Developing longitudinal qualitative designs: lessons learned and recommendations for health services research

published_fina

Supplemental prophylactic intervention for chemotherapy-induced nausea and emesis (spice) trial: Protocol for a multi-centre double-blind placebo-controlled randomized trial

Aim: There is significant recent interest in the role of ginger root (Zingiber officinale) as an adjuvant therapy for chemotherapy‐induced nausea. The supplemental prophylactic intervention for chemotherapy‐induced nausea and emesis (SPICE) trial aims to assess the efficacy by reduced incidence and severity of chemotherapy‐induced nausea and vomiting, and enhanced quality of life, safety and cost effectiveness of a standardised adjuvant ginger root supplement in adults undergoing single‐day moderate‐to‐highly emetogenic chemotherapy. Methods: Multisite, double‐blind, placebo‐controlled randomised trial with two parallel arms and 1:1 allocation. The target sample size is n = 300. The intervention comprises four capsules of ginger root (totalling 60 mg of active gingerols/day), commencing the day of chemotherapy and continuing for five days during chemotherapy cycles 1 to 3. The primary outcome is chemotherapy‐induced nausea‐related quality of life. Secondary outcomes include nutrition status; anticipatory, acute and delayed nausea and vomiting; fatigue; depression and anxiety; global quality of life; health service use and costs; adverse events; and adherence. Results: During the five‐month recruitment period from October 2017 to April 2018 at site A only, a total of n = 33 participants (n = 18 female) have been enrolled in the SPICE trial. Recruitment is expected to commence at Site B in May 2018. Conclusions: The trial is designed to meet research gaps and could provide evidence to recommend specific dosing regimens as an adjuvant for chemotherapy‐induced nausea and vomiting prevention and management.No Full Tex

Clinical expert guidelines for the management of cough in lung cancer: report of a UK task group on cough

Background Cough is a common and distressing symptom in lung cancer patients. The clinical management of cough in lung cancer patients is suboptimal with limited high quality research evidence available. The aim of the present paper is to present a clinical guideline developed in the UK through scrutiny of the literature and expert opinion, in order to aid decision making in clinicians and highlight good practice. Methods Two systematic reviews, one focusing on the management of cough in respiratory illness and one Cochrane review specifically on cancer, were conducted. Also, data from reviews, phase II trials and case studies were synthesized. A panel of experts in the field was also convened in an expert consensus meeting to make sense of the data and make clinical propositions. Results A pyramid of cough management was developed, starting with the treatment of reversible causes of cough/specific pathology. Initial cough management should focus on peripherally acting and intermittent treatment; more resistant symptoms require the addition of (or replacement by) centrally acting and continuous treatment. The pyramid for the symptomatic management starts from the simpler and most practical regimens (demulcents, simple linctus) to weak opioids to morphine and methadone before considering less well-researched and experimental approaches. Conclusion The clinical guidelines presented aim to provide a sensible clinical approach to the management of cough in lung cancer. High quality research in this field is urgently required to provide more evidence-based recommendations

Are nurse-led chemotherapy clinics really nurse-led?:an ethnographic study

Background: The number of patients requiring ambulatory chemotherapy is increasing year on year, creating problems with capacity in outpatient clinics and chemotherapy units. Although nurse-led chemotherapy clinics have been set up to address this, there is a lack of evaluation of their effectiveness. Despite a rapid expansion in the development of nursing roles and responsibilities in oncology, there is little understanding of the operational aspects of nurses’ roles in nurse-led clinics. Objectives: To explore nurses’ roles within nurse-led chemotherapy clinics. Design: A focused ethnographic study of nurses’ roles in nurse-led chemotherapy clinics, including semi-structured interviews with nurses. Settings: Four chemotherapy units / cancer centres in the UK Participants: Purposive sampling was used to select four cancer centres / units in different geographical areas within the UK operating nurse-led chemotherapy clinics. Participants were 13 nurses working within nurse-led chemotherapy clinics at the chosen locations. Methods: Non-participant observation of nurse-led chemotherapy clinics, semi-structured interviews with nurse participants, review of clinic protocols and associated documentation. Results: 61 nurse-patient consultations were observed with 13 nurses; of these 13, interviews were conducted with 11 nurses. Despite similarities in clinical skills training and prescribing, there were great disparities between clinics run by chemotherapy nurses and those run by advanced nurse practitioners. This included the number of patients seen within each clinic, operational aspects, nurses’ autonomy, scope of practice and clinical decision-making abilities. The differences highlighted four different levels of nurse-led chemotherapy clinics, based on nurses’ autonomy and scope of clinical practice. However, this was heavily influenced by medical consultants. Several nurses perceived they were undertaking holistic assessments, however they were using medical models / consultation styles, indicating medicalization of nurses’ roles. Conclusions: Four different levels of nurse-led chemotherapy clinics were identified, illustrating disparities in nurses’ roles. Although clinics are run by nurses they are often controlled by medical consultants, which can reduce nurses’ autonomy and negatively impact on patient care

Protocol for the trismus trial—therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study

201809 bcr

Assessment of Breathlessness in Lung Cancer: Psychometric Properties of the Dyspnea-12 Questionnaire.

CONTEXT: The Dyspnea-12 (D-12) Questionnaire is a well-validated instrument in respiratory illnesses for breathlessness assessment, but its psychometric properties have not been tested in lung cancer. OBJECTIVE: To demonstrate the psychometric properties of the D-12 in lung cancer patients. METHODS: Baseline data from a lung cancer feasibility trial were adopted for this analysis. D-12 and a series of patient-reported tools, including five Numeric Rating Scales (NRS), the Hospital Anxiety and Depression Scale (HADS), and the Lung Cancer Symptom Scale (LCSS), were used for the psychometric assessment. Spearman's correlation coefficients (rs) were used to estimate the convergent validity of the D-12 with the NRS, HADS, and LCSS. Exploratory factor analysis was performed to examine construct validity. Reliability was tested by Cronbach's alpha and item-to-total correlations. D-12 score difference between patients with or without anxiety, depression, and chronic obstructive pulmonary disease (COPD) was explored to identify its discriminate performance. RESULTS: One hundred and one lung cancer patients were included. There were significantly positive correlations between the D-12 and the HADS, LCSS, and NRS measuring breathlessness severity and its associated affective distress. Factor analysis clearly identified two components (physical and emotional) of the D-12. Cronbach's alpha for D-12 total, physical, and emotional subscales was 0.95, 0.92, and 0.94, respectively. Patients with anxiety or depression demonstrated significantly higher D-12 scores than those without it, and patients with COPD reported significantly more severe breathlessness than those without COPD. CONCLUSION: The D-12 is a valid and reliable self-reported questionnaire for use in breathlessness assessment in lung cancer patients

The impact of chemotherapy-related nausea on patients' nutritional status, psychological distress and quality of life.

PURPOSE: Nausea is a troublesome and distressing symptom for patients receiving chemotherapy. While vomiting is well controlled with current antiemetics, nausea is a more difficult symptom to manage. The aim of this study was to assess the impact of nausea on nutritional status, quality of life and psychological distress. METHODS: This was a prospective observational study over two cycles of chemotherapy. Patients completed the Multinational Association of Supportive Care in Cancer Antiemesis Tool, a measure of nutritional status (Patient-Generated Subjective Global Assessment), the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life scale and the Hospital Anxiety and Depression Scale at the end of each chemotherapy cycle (around day 10 post-chemotherapy). RESULTS: The sample consisted of 104 patients, primarily female, receiving anthracycline-based chemotherapy. While vomiting was minimal (5.2-14.6 % of the patients), high levels of nausea were observed (55.2-72.9 %), and severe nausea (>6 on a 0-10 scale) was reported by 20.5-29.2 % of the participants. Severe nausea had a borderline significant impact in relation to physical functioning (p = 0.025) and a significant impact on nutritional status (severe acute nausea, p = 0.003; severe delayed nausea, p = 0.017). Clinically meaningful changes were observed in relation to the FACT-G total score. CONCLUSION: Chemotherapy-induced nausea does have an impact on nutritional status and physical functioning and can impair anxiety and quality of life. As a key symptom associated with other symptoms, it is imperative that greater attention is given to managing treatment-related nausea through innovative non-pharmacological and nutritional interventions

Communication patterns in nurse-led chemotherapy clinics:A mixed-method study

Objective: To determine patterns of nurse-patient communication in fulfilling patients’ informational/psychosocial needs, effects of longer consultation/operational aspects on person-centred care experiences. Methods: Mixed-method design; secondary analysis of transcripts of nurse-patient communication within nurse-led chemotherapy clinics in UK [3]. Purposive sampling (13 nurses); non-participant observations (61 consultations). Qualitative content analysis of audio-recorded transcripts. Quantitative analysis using the Medical Interview Aural Rating Scale [14] to compare mean differences in the number of cues and level of responding using one-way ANOVA, and correlational analyses of discursive spaces. Results: Nurses responded positively to informational cues, but not psychosocial cues. Longer consultations associated with more informational and psychosocial cues (p < .0001), but not nurses’ cue-responding behaviours. Four main themes emerged: challenges/opportunities for person-centred communication in biomedical contexts; patients’ “life world” versus the “medical world”; three-way communication: nurse, patient and family; implications of continuity of care. Conclusions: The challenges/opportunities for cue-responding in nurse-led chemotherapy clinics were evident for informational and psychosocial support of patients. Shifting from a biomedical to biopsychosocial focus is difficult. Practice implications: Further evaluation is needed to integrate biopsychosocial elements into communication education/training. Careful planning is required to ensure continuity and effective use of time for person-centred care

Government interventions and control policies to contain the first COVID-19 outbreak: An analysis of evidence

Background: The overarching aim of this study was to evaluate the effectiveness over time of government interventions and policy restrictions and the impact of determinants on spread and mortality during the first-wave of the COVID-19 pandemic, globally, regionally and by country-income level, up to 18 May 2020. Methods: We created a global database merging World Health Organization daily case reports (from 218 countries/territories) with other socio-demographic and population health measures from 21 January to 18 May 2020. A four-level government policy interventions score (low to very high) was created based on the Oxford Stringency Index. Results: Our results support the use of very high government interventions to suppress both COVID-19 spread and mortality effectively during wave one globally compared to other policy levels of control. Similar trends in virus propagation and mortality were observed in all country-income levels and specific regions. Conclusions: Rapid implementation of government interventions was needed to contain the first wave of the COVID-19 outbreak and to reduce COVID-19-related mortality.Peer ReviewedPostprint (author's final draft