Dataset Information

The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training.

ABSTRACT:

Aims

To explore cancer trial coordinators' roles and challenges in administering patient-reported outcome (PRO) questionnaires, and establish what PRO-specific training and guidance they received and needed.

Methods

Eligible cancer trial coordinators experienced with PRO assessment from approved Australian sites participated in an audio-recorded, semi-structured interview (transcribed verbatim). Recruitment continued until data saturation. Transcripts underwent content analysis.

Results

Twenty coordinators participated (professional training: nursing (n = 12), science/research (n = 4), both (n = 4)). PRO administration formed a minor component of most (85%) coordinators' roles. PRO administration challenges included managing 'English second language' participants, participants' companions who attempted to complete questionnaires, burdensome questionnaires, and balancing their duty of care against trial requirements. Coordinators reported inconsistencies in PRO administration, which appeared to arise as a result of confusion and inconsistent or contradictory PRO training. Inconsistencies concerned whether/when they explained the purpose of PRO assessment, which participants they approached to complete PROs, and whether they used PRO trial data to inform care.Coordinators received PRO training from various sources; most commonly study-specific start-up meetings (45%) or from colleagues (30%). Two received no PRO-specific training. Despite the challenges reported, many (55%) felt they did not need further PRO training.

Conclusion

Trial coordinators receive inconsistent PRO-specific training and are often unclear how to prioritise different aspects of data quality when faced with everyday challenges, leading to inconsistent methods, missing data, poor quality data, and even bias. Agreement on how coordinators should prioritise the requirements of PRO studies is a necessary pre-requisite for the development of much-needed, consensus-based PRO administration guidelines.

SUBMITTER: Mercieca-Bebber R

PROVIDER: S-EPMC5898562 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training.

Mercieca-Bebber Rebecca R Calvert Melanie M Kyte Derek D Stockler Martin M King Madeleine T MT

Contemporary clinical trials communications 20171123

<h4>Aims</h4>To explore cancer trial coordinators' roles and challenges in administering patient-reported outcome (PRO) questionnaires, and establish what PRO-specific training and guidance they received and needed.<h4>Methods</h4>Eligible cancer trial coordinators experienced with PRO assessment from approved Australian sites participated in an audio-recorded, semi-structured interview (transcribed verbatim). Recruitment continued until data saturation. Transcripts underwent content analysis.<h ...[more]

PMID: 29696221

Similar Datasets

Project description:ObjectiveIn the wake of the coronavirus pandemic, teleneuropsychology utilization has increased. There is a need to characterize the first-hand experiences of individuals using teleneuropsychology, identify the common teleneuropsychology challenges, and devise practical strategies for mitigating/resolving these challenges.MethodSurvey data were collected from U.S. based neuropsychologists and other individuals (e.g., graduate students and research assistants) who were engaged in remote cognitive assessment with adults (n = 87). Frequency analyses were conducted to examine: how respondents used teleneuropsychology (e.g., duration of use, types of measures and devices/technology platforms used); challenges that were encountered with different technology platforms and teleneuropsychology use; and advice for navigating these challenges.ResultsMost respondents began using teleneuropsychology relatively recently in the context of the coronavirus pandemic, with home-to-home or clinic-to-home settings being the most frequently reported teleneuropsychology settings. Zoom®, Doxy.Me®, and MyChart® were the most frequently used platforms, largely due to workplace mandates and/or Health Insurance Portability and Accountability Act-compliant features. Common challenges with teleneuropsychology included internet connection issues and environmental distractions in examinees' homes, and examinees having limited-to-no access to technologies requisite for teleneuropsychology. Providing clear instructions to the examinee prior to the teleneuropsychology visit was the most common advice for ensuring a successful teleneuropsychology evaluation. Similar response patterns were generally noted for those who used TeleNP for clinical or research purposes.ConclusionsThese survey results reflect common experiences and challenges with teleneuropsychology and identify priority targets for increasing its feasibility, reliability, and validity. Findings provide context for the development of formal teleneuropsychology competencies.

Project description:BackgroundClinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.MethodsA qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.ResultsThe analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians' recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.ConclusionsIn conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.

Project description:BackgroundThe World Health Organization recommends promoting exclusive breastfeeding for six months. Women often end breastfeeding earlier than planned, however women who continue to breastfeed despite problems often experience good support and counselling from health professionals. The aim of this study was to evaluate the effects of a process-oriented training in breastfeeding support counselling for midwives and child health nurses, on women's satisfaction with breastfeeding counselling, problems with insufficient breast milk and nipple pain in relation to exclusive breastfeeding shorter or longer than 3 months.MethodsAn intervention through process-oriented training for health professionals regarding support in childbearing and breastfeeding took part in the south west of Sweden. This study was conducted in Sweden, in 2000 - 2003. Ten municipalities were paired, and within each pair, one was randomly assigned to the group of five intervention (IG) municipalities and one to the group of five control municipalities. Primiparas (n?=?540) were invited to participate in a longitudinal study to evaluate the care they received. A survey was distributed at 3 days, 3 months and 9 months postpartum. Data collection for control group A (n?=?162) started before the intervention was initiated. Data for control group B (n?=?172) were collected simultaneously with the intervention group (IG) (n?=?206). Women were also divided into two groups depending on whether they exclusive breastfed?<?3 months or???3 months.ResultsWomen in IG were more satisfied with the breastfeeding counselling (p?=?0.008) and felt the breastfeeding counselling was more coherent (p?=?0.002) compared to control groups, when exclusive breastfeeding was?<?3 months. In addition fewer women in the IG, among the group exclusively breastfeeding?<?3 months, had problems with insufficient breast milk compared to the control groups (p?=?0.01).ConclusionA process-oriented training for health professionals in support influenced women's ability to solve breastfeeding problems such as the experience of insufficient breast milk production. Women with exclusive breastfeeding lasting???3 months more often had breastfeeding duration in line with their planned breastfeeding duration, compared to women who had breastfeeding duration?<?3 months.Trial registrationACTRN12611000354987.

Project description:BackgroundData for health surveys are often collected using either mailed questionnaires, telephone interviews or a combination. Mode of data collection can affect the propensity to refuse to respond and result in different patterns of responses. The objective of this paper is to examine and quantify effects of mode of data collection in health surveys.MethodsA stratified sample of 4,000 adults residing in Denmark was randomised to mailed questionnaires or computer-assisted telephone interviews. 45 health-related items were analyzed; four concerning behaviour and 41 concerning self assessment. Odds ratios for more positive answers and more frequent use of extreme response categories (both positive and negative) among telephone respondents compared to questionnaire respondents were estimated. Tests were Bonferroni corrected.ResultsFor the four health behaviour items there were no significant differences in the response patterns. For 32 of the 41 health self assessment items the response pattern was statistically significantly different and extreme response categories were used more frequently among telephone respondents (Median estimated odds ratio: 1.67). For a majority of these mode sensitive items (26/32), a more positive reporting was observed among telephone respondents (Median estimated odds ratio: 1.73). The overall response rate was similar among persons randomly assigned to questionnaires (58.1%) and to telephone interviews (56.2%). A differential nonresponse bias for age and gender was observed. The rate of missing responses was higher for questionnaires (0.73-6.00%) than for telephone interviews (0-0.51%). The "don't know" option was used more often by mail respondents (10-24%) than by telephone respondents (2-4%).ConclusionThe mode of data collection affects the reporting of self assessed health items substantially. In epidemiological studies, the method effect may be as large as the effects under investigation. Caution is needed when comparing prevalences across surveys or when studying time trends.

Project description:ImportanceAn interview is considered the gold standard method of assessing global functional outcomes in clinical trials among patients with acute traumatic brain injury (TBI). However, several multicenter clinical trials have used questionnaires completed by a patient or caregiver to assess the primary end point.ObjectiveTo examine agreement between interview and questionnaire formats for assessing TBI outcomes and to consider whether an interview has advantages.Design, setting, and participantsThis cohort study used data from patients enrolled in the Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) project from December 2014 to December 2017. Data were analyzed from December 2020 to April 2021. Included patients were aged 16 years or older with TBI and a clinical indication for computed tomography imaging. Outcome assessments were completed using both an interview and a questionnaire at follow-up 3 and 6 months after injury.ExposuresTraumatic brain injury of all severities.Main outcomes and measuresRatings on the Glasgow Outcome Scale-Extended (GOSE) administered as a structured interview rated by an investigator and as a questionnaire completed by patients or caregivers and scored centrally were compared, and the strength of agreement was evaluated using weighted κ statistics. Secondary outcomes included comparison of different sections of the GOSE assessments and the association of GOSE ratings with baseline factors and patient-reported mental health, health-related quality of life, and TBI symptoms.ResultsAmong the 3691 eligible individuals in the CENTER-TBI study, both GOSE assessment formats (interview and questionnaire) were completed by 994 individuals (26.9%) at 3 months after TBI (654 [65.8%] male; median age, 53 years [IQR, 33-66 years]) and 628 (17.0%) at 6 months (409 [65.1%] male; median age, 51 years [IQR, 31-64 years]). Outcomes of the 2 assessment methods agreed well at both 3 months (weighted κ, 0.77; 95% CI, 0.73-0.80) and 6 months (weighted κ, 0.82; 95% CI, 0.78-0.86). Furthermore, item-level agreement between the 2 methods was good for sections regarding independence in everyday activities (κ, 0.70-0.79 across both time points) and moderate for sections regarding subjective aspects of functioning such as relationships and symptoms (κ, 0.41-0.51 across both time points). Compared with questionnaires, interviews recorded more problems with work (294 [30.5%] vs 233 [24.2%] at 3 months and 161 [26.8%] vs 136 [22.7%] at 6 months), fewer limitations in social and leisure activities (330 [33.8%] vs 431 [44.1%] at 3 months and 179 [29.7%] vs 219 [36.4%] at 6 months), and more symptoms (524 [53.6%] vs 324 [33.1%] at 3 months and 291 [48.4%] vs 179 [29.8%] at 6 months). Interviewers sometimes assigned an overall rating based on judgment rather than interview scoring rules, particularly for patients with potentially unfavorable TBI outcomes. However, for both formats, correlations with baseline factors (ρ, -0.13 to 0.42) and patient-reported outcomes (ρ, 0.29 to 0.65) were similar in strength.Conclusions and relevanceIn this cohort study, GOSE ratings obtained by questionnaire and interview methods were in good agreement. The similarity of associations of the ratings obtained by both GOSE methods with baseline factors and other TBI outcome measures suggests that despite some apparent differences, the core information collected by both interviews and questionnaires was similar. The findings support the use of questionnaires in studies in which this form of contact may offer substantial practical advantages compared with interviews.

Dataset Information

The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training.

Aims

Methods

Results

Conclusion

Publications

The administration of patient-reported outcome questionnaires in cancer trials: Interviews with trial coordinators regarding their roles, experiences, challenges and training.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets