One-stage prosthodontically driven jaw reconstruction in patients with benign and malignant pathologies: A 7- to 11-year cohort study.

OBJECTIVES: One stage functional jaw reconstruction is defined as the resection and reconstruction of segmental defects in conjunction with the placement of dental implants in an ideal prosthetic position and loaded with a provisional restoration, during one surgical procedure. The aim of the study is to describe clinical outcomes of patients who underwent one stage functional jaw reconstruction. METHODS: Patients who underwent one-stage functional jaw reconstruction, from January 2013 to March 2016 were recalled in 2022 and 2023. Planning and execution for the reconstruction utilized either analogue or digital techniques. Outcome parameters recorded were treatment-related outcomes at patient level, implant-related outcomes and patient-reported outcome measures. RESULTS: Eighteen patients underwent one-stage jaw reconstruction with a total of 57 implants. Four patients had maxillary and 14 had mandibular reconstructions. Ten patients underwent postoperative radiotherapy. Ten patients were planned using analogue and eight by digital planning. Three patients had partial flap necrosis, three patients had plate fractures, implant loss was seen in one patient and four patients died during the period. A functional prosthesis was provided in 16 out of the 18 patients. CONCLUSION: One-stage functional jaw reconstruction is a predictable method for providing rehabilitation with successful outcomes at 7-11 years. However, caution should be exercised when the treatment modality is carried out in patients with malignant pathologies who have undergone radiotherapy.

Postsurgical Pain Risk Stratification to Enhance Pain Management Workflow in Adult Patients: Design, Implementation, and Pilot Evaluation.

BACKGROUND: Exposure to opioids after surgery is the initial contact for some people who develop chronic opioid use disorder. Hence, effective postoperative pain management, with less reliance on opioids, is critical. The Perioperative Opioid Quality Improvement (POQI) program developed (1) a digital health platform leveraging patient-survey-reported risk factors and (2) a postsurgical pain risk stratification algorithm to personalize perioperative care by integrating several commercially available digital health solutions into a combined platform. Development was reduced in scope by the COVID-19 pandemic. OBJECTIVE: This pilot study aims to assess the screening performance of the risk algorithm, quantify the use of the POQI platform, and evaluate clinicians' and patients' perceptions of its utility and benefit. METHODS: A POQI platform prototype was implemented in a quality improvement initiative at a Canadian tertiary care center and evaluated from January to September 2022. After surgical booking, a preliminary risk stratification algorithm was applied to health history questionnaire responses. The estimated risk guided the patient assignment to a care pathway based on low or high risk for persistent pain and opioid use. Demographic, procedural, and medication administration data were extracted retrospectively from the electronic medical record. Postoperative inpatient opioid use of >90 morphine milligram equivalents per day was the outcome used to assess algorithm performance. Data were summarized and compared between the low- and high-risk groups. POQI use was assessed by completed surveys on postoperative days 7, 14, 30, 60, 90, and 120. Semistructured patient and clinician interviews provided qualitative feedback on the platform. RESULTS: Overall, 276 eligible patients were admitted for colorectal procedures. The risk algorithm stratified 203 (73.6%) as the low-risk group and 73 (26.4%) as the high-risk group. Among the 214 (77.5%) patients with available data, high-risk patients were younger than low-risk patients (age: median 53, IQR 40-65 years, vs median 59, IQR 49-69 years, median difference five years, 95% CI 1-9; P=.02) and were more often female patients (45/73, 62% vs 80/203, 39.4%; odds ratio 2.5, 95% CI 1.4-4.5; P=.002). The risk stratification was reasonably specific (true negative rate=144/200, 72%) but not sensitive (true positive rate=10/31, 32%). Only 39.7% (85/214) patients completed any postoperative quality of recovery questionnaires (only 14, 6.5% patients beyond 60 days after surgery), and 22.9% (49/214) completed a postdischarge medication survey. Interviewed participants welcomed the initiative but noted usability issues and poor platform education. CONCLUSIONS: An initial POQI platform prototype was deployed operationally; the risk algorithm had reasonable specificity but poor sensitivity. There was a significant loss to follow-up in postdischarge survey completion. Clinicians and patients appreciated the potential impact of preemptively addressing opioid exposure but expressed shortcomings in the platform's design and implementation. Iterative platform redesign with additional features and reevaluation are required before broader implementation.

Measurement properties of utility-based health-related quality of life measures in cardiac rehabilitation and secondary prevention programs: a systematic review.

PURPOSE: To identify utility-based patient-reported outcome measures (PROMs) for assessing health-related quality of life (HRQoL) in cardiac rehabilitation and secondary prevention programs (CR) and appraise existing evidence on their measurement properties. Secondly, to link their items to the International Classification of Functioning Disability and Health (ICF) and the International Consortium of Health Outcome Measures (ICHOM) domains for cardiovascular disease (CVD). METHODS: Eight databases were searched. The review followed the COSMIN and JBI guidelines for measurement properties systematic reviews and PRISMA 2020 reporting guidelines. Non-experimental and observational empirical studies of patients ≥ 18 years of age with CVD undergoing CR and assessed quality of life (QoL) or HRQoL using utility-based PROMs or one accompanied by health state utilities were included. RESULTS: Nine PROMs were identified with evidence on measurement properties for three measures: the German translations of SF-12, EQ-5D-5L, and MacNew heart disease HRQoL questionnaire. There was moderate quality evidence for responsiveness and hypothesis testing of the SF-12 and EQ-5D-5L, and high-quality evidence for responsiveness and hypothesis testing for the MacNew. All items of SF-12 and EQ-5D were linked to ICF categories, but four items of the MacNew were not classified or defined. All the PROM domains were mapped onto similar constructs from the ICHOM global sets. CONCLUSION: Three utility-based PROMs validated in CR were identified: the German versions of the EQ-5D and SF-12 and the MacNew questionnaire. These PROMs are linked to a breadth of ICF categories and all ICHOM global sets. Additional validation studies of PROMs in CR are required.

Socioeconomic Differences in Patient Reported Outcome Measures 3 Months After Stroke: A Nationwide Swedish Register-Based Study.

BACKGROUND: There is a well-known association between low socioeconomic status (SES), poor survival, and clinician-reported outcomes after stroke. We aimed to assess socioeconomic differences in Patient Reported Outcome Measures 3 months after stroke. METHODS: This nationwide cohort study included patients registered with acute stroke in the Swedish Stroke Register 2015-2017. Patient Reported Outcome Measures included activities of daily living (mobility, toileting, and dressing), and poststroke symptoms (low mood, fatigue, pain, and poor general health). Information on SES prestroke was retrieved from Statistics Sweden and defined by a composite measure based on education and income tertiles. Associations between SES and Patient Reported Outcome Measures were analyzed using logistic regression adjusting for confounders (sex and age) and additionally for potential mediators (stroke type, severity, cardiovascular disease risk factors, and living alone). Subgroup analyses were performed for stroke type, men and women, and younger and older patients. RESULTS: The study included 44 511 patients. Of these, 31.1% required assistance with mobility, 18% with toileting, and 22.2% with dressing 3 months after stroke. For poststroke symptoms, 12.3% reported low mood, 39.1% fatigue, and 22.7% pain often/constantly, while 21.4% rated their general health as poor/very poor. Adjusted for confounders, the odds of needing assistance with activities of daily living were highest for patients with low income and primary school education, for example, for mobility, odds ratio was 2.06 (95% CI, 1.89-2.24) compared with patients with high income and university education. For poststroke symptoms, odds of poor outcome were highest for patients with low income and university education (eg, odds ratio, 1.79 [95% CI, 1.49-2.15] for low mood). Adjustments for potential mediators attenuated but did not remove associations. The associations were similar in ischemic and hemorrhagic strokes and more pronounced in men and patients <65 years old. CONCLUSIONS: There are substantial SES-related differences in Patient Reported Outcome Measures poststroke. The more severe outcome associated with low SES is more pronounced in men and in patients of working age.

4 Domain Sports PROM in Spanish: Cross-cultural adaptation in the Chilean population and reliability analysis.

Background Patient-Reported Outcome Measures (PROMs) are tools of increasing interest in the sports population. The purpose of this study was to perform the cross-cultural adaptation and reliability analysis of the 4 Domain Sports Patient-Reported Outcome Measure (4 DSP) into Spanish. Methods A six-stage cross-cultural adaptation protocol was executed to obtain the Spanish version of the 4 DSP (S-4DSP). Subsequently, the questionnaire was administered to a population of 108 postoperative athletes with ACL (Anterior Cruciate Ligament) injuries. The questionnaire was administered again after 30 days. Acceptability, floor and ceiling effects, internal consistency (Cronbach's alpha), and reproducibility (Intraclass Correlation) were evaluated. Results The S-4DSP was fully completed by 108 participants (mean age 34 ± 10.75, 26% women), achieving 100% acceptability. No floor effect was detected. The statistical analysis yielded a global Cronbach's alpha for the questionnaire of 0.65, and domain-specific alphas of 0.88, 0.72, 0.27, and 0.68 for the first, second, third, and fourth domains, respectively. The Intraclass Correlation test reached a maximum of 0.94 and a minimum of 0.48 for the first and fifth questions, respectively. Conclusions The S-4DSP is a reliable and useful tool for evaluating Spanish-speaking athletes after ACL reconstruction.

Linking Patient-Reported Outcome Measure (PROM) Scores to Adverse Event Data to Gain Insight in Overestimation of Postoperative PROM Improvement after Total Hip Arthroplasty and Total Knee Arthroplasty Due to Selective Non-Response.

BACKGROUND: To gain insight into how clinically relevant improvement in Patient-Reported Outcome Measure (PROM) scores after Total Hip (THA) and Total Knee Arthroplasty (TKA) may be under- or overestimated, we compared PROM respondents and non-respondents on their adverse event rates and assessed whether adverse event occurrence was associated with clinically relevant PROM improvement from those without adverse events. METHODS: All primary THAs and TKAs performed in 19 Dutch hospitals between January 2017 and December 2019 were included. The Hip disability and Osteoarthritis Outcome Score-Physical function Short form (HOOS-PS) and Knee injury and Osteoarthritis Outcome Score-Physical function Short form (KOOS-PS) were used to assess the physical function after THA and TKA, respectively. Adverse events included 1-year revision, 30-day readmission, 30-day complications, and long (i.e., > 75th percentile) length-of-stay (LOS). A clinically relevant improvement was defined as at least a 10-point decrease in HOOS-PS and 9 points in KOOS-PS scores. Associations between adverse events and clinically relevant HOOS-PS and KOOS-PS improvement were assessed using binary logistic regression models adjusted for patient characteristics and clustering of patients within hospitals. RESULTS: There were 20,338 THA and 18,082 TKA procedures included. Adverse events mostly occurred more frequently in HOOS-PS and KOOS-PS non-respondents than in respondents. The THA patients experiencing revision, complications, or long LOS were less likely to experience clinically relevant HOOS-PS improvements (odds ratios of 0.11 [0.06 to 0.20], 0.44 [0.30 to 0.63], and 0.66 [0.50 to 0.88], respectively). The TKA patients experiencing revision or long LOS were less likely to experience clinically relevant KOOS-PS improvements (odds ratios of 0.26 [0.12 to 0.55] and 0.63 [0.50 to 0.80], respectively). CONCLUSION: Clinically-relevant HOOS-PS and KOOS-PS improvements are likely overestimated, as non-respondents had higher adverse event rates which were associated with lower likelihood to achieve clinically-relevant HOOS-PS and KOOS-PS improvements.

Menstrual Practice Needs Scale short form (MPNS-SF) and rapid (MPNS-R): development in Khulna, Bangladesh, and validation in cross-sectional surveys from Bangladesh and Uganda.

OBJECTIVES: Develop and validate short and rapid forms of the 36-item Menstrual Practice Needs Scale (MPNS-36). DESIGN: Item reduction prioritised content validity and was informed by cognitive interviews with schoolgirls in Bangladesh, performance of scale items in past research and stakeholder feedback. The original MPNS-36 was revalidated, and short and rapid forms tested in a cross-sectional survey. This was followed by further tests of dimensionality, internal consistency and validity in multiple cross-sectional surveys. SETTING AND PARTICIPANTS: Short form (MPNS-SF) and rapid form (MPNS-R) measures were developed in a survey of 313 menstruating girls (mean age=13.51) in Khulna, Bangladesh. They were further tested in the baseline survey of the Adolescent Menstrual Experiences and Health Cohort, in Khulna, Bangladesh (891 menstruating girls, mean age=12.40); and the dataset from the MPNS-36 development in Soroti, Uganda (538 menstruating girls, mean age=14.49). RESULTS: The 18-item short form reflects the six original subscales, with the four core subscales demonstrating good fit in all three samples (Khulna pilot: root mean square error of approximation (RMSEA)=0.064, 90% CI 0.043 to 0.084, Comparative Fit Index (CFI)=0.94, Tucker-Lewis Index (TLI)=0.92. Cohort baseline: RMSEA=0.050, 90% CI 0.039 to 0.062, CFI=0.96, TLI=0.95. Uganda: RMSEA=0.039, 90% CI 0.028 to 0.050, CFI=0.95, TLI=0.94). The 9-item rapid form captures diverse needs. A two-factor structure was the most appropriate but fell short of adequate fit (Khulna pilot: RMSEA=0.092, 90% CI 0.000 to 0.158, CFI=0.93, TLI=0.89). Hypothesised associations between the MPNS scores and other constructs were comparable between the MPNS-36 and MPNS-SF in all populations, and replicated, with attenuation, in the MPNS-R. Internal consistency remained acceptable. CONCLUSIONS: The MPNS-SF offers a reliable and valid measure of adolescent girls' menstrual hygiene experience while reducing participant burden, to support implementation and improve measurement in menstrual health research. The MPNS-R provides a brief measure with poorer structural validity, suited to short surveys and including menstrual health within broader research topics.

Engaging primary care professionals in OECD's international PaRIS survey: a documentary analysis.

Healthcare professionals have first-hand experience with patients in clinical practice and the dynamics in the healthcare system, which can be of great value in the design, implementation, data analysis and dissemination of research study results. Primary care professionals are particularly important as they provide first contact, accessible, coordinated, comprehensive and continuous people-focused care. However, in-depth examination of the engagement of health professionals in health system research and planning activities-how professionals are engaged and how this varies across national contexts- is limited, particularly in international initiatives. There is a need to identify gaps in the planning of engagement activities to inform the design and successful implementation of future international efforts to improve the responsiveness of health systems to the changing needs of patients and professionals. The aim of this study was to explore how primary care professionals were engaged in the design and implementation plans of an international health policy study led by the Organisation for Economic Co-operation and Development (OECD). The OECD's international PaRIS survey measures and disseminates information on patient-reported outcome and experience measures (PROMs and PREMs) of people living with chronic conditions who are managed in primary care. A documentary analysis of 17 written national implementation plans (country roadmaps) was conducted between January and June 2023. Two reviewers independently performed the screening and data abstraction and resolved disagreements by discussion. We reported the intended target primary care professionals, phase of the study, channel of engagement, level of engagement, and purpose of engagement. All 17 countries aimed to engage primary care professionals in the execution plans for the international PaRIS survey. While organisations of primary care professionals, particularly of family doctors, were the most commonly targeted group, variation was found in the timing of engagement activities during the different phases of the study and in the level of engagement, ranging from co-development (half of the countries co-developed the survey together with primary care professionals) to one-off consultations with whom. International guidance facilitated the participation of primary care professionals. Continuous collaborative efforts at the international and national levels can foster a culture of engagement with primary care organisations and individual professionals and enhance meaningful engagement of primary care professionals.

Measuring health related quality of life (HRQoL) in Lysosomal Storage Disorders (LSDs): a rapid scoping review of available tools and domains.

BACKGROUND: Lysosomal storage diseases (LSDs) are a group of rare inherited metabolic disorders, consisting of over 70 diseases that are characterised by lysosomal dysfunction. Due to their varied and progressive symptoms, LSDs have a continual impact on patients' health-related quality of life (HRQoL). Several recently published studies have provided insight into the HRQoL of individuals with LSDs. However, it is challenging to meaningfully synthesise this evidence, since studies often focus upon a particular type of LSD and / or utilise different self-report questionnaires or patient-reported outcome measures (PROMs) to assess HRQoL. AIMS: The aim of this study was to review the published literature in LSDs, to identify the PROMs which have been used to assess HRQoL and generate a conceptual map of HRQoL domains measured in individuals diagnosed with LSDs. METHODS: Three electronic databases were searched in March 2022. Primary studies of any design which utilised multi-item PROMs to assess at least one aspect of HRQoL in individuals with LSDs since 2017 were identified. Data were extracted to assess both the characteristics of each study and of the PROMs utilised within each study. The extraction of HRQoL domains and synthesis were informed by an a priori framework, inductively modified to reflect data emerging from the identified literature. Selection and extraction was undertaken independently by two reviewers; discrepancies were ratified by a third reviewer. RESULTS: Sixty nine studies were identified which were published 2017-2022, with a combined total of 52 PROMs (71 variants) used to assess HRQoL in individuals with LSDs. The final extracted HRQoL framework included 7 domains (Activities; Physical sensations; Autonomy; Cognition; Feelings and emotions; Self-identity; Relationships), characterised by 37 sub-domains. CONCLUSIONS: This review highlights the breadth and variety of HRQoL domains assessed in individuals with LSDs, across three broad domains of physical, psychological and social functioning. The resultant framework and mapped PROMs will aid researchers and clinicians in the selection of PROMs to assess aspects of HRQoL in people living with LSDs, based on their conceptual coverage.

Patient-centric care in primary immune thrombocytopenia (ITP): shared decision-making and assessment of health-related quality of life.

ABSTRACTImmune thrombocytopenia (ITP), an autoimmune disease characterized by low platelet counts and increased bleeding risk, can impair health-related quality of life (HRQoL), impacting patients' daily lives and mental health. A number of patient-reported outcome (PRO) measures (both generic and specific to ITP) can be used to understand the impact of ITP on HRQoL and generate evidence to guide disease management. As well-developed PRO tools could help in HRQoL assessment, their optimization could help to solidify a patient-centric approach to ITP management. Shared decision-making is a collaborative process between a patient and their healthcare professional in making decisions about care. Treatment decisions based on this shared process between physician and patient are recommended by clinical guidelines. The goal of this narrative review is to discuss treatment decisions with regards to patient-centric ITP management, with a focus on the impact of PRO measures and the process of shared decision-making in practice.

Examining the "revisability" benefit of hip resurfacing arthroplasty.

BACKGROUND: Hip resurfacing arthroplasty (HRA) is an alternative to total hip arthroplasty (THA) that is typically reserved for young active patients because it preserves bone. However, the benefits of HRA only hold true if conversion THA after failed HRA provides acceptable outcomes. AIM: To compare patient reported outcomes for conversion THA after HRA failure to primary THA. METHODS: A retrospective review of 36 patients (37 hips) that underwent conversion THA for failed HRA between October 2006 and May 2019 by a single surgeon was performed. Patient reported outcomes [modified Harris Hip Score (mHHS), University of California Los Angeles (UCLA) activity score] were obtained via an email-based responder-anonymous survey. Outcomes were compared to normative data of a primary THA cohort with similar demographics. Subgroup analysis was performed comparing outcomes of conversion THA for adverse local tissue reaction (ALTR) vs all other causes for failure. RESULTS: The study group had a lower mHHS than the control group (81.7 ± 13.8 vs 90.2 ± 11.6, P < 0.01); however, both groups had similar UCLA activity levels (7.5 ± 2.3 vs 7.2 ± 1.6, P = 0.51). Patients that underwent conversion for non-ATLR causes had similar mHHS (85.2 ± 11.5 vs 90.2 ± 11.6, P = 0.11) and higher UCLA activity levels (8.5 ± 1.8 vs 7.2 ± 1.6, P < 0.01) compared to the control group. Patients that underwent conversion for ATLR had worse mHHS (77.1 ± 14.5 vs 90.2 ± 11.6, P < 0.01) and UCLA activity levels (6.1 ± 2.3 vs 7.2 ± 1.6, P = 0.05) when compared to the control group. CONCLUSION: Patient outcomes equivalent to primary THA can be achieved following HRA conversion to THA. However, inferior outcomes were demonstrated for ALTR-related HRA failure. Patient selection and perhaps further studies examining alternative HRA bearing surfaces should be considered.

Growth Factor Concentrate (GFC) for the Management of Osteoarthritis of the Knee: A Systematic Review.

Introduction: The knee is the most commonly affected joint in osteoarthritis (OA), affecting millions of people worldwide. Knee OA significantly impacts the activities of daily living (ADL) along with affecting overall quality of life of patients (QoL), thereby leading to substantial socio-economic burden. Conservative therapies are prioritized, resorting to surgery only when needed. However, these traditional approaches have limitations. Regenerative medicine, involving the use of orthobiologics, including autologous peripheral blood-derived orthobiologics such as growth factor concentrate (GFC), has evolved and shown potential for managing knee OA. The primary goal of this review is to summarize the results of in vitro, preclinical and clinical studies involving GFC for the management of knee OA. Methods: Multiple databases (PubMed, Scopus, Google Scholar, Web of Science and Embase) were searched applying terms for the intervention 'GFC' and treatment 'knee OA' for the studies published in the English language to March 10, 2024. Results: Only three clinical studies met our pre-defined criteria and were included in this review. Conclusion: Intra-articular administration of GFC is safe and potentially efficacious to manage OA of the knee. More, adequately powered, multi-center, prospective, RCTs are warranted to demonstrate the long-term effectiveness of GFC in patients suffering from mild-to-moderate knee OA and to justify its routine clinical use. Further studies evaluating the efficacy of GFC compared to other orthobiologics are also required to allow physicians/surgeons to choose the optimal orthobiologic for the treatment of OA of the knee.

Personal recovery self-report outcome measures in serious mental illness: A systematic review of measurement properties.

BACKGROUND: Personal recovery represents a paradigm shift in mental healthcare. Validated self-report outcome measures (PROMs) are needed to facilitate the transformation towards recovery-oriented practices and services. Objectives were to identify published measures and analyze their measurement properties using a standardized methodology. METHODS: Following the COSMIN guidelines, we conducted a systematic review of personal recovery PROMs in serious mental illness. The MEDLINE, PMC, PsycINFO, PsycARTICLES, PBSC and Scopus electronic databases were searched for articles published between May 2012 and February 2024. Full-text articles from a previous systematic review were also examined. RESULTS: 91 studies were included in the review, describing 25 PROMs. Ten of them had not been identified in previous reviews. Quality of evidence was globally poor for most PROM measurement properties. Very little evidence was found for cross-cultural validity, measurement invariance, measurement error and criterion validity. The Recovery Assessment Scale and Questionnaire about the Process of Recovery showed the strongest evidence for sufficient psychometric data on a wide range of measurement properties. CONCLUSIONS: Several personal recovery measures are now available. While research is still needed to enhance their validity on some psychometric properties, the current tools appear sufficient to cover most research and clinical needs.

Design, implementation and usability analysis of patient empowerment in ADLIFE project via patient reported outcome measures and shared decision making.

INTRODUCTION: This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes. BACKGROUND: The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up. METHODS: ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox. RESULTS: User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated. CONCLUSIONS: Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.

Patient-Reported Outcome Measures in Routine Clinical Practice: Practical Guidance for Institutional Review Boards.

The use of patient-reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey-based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice.

Surgical site infection and patient-reported outcomes in surgically treated soft tissue facial injury: A meta-analysis.

BACKGROUND: Soft tissue facial injuries (STFI) constitute a huge portion of craniofacial trauma, but the risk of surgical site infection (SSI) and patient-reported outcomes (PROs) following surgical management of STFI are unknown. METHODS: A PRISMA-compliant search was conducted from January 1990 until March 2023, and meta-analysis was performed using R. Pooled effects of the outcomes were estimated using the DerSimonian and Laird random-effects model or generalised linear mixed model, when feasible. RESULT: Among the 8897 screened studies, 38 were included. Twelve studies reported PROMs (n = 985), whereas 28 studies reported SSI rates (n = 10,996) following operative treatment for STFI. The pooled SSI rate (n = 28) was 3.30 % (95 % CI 1.89 %-5.71 %). Surgical and non-surgical closure did not differ significantly in SSI rate. PROs focused on scar outcomes, cosmetic outcomes, quality of life and psychological impact. Subgroup analysis showed lower SSI risk in operative repair for general facial trauma compared to primary repair, and in general facial trauma compared to other aetiologies. The pooled patient scar assessment scale, score at 6-12 months post-intervention (5 studies, n = 217) was 16.16 (95 % CI 15.34-16.97). Limited evidence is available on the effect and superiority of surgical treatment in cosmetic outcomes, quality of life and psychological impact. CONCLUSION: Our findings emphasise the limited and unreliable evidence available on PROs following operative treatment for STFI. Future studies employing robust methodologies are needed to investigate optimal approaches for managing STFI.

Feasibility of Weekly Integrated Palliative Care Outcome Scale (IPOS) Within a Stepped Care Model.

CONTEXT: Patients with advanced cancer may experience symptoms and concerns that are inadequately identified by the healthcare team, leading to calls for patient-reported symptom monitoring. OBJECTIVES: Assess the feasibility of administering weekly patient-reported online Integrated Palliative care Outcome Scale (IPOS) questionnaires within the context of a stepped care model in the outpatient care setting. METHODS: Analysis of intervention group data in a randomized controlled trial to assess the effectiveness of a stepped care model of palliative care for patients with advanced cancer. Patients in the intervention group were invited to complete the IPOS weekly for 16 weeks through a remotely-administered online questionnaire. At the end of the 16-week period, patients were invited to complete a feedback survey. Multivariable logistic regression was used to assess factors associated with more versus less than 70% completion of weekly questionnaires. RESULTS: Among 111 patients who survived more than 16 weeks, the mean number of questionnaires completed was 9.2/16 (58%). A total of 53 out of the 111 patients (48%) completed more than 70% of the questionnaires. Higher education level was found to be associated with higher completion of the questionnaires. A total of 79 out of 111 (71%) patients responded to the feedback survey, of which 67 (85%) felt comfortable with completing the online questionnaire and 11 (14%) felt it was troublesome to complete it on a weekly basis. CONCLUSION: In our study, there was suboptimal completion of patient-reported IPOS questionnaire. Further research is needed to improve the uptake of patient-reported outcomes in real-world clinical settings.

Patient-Reported Outcome Measures as an Intervention: A Comprehensive Overview of Systematic Reviews on the Effects of Feedback.

OBJECTIVES: Patient-reported outcome measures (PROMs) have emerged as a promising approach to involve patients in their treatment process. Beyond serving as outcome measures, PROMs can be applied to provide feedback to healthcare providers and patients, thereby offering valuable insights that can improve health outcomes and care processes. This overview offers a comprehensive synthesis of the effects of PROM feedback, contributing to the evidence-based discussion on PROMs' potential to enhance patient care. METHODS: Following Cochrane Collaboration recommendations, this overview included literature reviews across diverse treatment areas, investigating the impact of PROM feedback on patient health outcomes (including quality of life, symptoms, or survival) and care process outcomes (including communication, symptom identification, or clinical practice). The methodological quality of the evidence was assessed with a modified version of A Measurement Tool to Assess Systematic Reviews 2, and the potential overlap of primary studies was quantified. Results were narratively synthesized. RESULTS: Forty reviews grouped into 4 categories of treatment areas were included. Overall, their methodological quality was low. The overall overlap of primary studies was 2.2%, reaching up to 15.7% within specific treatment areas. The results indicate that PROM feedback may enhance the quality-of-care processes, whereas its effects on patient health outcomes remained less conclusive. CONCLUSIONS: PROM feedback positively influences the interaction between physicians and patients across the included treatment areas. Further research is needed to comprehend the trickle-down effects of PROM feedback and how to enhance its potential in yielding health benefits for patients.

'It is important to feel invited': what patients require when using the Utrecht Symptom Diary - 4 Dimensional, a qualitative exploration.

Background: In palliative care, the Utrecht Symptom Diary - 4 Dimensional (USD-4D), a Dutch-adapted and validated patient-reported outcome measure, supports multidimensional symptom management through identification and monitoring of, as well as dialogue on symptoms and needs. For the USD-4D to optimally support patients' autonomy, it is essential to know what patients need to use it. Objective: This study aims to identify what patients need when using the USD-4D in clinical palliative care. Design: A generic qualitative design with primary and secondary analyses of semistructured interviews. Methods: Patients ⩾18 years with a life-limiting illness were purposefully recruited within hospice and home care settings if they were in their last year of life as identified by the surprise question. Patients had to be aware of their life-threatening condition. Patients were selected in two tranches. In the first tranche, patients had to have completed the USD-4D at least once. The second tranche consisted of patients who were not familiar with the USD-4D in clinical practice and were interviewed in a previous study on the content validity of the USD-4D. The interviews were transcribed verbatim and were subjected to thematic analysis. Results: Twenty-five patients were included (14 men, ages 44-87). Patients' needs when using the USD-4D were summarized in three themes: (1) feeling invited, (2) being aware of the purpose and function of the USD-4D, and (3) experiencing a personal and nonjudgmental approach. Conclusion: For patients to optimally benefit from the USD-4D as a supportive measure of their autonomy in clinical palliative care, it is essential that they feel invited to use it. Healthcare providers are tasked with setting the right preconditions for patients to want and to be able to use the USD-4D. For patients, this means healthcare providers should always be attuned to their personal preferences when communicating the purpose and function of the USD-4D and when they enter into dialogue with them.

Systematic Review of the Global Use of Validated Questionnaires in the Management of Stress Urinary Incontinence in Women.

INTRODUCTION: Our goal was to systematically review the most commonly used validated questionnaires in recent global literature on stress urinary incontinence (SUI) treatment. METHODS: PubMed, Embase, and Ovid databases were queried for manuscripts containing "female stress urinary incontinence" AND "diagnosis" AND "treatment" AND "questionnaire." Two independent reviewers screened studies for randomized controlled trials, prospective, and retrospective studies between 2018 and 2023. Exclusion criteria included male participants, non-SUI incontinence, and articles not originally written in English. The review was registered in PROSPERO [465721] and conformed to PRISMA guidelines. RESULTS: In 117 manuscripts meeting study criteria, the median of the mean ages was 52 years, with a median of 164 participants per study. Most studies originated in Europe (59/117). The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form was the most frequently used (52%), followed by the Patient Global Impression of Improvement (31%), the Urinary Distress Inventory 6 Short Form (25%), the Incontinence Quality of Life (20%), and the Incontinence Impact Questionnaire Short Form (19%). These leading questionnaires were short, translated into several languages, and globally addressed important SUI-related domains, including the presence and severity of SUI, additional lower urinary tract symptoms, and the impact of SUI on quality of life, as well as changes perceived after treatment. CONCLUSIONS: This systematic review of the validated questionnaires used in contemporary SUI management literature could help guide recommendations for incorporating these favored instruments into future SUI treatment outcome documents.