Patient-reported outcomes in integrated health and social care: A scoping review.

Background: Patient-reported outcomes (PROs) have potential to support integrated health and social care research and practice; however, evidence of their utilisation has not been synthesised. Objective: To identify PRO measures utilised in integrated care and adult social care research and practice and to chart the evidence of implementation factors influencing their uptake. Design: Scoping review of peer-reviewed literature. Data sources: Six databases (01 January 2010 to 19 May 2023). Study selection: Articles reporting PRO use with adults (18+ years) in integrated care or social care settings. Review methods: We screened articles against pre-specified eligibility criteria; 36 studies (23%) were extracted in duplicate for verification. We summarised the data using thematic analysis and descriptive statistics. Results: We identified 159 articles reporting on 216 PRO measures deployed in a social care or integrated care setting. Most articles used PRO measures as research tools. Eight (5.0%) articles used PRO measures as an intervention. Articles focused on community-dwelling participants (35.8%) or long-term care home residents (23.9%), with three articles (1.9%) focussing on integrated care settings. Stakeholders viewed PROs as feasible and acceptable, with benefits for care planning, health and wellbeing monitoring as well as quality assurance. Patient-reported outcome measure selection, administration and PRO data management were perceived implementation barriers. Conclusion: This scoping review showed increasing utilisation of PROs in adult social care and integrated care. Further research is needed to optimise PROs for care planning, design effective training resources and develop policies and service delivery models that prioritise secure, ethical management of PRO data.

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Paving the way for patient centricity in real-world evidence (RWE): Qualitative interviews to identify considerations for wider implementation of patient-reported outcomes in RWE generation.

Objectives: Real-world evidence (RWE) generation can be enhanced by including patient-reported outcomes (PROs). Methods for collecting and using PRO data in the real-world setting are currently underdeveloped and there is no international guidance specific to its use in this context. This study explored stakeholders' perspectives and needs for using PROs in RWE generation. Barriers, facilitators, and opportunities for wider use of PROs in real-world studies were also investigated. Methods: Online semi-structured interviews were conducted with international stakeholders: patients, patient advocates, regulators, payers, clinicians, academic researchers, and industry experts. Interviews were recorded, transcribed verbatim and analysed using NVivo 20. Thematic analysis was conducted based on the updated Consolidated Framework for Implementation Research (CFIR). Results: Twenty-three interviews were conducted. Participants confirmed that the use of PROs in RWE generation is not yet well established. Participants expressed a mixed level of confidence in the value of PROs collected in a real-world setting. Operational challenges associated with collecting routine PRO data to inform care delivery at the individual level (e.g., setting up infrastructure) need to be addressed. Methodological and other challenges (e.g., financing research) associated with collecting prospective de novo data in a real-world setting should be considered to facilitate PRO utilisation in real-world studies. Conclusions: Several opportunities and challenges were identified regarding the broader use of PROs in RWE research. Joint efforts from different stakeholders are needed to maximise PRO implementation, with consideration given to each stakeholders' specific needs (e.g., by developing good practices).

Patients' acceptance of outcome and experience measurements during hospitalisation for COPD exacerbations: a CICERO Clinical Research Collaboration-European Lung Foundation online patient survey.

Background: The lack of standardised outcome assessments during hospitalisation and follow-up for acute COPD exacerbations has hampered scientific progress and clinical proficiency. The objective of the present study was to evaluate patients' acceptance of selected outcome and experience measurements during hospitalisations for COPD exacerbations and follow-up. Methods: An online survey was held amongst COPD patients in France, Belgium, The Netherlands, Germany and the UK. The European Lung Foundation COPD Patient Advisory Group was involved in the conceptualisation, development and dissemination of the survey. The survey was complementary to a previously obtained expert consensus. We assessed patients' views and acceptance of selected patient-reported outcomes or experiences and corresponding measurement instruments (for dyspnoea, frequent productive cough, health status and hospitalisation experience), and of selected clinical investigations (blood draw, pulmonary function test, 6-min walk test, chest computed tomography, echocardiography). Findings: 200 patients completed the survey. All selected outcomes and experiences were deemed important, and acceptance of their methods of assessment was high. The modified Medical Research Council scale and a numerical rating scale to address dyspnoea, the COPD Assessment Test for quality of life and frequent productive cough, and the Hospital Consumer Assessment of Healthcare Providers and Systems for hospital experiences were the instruments preferred by patients. Consensus on importance of blood draw and spirometry was higher compared with the other investigations. Interpretation: The survey results endorse the use of the selected outcome and experience measurements during hospitalisations for COPD exacerbations. They can be used to optimise standardised and patient-centred care and facilitate multicentric data collection.

Implementation of patient-reported outcome measures in real-world evidence studies: Analysis of ClinicalTrials.gov records (1999-2021).

BACKGROUND: Real-world evidence (RWE) plays an increasingly important role within global regulatory and reimbursement processes. RWE generation can be enhanced by collecting and using patient-reported outcomes (PROs), which can provide valuable information on the effectiveness, safety, and tolerability of health interventions from the patient perspective. This analysis aims to examine and summarise the utilisation of patient-reported outcomes measures (PROMs) in real-world studies. METHODS: Descriptions of phase IV trials were downloaded on July 22, 2021 from the Clinicaltrials.gov database since its inception. An automated algorithm was built to detect trials utilising PROMs and composite measures including patient-reported components. Search terms were developed based on the PROQOLID database. RESULTS: Of 27,976 phase IV clinical trials posted on Clinicaltrials.gov between 1999 and July 2021, 21% and 4% used PROMs and composite measures, respectively. Recent years demonstrated a steady increase in the utilisation of PROMs in phase IV trials. CONCLUSIONS: The use of PROMs in phase IV trials seems to be lower than its use in earlier phases of clinical research. Increased uptake of PROMs in RWE studies can be facilitated in a number of ways including the development of standards for their collection, analysis and use.

Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy.

BACKGROUND: Real-world evidence (RWE) plays an increasingly important role within global regulatory and reimbursement processes. RWE generation can be enhanced by the collection and use of patient-reported outcomes (PROs), which can provide valuable information on the effectiveness, safety, and tolerability of health interventions from the patient perspective. This systematic review aims to examine and summarise the available PRO-specific recommendations and guidance for RWE generation. METHODS AND FINDINGS: Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, and websites of selected organisations were systematically searched to identify relevant publications. 1,249 articles were screened of which 7 papers met the eligibility criteria and were included in the review. The included publications provided PRO-specific recommendations to facilitate the use of PROs for RWE generation and these were extracted and grouped into eight major categories. These included: (1) instrument selection, (2) participation and engagement, (3) burden to health care professionals and patients, (4) stakeholder collaboration, (5) education and training, (6) PRO implementation process, (7) data collection and management, and (8) data analysis and presentation of results. The main limitation of the study was the potential exclusion of relevant publications, due to poor indexing of the databases and websites searched. CONCLUSIONS: PROs may provide valuable and crucial patient input in RWE generation. Whilst valuable insights can be gained from guidance for use of PROs in clinical care, there is a lack of international guidance specific to RWE generation in the context of use for regulatory decision-making, reimbursement, and health policy. Clear and appropriate evidence-based guidance is required to maximise the potential benefits of implementing PROs for RWE generation. Unique aspects between PRO guidance for clinical care and other purposes should be differentiated. The needs of various stakeholder groups (including patients, health care professionals, regulators, payers, and industry) should be considered when developing future guidelines.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance. Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

Which outcomes are most important to measure in patients with COVID-19 and how and when should these be measured? Development of an international standard set of outcomes measures for clinical use in patients with COVID-19: a report of the International Consortium for Health Outcomes Measurement (ICHOM) COVID-19 Working Group.

OBJECTIVES: The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives. DESIGN: A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance. RESULTS: The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors. CONCLUSION: Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.

Protocol for a scoping review exploring the use of patient-reported outcomes in adult social care.

INTRODUCTION: Patient-reported outcomes (PROs) are measures of a person's own views of their health, functioning and quality of life. They are typically assessed using validated, self-completed questionnaires known as patient-reported outcome measures (PROMs). PROMs are used in healthcare settings to support care planning, clinical decision-making, patient-practitioner communication and quality improvement. PROMs have a potential role in the delivery of social care where people often have multiple and complex long-term health conditions. However, the use of PROMs in this context is currently unclear. The objective of this scoping review is to explore the evidence relating to the use of PROMs in adult social care. METHODS AND ANALYSES: The electronic databases Medline (Ovid), PsychInfo (Ovid), ASSIA (ProQuest), Social Care Online (SCIE), Web of Science and EMBASE (Ovid) were searched on 29 September 2020 to identify eligible studies and other publically available documents published since 2010. A grey literature search and hand searching of citations and reference lists of the included studies will also be undertaken. No restrictions on study design or language of publication will be applied. Screening and data extraction will be completed independently by two reviewers. Quality appraisal of the included documents will use the Critical Appraisal Skills Programme and AACODS (Authority, Accuracy, Coverage, Objectivity, Date, Significance) checklists. A customised data charting table will be used for data extraction, with analysis of qualitative data using the framework method. The review findings will be presented as tables and in a narrative summary. ETHICS AND DISSEMINATION: Ethical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publically available sources. Review findings will be shared with service users and other relevant stakeholders and disseminated through a peer-reviewed publication and conference presentations. This protocol is registered on the Open Science Framework (www.osf.io).

Quadriceps tendon autograft ACL reconstruction has less pivot shift laxity and lower failure rates than hamstring tendon autografts.

PURPOSE: Quadriceps tendon (QT) autograft ACL reconstruction was hypothesized to possess less anterior knee laxity, pivot shift laxity, and lower failure rates than hamstring tendon (HT) autografts. METHODS: Terms "hamstring tendon autograft" and "ACL reconstruction" or "quadriceps tendon autograft" and "ACL reconstruction" were searched in Embase and PubMed. Inclusion criteria required that studies included patients treated for primary ACL injury with reconstruction using either a QT autograft (Group 1) or a HT autograft (Group 2) and instrumented anterior knee laxity assessment. Extracted information included surgical fixation method, graft type, graft thickness or diameter, single vs. double bundle surgical method, publication year, time between the index knee injury and surgery, % women, initial and final subject number, subject age, follow-up length, side-to-side anterior knee laxity difference, Lysholm Score, Subjective IKDC score, anterior knee laxity side-to-side difference grade, ipsilateral pivot shift laxity grade, and failure rate. The Methodological Index for Nonrandomized Studies was used to evaluate study methodological quality. RESULTS: The QT group (Group 1) had 17 studies and the HT group (Group 2) had 61 studies. Overall, Group 2 had greater pivot shift laxity (OR 1.29, 95% CI 1.05-1.59, p = 0.005). Group 2 suspensory femoral fixation had greater pivot shift laxity (OR 1.26, 95% CI 1.01-1.58, p = 0.02) than Group 1 compression femoral fixation. Group 2 compression femoral fixation also had more anterior knee laxity (OR 1.25, 95% CI 1.03-1.52, p = 0.01) than Group 1 compression femoral fixation and higher failure rates based on initial (OR 1.69, 95% CI 1.18-2.4, p = 0.002) and final (OR 1.89, 95% CI 1.32-2.71, p = 0.0003) subject number. Failure rate for HT compression femoral fixation was greater than suspensory femoral fixation based on initial (OR 2.08, 95% CI 1.52-2.84, p < 0.0001) and final (OR 2.26, 95% CI 1.63-3.16, p < 0.0001) subject number. CONCLUSIONS: Overall, QT autografts had less pivot shift laxity and lower failure rates based on final subject number than HT autografts. Compression QT autograft femoral fixation had lower pivot shift laxity than suspensory HT autograft femoral fixation. Compression QT autograft femoral fixation had less anterior knee laxity and lower failure rates than compression HT autograft femoral fixation. Suspensory HT autograft femoral fixation had lower failure rates than compression HT autograft femoral fixation. Greater knee laxity and failure rates may be related to a combination of HT autograft diameter and configuration (tissue quality and dimensions, strands, bundles, and suturing method) variability and fixation mode. LEVEL OF EVIDENCE: Level IV.

Periarticular Injection After Total Knee Arthroplasty Using Liposomal Bupivacaine vs a Modified Ranawat Suspension: A Prospective, Randomized Study.

BACKGROUND: The purpose of this study is to compare liposomal bupivacaine to a modified (Ranawat) local injection for total knee arthroplasty (TKA). METHODS: This is a prospective, randomized study of 105 consecutive patients undergoing primary TKA. Group A patients received a periarticular injection with liposomal bupivacaine and group B with a mixture of ropivacaine, epinephrine, ketorolac, and clonidine. There were 54 patients in the group A (liposomal bupivacaine) and 51 in group B. RESULTS: There were no differences in the groups with respect to age, sex, and preoperative knee scores. There were no differences with respect to postoperative narcotic usage and knee range of motion. CONCLUSION: Liposomal bupivacaine as a periarticular injection after TKA demonstrated similar pain levels, narcotic usage, and range of motion compared to a modified Ranawat suspension but improved walking distance.

Characteristics Associated With Active Defects in Juvenile Spondylolysis.

Diagnosis is crucial in early-stage lumbar spondylolysis, as osseous healing can occur with conservative treatment. Single-photon emission computed tomography (SPECT) traditionally has been the most sensitive modality for diagnosing active (early) spondylolysis. More recently, high signal change (HSC) in the pedicle or pars interarticularis on fluid-specific (T2) magnetic resonance imaging (MRI) has been shown to be important in the diagnosis of early spondylolysis. We conducted a study to determine the clinical and radiographic characteristics associated with the diagnosis of early or active spondylolysis. Fifty-seven patients with a total of 108 pars defects and a mean age of 14.6 years were retrospectively identified. Defects with a positive SPECT or HSC on T2 MRI were classified as active. There were 49 active and 59 inactive defects. The active and inactive groups did not differ in age, body mass index, symptom duration, lumbar lordosis, pelvic incidence, slip percentage, or laterality. There was a difference in sex (35 vs 19 males; P < .0001) and presence of listhesis (16 vs 35; P = .006). Active or early juvenile spondylolysis appears to be associated with male patients and the absence of listhesis, which may be important in identifying patients with a higher potential to experience osseous healing with nonoperative treatment.

A clinical trial of intravenous peramivir compared with oral oseltamivir for the treatment of seasonal influenza in hospitalized adults.

BACKGROUND: Seasonal interpandemic influenza causes >200,000 annual hospitalizations in the United States. Optimal antiviral treatment in hospitalized patients is not established. METHODS: During three interpandemic influenza seasons, 137 patients hospitalized with suspected acute influenza were randomized to 5-day treatment with intravenous peramivir 400 mg or 200 mg once daily or oral oseltamivir 75 mg twice daily. Time to clinical stability and quantitative changes in viral titres from nasopharyngeal specimens were primary and key secondary end points, respectively. RESULTS: Infection was confirmed in 122 patients with influenza A (H1N1), influenza A (H3N2) or influenza B. Median times (95% CI) to clinical stability were 37.0 h (22.0, 48.7) with peramivir 400 mg, 23.7 h (16.0, 38.9) with peramivir 200 mg and 28.1 h (22.0, 37.0) with oseltamivir (P=0.306). Patients (n=97) who were clinically unstable at enrolment had median times (95% CI) to clinical stability of 24.3 h (21.2, 47.5) with peramivir 400 mg, 31.0 h (17.2, 47.7) with peramivir 200 mg and 35.5 h (23.3, 37.9) with oseltamivir (P=0.541). Titres of influenza A viruses in nasopharyngeal specimens decreased similarly across treatments, but more rapid decreases in titres of influenza B occurred with peramivir treatment. There were no deaths among patients with confirmed influenza and the incidence of adverse events was low and generally similar among treatment groups. CONCLUSIONS: Treatment of acute seasonal influenza in hospitalized adults with either peramivir or oseltamivir resulted in generally similar clinical outcomes. Treatment with peramivir was generally safe and well tolerated and could be of benefit in this population.

Anatomical landmarks for safe elevation of the deep inferior epigastric perforator flap: a cadaveric study.

BACKGROUND: Breast reconstruction techniques have focused increasingly on using autologous tissue, with emphasis being placed on employing muscle sparing adipocutaneous flaps to reduce abdominal wall complications such as hernias, bulges, weakness, and length of hospital stay. The result has been the emergence of the deep inferior epigastric perforator (DIEP) flap for breast reconstruction. Isolating perforator vessels challenges most surgeons. We describe surface anatomical landmarks to predict the location of the deep inferior epigastric artery (DIEA) and its perforators to aid in the efficient elevation of this flap. METHODS: Ten fresh hemi-abdomens were dissected with loupe magnification. The DIEA and its perforators were identified, and measurements in relation to the rectus muscle, xiphoid, umbilicus, and pubis were taken. Statistical analysis was undertaken to determine distance ratios to account for variance in patient size. RESULTS: Average distance from the xiphoid to umbilicus was 18.2 +/- 1.27 cm. The distance from the umbilicus to pubis was 14.9 +/- 2.3 cm. The vertical distance from the umbilicus to the DRJ (DIEA rtctus junction) was 10.45 +/- 1.58 cm, and the vertical distance from the level of the umbilicus to where the first DIEA perforator traverses the RAM was 7.4 +/- 1.64 cm. The distance between the umbilicus and the DRJ is approximately 0.7 times the distance between the umbilicus and the pubic symphysis. The distance between the umbilicus and the first perforator is approximately 0.5 times the distance between the umbilicus and the pubic symphysis. CONCLUSIONS: Knowledge of anatomical landmarks can aid the surgeon in more efficiently harvesting the DIEP flap. Surface landmarks along the abdominal midline coupled with normalizing ratios can aid surgeons in predicting the location of the DIEA and its first perforator. The DIEA crosses the rectus at approximately two thirds of the distance between the umbilicus and pubis, and the first perforator can reliably be located at one half of this distance.