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Introduction Patient‐reported outcomes (PROs) are direct reports from patients about the status of their health condition without amendment or interpretation by others. Patient‐reported outcome measures (PROMs) are the tools used to measure PROs; they are usually validated questionnaires patients complete by self‐assessing their health status. Whilst the benefits of using PROs and PROMs to guide real‐time patient care are well established, they have not been adopted by many oncology institutions worldwide. This literature review aimed to examine the barriers associated with using PROs and PROMs in routine oncology care. Methods A literature search was conducted across EMBASE, Medline and CINAHL databases. Studies detailing barriers to routine PRO use for real‐time patient care were included; those focusing on PRO collection in the research setting were excluded. Results Of 1165 records captured, 14 studies informed this review. At the patient level, patient time, incapacity and difficulty using electronic devices to complete PROMs were prominent barriers. At the health professional level, major barriers included health professionals’ lack of time and knowledge to meaningfully interpret and integrate PRO data into their clinical practice and the inability for PRO data to be acted upon. Prominent barriers at the service level included difficulties integrating PROs and PROMs into clinical workflows and inadequate information technology (IT) infrastructures for easy PRO collection. Conclusion This review has outlined potential barriers to routine PRO use in the oncology setting. Such barriers should be considered when implementing PROs into routine clinical practice. Patient‐reported outcomes (PROs) are direct reports from patients about the status of their health condition without amendment or interpretation by others. This review article outlines potential barriers to routine PRO use in the oncology setting. Such barriers should be considered when implementing PROs into routine clinical practice.

Background Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition. Methods Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs. Results Eighty-four trials met the inclusion criteria, only 14 (17%) ( n  = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified. Conclusions Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

Tools have been developed to facilitate communication and support information exchange between people diagnosed with cancer and their physicians. Patient‐reported outcome measures, question prompt lists, patient‐held records, tape recordings of consultations, decision aids, and survivorship care plans have all been promoted as potential tools, and there is extensive literature exploring their impact on patient outcomes. Eleven systematic reviews of studies evaluating tools to facilitate patient‐physician communication were reviewed and summarized in this overview of systematic reviews. Across the systematic reviews, 87 publications reported on 84 primary studies involving 15,381 participants. Routine use of patient‐reported outcome measures and feedback of results to clinicians can improve pain management, physician‐patient communication, and symptom detection and control; increase utilization of supportive care; and increase patient involvement in care. Question prompt lists can increase the number of questions asked by patients without increasing consultation length and may encourage them to reflect and plan questions before the consultation. There is limited benefit in audio recording consultations or using patient‐held records during consultations. Physicians should be supported by adequately resourced health services to respond effectively to the range of clinical and broader patient needs identified through the routine use of tools to facilitate communication.

Background Patient‐reported outcome measures (PROMs) measure patients’ perspectives on health outcomes and are increasingly used in health care. To capture the patient's perspective, it is essential that patients are involved in PROM development Objective This article reviews in what ways and to what extent patients are involved in PROM development and whether patient involvement has increased over time. Search strategy Literature was searched in PubMed, EMBASE, MEDLINE and the Cochrane Methodology Register. Inclusion criteria Studies were included if they described a new PROM development. Data extraction Basic information and information regarding patient involvement in development phases was recorded. Main results A total of 189 studies, describing the development of 193 PROMs, were included. Most PROMs were meant for chronic disease patients (n = 59) and measured quality of life (n = 28). In 25.9% of the PROM development studies, no patients were involved. Patients were mostly involved during item development (58.5%), closely followed by testing for comprehensibility (50.8%), while patient involvement in determining which outcome to measure was minimal (10.9%). Some patient involvement took place in the development of most PROMs, but in only 6.7% patients were involved in all aspects of the development. Patient involvement did not increase with time. Conclusions Although patient involvement in PROM development is essential to develop valid patient‐centred PROMs, patients are not always involved. When patients are involved, their level of involvement varies considerably. These variations suggest that further attention to building and/or disseminating consensus on requirements for patient involvement in PROM development is necessary.

Clinical trials have demonstrated that patient-reported outcome measures (PROMs) can improve mortality and morbidity outcomes when used in clinical practice. This study aimed to prospectively investigate the implementation of PROMs in routine oncology. Outcomes measured included improved symptom detection, clinical response to symptom information, and health service outcomes. Two of 12 eligible clinics were randomized to implement symptom PROMs in a medical oncology outpatient department in Australia. Randomization was carried out at the clinic level. Patients in control clinics continued with usual care; those in intervention clinics completed a symptom PROM at presentation. This was a pilot study investigating symptom detection, using binary logistic models, and clinical response to PROMs investigated using multiple regression models. A total of 461 patient encounters were included, consisting of 242 encounters in the control and 222 in the intervention condition. Patients in these clinics most commonly had head and neck, lung, prostate, breast, or colorectal cancer and were seen in the clinic for surveillance and oral or systemic treatments for curative, metastatic, or palliative cancer care pathways. Compared with control encounters, the proportion of symptoms detected increased in intervention encounters (odds ratio 1.05, 95% CI 0.99-1.11; P=.08). The odds of receiving supportive care, demonstrated by nonroutine allied health review, increased in the intervention compared with control encounters (odds ratio 3.54, 95% CI 1.26-9.90; P=.02). Implementation of PROMs in routine care did not significantly improve symptom detection but increased the likelihood of nonroutine allied health reviews for supportive care. Larger studies are needed to investigate health service outcomes. Australian New Zealand Clinical Trials Registry ACTRN12618000398202; https://tinyurl.com/3cxbemy4.

ABSTRACT Background In the Phase 3 MycarinG study (NCT03971422), rozanolixizumab improved myasthenia gravis (MG)‐specific outcomes versus placebo in patients with generalised MG, including those measured by the five independent MG Symptoms patient‐reported outcome (PRO) scales: Muscle Weakness Fatigability (MWF), Physical Fatigue (PF) and Bulbar Muscle Weakness (BMW) as secondary endpoints and Ocular Muscle Weakness and Respiratory Muscle Weakness (exploratory endpoints). This research aimed to provide further insights into these improvements. Methods Post hoc analyses evaluated correlation (Pearson coefficient) between MG Symptoms PRO and subdomain scores of MG Activities of Daily Living (MG‐ADL) and Quantitative MG (QMG) at baseline. Proportions of responders reaching clinically meaningful thresholds and analyses at the item level (observed mean change and Rasch modelling of predicted change from baseline) are reported for MWF, PF, and BMW with rozanolixizumab versus placebo at Day 43. Results Correlation coefficients between MG Symptoms PRO and MG‐ADL were strong (≥ 0.7) for ocular and bulbar scores and moderate (0.5 to < 0.7) for other scores. Correlations with clinician‐assessed QMG scores were generally weak (< 0.5). For MWF, PF, and BMW, greater proportions of responders were observed with rozanolixizumab 7 mg/kg (46.9%, 31.3% and 26.6%, respectively) or 10 mg/kg (56.5%, 48.4% and 32.3%) versus placebo (28.1%, 26.6% and 10.9%). Item‐level analyses demonstrated rozanolixizumab benefit at a symptom‐specific level. Discussion MG Symptoms PRO scales correlate well with concepts in MG‐ADL while assessing additional concepts, such as PF and MWF. Results from the MG Symptoms PRO in MycarinG reflected improvements from baseline in patient‐relevant symptoms, including fatigue, with rozanolixizumab.

ABSTRACT Introduction Patient Acceptable Symptom State (PASS) is emerging as a valuable subjective measure of the overall myasthenia gravis (MG)‐related burden. This study aimed at identifying PASS‐positive thresholds for the most used clinical scales, investigating whether PASS and MGFA post‐intervention status capture different aspects of the disease outcome, and identifying clinical variables associated with PASS=YES response. Methods Adult AChR‐MG patients were prospectively enrolled at two Italian Centres (Rome: index cohort; Florence: validation cohort). PASS thresholds for MG‐ADL, QMG, and MG‐QOL15r were defined in the index cohort by ROC analysis and validated in the validation cohort; predictors of favorable PASS were identified by multivariable analysis. Results This study included 173 patients (44% females, median age at onset: 53 years). PASS=YES patients had significantly lower median MG‐ADL, QMG, and MG‐QOL15r scores, with the following thresholds for PASS=YES: MG ADL ≤ 2, QMG ≤ 8 and MG‐QOL15r ≤ 6. The MG‐ADL (OR = 0.46, 95% CI = 0.36–0.60, p < 0.001), QMG (OR = 0.72, 95% CI = 0.64–0.81, p < 0.001) and MG‐QOL15r (OR = 0.76, 95% CI = 0.70–0.84, p < 0.001), were independently associated with a favorable PASS. The degree of ocular involvement in each scale was the strongest negative determinant of PASS=YES. Conclusions This study validates the PASS question and highlights the relevance of ocular complaints in patients' perception of MG burden. The aim of this study was to further validate the patient‐acceptable symptom state (PASS) question in myasthenia gravis (MG), establish threshold scores on commonly used clinical scales that indicate whether a patient considers their current MG control to be acceptable (PASS = YES) and analyse its main clinical predictors. The study included 173 adult AChR‐MG patients and identified the following PASS‐positive cut‐offs: MG‐ADL ≤2, QMG ≤8 and MG‐QOL15r ≤6. These findings were validated across two independent cohorts. Lower scores on these scales were significantly associated with a favourable PASS. Furthermore, ocular symptoms emerged as the most significant negative factor influencing patients’ perception of well‐being, highlighting their substantial impact on the overall disease burden.

Purpose The purpose of this study was to investigate the impact of the type of data capture on the time and help needed for collecting patient-reported outcomes as well as on the proportion of missing scores. Methods In a multinational prospective study, thyroid cancer patients from 17 countries completed a validated questionnaire measuring quality of life. Electronic data capture was compared to the paper-based approach using multivariate logistic regression. Results A total of 437 patients were included, of whom 13% used electronic data capture. The relation between data capture and time needed was modified by the emotional functioning of the patients. Those with clinical impairments in that respect needed more time to complete the questionnaire when they used electronic data capture compared to paper and pencil (OR adj 24.0; p  = 0.006). This was not the case when patients had sub-threshold emotional problems (OR adj 1.9; p  = 0.48). The odds of having the researcher reading the questions out (instead of the patient doing this themselves) (OR adj 0.1; p  = 0.01) and of needing any help (OR adj 0.1; p  = 0.01) were lower when electronic data capture was used. The proportion of missing scores was equivalent in both groups (OR adj 0.4, p  = 0.42). Conclusions The advantages of electronic data capture, such as real-time assessment and fewer data entry errors, may come at the price of more time required for data collection when the patients have mental health problems. As this is not uncommon in thyroid cancer, researchers need to choose the type of data capture wisely for their particular research question.

Purpose This study aims to present the existing literature relating to patient-reported outcome measures (PROMs) and complications in patients undergoing total knee arthroplasty (TKA) due to posttraumatic osteoarthritis (PTOA) with prior fracture treatment around the knee compared with patients who underwent TKA because of primary osteoarthritis (OA). Methods A systematic review was undertaken and synthesised in accordance with the PRISMA guidelines by searching existing literature in the following databases: PubMed, Scopus, Cochrane Library and EMBASE. A search string according to the PECO was used. After analysing 2781 studies, 18 studies (5729 PTOA patients/149,843 OA patients) were included for a final review. An analysis revealed that 12 (67%) were retrospective cohort studies, four (22%) were register studies and the remaining two (11%) were prospective cohort studies. The mean Critical Appraisal Skills Programme (CASP) score was 23.6 out of 28, signifying studies of moderate quality. Results The most frequently reported outcome measure were postoperative complications, reported in all eighteen studies. Intraoperative complications were reported in ten (4165 PTOA/124.511 OA) and patient-reported outcome measures (PROMs) in six studies (210 PTOA/2768 OA). A total of nine different PROMs were evaluated. As far as PROMs were concerned, the scores were inferior for PTOA but did not differ statistically from OA, except for one study, which favoured the OA group. Across all studies, postoperative complications were higher in the PTOA group, reporting infections as the most common complication. Furthermore, a higher revision rate was reported in the PTOA group. Conclusion PROM analysis suggests that both patient groups benefit from a TKA in terms of functional outcome and pain relief, however, patient-reported outcomes could be inferior for PTOA patients. There is consistent evidence for increased complication rates following PTOA TKA. Patients undergoing TKA due to PTOA after fracture treatment should be informed about the risk for inferior results and refrain from comparing their knee function to patients with TKA after OA. Surgeons should be aware of the challenges that PTOA TKA poses. Level of evidence Level III.

We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal （TP） prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 （21.4%） of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy （with 95% scoring 〈5 in a 0-10 scale）. Twelve out of 196 men （6.1%） felt pain immediately after the procedure. Despite a high incidence of symptoms （e.g., up to 75% had some hematuria, 47% suffered some pain）, it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization （5.5%）. There were no inpatient admissions due to complications （hematuria, sepsis）. On repeat questioning at a later time point, only 25/199 （12.6%） of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use.