An increasing number of qualitative research papers in oncology and palliative care: does it mean a thorough development of the methodology of research?

BACKGROUND: In the second half of the nineties, a scientific debate about the usefulness of qualitative research in medicine began in the main medical journals as well as the amount of "qualitative" papers published on peer reviewed journals has noticeably increased during these last years. Nevertheless the label of qualitative methodology has been assigned to an heterogeneous collection of studies. Some of them show a complete awareness of the specificity of this kind of research, while others are still largely influenced by the quantitative paradigm prevailing in the medical field. The concern with the rigour and credibility of qualitative methods has lead to the development of a number of checklist for assessing qualitative research. The purposes of this review were to describe the quality of the development of qualitative research in the medical field, focusing on oncology and palliative care, and to discuss the applicability of a descriptive checklist. METHODS: A review was conducted on Medline and PsycINFO databases. On the basis of their abstract, papers found have been classified considering: publication year, kind of journal, paper type, data gathering method, sample size and declared methodological approach. A sub sample of the previous papers was than selected and their methodological characteristics were evaluated based on a descriptive checklist. RESULTS: 351 abstracts and 26 full papers were analysed. An increase over time in the number of qualitative studies is evident. While most of the papers before 1999 were published on nursing journals (43%), afterwards also medical journals were largely represented. Psychological journals increased from 7% to 12%. The 22% of studies used a sample size lower than 15 and the 15% did not specify the sample size in the abstract. The methodological approach was also often not specified and the percentage increased in the second time period (from 73% to 80%). Grounded theory was the most employed methodological approach while phenomenology shows a decrease. Interview remains the most used data gathering method in both periods, even if it shows a 10% reductions, while focus group and multiple methods application both increase to 12%. The use of the descriptive checklist on the full text of the 26 papers shows that all the items present a larger percentage of satisfaction after 1 January 1999 than it was for the paper published before 1999. There seems to be two different types of quality criteria: specific and unspecific. The first ones mainly refer to qualitative paradigm (such as the relationship with the subject of research or evidence about how subjects perceived the research) and they are often not satisfied. In contrast unspecific criteria (such as the connection to an existing body of knowledge or systematic data gathering) which are mainly shared with the quantitative paradigm are more frequently satisfied. CONCLUSIONS: In oncology and palliative care the publication of qualitative studies increased during the nineties, reaching its peak in around 2000. The use of descriptive checklists even if it was not easy to apply, allows researchers to get a deeper insight into methodological facets that a global judgement may leave out

Comparison of numerical and verbal rating scales to measure pain exacerbations in patients with chronic cancer pain

<p>Abstract</p> <p>Background</p> <p>Numerical rating scales (NRS), and verbal rating scales (VRS) showed to be reliable and valid tools for subjective cancer pain measurement, but no one of them consistently proved to be superior to the other. Aim of the present study is to compare NRS and VRS performance in assessing breakthrough or episodic pain (BP-EP) exacerbations.</p> <p>Methods</p> <p>In a cross sectional multicentre study carried out on a sample of 240 advanced cancer patients with pain, background pain and BP-EP intensity in the last 24 hours were measured using both a 6-point VRS and a 0-10 NRS. In order to evaluate the reproducibility of the two scales, a subsample of 60 patients was randomly selected and the questionnaire was administered for a second time three to four hours later. The proportion of "inconsistent" (background pain intensity higher than or equal to peak pain intensity) evaluations was calculated to compare the two scales capability in discriminating between background and peak pain intensity and Cohen's K was calculated to compare their reproducibility.</p> <p>Results</p> <p>NRS revealed higher discriminatory capability than VRS in distinguishing between background and peak pain intensity with a lower proportion of patients giving inconsistent evaluations (14% vs. 25%). NRS also showed higher reproducibility when measuring pain exacerbations (Cohen's K of 0.86 for NRS vs. 0.53 for VRS) while the reproducibility of the two scales in evaluating background pain was similar (Cohen's K of 0.80 vs. 0.77).</p> <p>Conclusions</p> <p>Our results suggest that, in the measurement of cancer pain exacerbations, patients use NRS more appropriately than VRS and as such NRS should be preferred to VRS in this patient's population.</p

From "Breakthrough" to "Episodic" Cancer Pain? A European Association for Palliative Care Research Network Expert Delphi Survey Towards a Common Terminology and Classification of Transient Cancer Pain Exacerbations

Context: Cancer pain can appear with spikes of higher intensity. Breakthrough cancer pain (BTCP) is the most common term for the transient exacerbations of pain, but the ability of the nomenclature to capture relevant pain variations and give treatment guidance is questionable. Objectives: To reach consensus on definitions, terminology, and sub classification of transient cancer pain exacerbations. Methods: The most frequent authors on BTCP literature were identified using the same search strategy as in a systematic review and invited to participate in a two-round Delphi survey. Topics with a low degree of consensus on BTCP classification were refined into twenty statements. The participants rated their degree of agreement with the statements on a numeric rating scale (NRS 0-10). Consensus was defined as a median NRS score of ≥ 7 and an interquartile range of ≤ 3. Results: Fifty-two authors had published three or more papers on BTCP over the past ten years. Twenty-seven responded in the first round and 24 in the second round. Consensus was reached for 13 of 20 statements. Transient cancer pain exacerbations can occur without background pain, when background pain is uncontrolled, and regardless of opioid treatment. There exist cancer pain exacerbations other than BTCP, and the phenomenon could be named “episodic pain”. Patient reported treatment satisfaction is important with respect to assessment. Sub classification according to pain pathophysiology can provide treatment guidance. Conclusion: Significant transient cancer pain exacerbations include more than just BTCP. Patient input and pain classification are important factors for tailoring treatment

A prospective study examining cachexia predictors in patients with incurable cancer

© 2019 The Author(s). Background: Early intervention against cachexia necessitates a predictive model. The aims of this study were to identify predictors of cachexia development and to create and evaluate accuracy of a predictive model based on these predictors. Methods: A secondary analysis of a prospective, observational, multicentre study was conducted. Patients, who attended a palliative care programme, had incurable cancer and did not have cachexia at baseline, were amenable to the analysis. Cachexia was defined as weight loss (WL) > 5% (6 months) or WL > 2% and body mass index< 20 kg/m2. Clinical and demographic markers were evaluated as possible predictors with Cox analysis. A classification and regression tree analysis was used to create a model based on optimal combinations and cut-offs of significant predictors for cachexia development, and accuracy was evaluated with a calibration plot, Harrell's c-statistic and receiver operating characteristic curve analysis. Results: Six-hundred-twenty-eight patients were included in the analysis. Median age was 65 years (IQR 17), 359(57%) were female and median Karnofsky performance status was 70(IQR 10). Median follow-up was 109 days (IQR 108), and 159 (25%) patients developed cachexia. Initial WL, cancer type, appetite and chronic obstructive pulmonary disease were significant predictors (p ≤ 0.04). A five-level model was created with each level carrying an increasing risk of cachexia development. For Risk-level 1-patients (WL < 3%, breast or hematologic cancer and no or little appetite loss), median time to cachexia development was not reached, while Risk-level 5-patients (WL 3-5%) had a median time to cachexia development of 51 days. Accuracy of cachexia predictions at 3 months was 76%. Conclusion: Important predictors of cachexia have been identified and used to construct a predictive model of cancer cachexia. Trial registration: ClinicalTrials.gov Identifier: NCT01362816

An international study of the quality of life of adult patients treated with home parenteral nutrition

Background & aims: Home parenteral nutrition-quality of life (HPN-QOL©) is a self-assessment tool for the measurement of QOL in patients on HPN. The aims of this study were: to re-assess the basic psychometric properties of the HPN-QOL© in a multinational sample of adult patients; to provide a description of QOL dimensions by short and long HPN treatment duration; to explore clinical factors potentially associated to QOL scores. Methods: Patients (n = 699) from 14 countries completed the HPN-QOL©. The questionnaires were analysed to evaluate data completeness, convergent/discriminant validity and internal-consistency reliability. The association of overall QOL and HPN treatment duration as well as other clinical factors were investigated using multivariable linear regression models. Results: The analysis of the multitrait-scaling and internal consistency indicates a good fit with the questionnaire structure for most items. Item discriminant validity correlation was satisfactory and psychometric evaluation of the HPN-QOL© in the different English, French and Italian language patient sub-groups confirmed psychometric equivalence of the three questionnaire versions. The results of the multivariable linear regression showed that QOL scores were significantly associated with HPN duration (better in long-term), underlying disease (better in Crohn's disease and mesenteric ischaemia) and living status (worse in living alone) and, after adjusting for the other factors, with the number of days of HPN infusion per week. Conclusions: The HPN-QOL©, is a valid tool for measurement of QOL in patients on HPN, to be used in the clinical practice as well as in research

A Wireless Health Outcomes Monitoring System (WHOMS): development and field testing with cancer patients using mobile phones

BACKGROUND: Health-Related Quality of Life assessment is widely used in clinical research, but rarely in clinical practice. Barriers including practical difficulties administering printed questionnaires have limited their use. Telehealth technology could reduce these barriers and encourage better doctor-patient interaction regarding patient symptoms and quality-of-life monitoring. The aim of this study was to develop a new system for transmitting patients' self-reported outcomes using mobile phones or the internet, and to test whether patients can and will use the system via a mobile phone. METHODS: We have developed a prototype of a Wireless Health Outcomes Monitoring System, which allows structured questionnaires to be sent to the patient by their medical management team. The patients' answers are directly sent to an authorised website immediately accessible by the medical team, and are displayed in a graphic format that highlights the patient's state of health. In the present study, 97 cancer inpatients were asked to complete a ten-item questionnaire. The questionnaire was delivered by display on a mobile phone, and was answered by the patients using the mobile phone keypad. RESULTS: Of the 97 patients, 56 (58%) attempted the questionnaire, and all of these 56 completed it. Only 6% of the total number of questions were left unanswered by patients. Forty-one (42%) patients refused to participate, mostly due to their lack of familiarity with mobile phone use. Compared with those who completed the questionnaire, patients who refused to participate were older, had fewer years of education and were less familiar with new communications technology (mobile phone calls, mobile phone SMS, internet, email). CONCLUSION: More than half of the patients self-completed the questionnaire using the mobile phone. This proportion may increase with the use of multichannel communications which can be incorporated into the system. The proportion may also increase if the patient's partner and/or family were able to assist the patient with using the technology. These preliminary results encourage further studies to identify specific diseases or circumstances where this system could be useful in patients' distance monitoring. Such a system is likely to detect patient suffering earlier, and to activate a well-timed intervention

Cancer patients' needs during hospitalisation: a quantitative and qualitative study

BACKGROUND: The evaluation of cancer patients needs, especially during that delicate period when they are hospitalized, allows the identification of those areas of care that require to be improved. Aims of the study were to evaluate the needs in cancer inpatients and to improve the understanding of the meanings of the needs expressed. METHODS: The study was conducted during a "sample day", with all the cancer patients involved having been hospitalized at the Istituto Nazionale Tumori of Milan (INT) for at least 48 hours beforehand. The study was carried out using quantitative and qualitative methodologies. The quantitative part of the study consisted in making use of the Needs Evaluation Questionnaire (NEQ), a standardized questionnaire administered by the INT Psychology Unit members, supported by a group of volunteers from the Milan section of the Italian League Against Cancer. The aim of the qualitative part of the study, by semi-structured interviews conducted with a small sample of 8 hospitalized patients, was to improve our understanding of the meanings, implications of the needs directly described from the point of view of the patients. Such an approach determines the reasons and conditions of the dissatisfaction in the patient, and provides additional information for the planning of improvement interventions. RESULTS: Of the 224 eligible patients, 182 (81%) completed the questionnaire. Four of the top five needs expressed by 40% or more of the responders concerned information needs (diagnosis, future conditions, dialogue with doctors, economic-insurance solutions related to the disease). Only one of the 5 was concerned with improved "hotel" services (bathrooms, meals, cleanliness). Qualitative analysis showed that the most expressed need (to receive more information on their future conditions) has the meaning to know how their future life will be affected more than to know his/her actual prognosis. CONCLUSIONS: Some of the needs which emerged from this investigation could be immediately satisfied (the need for psychological support, the need for economic aid, the need for spiritual support), while others will have to be faced in the longer term; for example, the presence of a high percentage of needs in patient-physician relationships and/or information-communication issues, could be resolved by setting up structured introductory training courses for all clinicians in the institution. On the other hand, the needs related to the living infrastructure (bathrooms, meals, etc...) could encourage the Institution to improve its services

Providing a nurse-led complex nursing INtervention FOcused on quality of life assessment on advanced cancer patients: The INFO-QoL pilot trial.

PURPOSE Unmet needs for advanced-disease cancer patients are fatigue, pain, and emotional support. Little information is available about the feasibility of interventions focused on patient-reported outcome measurement developed according to the Medical Research Council (MRC) Framework in advanced-disease cancer patients. We aimed to pilot a nurse-led complex intervention focused on QoL assessment in advanced-disease cancer patients. METHODS The INFO-QoL study was based on an exploratory, nonequivalent comparison group, pre-test-post-test design. Study sites received either the INFO-QoL intervention or usual care. Adult advanced-disease cancer patients admitted to hospice inpatient units that gave their informed consent were included in the study. Subjects were 187 patients and their families and 19 healthcare professionals. We evaluated feasibility, acceptability, and patients' outcomes using the Integrated Palliative Care Outcome Scale. RESULTS Nineteen healthcare professionals were included. The mean competence score increased significantly over time (p < 0.001) and the mean usefulness score was high 8.63 (±1.36). In the post-test phase, 54 patients were allocated to the experimental unit and 36 in the comparison unit. Compared to the comparison unit, in the experimental unit anxiety (R2 = 0.07; 95% CI = -0.06; 0.19), family anxiety (R2 = 0.22; 95% CI = -0.03; 0.41), depression (R2 = 0.31; 95% CI = -0.05; 0.56) and sharing feelings (R2 = 0.09; 95% CI = -0.05; 0.23), were improved between pre-test and post-test phase. CONCLUSIONS The INFO-QoL was feasible and potentially improved psychological outcomes. Despite the high attrition rate, the INFO-QoL improved the quality and safety culture for patients in palliative care settings