Illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh: A cross-sectional study.

BACKGROUND: Despite recognition that palliative care is an essential component of any humanitarian response, serious illness-related suffering continues to be pervasive in these settings. There is very limited evidence about the need for palliative care and symptom relief to guide the implementation of programs to alleviate the burden of serious illness-related suffering in these settings. A basic package of essential medications and supplies can provide pain relief and palliative care; however, the practical availability of these items has not been assessed. This study aimed to describe the illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh. METHODS AND
FINDINGS: Between November 20 and 24, 2017, we conducted a cross-sectional study of individuals with serious health problems (n = 156, 53% male) and caregivers (n = 155, 69% female) living in Rohingya refugee camps in Bangladesh, using convenience sampling to recruit participants at the community level (i.e., going house to house to identify eligible individuals). The serious health problems, recent healthcare experiences, need for medications and medical supplies, and basic needs of participants were explored through interviews with trained Rohingya community members, using an interview guide that had been piloted with Rohingya individuals to ensure it reflected the specificities of their refugee experience and culture. The most common diagnoses were significant physical disabilities (n = 100, 64.1%), treatment-resistant tuberculosis (TB) (n = 32, 20.5%), cancer (n = 15, 9.6%), and HIV infection (n = 3, 1.9%). Many individuals with serious health problems were experiencing significant pain (62%, n = 96), and pain treatments were largely ineffective (70%, n = 58). The average age was 44.8 years (range 2-100 years) for those with serious health problems and 34.9 years (range 8-75 years) for caregivers. Caregivers reported providing an average of 13.8 hours of care per day. Sleep difficulties (87.1%, n = 108), lack of appetite (58.1%, n = 72), and lack of pleasure in life (53.2%, n = 66) were the most commonly reported problems related to the caregiving role. The main limitations of this study were the use of convenience sampling and closed-ended interview questioning.
CONCLUSIONS: In this study we found that many individuals with serious health problems experienced significant physical, emotional, and social suffering due to a lack of access to pain and symptom relief and other essential components of palliative care. Humanitarian responses should develop and incorporate palliative care and symptom relief strategies that address the needs of all people with serious illness-related suffering and their caregivers.

Introduction

Humanitarian crises, by their nature, generate a large burden of suffering and mortality, necessitating palliative care [1]. A recent Lancet Commission report on pain relief and palliative care recognized palliative care as “an essential component of any response to humanitarian emergencies and crises” [2]. Despite the growing recognition of the need for palliative care in humanitarian settings, its provision has largely been neglected, due to a focus on saving lives [3]. In humanitarian settings, the need for palliative care and symptom relief often extends beyond individuals with life-limiting conditions. Illness-related suffering may occur for many individuals with serious acute or non-life-threatening conditions due to limited access to services to prevent, diagnose, or treat disease and limited social support systems [2]. The role of palliative care in a humanitarian crisis should be to respond to the specific needs of the populations experiencing the crisis.

Minimal evidence exists to guide humanitarian organizations in the design, development, and implementation of palliative care services [4,5]. A 2017 systematic review of humanitarian health programs that included palliative care or enhanced pain management identified only one publication fulfilling the selection criteria: a study of a pain treatment program for amputees [6]. Although palliative care projects are taking place in several other humanitarian situations, these have been accompanied by very little formal research [7]. An “essential package” of inexpensive and relatively simple interventions that can deliver effective palliative care and alleviate serious illness-related suffering in a variety of settings has been proposed [2]. Serious illness-related suffering is defined as suffering associated with an illness or injury that “compromises physical, social and emotional functioning” and requires medical intervention to be relieved [2]. To address the significant burden of serious illness-related suffering in humanitarian settings, evidence on palliative care priorities and effective interventions is urgently needed.

Ensuring patients can obtain strong pain medications is essential to reducing serious illness-related suffering, yet in humanitarian settings, this may pose significant challenges since national regulatory barriers can restrict the importation of opioids with humanitarian emergency supplies [8]. Many countries have opioid regulations that focus on reducing the risks of nonmedical use, but fail to ensure appropriate access for medical needs [8,9]. The World Health Organization (WHO) has published guidelines providing practical instructions on improving opioid availability while ensuring safe storage and dispensing [10]. International humanitarian organizations are beginning to acknowledge the need for improved pain management in the emergency setting, but there are very few examples reported in the literature of efforts to incorporate key policy lessons [1].

This study aims to describe the need for palliative care and symptom relief during an unfolding humanitarian crisis: the Rohingya refugee crisis in Cox’s Bazar, Bangladesh. Specifically, we sought to describe the burden of serious illness-related suffering, focusing on physical, social, and emotional suffering, and the availability of the essential package components.

Methods

The study was approved by the Civil Surgeon for Cox’s Bazar District and by the Research Ethics Board of the Children’s Hospital of Eastern Ontario, Canada (Study number: 18/54X). The STROBE statement for our paper can be found in S1 STROBE Checklist. Written informed consent was obtained from all participants. All analyses were non-prespecified. The original funding proposal can be found in S1 Text.

Recruitment and sampling

Individuals with serious health problems and caregivers for such individuals were invited to participate. In determining which patients (i.e., individuals with serious health problems) to include, we used WHO guidelines for palliative care in humanitarian settings, which suggest that palliative care is appropriate for those with serious health problems, including life-limiting conditions as well as non-life-limiting conditions, such as trauma, burns, paraplegia, quadriplegia, brain injuries, and congenital anomalies where significant suffering may occur [4]. Participants were identified at the community level. Interviewers spoke to individuals in the refugee camp community and went from house to house to identify individuals requiring palliative care or symptom relief and their caregivers. Once identified, these individuals were approached about their interest to learn about the study; if individuals expressed interest, then the interviewer explained the goals and process of the study, responded to any questions, and then asked if the individual would be willing to participate. For individuals whose diagnosis was uncertain, interviewers reviewed the cases with the study coordinators (MD and FK) to determine if the individual should be included as having a serious health problem, prior to conducting the interview. Patients who had significant impairments in movement, muscle tone, and/or balance were categorized as having a significant physical disability, and the breadth of this category was due to a lack of clarity from individuals about their exact diagnosis or the cause of their disability and a lack of access to diagnostic healthcare services. For children (0–17 years), a parent or the primary adult caregiver was approached for consent and completed the interview as a source of proxy information. Participants were identified through convenience sampling, and sample size was determined by the maximum number of eligible participants that could be consented and interviewed during the data collection period. For all pharmacies that could be identified in the defined locations for the study, we interviewed a pharmacy representative about the availability of essential palliative care medications and supplies.

Design and content of interviews

The interview guide was developed through a literature review that identified key themes from previous assessments of palliative care in low-and middle-income countries (LMICs) and from the 2017 draft Sphere Handbook [5,11,12]. Six of the study authors (MD, MP, RP, LG, BS, and FK) and 3 additional individuals with expertise in humanitarian medicine, palliative care, and noncommunicable diseases provided feedback on the validity and comprehensibility of draft interview questions, which led to the development of a pilot interview guide. This pilot guide was tested with 10 Rohingya interviewers from the refugee camps and 20 Rohingya individuals (11 with serious health problems and 9 caregivers). Modifications were made to improve the clarity of questions and response options to reflect the specificities of the Rohingya refugees’ experiences and culture. The pharmacy representative interview included questions about medications and supply items included in the essential package [2].

Demographic information about individuals’ age, sex, household size, education, and occupation was collected. Participants with serious health problems were asked to report on the characteristics of their pain and other symptoms, including severity, and treatments and their efficacy. Participants with serious health problems and caregivers were also asked about their needs for medications and medical supplies, as well as their basic needs for items such as food, shelter, and money. Participants with serious health problems were asked about recent healthcare experiences and the barriers to accessing care, medicines, and medical supplies.

Individuals were informed that they could skip any questions that they did not want to answer. This, as well as the lack of relevance of certain items, led to variable sample size for responses across certain interview items. In all such cases, the sample size is noted in the text and/or tables.

Interviewer training and linguistic adaptation

Two co-authors (MD and FK), who had previous experience with conducting similar studies in Bangladesh, recruited and trained 10 Rohingya-speaking interviewers to conduct structured interviews for this study. The interviewers were identified through a partnership with a local health non-governmental organization (NGO) working in the refugee camps (OBAT Helpers) that had previously employed the majority of these individuals in various health promotion and/or translator roles for programs in the refugee camps. All interviewers had completed secondary school and were fluent in both written and spoken English and in the Rohingya language (spoken only, as there is no widely accepted written form of Rohingya). All interviewers were of Rohingya ethnicity, and the majority (90%) had been living in the refugee camps for more than 5 years, having arrived during previous waves of refugee movement from Myanmar.

Interviewer training was conducted in English and consisted of 2 days of theoretical and practical in-person training that included didactic teaching and practical examples related to research ethics and informed consent, the goals of the study, and key concepts related to the study (palliative care, serious health problems, cancer, HIV/AIDS, medications, medical equipment, and symptoms). During the training, the interviewers reviewed each question in the interview guide with the trainers, discussed the meaning of the question and the response options, and provided suggestions about cultural or other adaptations that would improve the clarity of the interview guide. The interviewers then agreed upon a single translation of each interview question into Rohingya, after group discussion. During the practical portion of the training, interviewers conducted practice interviews in pairs, with observation and coaching by the trainers, who provided feedback about interview technique and clarified the interview guide questions and response options. During the final phase of training, interviewers conducted interviews in the refugee camps, under the same conditions as those in the actual study, with observation by the 2 trainers, to ensure fidelity to the interview guide. The interviews were conducted over a 5-day period (November 20–24, 2017) immediately following training. Interviews typically took 30–45 minutes.

Setting

Between August and November 2017, violence towards Rohingya people in Myanmar forced 687,000 people into Bangladesh, where an estimated 213,000 Rohingya refugees were already living [13]. Since arriving, the majority are living in makeshift accommodations, and it is estimated that 55% of the newly arrived are children [13]. Interviews with patients and caregivers were conducted among Rohingya refugees living in the main refugee settlement areas of Kutupalong, Jamtoli, Tenkhali, and Balukhali in the Cox’s Bazar District of Bangladesh between November 20 and 24, 2017. Retail pharmacy representatives in the refugee camp area, the nearest town center (5.5 km from the entrance to Kutupalong refugee camp), and the nearest government health complex (7.0 km from the Kutupalong camp entrance) were also interviewed. There are many NGO medical clinics (with basic outpatient facilities) and hospitals (inpatient and outpatient facilities) located within the Rohingya settlements or in close proximity, where basic and advanced-level medical and surgical care is available. Additionally, refugees may visit Bangladesh government health facilities, with the nearest primary-level government facility 7.0 km from the Kutupalong camp and a tertiary facility 37 km away.

Data analysis

Descriptive statistics were obtained using Microsoft Excel.

Results

Sample size and composition

There were 311 individuals who participated in this study, including 156 persons living with serious health problems and 155 current or bereaved caregivers. The majority (198, 70.7%) of participants had arrived in Bangladesh in the past 6 months, and nearly all individuals had arrived within the last year (n = 247, 88.2%).

Socio-demographic profile: Individuals with serious health problems

The mean age of those with serious health problems was 44.8 years (median 42, range 2–100 years), and 52.6% (n = 82) were male. The majority (n = 141, 90.4%) reported having no formal schooling beyond primary level. The most common diagnoses reported were significant physical disabilities (n = 100, 64.1%), treatment-resistant tuberculosis (TB) (n = 32, 20.5%), cancer (n = 15, 9.6%), and HIV infection (n = 3, 1.9%). For patients with HIV infection, cancer, or TB, 55.8% (n = 29) had received disease-directed treatment (i.e. anti-retroviral therapy, chemotherapy, or TB treatment) while in Myanmar, and 23.1% (n = 12) continued to receive these treatments upon arrival in Bangladesh. Additional demographic and diagnostic data are shown in Table 1.

Table 1

Socio-demographic data for individuals with serious health problems (n = 156).

Characteristic	Prior to leaving Myanmar		Current
	n	Percent or mean; range (SD)	n	Percent or mean; range (SD)
Sex
Male			82	52.6%
Female			73	46.8%
Missing data			1	0.6%
Age (years)
0–4			8	5.1%
5–17			15	9.6%
18–49			58	37.2%
≥50			68	43.6%
Missing data			7	4.5%
Highest level of education completed
None			87	55.8%
Primary			54	34.6%
Secondary			11	7.1%
Post-secondary (college)			2	1.3%
Missing data			2	1.3%
Primary serious health problem
Significant physical disabilitya			100	64.1%
Treatment-resistant tuberculosis			32	20.5%
Cancer			15	9.6%
HIV infection			3	1.9%
Burns			2	1.3%
Diabetes			1	0.6%
Chronic respiratory disease			1	0.6%
Kidney disease			1	0.6%
Intellectual disability			1	0.6%
Number of individuals living in householdb			150	5.3; 1–19 (2.4)
Number of children (0–18 years of age) the individual hasc			109	1.7; 0–8 (1.9)
Occupation
Homemaker	40	25.6%	21	13.5%
Farmer	34	21.8%	2	1.3%
Unemployed	31	19.9%	70	44.9%
Self-employed	7	4.5%	0	0.0%
Missing data	7	4.5%	7	4.5%
Otherd	5	3.2%	2	1.3%
Public sector worker	2	1.3%	0	0.0%
Unable to work due to illness	4	2.6%	29	18.6%
Teacher	2	1.3%	2	1.3%
Student	1	0.6%	0	0.0%
Child <18 years old (therefore no occupation)	23	14.7%	23	14.7%

aIncludes individuals with cerebral vascular accident, spinal cord injury, cerebral palsy, and undiagnosed conditions resulting in similar impairments.

bMissing data for 6 patients.

cIncludes individuals ≥18 years of age, and individuals <18 years of age if they are married.

dIncludes carpenter, tailor, shopkeeper, and unspecified responses.

Physical symptoms and greatest needs

Pain due to the serious illness in the past 3 days was reported by 110 patients (70.5%) and was frequently self-rated as being of moderate (n = 48, 30.8%) or severe intensity (n = 48, 30.8%). There were 83 patients (53.2%) who reported receiving medication for their pain. Nearly half (n = 51, 46.4%) of those who received treatment for pain could not recall the name of the medication. The most frequent medications reported were paracetamol (n = 19, 17.3%) and non-steroidal anti-inflammatories (n = 9, 8.2%). Only 1 patient (0.9%) reported receiving an opioid pain medication, oxycodone. In addition to pain, individuals with serious illnesses reported an average of 3.8 (SD 2.2, range 0–9) other symptoms that were causing them physical discomfort. When asked about their greatest needs, patients most frequently reported medications (97.4%, n = 152), money (94.2%, n = 147), and food (76.9%, n = 120). Table 2 shows additional details of physical symptoms and greatest needs reported by patients.

Table 2

Pain severity, treatment, treatment outcomes, and greatest needs (n = 156).

Item	n	Percent
Severity of pain caused by illness
None	41	26.3%
Mild	14	9.0%
Moderate	48	30.8%
Severe	48	30.8%
Missing data	5	3.2%
Treatments received by individuals experiencing paina (n = 110) (medications identified in bold are potentially pain relieving)
Paracetamol	19	17.3%
Non-steroidal anti-inflammatory drug	9	8.2%
Gastro-esophageal reflux treatment	9	8.2%
Antibiotic	5	4.5%
Vitamins/minerals	4	3.6%
Antihistamine	4	3.6%
Gabapentinoid	2	1.8%
Other prescription medication	2	1.8%
Oxycodone	1	0.9%
Cannot identify or remember name of treatment	51	46.4%
Missing data	4	3.6%
Did not receive treatment for pain	23	20.9%
Pain severity after treatment (n = 83)
None	3	3.6%
Mild	22	26.5%
Moderate	31	37.3%
Severe	27	32.5%
Other physical symptomsa
Fever	116	74.4%
Sleep difficulties	86	55.1%
Cough	81	51.9%
Lack of appetite	71	45.5%
Breathing problems	66	42.3%
Fatigue	51	32.7%
Nausea/vomiting	39	25.0%
Diarrhea	17	10.9%
Otherb	29	18.6%
Ill individuals’ greatest needsa
Medications	152	97.4%
Money	147	94.2%
Food	120	76.9%
Pain relief	72	46.2%
Someone to help	70	44.9%
Love	47	30.1%
Help with sadness or depression	40	25.6%
Respect	35	22.4%
Care for my children	32	20.5%
Schooling for my children	24	15.4%
A job or source of income	10	6.4%
Medical equipment	4	2.6%
Otherc	4	2.6%

aPatients could provide more than 1 response.

bIncludes weight loss, bone/joint pains, anxiety, paralysis, loss of sensation, headache, drooling, constipation, muscle spasms, bleeding, swelling, dizziness, coryza.

cIncludes sympathy or understanding, medical imaging, a car, and a toilet.

Essential medications and medical equipment

Sixty-one patients (39.1%) reported needing medications, including paracetamol (n = 21, 34.4%), antibiotics (n = 16, 26.2%), medications for chronic diseases (n = 16, 26.2%), and medications for gastro-esophageal reflux (n = 14, 23.0%). Only 52.5% (n = 32) of these patients were able to access their medications at the time of the interview. Eighty-two patients (52.6%) reported needing at least 1 medical supply item, and 72.0% (n = 59) of these patients were unable to access needed equipment. The most commonly needed items were urinary catheters (n = 29, 35.4%), adult diapers (n = 21, 25.6%), and oxygen (n = 21, 25.6%). Table 3 shows the complete list of reported medication and medical supply needs.

Table 3

Current medication and equipment requirements and barriers to access.

Item	n	Percent
Required medication (n = 61)
Paracetamol	21	34.4%
Antibiotic	16	26.2%
Other chronic disease medicationb	16	26.2%
Gastro-esophageal reflux treatmentc	14	23.0%
Vitamins/minerals/nutritional supplements	13	21.3%
Medication could not be identifiedd	12	19.7%
TB treatment	8	13.1%
Non-steroidal anti-inflammatory drug	6	9.8%
Medication for minor ailment (includes cough syrups and decongestants)	6	9.8%
Antihistamine	4	6.6%
Antifungal medication	4	6.6%
Gabapentinoid	3	4.9%
Topical preparation	3	4.9%
Baclofen	2	3.3%
Oral rehydration solution	2	3.3%
Steroid	2	3.3%
Opioid	1	1.6%
Anticonvulsant	1	1.6%
Eye drops	1	1.6%
Currently required medical supplies and equipment (n = 82)
Urinary catheter	29	35.4%
Adult diapers	21	25.6%
Oxygen	21	25.6%
Wheelchair	16	19.5%
Pressure-reducing mattress	13	15.9%
Feeding tube (nasogastric tube)	10	12.2%
Equipment to assist with using washroom (e.g., commode, bedpan)	9	11.0%
Other	7	8.5%
Reported barriers and challenges to access (n = 108)
Lack of money	65	60.2%
Surrounding health facilities do not have access to the treatment needed	14	13.0%
Difficulty getting to healthcare facility, due to distance and/or mobility problems	11	10.2%
Individual does not know where to get treatment	8	7.4%
Individual believes there is no treatment for their condition	8	7.4%
Poor quality of treatment given at health facility	6	5.7%
Individual is waiting for TB test results	1	0.9%
Individual does not know what treatment he/she needs	1	0.9%

aIndividuals could provide more than 1 response.

bIncludes antihypertensives, salbutamol, theophylline, montelukast, dyslipidemic agents, oxybutynin, antiplatelet agents, and allopurinol.

cIncludes proton pump inhibitors, H2 blockers, and antacids.

dPatient could not recall the name of the medication, or research team could not identify the medication from the response provided.

TB, tuberculosis.

Patterns of care and challenges

Sixty percent of individuals (n = 93, 59.6%) reported visiting a health facility in the past month. Of those patients, 53.7% (n = 50) reported visiting an NGO hospital, 18.3% (n = 17) a health clinic, and 9.7% (n = 9) a government primary-level health facility. Forty-three percent (n = 40) of patients who visited a healthcare facility sought medical care for concerns related to their serious health problem, and 29.0% (n = 27) visited specifically for pain relief. More than half (59.1%, n = 55) of those who visited a healthcare facility reported that their visit was unsuccessful at treating their presenting problem. Commonly identified barriers and challenges to accessing healthcare included lack of money (n = 65, 60.2%), lack of treatment availability at the health facility (n = 14, 13.0%), and difficulty getting to the healthcare facility (n = 11, 10.2%). Further details of barriers and challenges to healthcare access are found in Table 3.

Socio-demographic profile: Caregivers

There were 155 caregivers who were interviewed. We excluded from further analysis 31 caregivers who were bereaved longer than 6 months, as their caregiving occurred primarily in Myanmar, prior to the refugee crisis. For the remaining 124 caregivers, the mean age was 34.9 years (median 32 years, range 8–75 years). Caregivers were frequently women (n = 85, 68.5%) and were caring for an average of 3.8 children (0–18 years) of their own (range 0–12, SD 2.5). Caregivers were most commonly members of the ill patient’s family (n = 118, 95.2%) and provided an average of 13.8 hours of care per day (range 2–24, SD 9.4). Further characteristics of caregivers are shown in Table 4.

Table 4

Socio-demographic data for caregivers (n = 124).

Characteristic	Prior to leaving Myanmar		Current
	n	Percent	n	Percent or mean; range (SD)
Sex
Female			85	68.5%
Male			38	30.6%
Missing data			1	0.8%
Highest level of education completed
None			48	38.7%
Primary			65	52.4%
Secondary			8	6.5%
College			2	1.6%
Missing data			1	0.8%
Age (years)
8–17			4	3.2%
18–49			99	79.8%
≥50			16	12.9%
Missing data			5	4.0%
Household size (number of individuals)			122	6; 2–19 (2.5)
Occupation
Homemaker	98	79.0%	84	53.8%
Farmer	11	8.9%	3	1.9%
Student	5	4.0%	2	1.3%
Othera	3	2.4%	2	1.3%
Self-employed	3	2.4%	3	1.9%
Unemployed	2	1.6%	25	16.0%
Public sector worker	1	0.8%	0	0.0%
Private sector worker	1	0.8%	3	1.9%
Missing data	0	0.0%	2	1.3%

aIncludes committee member (unspecified), teacher, fisherman, and unspecified responses.

Dimensions of caregiving

The most frequent activities performed by caregivers included bathing (n = 117, 94.4%), administering medications (n = 99, 79.8%), and feeding the ill individual (n = 98, 79.0%). Only 11.3% (n = 14) reported having received training on how to provide care. Caregivers commonly reported having sleep difficulties (87.1%, n = 108), lack of appetite (58.1%, n = 72), and lack of pleasure in life (53.2%, n = 66) due to their caregiving role. When asked about their greatest needs, caregivers commonly reported money (88.7%, n = 110), food (74.2%, n = 92), and someone to help them (65.3%, n = 81). Further details of the roles, challenges, and needs of caregivers are shown in Table 5.

Table 5

The roles, challenges, and needs of caregivers (n = 124).

Item	n	Percent
Activities performed by caregiver for ill individual
Bathing	117	94.4%
Administering medications	99	79.8%
Feeding	98	79.0%
Massage	68	54.8%
Providing emotional support	31	25.0%
Providing care for pain or other symptoms	17	13.7%
Other	7	5.6%
Challenges faced by caregivers
Insufficient financial resources	120	96.8%
Caregiving is very hard work	84	67.7%
Lack of help in caregiving	58	46.8%
Feeling sadness	48	38.7%
Worrying about the future	45	36.3%
Discrimination	24	19.4%
Insufficient time	16	12.9%
Unsure of how to provide care to ill individual	18	14.5%
Other	1	0.8%
Problems experienced by caregivers
Difficulty sleeping	108	87.1%
Lack of appetite	72	58.1%
Lack of pleasure	66	53.2%
Stress or anxiety	46	37.1%
Not wanting to be with others	46	37.1%
Difficulty concentrating	40	32.3%
Not feeling anything emotionally	28	22.6%
Other	3	2.4%
Caregivers’ greatest needs
Money	110	88.7%
Food	92	74.2%
Someone to help me	81	65.3%
Love	32	25.8%
A way to make money	30	24.2%
Help dealing with emotions	26	21.0%
Respect	25	20.2%
Care for my children	23	18.5%
Schooling for my children	19	15.3%

aParticipants could provide multiple responses for each question.

Availability of essential medicines and supplies

Shopkeepers at 17 pharmacies were interviewed about the availability of essential palliative care medications and supplies. Morphine was not available in any pharmacy, and only 1 pharmacy (5.9%) had any suitable oral opioids available, in the form of oxymorphone tablets. Table 6 provides further details of medication and supply availability.

Table 6

Medicine and medical equipment availability in local pharmacies by location.

Item	Number of pharmacies with medication or equipment in stock
	Pharmacies in refugee camps (n = 7)	Pharmacies in market in nearest town (n = 7)	Pharmacies at nearest government primary health center (n = 3)	Total number of pharmacies with item available	Percent of all pharmacies (n = 17) with item available
Medications from essential package
Amitriptyline	0	4	2	6	35.3%
Bisacodyl	0	2	0	2	11.8%
Dexamethasone	4	6	3	13	76.5%
Diazepam	1	6	2	9	52.9%
Fluconazole	4	6	3	13	76.5%
Furosemide	2	4	1	7	41.2%
Fluoxetine or sertraline or citalopram	0	3	0	3	17.6%
Hyoscine butylbromide	1	2	1	4	23.5%
Haloperidol	0	3	0	3	17.6%
Ibuprofen	1	6	2	9	52.9%
Lactulose	3	7	3	13	76.5%
Loperamide	3	5	3	11	64.7%
Metoclopramide	0	0	0	0	0.0%
Metronidazole	4	7	3	14	82.4%
Morphine—immediate release tablet	0	0	0	0	0.0%
Morphine—sustained release tablet	0	0	0	0	0.0%
Morphine—injectable	0	0	0	0	0.0%
Naloxone—injectable	0	0	0	0	0.0%
Ondansetron	1	7	3	11	64.7%
Paracetamol	7	7	3	17	100.0%
Petroleum jelly	0	1	2	3	17.6%
Medical equipment from essential package
Adult diapers	0	0	0	0	0.0%
Nasogastric tube	0	1	2	3	17.6%
Urinary catheter	0	1	2	3	17.6%
Other opioids available in Bangladesh
Fentanyl injection	0	0	0	0	0.0%
Nalbuphine injection	0	1	2	3	17.6%
Oxymorphone tablets	0	1	0	1	5.9%
Pethidine injection	0	0	0	0	0.0%
Tramadol tablets	0	5	2	7	41.2%
Tramadol suppositories	0	3	3	6	35.3%
Tramadol injection	0	2	3	5	29.4%

Discussion

We describe the need for palliative care and symptom relief during an unfolding humanitarian crisis, including the illness-related suffering experienced by individuals with serious health problems and the impact on their caregivers of providing care for such individuals. We found that the majority of ill individuals were experiencing significant pain and other physical symptoms and were unable to access the medical treatments necessary to relieve their suffering. Caregivers provided a considerable amount of care for ill individuals, with significant negative consequences for their own physical and emotional health.

Pain

Prevalence and treatment

A significant proportion of patients (70%) reported pain, and many (21%) had received no medications to treat their pain. To our knowledge, there are no other comparable studies from humanitarian settings, but several studies from India and Bangladesh report similar pain prevalence rates of 71%–100% in patients with serious health problems at the time of initial assessment [14-16]. In our study, those who received treatment frequently reported limited improvement, with 70% reporting moderate or severe pain despite treatment. This may be because the most common pain treatments were paracetamol and non-steroidal anti-inflammatories, which are recommended only for mild pain [17]. Additionally, many of the reported treatments for pain were not analgesics. Our findings support the recent Lancet Commission conclusion that pain contributes significantly to the burden of serious illness-related suffering worldwide [2]. A recently published WHO guide provides practical guidance for humanitarian health actors to implement emergency health system responses that integrate pain and symptom management [4].

Opioid policy barriers

We found very little use or pharmacy availability of oral morphine, which is widely accepted as essential for achieving adequate pain control in humanitarian settings [4,18]. Despite morphine and other opioids being included on the Bangladesh Essential Drug List, morphine is not practically available outside of the capital city of Dhaka [14]. The International Narcotics Control Board reports that only 18 kg of morphine was consumed in Bangladesh in 2017, which previous studies have estimated represents less than 1% of the anticipated national opioid need [8,19]. Overly restrictive opioid policies are a common barrier to opioid availability in LMICs; however, several LMICs, including Uganda and Mongolia, provide examples of an appropriately balanced approach to opioid control, which provides for medical needs while addressing the risk of nonmedical use [18,20,21]. Applying these lessons to humanitarian situations may improve morphine availability in these settings. There are no published studies to our knowledge about the availability of opioids in humanitarian crisis situations and the barriers to humanitarian health organizations importing these medications as part of their relief efforts [6]. Humanitarian health organizations may choose not to include opioids in their essential supply packages, fearing that country-specific opioid policies may delay the import of the entire shipment of essential medications and supplies or because of a lack of knowledge among healthcare providers about the safe and effective use of such medications.

Role of healthcare in pain management

Many patients had sought healthcare for pain relief, yet few had received adequate pain relief. Barriers to accessing medical care included facilities not having the necessary treatment for the individual’s complaint or facilities providing poor quality of treatment. While we did not collect data directly from healthcare professionals, it is plausible that healthcare professionals’ fears and misinformation about opioids may have contributed to such patient experiences, since misconceptions about the essential role of opioids in cancer pain relief have been described as a significant barrier to effective pain management in many resource-limited settings [4,18,22]. Education for clinicians about the safe use of opioids can improve pain management for patients, and the Lancet Commission proposed basic mandatory training for all healthcare providers [2,23,24]. Implementation of these strategies should be considered by humanitarian organizations to improve pain management [6].

Medical interventions

The majority of patients required a range of medical interventions, including medications, medical equipment, visits to health facilities, and basic care. We identified significant barriers to accessing these interventions, including financial problems, unavailable treatments or medications, and a lack of support for caregivers. Humanitarian health facilities generally provide free medicines, but patients are usually given only 1–2 weeks’ supply, which creates significant barriers to continuing treatment for individuals with a chronic condition who require medications indefinitely. Despite free medications, the costs for transportation to health facilities and lost wages may be a significant financial burden for patients, and these factors may have contributed to the significant number of patients who reported being unable to obtain necessary medical interventions in our study.

Caregivers

Family caregivers provided many hours of assistance daily, most often helping with bathing, feeding, and administering medicines, while also providing emotional support. Very few caregivers had received any training in their role. A basic palliative care training manual for caregivers has recently been published, and efforts are underway to adapt this training to humanitarian situations [25]. Previous studies have demonstrated the feasibility of training for family caregivers, showing reductions in caregiver burnout by providing skills to cope with the emotional stress of caregiving [26,27].

Strengths and limitations

This study, which as far as we are aware is the first formal assessment of palliative care needs in an unfolding humanitarian crisis, used a relatively simple method of assessing palliative care needs, which was easily implemented with limited resources early in a humanitarian crisis. The involvement of local community interviewers enabled the refinement of the study instruments to reflect features of the local culture and is also likely to have facilitated participant recruitment. Despite our efforts to adapt interview items, outstanding issues of cultural relevance and linguistic equivalence may have impacted the assessment. The use of closed-ended interview questions limited the depth and richness of the data, while our sampling methodology may limit the generalizability of the findings.

Future study

Future studies should validate the methodology we describe, examining its ability to assess palliative care needs and serious illness-related suffering in other populations affected by humanitarian crises or in resource-limited settings. Research priorities should also include quantifying the serious-illness-related suffering experienced by populations in humanitarian settings, evaluating programs designed to alleviate this suffering, and testing published guides and recommendations [2]. Further studies are needed to explore best models for palliative care training in humanitarian situations.

STROBE checklist.

(DOCX)

Click here for additional data file.

Original funding proposal.

(DOCX)

Click here for additional data file.

31 Oct 2019

Dear Dr. Doherty,

Thank you very much for submitting your manuscript "Assessing the serious health-related suffering and need for palliative care in an unfolding humanitarian emergency: A cross-sectional observational study of Rohingya refugees in Bangladesh" (PMEDICINE-D-19-03771) for consideration at PLOS Medicine.

Your paper was discussed among the editorial team and sent to independent reviewers, including a statistical reviewer. The reviews are appended at the bottom of this email and any accompanying reviewer attachments can be seen via the link below:

[LINK]

In light of these reviews, we will not be able to accept the manuscript for publication in the journal in its current form, but we would like to invite you to submit a revised version that fully addresses the reviewers' and editors' comments. You will appreciate that we cannot make a decision about publication until we have seen the revised manuscript and your response, and we expect to seek re-review by one or more of the reviewers.

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Requests from the editors:

Please begin the process of depositing study data in a public repository.

Please revise your title to better match journal style. We suggest "Illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh: a cross-sectional study".

To your abstract, please add the start and end dates of recruitment for your study; and brief demographic details for study participants.

The final sentence of the "methods and findings" subsection of your abstract should summarize the study's main limitations.

Around line 67, please begin your discussion of conclusions by referring to your findings (i.e., "In this study, we found that ..." or similar).

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The "Lancet Commission" is mentioned three times in your introduction, and we suggest that once would suffice.

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Throughout your text, please format reference call-outs as follows: "...saving lives [1,3]."

Please avoid using italics for emphasis.

Please substitute "sex" for "gender" as appropriate.

Please remove the "Role of the funding source" section from your text.

In your reference list, please ensure that journal name abbreviations are consistently observed (e.g., "Lancet" for references 2 and 3; "JAMA" for reference 27.

Please add full access details to references 2 and 7.

Please add author names where available, e.g. to references 11 and 12; please format the author names for reference 1 consistently with other references; and make the author of reference 4 "WHO" (or the fully spelt-out version).

Please correct the typo in reference 12.

You mention the STROBE reporting guideline in your text, and we ask you to add a completed checklist as a supplementary file, referred to in the methods section. In the checklist, individual items should be referred to by section (e.g., "Methods") and paragraph number rather than by line or page numbers, as the latter generally change in the event of publication.

Comments from the reviewers:

*** Reviewer #1:

The authors have assessed the symptom load and the palliative care needs of a large convenience sample of patients and caregivers from the Rohingya refugee communities in Bangladesh. They found significant physical, emotional and social suffering, lack of access to medicines and other medical supplies, and high burden on caregivers.

The survey covers a most important topic, which has been neglected by research until now. The authors are to be recommended for the clear structure of their survey and the concise and clear presentation of the results. I have only a few minor comments.

Reference 4 needs to be corrected (World Health Organization)

Reference 7 does not seem to be complete

Page 7, line 128: When exactly was the data collection period?

Page 7, line 134: how many experts provided feedback?

Page 7, line 138: did the authors consider cultural adaptation of the questions and if so, how?

Page 8, line 156: how many interviewers were trained? Did I understand correctly that there was only one training workshop and an 8-day sampling period immediately following that workshop? When did you have the workshop? What contents were included in the practical and the theoretical parts of the workshop?

Page 10, line 188: are you able to estimate how many patients were approached in the recruitment period? Where die the interviewers identify and approach patients? Did they participate in clinics?

Page 13, table 2: antibiotics or vitamins /minerals would not be considered pain relieving medication. Could you include this point in the discussion?

Page 21, line 333: you should compare the lack of opioid availability and accessability to the INCB data or any other data on opioid consumption in Bangladesh

Page 21, line 339: do humanitarian organizations such as MSF bring opioids to the Rohingya refugee camps? If not, why not?

Page 23, line 379: another limitation that you should discuss here is that you could not quantify SHS. The Lancet report gave a good methodology for quantification of SHS, and I would have loved to see some data for example on days with SHS.

*** Reviewer #2:

I confine my remarks to statistical and methodological aspects of this paper.

I marked "proceed without recommendation" because I can't decide between "reject" and "accept". The statistics themselves are very simple and there's nothing really to do to improve them. But (as the authors acknowledge) this is a convenience sample of a rather difficult population; it's unclear what it says about any other population in any other, similar, situation. (To be fair, the authors don't say that it says anything about such people).

The problem is not the article itself but what people may make of it. I know (and I am sure the editors do too) that limitations of a study often get ignored. I don't know how to deal with that in this case, hence my "no recommendation". I leave it to the editors to judge.

Other than that, my only concern is the translation into Rohingya. Translation is tricky; translation of questions about pain can be particularly tricky. I remember one study (although I don't remember the citation) of menstrual pain in bilingual Chinese-American women. The questions were carefully translated, then back tranlsated into English, then edited. The questionnaire was given to the women in both languages and there were significantly different results.\\

Sorry to be so vague but I am not sure what to recommend here.

Peter Flom

*** Reviewer #3:

1) Congratulations on this important effort to generate evidence of palliative care needs in humanitarian crises.

2) I applaud your inclusion in your study of caregiver burden.

3) The term "health-related suffering" is an oxymoron. While it was used in the Report of the Lancet Commission on Palliative Care, this seems misguided. Please use instead "illness-related suffering."

4) Per the WHO document entitled "Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises: a WHO guide." palliative care is not only for people with "life-limiting condition." In humanitarian crises, many people, perhaps most people, who suffering requires palliative care may not have a "life-limiting condition." Please make clear, per WHO guidance, that palliative care should respond to the local need and that this need varies by location, culture, and socio-economic situation.

5) Your study population is not limited to people with "life-limiting conditions." It includes people with "significant physical disability", burns, drug-resistant TB, and HIV infection. At least some of these people may live long lives, and some may lead relatively healthy long lives. Thus, please change the term "life-limiting condition" to "serious health problem."

6) Line 70: Should state: " ... palliative care which addresses the needs of all people with serious illness-related suffering and their caregivers."

7) Line 77: More relevant and up to date citation: Krakauer EL, Daubman BR, Aloudat T. Integrating palliative care and symptom relief into responses to humanitarian crises. Med J Australia 2019;211;201-203.

8) Lines 107-108: Text should recommend the essential package of palliative care described by WHO specifically for humanitarian crises, not the general package from the Report of the Lancet Commission.

9) In light of the documented lack of access to disease treatment, please emphasize that palliative care is never a substitute for disease treatment and that efforts to make palliative care accessible for people affected by humanitarian crises should be accompanied by and integrated with efforts to make disease prevention, early diagnosis and treatment accessible to the same population.

***

Any attachments provided with reviews can be seen via the following link:

[LINK]

7 Nov 2019

Submitted filename: Response to reviewers.docx

Click here for additional data file.

21 Nov 2019

Dear Dr. Doherty,

Thank you very much for re-submitting your manuscript "Illness related-suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh: a cross-sectional study" (PMEDICINE-D-19-03771R1) for consideration at PLOS Medicine.

I have discussed the paper with editorial colleagues and our academic editor, and it was also seen again by two of our reviewers. I am pleased to tell you that, provided the remaining editorial and production issues are dealt with, we expect to be able to accept the paper for publication in the journal.

The remaining issues that need to be addressed are listed at the end of this email. Any accompanying reviewer attachments can be seen via the link below. Please take these into account before resubmitting your manuscript:

[LINK]

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Please ensure that the paper adheres to the PLOS Data Availability Policy (see http://journals.plos.org/plosmedicine/s/data-availability), which requires that all data underlying the study's findings be provided in a repository or as Supporting Information. For data residing with a third party, authors are required to provide instructions with contact information for obtaining the data. PLOS journals do not allow statements supported by "data not shown" or "unpublished results." For such statements, authors must provide supporting data or cite public sources that include it.

Please let me know if you have any questions, and otherwise we look forward to receiving your revised manuscript shortly.

Kind regards,

Richard Turner, PhD

Senior Editor, PLOS Medicine

rturner@plos.org

------------------------------------------------------------

Requests from Editors:

Please finalize the arrangements for data deposition.

Around lines 57-58 of your abstract, please add an additional 1-2 sentences to describe your approaches. For example, please summarize your methods of recruitment, sampling, health assessment and interviewing.

Please add summary information on participants' ages to your abstract.

At line 60, please amend the text to "... individuals reported experiencing significant pain" or similar.

Around line 63 of the abstract, we suggest adding an additional sentence, say, summarizing caregivers' health and wellbeing.

At line 64, we suspect that "closed-ended" should be substituted.

At line 95, please adapt the text to "... and their caregivers are not being addressed adequately." or similar.

At line 101, please adapt the text to "... should quantify serious illness-relates suffering ...".

We ask you to refer to the attached STROBE checklist in your main text, perhaps around line 150.

You note in your responses that "We have clarified that there was no prespecified analysis plan."; please add a statement to this effect around line 150, including additional wording such as "All analyses were non-prespecified.".

As an alternative, is there a submission to a funding body, say, that could be uploaded as a supplementary file in place of a study plan?

Please make that "problems" at line 184.

At lines 464-465, we suspect that "... should quantifying the need for serious illness-related suffering" should become "... should quantify serious illness-related suffering" or similar.

Please reformat reference call-outs throughout your text, e.g., "... care services [4,5]."

Please amend the formatting of author names for reference 1, and address any journal names needing abbreviation (e.g., "Lancet" for reference 2).

You note in the STROBE checklist that information on funding was "removed on the request of the editor". We ask you to substitute "See Metadata" or similar (the current wording could be taken to indicate an intent to conceal, whereas the aim is to present the information in a standardized format rather than in the main text).

Comments from Reviewers:

*** Reviewer #1:

The authors have revised the paper and fully included all comments from the reviewers. As for the open question on table 2: I like the way they have solved this issue.

*** Reviewer #3:

Efforts to make palliative care accessible to the global poor have been sharply and justifiably criticized in the past if they were not linked to efforts to make disease prevention, diagnosis and treatment accessible. If there is a focus purely on relieving symptoms without trying to prevent, diagnose and treat the illnesses that CAUSE the symptoms, this endeavor risks being called immoral and "second rate care for the poor." While I have approved the current draft of the paper, I still think you should consider emphasizing that palliative care in humanitarian crises should be linked to efforts to prevent and treat serious illnesses and to strengthen local healthcare systems.

***

Any attachments provided with reviews can be seen via the following link:

[LINK]

24 Jan 2020

Dear Dr Doherty,

On behalf of my colleagues and the academic editor, Dr. Terry McGovern, I am delighted to inform you that your manuscript entitled "Illness-related suffering and need for palliative care in Rohingya refugees and caregivers in Bangladesh: a cross-sectional study" (PMEDICINE-D-19-03771R2) has been accepted for publication in PLOS Medicine.

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