A Multicentric Field Test to Study the Validity and Feasibility of the SHS-tool to Screen for Serious Health-related Suffering in Adult Patients with Cancer

INTRODUCTION

The relief of suffering and access to palliative care are neglected dimensions of global healthcare. The report of the Lancet Commission on Global Access to Palliative Care and Pain Relief (GAPCPR) -2017^[1] (report) highlights the concept of ‘Serious Health-related Suffering’ (SHS) at physical, psychological, social and spiritual domains notable at end-of-life; and during acute or chronic life-limiting, life-threatening illnesses, or injury. It states the suffering to be ‘health-related’ when it is associated with illness or injury of any kind and as ‘serious’ when it cannot be relieved without professional intervention and when it compromises the functioning of the individual. The report lists fifteen symptoms from twenty life-limiting and life-threatening conditions, as most associated with SHS.^[1] It estimates that 61 million persons experienced SHS in 2015 alone, of whom 80% resided in low- and middle-income countries (LMICs).^[2] The burden of SHS is expected to double by 2060, with the fastest increases occurring in low-income countries.^[3] Around 7.2 million Indians were noted to have SHS.^[3]

The Lancet Report recommends an ‘essential palliative care package’ to alleviate SHS. The consensus-based definition of palliative care by the International Association for Hospice and Palliative Care integrates and emphasises the critical need for assessment and management of SHS.^[4]

To alleviate suffering, it is essential first to identify it. The framework developed by the GAPCPR attempts to measure the SHS burden from a population perspective.^[2] However, perceptions of suffering, particularly when health-related, are subjective. Identifying and responding to the suffering endured by individuals requires a suitable screening tool. An appraisal of tools measuring suffering in health conditions yielded seven instruments. They measure certain domains that contribute to suffering but not those emphasised in the Lancet Report [Supplementary Table 1].

Cancer has emerged as a significant contributor to SHS, with an estimated 19.3 million new cases worldwide in 2020.^[5] National Cancer Grid (NCG) of India is a robust network of over three hundred cancer-care institutions across India, which supports the establishment of uniform standards and best practices in cancer care.^[6] NCG covers over 90% of cancer care in India. The NCG envisaged developing a tool to facilitate early recognition and address of SHS amongst cancer patients in busy cancer-care settings in India. For satisfactory screening, the SHS screening tool, hereafter referred to as ‘the tool’ or ‘SHS tool,’ is required to be sensitive, easy and quick to administer to identify those with possible SHS who would then need in-depth evaluation and suitable care.

The tool was developed and evaluated in two phases. Phase 1 of developing the SHS tool describes the concept clarification and the consensus-building processes (Delphi, Nominal Group Technique, Transparent Expert Consultation and online poll).^[7] The questionnaire framework of the tool that emerged during Phase 1 has two sections. Section 1 screens for the presence of ‘health-related suffering’ using questions framed along five domains of suffering: Physical, psychological, social and spiritual domains, as articulated in the Lancet Report, along with a fifth domain of financial suffering. This additional domain emerged during the consensus-building process of phase 1 as quintessential for the population served in LMICs like India, where the cost of healthcare is out-of-pocket.^[7] Section 2 of the SHS tool screens for the ‘seriousness’ of the health-related suffering in that patient through (i) its impact on daily functions and (ii) the expressed need for professional help to address the suffering [Appendix 1]. The Phase-2 study describes the multicentric field test of the SHS tool that evaluated its validity, reliability, feasibility, relevance and acceptability. Figure 1 provides an overview of the flow of events during Phase 1 and Phase 2 of the study on the SHS screening tool.

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Figure 1:

The phase 1 and phase 2 processes of development and validation of the serious health-related suffering (SHS)-screening tool.

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MATERIALS AND METHODS

The SHS screening tool developed through phase 1 [Appendix 1] was field-tested for validity and feasibility across nine tertiary cancer-care centres (TCC sites) selected from different healthcare sectors and regions of India [Figure 2]. The study utilised a purposive sample of 254 cancer patients attending the TCC sites. Selecting the prevalence of suffering as 50%^[8,9] and a tool sensitivity of 70% (10% precision), this sample size returned power of 95% on power analysis.

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Figure 2:

Names and locations of participating tertiary cancer centre sites.

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The field test process began by identifying the nine TCC sites and principal investigators (PIs) from across the country to participate. Online interactions helped introduce the SHS tool to the PIs, finalise the standard procedure for field testing and support the submission of study proposals to respective institutional ethics committees (IECs). Personnel at each site included the PI, co-investigators and a research associate (RA) nominated by the PI, who administered the electronic version of the SHS tool using smartphone technology. An interview of the same patient to elicit SHS within the same period served as the standard to validate the tool output, as eliciting SHS was a de novo activity without established practices to compare within the settings. In addition, the study used survey questionnaires to ascertain the feasibility, relevance and acceptability of patient respondents (n = 121) and all RAs (n = 11). Feedback comments from PIs were recorded at the end of the field test study.

PIs selected the personnel to engage with the study (the RA and the professional to interview the patient) and setting(s) suitable for conducting the field test: patient waiting area and in-patient/daycare ward. All RAs received standardised training and the interviewers received an orientation on the concept of SHS. To reduce bias, interviewers were kept blinded to the design and contents of the SHS tool.

RAs at the selected setting identified the potential participants who fulfilled the inclusion criteria: (1) adult patient (age more than 18 years); (2) with a cancer diagnosis; (3) on follow-up/review visit; and (4) able to comprehend English. After eliciting their inclination with a brief overview of the study, the RA, under the supervision of PIs, shared the Participant Information Sheet, clarified their questions and obtained written consent. They then administered the electronic version of the SHS tool through a secure link. (https://efficiency365.com/shs). The interviewer interacted with the patient-respondent, built rapport and elicited their concerns related to their health condition without time delay to avoid variance in the SHS status due to fresh interventions. Interviewers assessed for the presence of health-related-suffering using conversation/interview/observation methods. Notes of the interviewer, with their impression on the presence or absence of SHS and their responses to additional questions, were uploaded using the Google form designed for this purpose. The question ‘Did you get the impression that this patient currently has SHS?’ directed the interviewer to focus on the ongoing status of suffering. They also responded, ‘Would the patient have reached a professional like you for evaluation as per the usual processes in your setting, outside of this study?’ When interviews could not be initiated or completed due to lapse in time, withdrawal or absenteeism, the corresponding tool-related data was discarded.

Google-based survey questionnaires on the feasibility, acceptability, relevance and ease of using/administering the SHS tool were used to elicit perceptions of patients and RAs. The RAs administered a feasibility questionnaire to a convenience sample of patient respondents (n = 121/254), and PIs conducted the survey for all RAs (n = 11/11). Patients and RAs who recorded <7/10 on the feasibility survey (0 indicating extreme dissatisfaction and 10 extreme satisfaction) were asked to post their comments and suggestions. In addition, the PIs of each site shared their feedback comments at the end of their field test. Data output of the SHS-tool, notes uploaded by the interviewers, as well as feasibility survey outcomes were captured centrally in real-time by the research team. Data collection across nine TCCs-sites took place between September 2021 and December 2022, with successive waves of COVID-19 contributing to significant delays. Analyses were done using Microsoft Excel. The sites followed their own institutional policy to care for those patients screened as having SHS by either the SHS tool or the interview.

This study was approved by the IEC of NCG-India and by the IECs of all sites. The registration number with the Clinical Trials Registry-India (CTRI) is CTRI/2021/09/036681. There were no financial incentives involved. PIs ensured that care-related processes of patients, for which they visited the hospital, were left undisturbed. The de-identified data was stored on password protected devices accessible only to the research team, to protect confidentiality.

RESULTS

The field test was conducted across nine sites in India, situated in the south, east and west zones [Figure 2 and Table 1] and yielded complete data from 254 respondents for analysis using descriptive statistics. Of the field-test TCC sites, three were stand-alone government-authorised TCC sites, three were academic institutions, two belonged to the non-government sector, and one was privately funded. Three sites used a patient waiting area, one used an in-patient/daycare ward and five sites used both settings for conducting the field test. The profile of interviewers and RAs is listed in Supplementary Tables 2 and 3.

Table 1 describes the demographics of patient-respondents; with 53.15% male and 69.69% in the age-group of 31–70 years. Furthermore, 76.38% were graduates or postgraduates, 54.33% were employed and 64.57% were registered under Medical Oncology. Three TCC-sites selected patient waiting area, one selected in-patient/daycare ward and five sites tested the tool in both settings.

Applying Cronbach’s alpha, the internal consistency of the section 1 questionnaire of the SHS tool was 0.728. The tool detected SHS in 137 instances, while the interviewer recorded SHS in 116 instances. The SHS-tool outcomes concurred with the interview outcomes in 64.17% (163/254) instances. Of the 137 patients screened as having serious suffering by the tool, 51 (37.23%) were based on the impact on functions, 37 (27 %) on seeking professional help, and 49 (35.77%) responded with ‘yes’ to both. The tool exhibited a sensitivity of 70%, specificity of 59%, positive predictive value of 59% and negative predictive value of 70%, all at 95% confidence intervals [Table 2].

Analysis of the patient feasibility questionnaire responses (n = 121) showed that 91.74% of respondents found the SHS tool easy to understand, 92.56% found it easy to use, 89.26% felt the questions were relevant to their condition, and 96.69% of patients found the settings selected for screening to be suitable [Table 3]. Analysis of feasibility questionnaire responses from RAs (n = 11) showed that 10/11 found the tool easy to administer, 8/11 found it relevant to the patient’s situation, and 8/11 found no reasons preventing its regular use [Table 3]. The interviewers reported that, in 66.67% of instances, patients would not have reached them if not for the field test. The PIs shared their feedback and observations on administering the SHS tool within their settings. Analysis of comments in the feasibility surveys of patients and RAs yielded insights, as shown in Supplementary Table 2.

DISCUSSION

Suffering is a subjective experience that can be difficult to measure, even more so within the complex settings of health care, and a questionnaire-based screening tool to identify a complex phenomenon like suffering might appear simplistic. The purpose of this study was to develop and evaluate a brief, user-friendly screening tool for frontline staff in oncology settings to screen patients for SHS where none exists. There is a dearth of validated tools with the right combination of psychometric properties to screen for the presence and S HS.^[3,10-20] The purpose of this study was to develop and validate a useful tool to screen to recognize SHS in adult cancer patients at busy tertiary-care centres. The SHS tool designed and developed during phase 1^[10] was validated and found feasible to use through this phase 2 field-test study.

The TCC-sites from government, academic institutions, non-government and private sectors participated in the field-test, representing diverse population of patients from geographically different regions of India, with various socio-cultural-linguistic and economic backgrounds.

An interview conducted by a skilled professional (health-care professionals or post-graduates with counselling skills [Supplementary Table 3] allows for a detailed bio-psychosocial formulation to screen and identify suffering and can elicit several contributing factors. Interviews hence served as the ‘relevant standard’ in this study, against which the SHS tool was compared, although the logistical limitations may preclude it from routine usage in time- and resource-constrained cancer-care settings such as seen in India. The field test, along with the feedback observations from PIs, indicate that the tool may be administered satisfactorily by trained RAs with modest educational backgrounds [Supplementary Table 4].

The Cronbach’s alpha of 0.728 of the SHS-tool contents, although not ideal, indicates acceptable internal consistency for screening at 95% Confidence Intervals. The SHS tool’s sensitivity of 70% and specificity of 59% suggest a moderate level of accuracy with the possibility of false positives and negatives. There was a moderate concordance rate of 64.17% between the tool output with that of the interview. This may be considered reasonable, as an interview to elicit SHS is not part of routine cancer-care processes and was introduced as the relevant standard for the purpose of this study. The feasibility survey of patient-respondents and RAs indicates the SHS tool to be relevant, easy to understand and use [Table 3]. The above findings support the applicability of the field-tested SHS tool mainly as a screening tool in busy cancer settings in India, where none exists [Table 2]. The screen-positive patients will need to undergo in-depth evaluation by the primary or palliative care team, as per the institutional protocol, to confirm and address the SHS.

An interesting observation was that 46.06% of patient-respondents in the interview sought professional help to reduce their suffering, much higher than the 33.86% self-reported on the SHS tool. Analysis of interviewer notes indicates influencers; for example, patients were made aware of the potential avenues of support available to them during the interview; some of them experiencing SHS preferred to ‘be strong’ and ‘did not want help from anyone as of now;’ which may have contributed to the fewer instances of seeking help while responding on the-tool.

A survey on the suitability of the waiting areas versus in-patient settings for administering the SHS tool did not favour a particular setting. From the overall comments, it may be inferred that an unhurried environment with sufficient rapport-building may be of greater significance than the actual venue.

PIs reported comfort with conducting the field test on the SHS tool and noted that it did not impact or cause a delay in the clinical processes of their setting. The key feedback comments posted by patients and RAs who recorded <7/10 satisfaction on any one of the feasibility survey questions were thematically grouped and analysed [Supplementary Table 2]. The table also provides corresponding insights, responses and actions taken by the research team. Certain comments indicate that patients, as well as RAs, differentiated concerns stemming from treatment from those due to the disease. This attitude may be linked with the hopefulness accompanying treatment, which can impact the meaning and experience of suffering.^[21] The post-field-test version of the tool includes an ‘Instructions for use’ section to support the appropriate administration of the tool. It also encourages the person using the tool to reflect upon all health-related suffering experienced over the previous 2 weeks, irrespective of whether it is due to cancer or treatment. The revised, post-field-test version of the SHS tool, with instructions and context for routine use, is depicted in Appendix 2. It emphasises the need for institutional policies, for in-depth evaluation of the screened-positive patients and for aligning them with the essential palliative care package.

CONCLUSION

The development of the SHS tool was in response to the evident need emphasised by the Lancet Report (2017) to recognise and alleviate SHS and to improve access to essential palliative care packages as a global priority. The SHS tool is likely to provide an opportunity to identify patients with SHS who remain unrecognised hitherto to communicate their suffering and seek help and, thus, influence subsequent clinical encounters. The SHS tool that was designed and developed for the highly subjective domain of SHS has completed the field test to substantiate its validity, feasibility, relevance and usefulness for screening SHS in adult cancer patients attending Indian cancer-care settings. Those screened as having SHS may be evaluated in-depth, with expedited access to essential palliative care packages. The effectiveness of the tool outside of field-test conditions is yet to emerge. This study responds to the fundamental need for routine screening for SHS in vulnerable patient populations and aligns with the recommendations of the Lancet Report (2017) to alleviate the access bias to essential care.