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The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing.

ABSTRACT: OBJECTIVES:To investigate, prior to an oncology consultation, the use of a pre-prepared list of evidence based questions, Question Prompt Sheet (QPS), compared with a Question List (QL), a patient self-generated list of questions. DESIGN:Multi-centred, randomised controlled trial. SETTING:Secondary-care patients attending three outpatient oncology clinics in Northern Italy. PARTICIPANTS:308 women completed the study. Inclusion criteria were an age between 18 and 75 years, a recent diagnosis of early stage, non-metastatic breast cancer, adequate Italian language skills, no previous oncology visits and no evidence of cognitive impairment. INTERVENTION:Patients received the QPS or the QL prior to the consultation, completed it without suggestion or coaching session and delivered back before the visit.The consultations were audio-recorded and analysed for the number and content of questions. Multilevel linear models were used to compare the two groups. OUTCOME MEASURES:The primary outcome was the comparison of questions asked between QPS and QL group. Secondary outcomes included satisfaction about questions asked, satisfaction with decision, and level of anxiety. RESULTS:Patients in the QPS and QL group asked 13 and 16 questions respectively. The difference was not significant (b=1.7, CI -0.3 to 3.6, p=0.10). A mean of 22 questions was selected in the QPS, while a mean of 2 questions was written in the QL. Patients in the QPS group were significantly less satisfied (t=3.60, p<0.01) with questions asked but wanted less additional information (t=2.20, p<0.05). Levels of patient decisional satisfaction were equivalent between groups. Similarly, anxiety levels were equal between groups prior to the consultation and decreased in similar way after the consultation. CONCLUSIONS:Both interventions have similar impact on patients' participation in terms of question asking during the consultation. Future research is needed in order to explore which components of the interventions are really useful and efficacious. TRIAL REGISTRATION:ClinicalTrials.gov NCT01510964.

SUBMITTER: Bottacini A

PROVIDER: S-EPMC5724137 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing.

Bottacini Alessandro A Goss Claudia C Mazzi Maria Angela MA Ghilardi Alberto A Buizza Chiara C Molino Annamaria A Fiorio Elena E Nortilli Rolando R Amoroso Vito V Vassalli Lucia L Brown Richard F RF

BMJ open 20170811 8

<h4>Objectives</h4>To investigate, prior to an oncology consultation, the use of a pre-prepared list of evidence based questions, Question Prompt Sheet (QPS), compared with a Question List (QL), a patient self-generated list of questions.<h4>Design</h4>Multi-centred, randomised controlled trial.<h4>Setting</h4>Secondary-care patients attending three outpatient oncology clinics in Northern Italy.<h4>Participants</h4>308 women completed the study. Inclusion criteria were an age between 18 and 75 y ...[more]

PMID: 28801395

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Project description:IntroductionQuestion prompt lists (QPLs) are lists of questions that patients may want to discuss with clinicians. QPLs support person-centred care and have been associated with many beneficial outcomes including improved patient question-asking, and the amount and quality of the information provided by clinicians. The purpose of this study was to review published research on QPLs to explore how QPL design and implementation can be optimized.MethodsWe performed a scoping review by searching MEDLINE, EMBASE, Scopus, CINAHL, Cochrane Library and Joanna Briggs Database from inception to 8 May 2022, for English language studies of any design that evaluated QPLs. We used summary statistics and text to report study characteristics, and QPL design and implementation.ResultsWe included 57 studies published from 1988 to 2022 by authors in 12 countries on a range of clinical topics. Of those, 56% provided the QPL, but few described how QPLs were developed. The number of questions varied widely (range 9-191). Most QPLs were single-page handouts (44%) but others ranged from 2 to 33 pages. Most studies implemented a QPL alone with no other accompanying strategy; most often in a print format before consultations by mail (18%) or in the waiting room (66%). Both patients and clinicians identified numerous benefits to patients of QPLs (e.g., increased patient confidence to ask questions, and patient satisfaction with communication or care received; and reduced anxiety about health status or treatment). To support use, patients desired access to QPLs in advance of clinician visits, and clinicians desired information/training on how to use the QPL and answer questions. Most (88%) studies reported at least one beneficial impact of QPLs. This was true even for single-page QPLs with few questions unaccompanied by other implementation strategies. Despite favourable views of QPLs, few studies assessed outcomes amongst clinicians.ConclusionThis review identified QPL characteristics and implementation strategies that may be associated with beneficial outcomes. Future research should confirm these findings via systematic review and explore the benefits of QPLs from the clinician's perspective.Patient/public contributionFollowing this review, we used the findings to develop a QPL on hypertensive disorders of pregnancy and interviewed women and clinicians about QPL design including content, format, enablers and barriers of use, and potential outcomes including beneficial impacts and possible harms (will be published elsewhere).

Project description:ImportanceThere are few robust evaluations of disease-specific question prompt sheets (QPS) in patient-physician communication among patients with advanced cancer.ObjectiveTo compare the patient perception of helpfulness, global evaluation, and preference for the QPS vs a general information sheet (GIS), and to examine the effect of the QPS on participants' anxiety, participants' speaking time, number of questions asked, and length of the clinical encounter.Design, setting, and participantsThis controlled, double-blind randomized clinical trial was conducted at an outpatient palliative and supportive care clinic in a cancer center in the US. Eligible patients were 18 years or older, had a cancer diagnosis, and were undergoing their first outpatient consultation visit with a palliative care physician from September 1, 2017, to May 31, 2019. Data analysis used a modified intention-to-treat design. Data were analyzed from May 18 to June 27, 2022.InterventionQPS, a 25-item list of questions developed by expert palliative care clinicians using a Delphi process and tested among ambulatory advanced cancer patients. The control was GIS, generic information material given routinely to patients seen at the supportive care clinic.Main outcomes and measuresThe main outcome was patient perception of helpfulness. Secondary outcomes included global evaluation and preference of QPS compared with GIS immediately after the encounter.ResultsA total of 130 patients (mean [SD] age, 58.6 [13.3] years; 79 [60.8%] female) were randomized to receive either QPS (67 patients [51.5%]) or GIS (63 patients [48.5%]). Patients considered QPS and GIS equally helpful, with no statistically significant difference (mean [SD] helpfulness score, 7.2 [2.3] points vs 7.1 [2.7] points; P = .79). The QPS group, compared with the GIS group, had a higher global positive view of the material (mean [SD] global perception score, 7.1 [1.3] vs 6.5 [1.7]; P = .03) and felt it prompted them more to generate new questions (mean [SD] rating, 7.0 [2.9] vs 5.3 [3.5]; P = .005). Of 47 patients asked their preference between the items, more participants preferred the QPS to the GIS in communicating with their physicians (24 patients [51.1%] vs 7 patients [14.9%]; P = .01) at the 4-week follow-up. No significant differences between the QPS and GIS groups were observed regarding participant anxiety, speaking time, number of questions asked, or consultation length (eg, mean [SD] anxiety rating, 2.3 [3.7] vs 1.6 [2.7]; P = .19).Conclusions and relevanceIn this randomized clinical trial, participants perceived both QPS and GIS as equally helpful, but they had a more positive global view of and preferred the QPS. QPS facilitated generation of new questions without increasing patient anxiety nor prolonging the consultation. The findings provide support for increased adoption and integration of QPS into routine oncologic care.Trial registrationClinicalTrials.gov Identifier: NCT03287492.

Project description:BackgroundAdherence to the diet prescription for chronic kidney disease is suboptimal. Interventions to improve dietary adherence suggest that improving communication between the patient and the health professional is fundamental to improving outcomes. Providing patients with a question prompt sheet prior to the consultation has been demonstrated to be an effective method for improving communication between patient and health professional. In the absence of a renal diet specific version, the aims of this study were to develop and test the feasibility of a renal diet specific question prompt sheet for use in nephrology clinics.MethodsPhase one utilized social listening methodology, online content analysis and clinic observations to obtain an extensive list of frequently asked questions about the renal diet. Following refinement with health professionals, the draft question prompt sheet was then sent in Phase two to patients one week prior to their scheduled consultation with the renal dietitian. Feedback was obtained from patients, carers and dietitians using semi structured interviews post clinic consultation. Quantitative data was analyzed using counts and proportions, while free text responses were analyzed thematically.ResultsA total of 769 unique renal diet related questions were reduced to an 18-item question prompt sheet. Feedback from thirteen patients (six males), six carers and six dietitians involved in the preliminary feasibility study was overwhelmingly positive. The majority of patients found the question prompt sheet to be easy to understand and agreed it facilitated communication with the dietitian. All participants agreed that they would recommend use of question prompt sheet to other patients. Suggestions for future use included health professional training in use of the sheet, particularly about how to help patients prioritize their most important questions.ConclusionsThe 18-item renal diet question prompt sheet developed in this preliminary study appears to be a feasible tool for use in nephrology consultations especially by dietitians. Further research quantifying the impact on question asking and patient centeredness should be undertaken. In addition, user testing with patients from culturally diverse and low literacy backgrounds would be useful.

Project description:BackgroundMost conditions in orthopaedic surgery are preference-sensitive, where treatment choices are based on the patient's values and preferences. One set of tools increasingly used to help align treatment choices with patient preferences are question prompt lists (QPLs), which are comprehensive lists of potential questions that patients can ask their physicians during their encounters. Whether or not a comprehensive orthopaedic-specific question prompt list would increase patient-perceived involvement in care more effectively than might three generic questions (the AskShareKnow questions) remains unknown; learning the answer would be useful, since a three-question list is easier to use compared with the much lengthier QPLs.Question/purposeDoes an orthopaedic-specific question prompt list increase patient-perceived involvement in care compared with the three generic AskShareKnow questions?MethodsWe performed a pragmatic randomized controlled trial of all new patients visiting a multispecialty orthopaedic clinic. A pragmatic design was used to mimic normal clinical care that compared two clinically acceptable interventions. New patients with common orthopaedic conditions were enrolled between August 2019 and November 2019 and were randomized to receive either the intervention QPL handout (orthopaedic-specific QPL with 45 total questions, developed with similar content and length to prior QPLs used in hand surgery, oncology, and palliative care) or a control handout (the AskShareKnow model questions, which are: "What are my options? What are the benefits and harms of those options? How likely are each of those benefits and harms to happen to me?") before their visits. A total of 156 patients were enrolled, with 78 in each group. There were no demographic differences between the study and control groups in terms of key variables. After the visit, patients completed the Perceived Involvement in Care Scale (PICS), a validated instrument designed to evaluate patient-perceived involvement in their care, which served as the primary outcome measure. This instrument is scored from 0 to 13, with higher scores indicating higher perceived involvement.ResultsThere was no difference in mean PICS scores between the intervention and control groups (QPL 8.3 ± 2.3, control 8.5 ± 2.3, mean difference 0.2 [95% CI -0.53 to 0.93 ]; p = 0.71.ConclusionIn patients undergoing orthopaedic surgery, a QPL does not increase patient-perceived involvement in care compared with providing patients the three AskShareKnow questions. Implementation of the three AskShareKnow questions can be a more efficient way to improve patient-perceived involvement in their care compared with a lengthy QPL.Level of evidenceLevel II, therapeutic study.

Project description:IntroductionThe Last Year of Life Study-Cologne Part I (LYOL-C I) has identified general hospital units as the most important checkpoints for transitions in the last year of life of patients. Yet, satisfaction with hospitals, as reported by bereaved relatives, is the lowest of all health service providers. Thus, the LYOL-C Part II (LYOL-C II) focuses on optimising patient-centred care in acute hospitals for patients identified to be in their last year of life. LYOL-C II aims to test an intervention for hospitals by using a two-sided (healthcare professionals (HCPs) and patients) trigger question-based intervention to 'shake' the system in a minimally invasive manner.Methods and analysisProspective interventional mixed-methods study following a two-phase approach: phase I, individual interviews with HCPs and patient representatives to design the intervention to maximise ease of implementation and phase II, exploratory study with two arms and a prepost design with patients in their last year of life. The intervention will consist of the Surprise Question and the German version of the Supportive and Palliative Care Indicators Tool (SPICT-DE) for HCPs to identify patients and provide patient-centred care, plus question prompt sheets for patients, encouraging them to initiate discussions with their HCPs. Data on transitions, changes in therapy, quality of care, palliative care integration and death of patients will be analysed. Furthermore, a staff survey (pre/post) and guided interviews with staff, patients and relatives (post) will be conducted. Finally, a formative socioeconomic impact assessment to provide evidence regarding the sustainability of the intervention will be performed.Ethics and disseminationThe study was approved by the Ethics Committee of the Faculty of Medicine of the University of Cologne (#20-1431). Results will be published in peer-reviewed journals and presented at national and international conferences.Trial registration numberDRKS00022378.

Project description:ObjectivesThis study involved the development of a question prompt list (QPL) booklet designed to facilitate communication and shared decision-making between parents/carers of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) and their clinicians; and user-testing of the QPL to assess its usability.DesignBest practice in information writing and design was used to format the QPL content into a 16-page booklet. We then applied user-testing, which uses mixed methods to assess document performance with small cohorts of participants and then improves it in an iterative process. Individual interviews assessed the ability of QPL users to locate and understand key points of information, followed by a semistructured questionnaire, to ascertain their general views about the booklet.Setting and participantsTesting was undertaken with two cohorts of 10 parents/carers of children with ADHD (n=20); matched on age, gender and educational attainment.Tested documentsIn round 1, we tested 15 key points of information related to the QPL. Participant responses and feedback from round 1 informed a revised version of the booklet, tested in a subsequent round.Primary outcome measureThe target was for 8/10 of the participants to be able to find and demonstrate an understanding of all key information points, in accordance with European guidelines for medicine leaflet testing.ResultsAfter round 1, problems related to 4/15 information points were identified (booklet purpose; preparing for appointments; asking about a second medical opinion; selecting which questions to ask). Participants also made suggestions regarding the booklet's layout and design. After round 2, all information points were located and understood by at least 8/10 participants.ConclusionsThis is the first study to have developed a usable ADHD-specific QPL for use by parents/carers of children with ADHD during clinical consultations, and the first demonstration of the utility of user-testing methods in ensuring QPL usability.

Dataset Information

The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing.

Publications

The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a question prompt sheet versus question listing.

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