Developing a Screening Tool for Serious Health-related Suffering for Low- and Middle-Income Countries – Phase-1: Domain Identification and Item Generation

INTRODUCTION

Suffering is an aversive multidimensional dynamic experience of severe distress, associated with events that potentially threaten the intactness of a person.^[1-4] The Lancet Commission on Global Access to Palliative Care and Pain Relief explored the concept of ‘health-related suffering’ as its central precept. It used an innovative conceptual framework to describe the global prevalence of ‘serious health-related suffering’ (SHS) from a population perspective.^[5] Approximately 61 million adults experienced SHS globally in the year 2015, and 80% of them were from low- and middle-income countries (LMICs).^[5,6] It is estimated that 21.3 million patients experience SHS in LMIC alone, and 7.2 million of them are Indians.^[7] Moreover, 2.5 million children die with SHS every year and 98% of them belong to LMICs.^[5]

The Lancet report highlights SHS across the physical, psychological, spiritual, and social domains, as a crucial, unrecognised, and unmet care need. It also recommends an essential package for the physical and emotional domains of the SHS, to help mitigate the suffering, strengthen the national health systems, and meet the sustainable development goals of universal health coverage.^[5]

Alleviating suffering is the goal of healthcare and the central tenet of palliative care.^[8,9] Recently, the International Association for Hospice and Palliative Care (IAHPC) published a consensus-based definition of palliative care in terms of SHS, which includes its assessment and management at physical, psychological, spiritual, and social levels.^[9] Identification of this multidimensional experience of SHS at an individual level is imperative to its evaluation and management.^[10] It is challenging to capture a subjective phenomenon like SHS, as the experience of suffering under similar conditions may be different amongst individuals.^[11] Although a qualitative interview might be more appropriate to explore suffering at an individual level, a screening tool would be a more direct and practical strategy in a time and resource-constrained setting. The ideal tool should be able to measure the multidimensional subjective elements of suffering, be brief, simple, meaningful, and not trigger emotional distress. [12,13] This research was necessitated, as no screening tools for SHS were identified during the scoping search of the literature, for reasons elaborated under the discussions section.

Cancer is recognised as a significant contributor to SHS.^[5] The National Cancer Grid of India (NCG) is a collaborative network of cancer care organisations, research institutions, patient groups, and professional societies, funded by the Government of India with the mandate of facilitating uniform standards of cancer care.^[14] Based on the evidence for health-related suffering reported by the Lancet Commission, the NCG-India, with support from the Indian Association of Palliative Care, initiated the process of developing a screening tool to assess SHS at an individual patient level, appropriate for resource-constrained settings.

MATERIALS AND METHODS

Overview: Domain identification and item generation were done according to prescribed recommendations for tool development.^[15-17] The initial draft contents, domains, and items are based on the elucidation of key concepts; ‘health-related suffering’ and ‘its seriousness’ as defined in the Lancet report. The draft tool content then underwent consensus evolving techniques; the Delphi process, nominal group technique (NGT), and expert review. To enhance its robustness and achieve concurrence, the transparent expert consultation (TEC) process with an online ranking of tool versions was used additionally [Figure 1].^[16,18] Details of the methodology are described below.

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Figure 1:

The sequential methodological steps used to build consensus on the National Cancer Grid of India-serious health-related suffering screening tool.

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RESULTS

Among the 282 poll participants, palliative care physicians formed 40.78% of voters, followed by 17.38% specialist oncologists and 10.99% nurses with a smaller representation from social workers, counsellors, medical students, patients, and family members. Southern states of India contributed 41.13% votes, with a smaller percentage from the west (19.15%), north (17.02%), north-east (10.99%), east (8.51%), and central (2.13%) states [Appendix-4 of the supplementary file].

About 65.3% of the poll participants voted for the 5Q version of the tool with five questions representing physical, psychological, social, spiritual, and financial domains. 4Q version received 17.38% and 3Q received 14.18% of the votes, respectively. Moreover, 52.8% of participants felt that impact of suffering on functional capacities determined its seriousness, while 34.40% of selected patients wish for additional help to determine the seriousness of health-related suffering [Appendix-5 of the supplementary file]. Eighty-three participants posted comments.

[Table 1] depicts the content analysis performed on the comments provided by poll participants. This allowed for fine tuning and simplification of the terminologies and descriptors of the domains and items. For example, the item ‘breathlessness’ was replaced by ‘breathing difficulty,’ and ‘depression’ was replaced by ‘feeling sad.’ The voting and comments helped determine tool content to screen for ‘seriousness,’ once a score of ≥2 suggested the presence of health-related suffering.

The NCG-SHS tool developed through this study has two sections, as shown in [Table 2]. The initial section has questions related to the five domains of health-related suffering, with a 3-point scoring system on a Likert scale with values of 0 (Not at all), 1 (A little), and 2 (A lot) overall, for each domain. A total score of ≥2 indicates that the patient has health-related suffering. The latter section determines the seriousness of the suffering by checking for (i) functional limitation of at least 14 days over the past 30 days and (ii) the patient’s felt need to seek additional professional help. Screening positive for SHS required a score of ≥2 in the ^1st section along with a ‘yes’ to either or both questions of the latter section.

DISCUSSION

This article narrates the development methodology and drafting of a novel tool to measure SHS suitable to LMICs. Evidence suggests that SHS among cancer decedents will increase (2016–2060) more quickly in low- and lower-middle-income countries compared to upper-middle- and high-income countries. Hence, this study to develop the NCG-SHS screening tool is timely, relevant, and in response to the critical need to identify, evaluate and respond to the multidimensional health-related suffering at individual patient level.^[32]

Four out of the five domains included in the NCG-SHS tool have ample evidence as contributors to SHS.^[5,8,9] The fifth domain that is, suffering due to financial toxicities, was identified as a distinct domain during this study, as a majority of health-related expenditure in India is out-of-pocket.

To make the domain questions easy to understand, they are supported by item descriptors. For example, the 1^st domain question is – Associated with your health, do you suffer physically? Here, the item descriptors orient the patient to suffering due to their physical concerns. The scoring for all domains is kept simple; as, ‘not at all,’ ‘a little’ or ‘a lot’ based on the patient’s perception of suffering in that domain. A score of ≥2, will trigger second level enquiry for seriousness.

For the social, spiritual, and financial domains, the questions are worded carefully. For example, if the spiritual domain question had been formulated as, Associated with your health, do you suffer spiritually?, patients may/may not comprehend the scope and extent of that domain. The current phrasing of this domain question without the word ‘spiritual’, but with its accompanying descriptors items; ‘feeling punished/fearful/ shame/guilty/angry with God/no meaning in life/feeling disconnected,’ clarifies the intent of the domain more clearly. Cancer with its chronic fluctuating illness trajectory interspersed with relapses and complications demands high-cost treatment and result in catastrophic out-of-pocket expenses and healthcare-related poverty. Accordingly, the financial domain of suffering is incorporated as contextual to India (and other LMICs). Again, this domain question does not contain the word ‘financial,’ which can limit the scope of this question to treatment affordability of the patient/family. Instead, the item descriptors allude to the negative impact that ill-health and treatment may have had on their economic self-sufficiency, such as, loss of employment, interruption of studies, new loan, debt, sold property or assets, or migration to access treatment etc. When financial associated suffering is recognised, it can activate an early referral to the social worker and align patient/families to the available resources as per their eligibility for example, (a) state/central government schemes (support for travel for treatment), (b) patient welfare funds of the institution and (c) access to educational or vocational training/ support programs (for eligible family members) and assist toward economic self-sufficiency of patients/family members, including educational support for affected children. Unveiling financial toxicity as an important contributor to suffering could pre-empt the oncology team toward proportionate cost-beneficence of offered therapies. This can also avoid deepening sense of guilt/helplessness for the patient/family.

Although there are no existing gold standards tool to compare the SHS tool, the distress thermometer (DT), the Edmonton Symptom Assessment System (ESAS), and the integrated Palliative care Outcome Scale (iPOS) have been used in Indian settings, to identify symptoms and distress of patients. The DT elicits the subjective distress score in cancer patients under multiple domains. However, the contributors to distress are not all health-related.^[33] Furthermore, DT is not linked to an essential care package. ESAS is a patient-centred symptom assessment tool that documents the presence and severity of nine physical/emotional symptoms, along with the sense of wellbeing, which is quick and easy to administer, interpret and report.^[34] However, the sum of its unidimensional scores may not represent the multidimensional experience of suffering in an individual. Two patients with the same ESAS score for pain may have a different perception of suffering due to that pain. The iPOS evaluates care needs and monitors care outcomes within a palliative care setting.^[35] However, significant limitations of iPOS as a screening tool for SHS are that (i) the contents do not represent SHS domains relevant to India, (ii) the competencies to administer and analyse iPOS as a screening tool in the rushed oncology settings in India are low and (iii) the time factor, as iPOS on an average, requires >10 min to complete. Moreover, none of these tools explore the patient’s awareness of the suffering and their perceived need for additional professional help.

The NCG-SHS tool appraises the domains of health-related suffering specific to the resource-constrained healthcare setting, which aligns well with the LMIC context. Moreover, it ensures and respects the patient’s perception of the seriousness of suffering and their perceived need for additional professional help. Once validated through field testing, this tool may be used to screen, and trigger detailed evaluation of contributors for planning further care.

CONCLUSION

In this paper we have described the process of generation of domains, items and screening questions for health-related suffering and its seriousness during the preliminary phase of developing the SHS screening tool applicable to a resource-limited healthcare setting. Field-testing of the tool is being conducted as phase-2 of this study, to validate it in clinical settings.