Nancy Gikaara

Research into palliative care in sub-Saharan Africa

Roughly half a million people die of cancer in sub-Saharan Africa every year. Despite rapid expansion of palliative care for cancer, coverage remains woefully inadequate. The WHO public health strategy for palliative care aims to increase access to palliative care services through its integration into health-care systems. We present the available evidence for the four WHO strategy pillars of policy, education, drug availability, and implementation, and propose a fifth pillar of research activity to stimulate improvement of care. Increased attention to the generation of research evidence is essential to achieve quality and coverage of appropriate palliative care for patients with advanced cancer in sub-Saharan Africa. The use of locally validated, patient-reported outcome measures is an important advance in the measurement and improvement of care and patient wellbeing. Palliative care for patients with cancer in Africa currently receives far less research attention than does palliative care for patients with HIV/AIDS, but in view of projected increasing cancer incidence in the region, generation of local evidence to inform and allow assessment of palliative care for patients with cancer is urgently needed.

Availability of essential drugs for managing HIV-related pain and symptoms within 120 PEPFAR-funded health facilities in East Africa: A cross-sectional survey with onsite verification.

Background: World Health Organization’s essential drugs list can control the highly prevalent HIV-related pain and symptoms. Availability of essential medicines directly influences clinicians’ ability to effectively manage distressing manifestations of HIV. Aim: To determine the availability of pain and symptom controlling drugs in East Africa within President’s Emergency Plan for AIDS Relief–funded HIV health care facilities. Design: Directly observed quantitative health facilities’ pharmacy stock review. We measured availability, expiration and stock-outs of specified drugs required for routine HIV management, including the World Health Organization pain ladder. Setting: A stratified random sample in 120 President’s Emergency Plan for AIDS Relief–funded HIV care facilities (referral and district hospitals, health posts/centres and home-based care providers) in Kenya and Uganda. Results: Non-opioid analgesics (73%) and co-trimoxazole (64%) were the most commonly available drugs and morphine (7%) the least. Drug availability was higher in hospitals and lower in health centres, health posts and home-based care facilities. Facilities generally did not use minimum stock levels, and stock-outs were frequently reported. The most common drugs had each been out of stock in the past 6 months in 47% of facilities stocking them. When a minimum stock level was defined, probability of a stock-out in the previous 6 months was 32.6%, compared to 45.5% when there was no defined minimum stock level (χ2 = 5.07, p = 0.024). Conclusion: The data demonstrate poor essential drug availability, particularly analgesia, limited by facility type. The lack of strong opioids, isoniazid and paediatric formulations is concerning. Inadequate drug availability prevents implementation of simple clinical pain and symptom control protocols, causing unnecessary distress. Research is needed to identify supply chain mechanisms that lead to these problems.

Nurse-led palliative care for HIV-positive patients taking antiretroviral therapy in Kenya: a randomised controlled trial

BACKGROUND People with HIV accessing antiretroviral therapy (ART) have persistent physical, psychological, social, and spiritual problems, which are associated with poor quality of life and treatment outcomes. We assessed the effectiveness of a nurse-led palliative care intervention on patient-reported outcomes. METHODS We did this randomised controlled trial at a clinic in Kenya for adults with HIV, established on ART, and reporting moderate-to-severe pain or symptoms. We randomly assigned participants (1:1) either to a palliative care intervention (including assessments of physical, emotional, and spiritual wellbeing and quality of life) given six times over 4 months, or to usual care. Participants and investigators were not masked to allocation. The primary outcome was pain (scored on the African Palliative Care Associations African Palliative Outcome Scale). This trial is registered with ClinicalTrials.gov, number NCT01608802. FINDINGS We screened 2070 patients, of whom we enrolled 120: 60 allocated to each group. In the control group, median pain score improved from 1·0 (IQR 0·0-2·0) at baseline to 5·0 (3·0-5·0) at 4 months; in the intervention group, it improved from 1·0 (0·0-2·0) at baseline to 4·5 (3·0-5·0) at 4 months. Compared with standard care, the intervention had no significant effect on pain (coefficient -0·01, 95% CI -0·36 to 0·34, p=0·95). INTERPRETATION A nurse-led palliative care intervention was not effective in reducing pain. However, person-centred assessment and care delivered by staff who have received additional training had positive effects on self-reported mental health related quality of life and psychosocial wellbeing. FUNDING Diana Princess of Wales Memorial Fund.

Multidimensional Patient-Reported Problems within Two Weeks of HIV Diagnosis in East Africa: A Multicentre Observational Study

Objectives We aimed to determine for the first time the prevalence and severity of multidimensional problems in a population newly diagnosed with HIV at outpatient clinics in Africa. Methods Recently diagnosed patients (within previous 14 days) were consecutively recruited at 11 HIV clinics in Kenya and Uganda. Participants completed a validated questionnaire, the African Palliative Outcome Scale (POS), with three underpinning factors. Ordinal logistic regression was used to evaluate risk factors for prevalence and severity of physical, psychological, interpersonal and existential problems. Results There were 438 participants (62% female, 30% with restricted physical function). The most prevalent problems were lack of help and advice (47% reported none in the previous 3 days) and difficulty sharing feelings. Patients with limited physical function reported more physical/psychological (OR = 3.22) and existential problems (OR = 1.54) but fewer interpersonal problems (OR = 0.50). All outcomes were independent of CD4 count or ART eligibility. Conclusions Patients at all disease stages report widespread and burdensome multidimensional problems at HIV diagnosis. Newly diagnosed patients should receive assessment and care for these problems. Effective management of problems at diagnosis may help to remove barriers to retention in care.

Quality of life and wellbeing among HIV outpatients in East Africa: a multicentre observational study

BackgroundGlobal health investment has reduced HIV mortality and transmission. However, little is known of patient-reported outcomes alongside ART rollout. This study aimed to measure wellbeing using patient-reported outcome measures (PROMS) among outpatients at PEPFAR-funded facilities.MethodsIn a multicentre 2 country cross-sectional study, adults attending 12 facilities in Kenya and Uganda gave self-reported data on quality of life (physical and mental wellbeing dimensions), functional and a measure of multidimensional problems (physical, psychological, social and spiritual).ResultsAmong the 1,337 participants, multidimensional problems were more common in psychological, spiritual and social domains than in physical. In multivariable analysis using GEE to adjust for facility effect, the mental health subscale of quality of life was lower for people with limited functional status (B = -5.27, 95% CI -5.99, 1. -4.56 p < 0.001) and higher for wealthier people (B = 0.91, 95% CI 0.48, 1.33, p < 0.001). The physical health subscale of quality of life was lower for those with limited functional status (B = -8.58, 95% CI -9.46 to -7.70, p < 0.001) and those who had a caregiver present (B = -1.97, 95% CI -3.72 to -0.23, p = 0.027), higher for wealthier people (B = 1.14, 95% CI 0.65, 1.64, p < 0.001), and positively associated with CD4 count (B = 1.61, 95% CI 1.08-2.14, p < 0.001). Multidimensional problems were more burdensome for people with limited functional status (B = -2.06, 95% CI -2.46 to -1.66, p < 0.001), and less burdensome with more education (B = 0.63, 95% CI 0.25-1.00, p = 0.001) or ART use (B = 0.94, 95% CI 0.34-1.53, p = 0.002).ConclusionsMultidimensional problems are highly prevalent, and worse with declining function. Importantly, ART use does not appear to be protective for self-reported physical and mental dimensions of quality of life. Assessment and management of self-reported wellbeing must form part of HIV care and treatment services to ensure maximum benefit from ART investment.

The presence of CD4 counts for the management of HIV patients in East Africa: A multicentred study

New WHO guidance stipulates six-monthly CD4 testing and treatment initiation at CD4 less than 350. This study aimed to determine the presence of CD4 results in patient records across five care facilities in Kenya, and to identify factors associated with the presence of CD4 count. This is a cross-sectional study of consecutive outpatients. Participants completed self-reported outcomes of demographics, and both physical and mental health dimensions of quality of life and function; charts were reviewed for a CD4 count in the previous 13 months; 548 patients participated. For those diagnosed during the 13-month study period, 7.1% of the sample had no CD4 result on record. For those diagnosed prior to the study, 8.7% had no result. Multivariate logistic regression revealed that 30 days post-HIV diagnosis, facility and antiretroviral therapy use were associated with the odds of having a CD4 result on file. At six months, poverty and prevalence of multidimensional problems were associated with lack of CD4 result. For those diagnosed prior to the observation period, education level was associated with more infrequent CD4 counts, and facility and number of dependants were associated with odds of a CD4 result within six months. Our data suggest inconsistencies in CD4 results availability within and between facilities. Implementation of new guidance will require a shift in practice.

Patients’ and caregivers’ needs, experiences, preferences and research priorities in spiritual care: A focus group study across nine countries:

Background: Spiritual distress is prevalent in advanced disease, but often neglected, resulting in unnecessary suffering. Evidence to inform spiritual care practices in palliative care is limited. Aim: To explore spiritual care needs, experiences, preferences and research priorities in an international sample of patients with life-limiting disease and family caregivers. Design: Focus group study. Setting/participants: Separate patient and caregiver focus groups were conducted at 11 sites in South Africa, Kenya, South Korea, the United States, Canada, the United Kingdom, Belgium, Finland and Poland. Discussions were transcribed, translated into English and analysed thematically. Results: A total of 74 patients participated: median age 62 years; 53 had cancer; 48 were women. In total, 71 caregivers participated: median age 61 years; 56 were women. Two-thirds of participants were Christian. Five themes are described: patients’ and caregivers’ spiritual concerns, understanding of spirituality and its role in illness, views and experiences of spiritual care, preferences regarding spiritual care, and research priorities. Participants reported wide-ranging spiritual concerns spanning existential, psychological, religious and social domains. Spirituality supported coping, but could also result in framing illness as punishment. Participants emphasised the need for staff competence in spiritual care. Spiritual care was reportedly lacking, primarily due to staff members’ de-prioritisation and lack of time. Patients’ research priorities included understanding the qualities of human connectedness and fostering these skills in staff. Caregivers’ priorities included staff training, assessment, studying impact, and caregiver’s spiritual care needs. Conclusion: To meet patient and caregiver preferences, healthcare providers should be able to address their spiritual concerns. Findings should inform patient- and caregiver-centred spiritual care provision, education and research.

Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya

ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care. The implications of study participation on outcome data in such populations have been discussed theoretically, but rarely empirically examined. We aimed to explore the effects of participating in a randomised controlled trial conducted in an HIV clinic in Mombasa, Kenya. We report qualitative data from the Treatment Outcomes in Palliative Care trial, which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to standard care. Participants in both arms attended five monthly quantitative data collection appointments. Post-trial exit, 10 control and 20 intervention patients participated in semi-structured qualitative interviews, analysed using thematic analysis. We found benefit attributed to the compassion of the research team, social support, communication, completion of patient reported outcome measures (PROMs) and material support (transport reimbursement). Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team, which improved mental health and well-being. Open and non-judgmental communication made participants feel accepted. Participants described how repeated completion of the PROMs was a prompt for reflection, through which they began to help themselves and self-care. Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities, enhancing self-worth. These findings emphasise the importance of compassion, support and effective communication in the clinical encounter, particularly in stigmatised and isolated populations, and the potential of the integration of simple PROMs to improve patient outcomes. Participation in research has unexpected positive benefits for participants, which should be taken into account when designing research in similar populations. Researchers should be aware of the effects of financial reimbursement and contact with researchers in isolated and impoverished communities.

A Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) Scale With Palliative Care Samples in Three African Countries

CONTEXT Although sub-Saharan Africa suffers the greatest burden of progressive illness, there are few outcome measures with adequate properties to measure needs and outcomes. OBJECTIVES To examine the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) among people receiving palliative care in three African countries. METHODS Adult patients in South Africa, Kenya, and Uganda gave self-reported data to the core FACIT-G plus Pal subscale. Data were subjected to factor analysis, corrected item-total correlations, and Cronbachs α for full scale and subscales. RESULTS The resulting four factors bear a strong similarity to the original Functional Assessment of Cancer Therapy-General in our sample of 461: physical symptoms, functional well-being, friends and family, and emotional well-being. Cronbachs α for the full 27-item scale was 0.90 and for the physical well-being, social/family well-being, emotional well-being, and functional well-being subscales, it was 0.83, 0.78, 0.80, and 0.87, respectively. Varimax rotation of the 19-item FACIT-Pal scale showed three clear interpretable factors. Factor 1, a sense of purpose and meaning in life; Factor 2, physical symptoms; and Factor 3, social integration. For the 19-item FACIT-Pal, Cronbachs α was 0.81, and individual corrected item-total correlations ranged from 0.24 to 0.61. Cronbachs α for the eight items comprising Factor 1 (meaning in life) was 0.83. For the other two factors, it was 0.70 (physical symptoms, six items) and 0.68 (social integration, three items). CONCLUSION The FACIT-Pal is a reliable multidimensional scale for people with life-limiting incurable diseases in sub-Saharan Africa, and the observed factors are interpretable and clinically meaningful.

Effect of participation in a randomised controlled trial of an integrated palliative care intervention on HIV-associated stigma.

ABSTRACT We conducted in Kenya a mixed-methods randomised controlled trial (RCT) of a nurse-led palliative care intervention integrated with anti-retroviral therapy (ART) provision for the management of HIV. Here we report qualitative findings showing increased resistance to HIV-associated stigma among trial participants. A mixed method design was chosen to enable identification of the active ingredients of the intervention and exploration of participants’ experiences of receiving the intervention. The RCT was conducted from July 2011 to November 2012 in a community hospital in the city of Mombasa, Kenya, with a sample of 120 adults with HIV on ART. Thirty participants were purposively selected to take part in a qualitative exit interview, based on study arm and mental health outcome. Inductive thematic analysis revealed increased resistance to HIV-associated stigma in both the intervention and control groups. Specifically, patients in both groups described benefit from the social support, compassionate care, and open and respectful communication they received through study participation. Participants described improved self-image, increased access to social agency, and increased resistance to HIV-associated stigma. Our findings suggest that there is potential to increase resistance to stigma through simple mechanisms of support, compassion, and improved communication in routine care. The self-reported impact of trial participation on stigma also has implications for future trials in populations in resource-constrained settings where stigma is common.