Factors influencing functional recovery after limb-salvage surgery for lower extremity musculoskeletal tumours: a qualitative study combining patients' and healthcare professionals' perspectives.

PURPOSE: Survival rates of lower extremity musculoskeletal tumours (LEMTs) have been increasing. However, patients continue to experience functional limitations after LEMT followed by limb-salvage surgery (LSS). This study aimed to identify factors influencing functional recovery after LSS for LEMT. METHODS: A qualitative study was conducted using semi-structured interviews with a purposive sample of adult patients who underwent LSS for LEMT (n=7) and healthcare professionals (HCPs) with expertise in orthopaedic oncology (n=7). Recruitment continued until data saturation. A combination of deductive and inductive qualitative content analysis was performed to analyse the transcribed data, producing subthemes under the main International Classification of Functioning, disability and health (ICF)-model domains. RESULTS: Four themes were described: (1) bodily functions and structures, (2) activities and participation, (3) environmental factors, and (4) expectations. Physical aspects such as larger resection size and complications negatively affected recovery. The importance of communication strategies of tertiary HCPs and the unfamiliarity of the primary physical therapists with the disease, its surgical treatment, and related consequences were emphasised by both the interviewed patients and HCPs. CONCLUSIONS: Functional recovery after LSS for LEMT is a multifactorial process. To improve patient care, improving (intercollegiate) communication strategies on treatment details and expectations about functional outcomes is warranted.Implications for rehabilitationHealthcare professionals should be aware some patients experience limited functional recovery after limb-salvage surgery (LSS) for lower extremity musculoskeletal tumours.Healthcare professionals should use multiple communication strategies to bridge the gap between the information provided and what the patient recalls.Knowledge exchange and communication between primary and tertiary care should be more extensive.Multidisciplinary consultations and/or case managers are needed to address all aspects of the individual's functional recovery after LSS.

Exploring the Content Validity of the Unified Wilson Disease Rating Scale: Insights from Qualitative Research.

INTRODUCTION: Wilson disease (WD) is a rare metabolic disorder of impaired copper transport manifesting in hepatic, neurological, and psychiatric symptoms. To evaluate the clinical symptoms of WD in clinical trials, a group of clinicians created the Unified Wilson Disease Rating Scale (UWDRS). Content validity of this scale has not been established. The aim of this study was to evaluate the content validity of the UWDRS Part II from the patient perspective. METHODS: This study utilized multiple qualitative research methods including concept elicitation interviews, concept/instrument mapping, and cognitive debriefing interviews. RESULTS: Concept elicitation interviews with a sample of patients with WD and one or more neurological signs/symptoms identified several signs, symptoms, and impacts related to neurological dysfunction, strengthening our understanding of the importance of the neurological aspects of the WD patient experience. Mapping neurological concepts to Part II and III items of the UWDRS showed complete coverage of all salient neurological concepts and near complete coverage of all neurological concepts reported by patients in concept elicitation interviews. Item debriefing of Part II of the UWDRS revealed that patients generally found the items clear and personally relevant to their experience with WD. CONCLUSION: Overall, the findings from this study provide evidence for the content validity of the UWDRS Part II and supportive evidence for the content validity of Part III. The UWDRS should be used in conjunction with additional clinical outcomes assessments, specifically those evaluating the hepatic and psychiatric signs/symptoms of WD, to provide a comprehensive evaluation of the WD patient experience.

Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study.

BACKGROUND: The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemented. METHODS: Women aged ≥ 46 years with a histologically confirmed diagnosis of non-high-grade DCIS were eligible for 1:1 randomisation to either surgery or active monitoring. Prior to randomisation, all eligible women were invited to complete: (1) the Clinical Trials Questionnaire (CTQ) examining reasons for or against participation, and (2) interviews exploring in depth opinions about the study information sheets and film. Women agreeing to randomisation completed validated questionnaires assessing health status, physical and mental health, and anxiety levels. Hospital site staff were invited to communication workshops and refresher site initiation visits to support recruitment. Their perspectives on LORIS recruitment were collected via surveys and interviews. RESULTS: Eighty percent (181/227) of eligible women agreed to be randomised. Over 40% of participants had high anxiety levels at baseline. On the CTQ, the most frequent most important reasons for accepting randomisation were altruism and belief that the trial offered the best treatment, whilst worries about randomisation and the influences of others were the most frequent most important reasons for declining. Most women found the study information provided clear and useful. Communication workshops for site staff improved knowledge and confidence but only about half said they themselves would join LORIS if eligible. The most common recruitment barriers identified by staff were low numbers of eligible patients and patient preference. CONCLUSIONS: Recruitment to LORIS was challenging despite strategies aimed at both patients and site staff. Ensuring that recruiting staff support the study could improve recruitment in similar future trials. TRIAL REGISTRATION: ISRCTN27544579, prospectively registered on 22 May 2014.

Perspectives of patients with advanced or metastatic non-small cell lung cancer on symptoms, impacts on daily activities, and thresholds for meaningful change: a qualitative research study.

Introduction: Advanced or metastatic non-small cell lung cancer (NSCLC) is associated with significant symptom burden. It is important to understand the impact of these disease-and treatment-related symptoms on patients' daily lives and explore from a patient perspective what constitutes a meaningful change in NSCLC symptoms. Methods: Patient experience of advanced or metastatic NSCLC was explored in this prospective, non-interventional qualitative research study recruiting patients from the United States (US). Interviews were conducted to explore the most important symptoms, daily life impacts, and patients' perspectives of what constitutes meaningful change when considering their current symptoms versus 6-12 months prior, based on the Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) items. Results: Between February and April 2022, 19 US-based patients with Stage IV NSCLC were recruited; 95% were female, 63% were White, 79% had been diagnosed >1 year prior, and 63% were receiving targeted therapy. Over half the patients indicated their most important symptoms were fatigue, shortness of breath, and cough. Patient differentiation between whether symptoms were disease- or treatment-related lacked concordance, and often patients were unable to distinguish the two. The most frequently mentioned impacts of these symptoms on patients' daily lives were difficulty walking, sleep disturbance, anxiety/depression, impact on relationships, and difficulty doing daily tasks. Most patients considered a one-point change on the PGI-S or PGI-C to be meaningful based on rating their symptom severity at the time of the interview compared with 6-12 months before the interview. Conclusion: Based on their own symptom experience, patients with advanced or metastatic NSCLC indicated a one-point threshold for meaningful change, whether improvement or worsening. This suggests a one-point change on the PGI-S or PGI-C may be a potential anchor for patient-reported outcome (PRO) endpoints used in clinical trials. It is important to use PRO instruments that capture the symptoms and impacts identified as most important to patients. These findings highlight the importance of using qualitative methods to assess disease-related symptoms, treatment-related side effects, and the impacts on daily life for patients with advanced or metastatic NSCLC, underscoring how qualitative assessments can complement quantitative PRO instruments for evaluating clinical trials.

Development of the Cold Agglutinin Disease Symptoms and Impact Questionnaire (CAD-SIQ).

OBJECTIVES: Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia. This study aimed to identify disease-related symptoms and impacts important to patients with CAD, and to develop a novel CAD-specific patient-reported outcome measure. METHODS: Adults with CAD were randomly selected from a United States patient panel to participate in concept elicitation (CE) interviews to identify important symptoms and impacts or cognitive debriefing (CD) interviews to assess the comprehension and relevance of the draft item set. RESULTS: Overall, 37 adults were included (mean [range] age 67.2 [35-87] years). In CE interviews (n = 16), the most frequently reported CAD-related symptoms were reactions to cold environments and fatigue (both 93.8%). CAD had negative impacts on enjoyable activities (81.3%) and daily activities (75.0%). Following CE, standard survey methodological principles were used to develop a draft item pool of 14 concepts. Items were refined through three iterative rounds of CD interviews (n = 21), yielding 11 final items: fatigue; cold sensitivity; dyspnea; wearing extra clothing; limited physical, social, and enjoyable activities; difficulty with usual activities; mood; frustration; and anxiety/stress. CONCLUSIONS: The novel 11-item CAD-Symptoms and Impact Questionnaire provides a measure of the symptoms and impacts of CAD that are important to patients.

Eliciting Patient Insights on the Burden of Nontuberculous Mycobacterial Lung Disease (NTM-LD) and Healthcare Gaps in Germany Through Qualitative Semi-structured Interviews.

INTRODUCTION: Nontuberculous mycobacterial lung disease (NTM-LD) is a rare but growing health concern, particularly affecting vulnerable patients with chronic lung conditions. Understanding the patients' perspective on their disease and treatment expectations can help to identify healthcare gaps and improve overall patient care. Therefore, the main objective of the survey study was the evaluation of patient insights on the burden of the disease and healthcare gaps. METHODS: The study used an online survey as a pre-screener to facilitate recruitment followed by semi-structured qualitative interviews. The interviews were conducted by phone from April 2019 to February 2020 in German language. Only patients with a self-reported confirmed NTM-LD diagnosis, managed and insured in Germany were included in this study. RESULTS: In total, 20 semi-structured qualitative interviews were conducted. Most (85%) patients had at least one coexisting pulmonary condition with cystic fibrosis (CF, n = 9) being most common. Chronic cough, fatigue, and dyspnea were the most reported symptoms. Of all the symptoms reported, fatigue was perceived as the most burdensome and 85% of patients felt limited in their daily life. It took a median of 5 months for patients to receive an accurate diagnosis of NTM-LD and that time was doubled when excluding patients with CF (range 0-480 months). Ninety percent of interviewed patients (n = 18) received drug treatment for NTM-LD and most of them (n = 17) reported having experienced side effects from their treatment. Patients' expressed a particular need for more comprehensive and reliable patient-friendly information on NTM-LD and a better awareness of physicians as well. CONCLUSIONS: NTM-LD can considerably impair the lives of patients and their families and/or caregivers. A multidisciplinary approach and establishment of more widespread regional expert centers for NTM-LD management in Germany with well-structured referral and communication pathways accompanied by peer-to-peer support of patient advocacy groups are urgently needed.

Patient perceptions regarding alcohol use after bariatric surgery.

INTRODUCTION: Patients who have undergone bariatric surgery are at increased risk of an alcohol use disorder. Though patients understand this risk, the majority engage in post-surgical alcohol use. This suggests that education alone is not sufficient to reduce post-surgical drinking. To prevent development of post-surgical alcohol use disorders, we need better understanding of the reasons patients use alcohol following surgery. The purpose of this study was to identify factors associated with post-surgical alcohol use. METHOD: Patients (N = 20) who were 1-3 years post-bariatric surgery and were consuming alcohol at least twice monthly participated in a 60-min interview. Participants responded about their knowledge regarding risk of post-surgical alcohol use and reasons why patients may start drinking. Deductive and inductive coding were completed by two independent raters. RESULTS: Although nearly all participants were aware of the risks associated with post-surgical alcohol use, most believed that lifelong abstinence from alcohol was unrealistic. Common reasons identified for using alcohol after bariatric surgery included social gatherings, resuming pre-surgical use, and addiction transfer. Inductive coding identified three themes: participants consumed alcohol in different ways compared to prior to surgery; the effect of alcohol was substantially stronger than pre-surgery; and beliefs about why patients develop problematic alcohol use following surgery. CONCLUSION: Patients consume alcohol after bariatric surgery for a variety of reasons and they do not believe recommending abstinence is useful. Understanding patient perceptions can inform interventions to minimize alcohol use after bariatric surgery. Modifications to traditional alcohol relapse prevention strategies may provide a more robust solution to decreasing negative outcomes experienced by individuals undergoing bariatric surgery.

Natural Language Processing for Automated Classification of Qualitative Data From Interviews of Patients With Cancer.

OBJECTIVES: This study sought to explore the use of novel natural language processing (NLP) methods for classifying unstructured, qualitative textual data from interviews of patients with cancer to identify patient-reported symptoms and impacts on quality of life. METHODS: We tested the ability of 4 NLP models to accurately classify text from interview transcripts as "symptom," "quality of life impact," and "other." Interview data sets from patients with hepatocellular carcinoma (HCC) (n = 25), biliary tract cancer (BTC) (n = 23), and gastric cancer (n = 24) were used. Models were cross-validated with transcript subsets designated for training, validation, and testing. Multiclass classification performance of the 4 models was evaluated at paragraph and sentence level using the HCC testing data set and analyzed by the one-versus-rest technique quantified by the receiver operating characteristic area under the curve (ROC AUC) score. RESULTS: NLP models accurately classified multiclass text from patient interviews. The Bidirectional Encoder Representations from Transformers model generally outperformed all other models at paragraph and sentence level. The highest predictive performance of the Bidirectional Encoder Representations from Transformers model was observed using the HCC data set to train and BTC data set to test (mean ROC AUC, 0.940 [SD 0.028]), with similarly high predictive performance using balanced and imbalanced training data sets from BTC and gastric cancer populations. CONCLUSIONS: NLP models were accurate in predicting multiclass classification of text from interviews of patients with cancer, with most surpassing 0.9 ROC AUC at paragraph level. NLP may be a useful tool for scaling up processing of patient interviews in clinical studies and, thus, could serve to facilitate patient input into drug development and improving patient care.

Improvement of medical students' performance in simulated patient interviews by pre-clinical communication training.

Objectives: To compare the communication skills shown by medical students during simulated patient interviews between those who received training in communication during the preclinical years and those who did not. Methods: A retrospective study was conducted to analyze the communication skills of several cohorts of fourth-year medical students from Universitat Internacional de Catalunya during simulated patient interviews. Out of a total of 477 students included in the study, 229 (48%) had received training in communication skills through a 60-hour elective course during the preclinical second year, while the remaining 248 (52%) had received none. Communication skills were assessed by an evaluation team using a numerical scale (0 to 10) that included eight categories: "verbal", "non-verbal", "empathy", "concreteness", "warmth", "message content", "assertiveness", and "respect". Scores obtained by trained and non-trained students were compared using the t-test. Results: A trend towards obtaining better results was observed among students who had received communication training (mean score: 6.98/10) versus none (6.83/10, t(1,869)=-1.95, p=0.05). Non-trained male students obtained significantly lower mean scores than non-trained females in the categories of "respect" (7.48/10 vs. 7.83/10, t(968)=-2.89, p<0.01), "verbal communication" (6.87/10 vs. 7.15/10, t(968)=-2.61, p=0.01), "warmth" (6.53/10 vs. 6.95/10, t(968)=-3.40, p<0.01), and "non-verbal communication" (6.49/10 vs. 6.79/10, t(968)=-2.48, p=0.01). Trained female and male students had similar scores. Conclusions: Training in communication skills during the preclinical years may improve fourth-year students' performance in simulated interviews with patients, particularly among males. These results demonstrate the importance of introducing specific training in communication skills early in the undergraduate medical curriculum.

Women´s experiences of preeclampsia as a condition of uncertainty: a qualitative study.

BACKGROUND: Preeclampsia is a severe condition that annually affects about 3-8% of pregnancies worldwide. Preeclampsia is thereby one of the most common pregnancy complications for both mother and child. Despite that, there is limited research exploring the women´s perspective of experiencing preeclampsia. AIM: The aim of this study was to describe women´s experiences of preeclampsia to improve the support and care given during and after pregnancy. METHODS: A qualitative descriptive interview study was undertaken. Nine women, diagnosed with preeclampsia, were recruited from a maternity unit in southern Sweden. The descriptive phenomenological method according to Amadeo Giorgi was used to analyse the data. RESULTS: The women´s experiences of PE were expressed as A condition of uncertainty, meaning that it was an unexpected and unknown situation. This main result consisted of 1) incomprehensible diagnosis message, 2) ambivalent feeling when the unexpected happens, 3) confusing contradictory messages, 4) appreciated support from the midwife, 5) need for continuous information. The nature of preeclampsia can sometimes deteriorate rapidly both for the mother and/or the child, often resulting in conversion from a planned vaginal spontaneous delivery to an emergency Caesarean section. The women narrated diffuse symptoms, and they experienced that they got contradictory information from different health care professionals regarding the severity of their disease. Detailed and continuous information is requested throughout the course of the disease, and the postpartum period. CONCLUSION: This qualitative study reveal a need for improved clinical management. Health care professionals must be aware that women and their partners need detailed, consistent and repeated information about severity and prognosis to diminish the condition of uncertainty, confusion and fearful experience. The clinical implication would be a standardized preeclampsia education for pregnant women early on in the pregnancy, to raise awareness of preeclamptic symptoms. Furthermore, there is a need for harmonized guidelines and individualized support to the woman and her partner both at the antenatal care and the maternity ward and inpatient care at the hospital.

Patient interviews in interprofessional and intercultural contexts (PinKo) - project report on interdisciplinary competence development in students of medicine, pharmacy, and community interpreting.

Background: Hospitals and other medical institutions must prepare for a further increase in patients who are either immigrants or Germans with a migration background. In spite of the unquestionable educational and socio-political relevance of this topic, most German universities do not offer a comprehensive curriculum aimed at increasing intercultural awareness and putting it into practice in the training of students in medicine and pharmacy. Against this background, this article presents the innovative teaching project "Die Triade", which was jointly implemented by the Departments of Medicine, Pharmacy and Translation Studies at the University of Mainz. Aim: The aim is to give an overview of the development, realisation, implementation and consolidation of the course "Patient interviews in interprofessional and intercultural contexts" (PinKo), which was designed in the project "Die Triade". Project description: A two-day course was developed, starting with a block session for all participating students to teach the basics of interprofessional and intercultural competence development. On the second practical training day, students learn and practice triadic conversation in different language groups using scripted roles. While the trainee doctors and pharmacists represent their respective professions in the prepared conversational situations, the interpreting students take on the roles of interpreters and patients. The event is jointly supervised by lecturers from the participating professions and language groups. Results: In the 2016 summer semester and the following winter semester, the course was organised for a total of 112 students. The event as a whole was evaluated by means of a questionnaire by the students of the participating departments (Medicine (M) N=8, Pharmacy (P) N=60; Translation (T) N=44). Overall, the event was rated as good (1=very good, 6=insufficient) ((M) 1.67/2.00; (P) 2.29/3.33; (T) 1.50/1.86). The course tended to be rated lower by pharmacy students; this also applies to the rating of the development of interprofessional competences ((M) 1.33/2.00, (P) 2.00/2.93, (T) 1.82/2.25). Discussion: The course is suitable for the acquisition of interprofessional as well as intercultural competences. However, in order to improve the course in a participant-centred way, train larger numbers of participants and include additional healthcare occupations such as nursing or assistant medical professions, adaptations of the concept would be necessary. In this context, the digitalisation of the learning content appears to be particularly useful for ensuring that the course can be adapted to heterogeneous groups of participants and to optimise in-person times for further opportunities for practice.

The development of a faecal incontinence core outcome set: an international Delphi study protocol.

PURPOSE: Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. METHODS: Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. DISCUSSION: This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. TRIAL REGISTRATION: This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554 . The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336 .

Methodology in core outcome set (COS) development: the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study.

BACKGROUND: As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques. METHODS: Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes. RESULTS: Four of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale. CONCLUSIONS: Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted.

Patient-reported burden of hereditary transthyretin amyloidosis on functioning and well-being.

BACKGROUND: Hereditary transthyretin (hATTR) amyloidosis is a rare, systemic, progressive, and life-threatening disease in which transthyretin proteins misfold and aggregate as insoluble amyloid deposits, disrupting nervous, cardiac, gastrointestinal, and other organ tissues. There are limited available data about the experience of patients living with hATTR amyloidosis. This study used a qualitative, non-interventional design to explore the humanistic burden of hATTR amyloidosis from the patient's perspective. RESULTS: Fourteen adults with hATTR amyloidosis, recruited from a patient advocacy group or an academic clinical center, participated in individual semi-structured interviews either in person or by telephone. Patients were asked to describe their experiences living with the condition, including symptoms and disease-related impacts on functioning and well-being, work, and activities of daily living (ADLs). Interviews were transcribed verbatim and analyzed for key concepts using a grounded theory approach. Patients described many symptoms of hATTR amyloidosis, particularly those associated with peripheral neuropathy such as pain, numbness, weakness, and paresthesia. Symptoms of autonomic neuropathy, such as gastrointestinal dysfunction, and symptoms related to cardiac dysfunction were also common. Worsening symptoms, especially those impacting patients' ability to walk or use their hands, often led to a loss of autonomy and an inability to work or perform ADLs. Disease-related disability also interfered with patients' participation in social activities, and contributed to feelings of fear, frustration, or sadness. CONCLUSIONS: The impacts of hATTR amyloidosis were profound for the patients interviewed for this study. They described a sense of loss as their condition progressed and impacted them physically, emotionally, and socially. Patients' reports of symptoms and impacts of hATTR amyloidosis illustrate the complex and varied manifestations of this disease. The progression of symptoms and increasing impacts of hATTR amyloidosis also highlight the need for an earlier diagnosis and effective clinical intervention to preserve patients' functioning and well-being.

Doing time in an Australian ICU; the experience and environment from the perspective of patients and family members.

BACKGROUND: The intensive care environment and experiences during admission can negatively impact patient and family outcomes and can complicate recovery both in hospital and after discharge. While their perspectives based on intimate experiences of the environment could help inform design improvements, patients and their families are typically not involved in design processes. Rather than designing the environment around the needs of the patients, emphasis has traditionally been placed on clinical and economic efficiencies. OBJECTIVE: The main objective was to inform design of an optimised intensive care bedspace by developing an understanding of how patients and their families experience the intensive care environment and its impact on recovery. METHODS: A qualitative descriptive study was conducted with data collected in interviews with 17 intensive care patients and seven family members at a large cardiothoracic specialist hospital, analysed using a framework approach. RESULTS: Participants described the intensive care as a noisy, bright, confronting and scary environment that prevented sleep and was suboptimal for recovery. Bedspaces were described as small and cluttered, with limited access to natural light or cognitive stimulation. The limited ability to personalise the environment and maintain connections with family and the outside world was considered especially problematic. CONCLUSIONS: Intensive care patients described features of the current environment they considered problematic and potentially hindering their recovery. The perspective of patients and their families can be utilised by researchers and developers to improve the design and function of the intensive care environment. This can potentially improve patient outcomes and help deliver more personalised and effective care to this vulnerable patient population and their families.

Sources of Information for Learning and Decision-Making in Men With Localized Prostate Cancer.

Information seeking is essential for effective patient-centered decision-making. However, prostate cancer patients report a gap between information needed and information received. The importance of different information sources for treatment decision remains unclear. Thus, using the Comprehensive Model of Health Information (CMIS) framework, we assessed the antecedent factors, information carrier factors, and information-seeking activities in localized prostate cancer patients. Data were collected via semistructured one-on-one, interviews and structured survey. Men with localized prostate cancer were recruited from two urban health-care centers. Following the interview, participants completed a survey about sources that were helpful in learning about prostate cancer treatment and decision-making. The interviews were audio-recorded, transcribed, and subjected to a thematic analysis using NVivo 10. Fifty localized prostate cancer survivors completed the interviews and surveys. Important antecedent factors that were observed were age, marital status, uncertainty, anxiety, caregiver burden, and out-of-pocket expenses. We identified complexity, magnitude, and reliability as information carrier characteristics. Preferred sources for information were health providers, medical websites, and pamphlets from the doctor's office. These sources were also perceived as most helpful for decision-making. Urologists, urological oncologists, and radiation/radiation oncologists were important sources of information and helpful in decision-making. Prostate cancer patients obtained information from multiple sources. Most prostate cancer patients make patient-centered choices by incorporating personal factors and medical information. By considering factors that influence patients' treatment decisions, health-care providers can enhance the patient-centeredness of care. Multiple strategies and interventions are necessary for disseminating valid, reliable, and unbiased information to prostate cancer patients to facilitate informed decisions.

Elicitation of disease concepts in patients with diabetic foot ulcers: a qualitative study.

OBJECTIVE: To identify in-depth information directly from patients with diabetic foot ulcers (DFU) on DFU symptoms, impacts on functioning and effects on health-related quality of life (HRQoL). METHOD: Semi-structured, qualitative concept elicitation interviews were conducted with patients with DFUs (Wagner grade 1 or 2) until saturation was reached. Qualitative analysis (using MAXQDA, VERBI GmbH, Germany) of interview transcripts was conducted to identify concepts relevant to patients with DFUs, based on the frequency of mentions, and elucidate themes regarding impacts on HRQoL. RESULTS: Of the 18 participants, most were male (n=14; 78%) and 10 (56%) presented with a Wagner grade of 1. Frequently reported symptoms were pain/discomfort (n=15; 83%), weeping/discharge (n=10; 56%), bleeding (n=10; 56%) and swelling (n=8; 44%). Overall, patients reported more impacts than symptoms-wound care/treatment burden (n=14; 78%), limitations on exercise/physical activity (n=13; 72%), mobility limitations (n=12; 67%), and offloading (n=12; 67%) were the most frequently mentioned. Based on findings from the patient interviews, a draft conceptual model was developed outlining interrelationships between DFU symptoms, impacts, and HRQoL from the patient perspective. CONCLUSION: Qualitative interviews captured the breadth of disease-related concepts of direct importance to patients. The draft conceptual model developed from the analysis can help identify measures or instruments for use in assessing patient-reported symptoms or HRQoL in clinical practice and may have wider research applicability, including evaluation of treatment benefits in patients with DFUs.

The unmet needs of patients with sarcoma.

OBJECTIVE: Sarcoma is a rare cancer that imposes a significant burden on the lives of patients. Many survivors have long-term disability as a result of treatment and the disease. Patients often experience functional issues, poorer mental health, reduced quality of life, and interpersonal issues. There is a need to explore the unmet needs of sarcoma patients as it is unclear how these issues are being addressed. The aim of this study was to explore the unmet needs of patients who have been diagnosed with sarcoma. METHODS: The participants were individuals previously diagnosed with a sarcoma (n = 22). Participants completed a semi-structured interview about their unmet needs relating to sarcoma. The transcripts were analyzed using thematic analysis. RESULTS: Five overarching themes were identified: daily living, financial needs, lack of information, need for a community, and navigating the healthcare system. Participants reported a range of practical needs, including transport, limited understanding of their treatments, and financial issues. Participants also described a need to connect with people who had gone through similar experiences. CONCLUSIONS: Sarcoma patients have fundamental needs that affect their capacity to live their life in the best possible way. Health services need to better facilitate sarcoma patients at each stage of their experience by providing individualized referrals, support, and coordination. Support interventions are needed to help patients adjust to sarcoma and to improve their quality of life as an outpatient. Connecting patients with sarcoma support groups may provide them with more relevant and intimate support.

The development of a cryptoglandular Anal Fistula Core Outcome Set (AFCOS): an international Delphi study protocol.

PURPOSE: Cryptoglandular anal fistula is a disorder with an incidence of around 1 per 5,000 people per year in European countries. Many studies have been conducted to evaluate the effectiveness of interventions for anal fistula. However, there is considerable heterogeneity in the outcomes assessed and reported in these studies. This limits research quality and complicates evidence synthesis. A solution for heterogeneity in outcome reporting is the development of a Core Outcome Set (COS). This paper describes the protocol for the development of a European COS for Anal Fistula (AFCOS). METHODS: The first step will be a systematic review of the literature to identify potential outcomes that may be included in the COS. Patient interviews will be conducted in The United Kingdom and The Netherlands to ensure that both clinician-important and patient-important outcomes are captured. The outcomes will be categorized using the COMET taxonomy and taken forward to a Delphi consensus exercise. In up to three web-based Delphi surveys the outcomes will be prioritized by patients, clinicians (surgeons, gastroenterologists, and radiologists), and (clinical) researchers. The responses will be summarized and reported anonymously in subsequent round(s) facilitating convergence to a consensus opinion. The final COS will be decided during a face-to-face consensus meeting with patients, clinicians, and (clinical) researchers. DISCUSSION: This study protocol describes the development of a European COS for anal fistula to improve research quality, evidence synthesis, and patient care.

The Voices of Young Women with Breast Cancer: Providing Support and Information for Improved Fertility Preservation Discussions.

Purpose: Fertility is a concern for young women with breast cancer. We explore patient experiences with fertility discussions at diagnosis to identify barriers and preferences to patient-centered delivery of care. Methods: A qualitative study was conducted on consecutive, female breast cancer survivors, 39 years of age or younger at diagnosis and within 2 years of diagnosis, who attended routine outpatient follow-up at a large academic teaching center. Interviews lasted 30 minutes and were transcribed verbatim. Thematic analysis was conducted to explore experiences around fertility discussions. Strength of the theme was determined by examining the frequency of a response. Data collection and analysis continued until theoretical saturation was reached. Results: Analysis comprised 50 women with a median age of 34.5 years (range 25-39 years). Thirty-nine women (78%) had completed university education. Thirty-three women (66%) recalled having fertility preservation discussions at diagnosis. The most common themes identified include the following: (i) the requirement for more patient support, (ii) improving information, (iii) integration of patient values, (iv) creating options for patients, (v) financial limitations, and (vi) the need to look beyond the immediate impact. Conclusions: In this contemporary cohort of young adult breast cancer survivors, fertility discussion experiences at diagnosis remain suboptimal. Improved information and a focus on individual patient desires can improve experiences.