmaniasis was reported as the most prevalent form of leishmaniasis in the country by 176 (94.1%). Nearly half of the respondents (98, 54.1%) were aware of the fact that the Anuradhapura district has the highest disease burden. Many of them had the idea that leishmaniasis is an emerging disease (155, 84.3%,) and early diagnosis is important in controlling the disease (163, 89.1%). Although about three fourth (123, 73.7%,) of the participants mentioned that leishmaniasis should be notified at first clinical suspicion, only 74 (42.5%) were aware that it is a legal requirement. Some medical officers (39, 22%) believed that the current notification system in the country is not effective. Unavailability of notification forms (60, 36.8%) heavy workload (85, 50.3%) and inadequate supportive staff (55, 35.1%) were reported as barriers for timely notification. Even though 105 (58.0%) of medical officers had suspected leishmaniasis during the last 8 years period only 35 (19.4%) had notified.ConclusionsEven though more than 90% of the participants had good theoretical knowledge about leishmaniasis; notification of leishmaniasis is considerably inadequate. This study emphasizes the need for greater efforts to improve the notification of leishmaniasis in Sri Lanka.

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Are predominantly western standards and expectations of informed consent in surgery applicable to all? A qualitative study in a tertiary care hospital in Sri Lanka.

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Are predominantly western standards and expectations of informed consent in surgery applicable to all? A qualitative study in a tertiary care hospital in Sri Lanka.

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