Clinical trials in low-resource settings: the perspectives of caregivers of paediatric participants from Uganda, Tanzania and Kenya.

OBJECTIVES: Vaccine clinical trials in low-resource settings have unique challenges due to structural and financial inequities. Specifically, protecting participant and caregiver autonomy to participate in the research study can be a major challenge, so understanding the setting and contextual factors which influence the decision process is necessary. This study investigates the experience of caregivers consenting on behalf of paediatric participants in a malaria vaccine clinical trial where participation enables access to free, high-quality medical care. METHODS: We interviewed a total of 78 caregivers of paediatric participants previously enrolled in a phase II or III malaria vaccine clinical trial in Uganda, Tanzania and Kenya. Interviews were qualitative and analysed using a thematic framework analysis focusing on the embodied caregiver in the political, economic and social reality. RESULTS: Caregivers of participants in this study made the decision to enrol their child based on economic, social and political factors that extended beyond the trial into the community and the home. The provision of health care was the dominant reason for participation. Respondents reported how social networks, rumours, hierarchal structures, financial constraints and family dynamics affected their experience with research. CONCLUSIONS: The provision of medical care was a powerful motivator for participation. Caregiver choice was limited by structural constraints and scarce financial resources. The decision to participate in research extended beyond individual consent and was embedded in community and domestic hierarchies. Future research should assess other contexts to determine how the choice to participate in research is affected when free medical care is offered.

OBJECTIFS: Les essais cliniques de vaccins dans les régions à faibles ressources présentent des défis uniques en raison d'iniquités structurelles et financières. En particulier, la protection de l'autonomie des participants et des soignants dans la participation à l'étude de recherche peut être un défi majeur. Il est donc nécessaire de comprendre le contexte et les facteurs contextuels qui influencent le processus de décision. Cette étude examine l'expérience de soignants consentants au nom de participants pédiatriques à un essai clinique de vaccin antipaludique où la participation permet l'accès à des soins médicaux gratuits et de haute qualité. MÉTHODES: Nous avons interviewé un total de 78 soignants de participants pédiatriques qui avaient participé à un essai clinique de vaccin antipaludique de phase II ou III en Ouganda, en Tanzanie et au Kenya. Les entretiens ont été qualitatifs et analysés à l'aide d'une analyse de cadre thématique centrée sur le soignant, en tenant compte de la réalité politique, économique et sociale. RÉSULTATS: Les soignants des participants à cette étude ont pris la décision d'inscrire leur enfant sur base de facteurs économiques, sociaux et politiques qui s'étendaient au-delà de l'essai dans la communauté et à la maison. La fourniture de soins de santé était la principale raison de la participation. Les répondants ont rapporté comment les réseaux sociaux, les rumeurs, les structures hiérarchiques, les contraintes financières et la dynamique familiale ont affecté leur expérience avec la recherche. CONCLUSIONS: La fourniture de soins médicaux était un puissant facteur de motivation pour la participation. Le choix du soignant était limité par des contraintes structurelles et les ressources financières limitées. La décision de participer à la recherche allait au-delà du consentement individuel et s'inscrivait dans les hiérarchies communautaires et domestiques. Les recherches futures devraient évaluer d'autres contextes afin de déterminer comment le choix de participer à la recherche est affecté par la gratuité des soins médicaux.

Measuring spirituality as a universal human experience: development of the Spiritual Attitude and Involvement List (SAIL).

Many cancer patients experience spirituality as highly supportive while coping with their disease. Most research as well as most questionnaires in this field is religious orientated. The Spiritual Attitude and Involvement List was developed to enable research on spirituality among religious and nonreligious people. It consists of seven subscales that measure connectedness with oneself, with others and nature, and with the transcendent. Among a student, a healthy population, a healthy interested, a curative cancer, and a palliative cancer sample factorial, convergent and discriminant validity were demonstrated, as well as adequate internal consistency and test-retest reliability.

Measuring spirituality as a universal human experience: a review of spirituality questionnaires.

Spirituality is an important theme in health research, since a spiritual orientation can help people to cope with the consequences of a serious disease. Knowledge on the role of spirituality is, however, limited, as most research is based on measures of religiosity rather than spirituality. A questionnaire that transcends specific beliefs is a prerequisite for quantifying the importance of spirituality among people who adhere to a religion or none at all. In this review, we discuss ten questionnaires that address spirituality as a universal human experience. Questionnaires are evaluated with regard to psychometric properties, item formulation and confusion with well-being and distress. Although none of the questionnaires fulfilled all the criteria, the multidimensional Spiritual Well-Being Questionnaire is promising.

Communities and Clinical Trials: A Case Study from the RTS,S Malaria Vaccine Trials in Eastern Africa.

When clinical trials enter human communities, two complex systems merge-creating challenges for the clinical trial team and the local human community. This is of particular relevance for clinical trials in low-resource settings where the resource scarcity can intensify existing inequities. Here we present a case study of a phase III malaria vaccine clinical trial. Through qualitative interviews with researchers and caregivers of pediatric participants we elucidate themes that shape the clinical trial system. These themes can be a useful complementary planning tool to existing research guidelines for clinical trial researchers. Respondents from both groups reported financial and social contextual realities to be major drivers in the system. We found a strong historical path dependency in the community that was closely tied to the relationships with researchers and indicative of the structural inequities. We elaborate on these findings and offer recommendations to improve trial design.

RTS,S malaria vaccine pilot studies: addressing the human realities in large-scale clinical trials.

A malaria vaccine as part of the integrated malaria control and elimination efforts will have a major impact on public health in sub-Sahara Africa. The first malaria vaccine, RTS,S, now enters pilot implementation in three African countries. These pilot implementation studies are being initiated in Kenya, Malawi, and Ghana to inform the broader roll-out recommendation. Based on the malaria vaccine clinical trial experiences, key ethical practices for effective clinical trial research in low-resource settings are described. For successful vaccine integration into malaria intervention programs, the relational dynamics between researchers and trial communities must be made explicit. Incorporating community values and returning to research practices that serve the intended benefactors are key strategies that address the human realities in large-scale clinical trials and pilot implementation, leading to positive public health outcomes.

Evaluation of haptotherapy for patients with cancer treated with chemotherapy at a day clinic.

OBJECTIVE: The purpose of this study was to evaluate a haptotherapeutic treatment and its effects on the perceived well-being of patients with cancer treated with chemotherapy in day care. METHODS: The study had a pre-test-post-test semi-experimental design, with 31 patients in the intervention group and 26 in the control group. Patients in the control group were matched with patients in the experimental condition with respect to age, gender, type of cancer, type of chemotherapy, prognosis and the period between pre- and post-test. Standardized questionnaires were used measuring perceived well-being and satisfaction with care (haptotherapy). Indicators of well-being measured were quality of life, mood, meaning in life, general functioning, physical and psychological symptoms, sleep quality and body awareness. The intervention consisted of five haptotherapy sessions of 45 minutes each. Patients in the control condition received standard medical care. RESULTS: Patients were highly satisfied with the haptotherapy treatment, and especially valued the personal attention and the relaxation they experienced. The haptotherapy treatment improved both the perceived general quality of life and the perceived cognitive and social functioning of patients. No improvement was found for mood, meaning in life, general functioning, physical symptoms, sleep quality and body awareness. CONCLUSION: It may be concluded that haptotherapy positively contributes to several indicators of perceived well-being of patients with cancer during the period they receive chemotherapy. More rigorous experimental studies are necessary in this field, especially concerning randomization, number of participants and homogeneity of the sample. PRACTICE IMPLICATIONS: Haptotherapy as a type of complementary medicine is a potentially valuable and effective intervention to raise the well-being of patients with cancer undergoing invasive treatments like chemotherapy.

Methodological reflections on body-mind intervention studies with cancer patients.

OBJECTIVE: Methodological reflection on the content, results and limitations of three body-mind intervention studies with cancer patients (CPs) in order to improve the quality of studies on body-mind interventions and to raise the potential value for CPs. METHODS: A secondary analysis of a study on haptotherapy and two studies applying relaxing face massage, using a variety of well-being effect measures. Six methodological themes are discussed: (1) drop-out; (2) characteristics of participating patients, (3) participation of patients in other complementary interventions; (4) satisfaction of participants; (5) effects of the three interventions, and (6) role of response shift. RESULTS: The three interventions showed limited effects after controlling for relevant confounding factors. They are mainly the small sample sizes, the low intensity of the intervention, the possible inadequate measure moments and the use of other CAM that may be responsible for the absence of effects. CONCLUSIONS: Body-mind interventions require more methodological reflections to develop attractive and effective interventions for CPs. Attention needs to be paid to measuring short term effects, practically fitting research designs, and response shift. PRACTICE IMPLICATIONS: Interventions should be intensive, repeated and not too short. The implementation of interventions requires attention to several organizational factors in the health care.

Are patients with rheumatoid arthritis less physically active than the general population?

BACKGROUND: Although promoting physical activity (PA) and exercise among patients with rheumatoid arthritis (RA) is highly advocated nowadays, little is known about actual PA levels of these patients. In particular, the literature investigating how these PA levels are in proportion to the levels among the general population is scarce. OBJECTIVE: To compare the self-reported PA levels of patients with RA with those of the general Dutch population. METHODS: A sample of 400 RA patients were sent the Short QUestionnaire to ASsess Health-Enhancing PA comprising 10 questions about PA. From these data the proportions meeting the Dutch public health recommendation for PA (i.e., moderate PA for 30 minutes on > or = 5 days/wk) and the total number of minutes of PA per week were calculated. These data were compared with similar data from a representative sample of the general Dutch population. RESULTS: Two hundred fifty-two patients returned the questionnaire (response 63%). The proportions of RA patients meeting the PA recommendation were similar to those of the general population (57% in categories 45-64 years; 59% in categories > or = 65 years, and 58% in the total groups). The average number of minutes of PA per week was significantly lower in the RA population compared with the general population in the category 45 to 64 years (1836 vs. 2199, respectively, P = 0.001), whereas the difference in the category > or = 65 years was not significant (1115 vs. 1218 minutes, respectively, P = 0.33). CONCLUSIONS: The proportion of RA patients meeting the Dutch PA recommendation was similar to the general Dutch population. However, with respect to the average number of minutes of PA per week, the RA patients were less physically active. Because patients with RA have an increased risk of chronic conditions such as osteoporosis or cardiovascular diseases along with their arthritis, it remains a matter of utmost importance for health care professionals such as rheumatologists, physical therapists, and clinical nurse specialists to promote PA in daily clinical practice and guide patients in achieving and maintaining a healthy lifestyle.