Patient-Led Research to Develop a Training Programme for Restoring Musical Joy in Cochlear Implant Recipients: A Reflexive Process Evaluation.

BACKGROUND: The role of patients in healthcare research is slowly evolving, although patient roles in the research process are limited. This paper reports on a patient-led research project aiming to develop a musical hearing training programme for patients with a cochlear implant (CI): the Musi-CI programme. A CI is an inner ear prosthesis that allows people with severe hearing loss to hear. However, while speech can be understood, CI users cannot fully enjoy music or feel aversion to it. The Musi-CI programme aims to reduce this music aversion to ultimately improve music enjoyment and social participation. The development of the Musi-CI programme was supported by a consortium of professionals in CI rehabilitation and research. The aim of this paper is to describe and evaluate the Musi-CI programme development process and its impact on professional CI rehabilitation and research. METHODS: Programme development was described using a 3-layered process model of action research, distinguishing the CI user process, the healthcare professional process and the research process. To evaluate perceptions on the programme development process, consortium partners provided written comments and participated in a reflexive evaluation session that was video-recorded. Reflexive evaluation aims for collective learning and strengthening collaboration among participants. Written comments and video data were analysed using template analysis. RESULTS: The involvement of an expert by experience was perceived as challenging but rewarding for all consortium partners, opening up new perspectives on CI-rehabilitation practice and research. Data analysis revealed two themes on the programme development process, professional space and acknowledgement, and two themes on the outcomes on CI rehabilitation and research: critical reflection and paradigm shift. CONCLUSION: Experts by experience represent a different knowledge domain that may contribute to change in rehabilitation and research. PATIENT OR PUBLIC CONTRIBUTION: The development of the programme was initiated by a professional musician and CI user who organized the funding, had a leading role throughout the research process, including the write-up of the results, and co-authored this paper.

Evaluating patient participation in value-based healthcare: Current state and lessons learned.

INTRODUCTION: Value-based healthcare (VBHC) focusses on increasing value for patients. Hospitals aim to implement VBHC via value improvement (VI) teams for medical conditions. To determine the patient's perspective on value, collective patient participation is important in these teams. We therefore evaluated the current state of patient participation in VI teams and share lessons learned. METHODS: This mixed-methods study was conducted at seven collaborating hospitals in the Netherlands. A questionnaire (the public and patient engagement evaluation tool) was tailored to the study's context, completed by VI team members (n = 147 from 76 different VI teams) and analysed with descriptive statistics. In addition, 30 semistructured interviews were held with VI team members and analysed through thematic analysis. Data were collected between February 2022 and January 2023 and were triangulated by mapping the quantitative results to the interview themes. RESULTS: Thirty-eight of the 76 included VI teams reported using a form of patient participation. Many respondents (71%) indicated a lack of a clear strategy and goal for patient participation. Multiple VI team members believed that specific knowledge and skills are required for patients to participate in a VI team, but this led to concerns regarding the representativeness of participating patients. Furthermore, while patients indicated that they experienced some level of hierarchy, they also stated that they did not feel restricted hereby. Lastly, patients were satisfied with their participation and felt like equal VI team members (100%), but they did mention a lack of feedback from the VI team on their input. CONCLUSION: The results imply the lack of full implementation of patient participation within VI teams. Guidelines should be developed that provide information on how to include a representative group of patients, which methods to use, how to evaluate the impact of patient participation, and how to give feedback to participating patients. PATIENT AND PUBLIC CONTRIBUTION: Two patient advisors were part of the research team and attended the research team meetings. They were involved as research partners in all phases of the study, including drafting the protocol (e.g., drafting interview guides and selecting the measurement instrument), interpreting the results and writing this article.

The association of the STarT Back Screening Tool and type of leg pain with low back pain disability trajectories: a prospective cohort study.

BACKGROUND: Multiple factors influence the recovery process of low back pain (LBP). The identification and increased knowledge of prognostic factors might contribute to a better understanding of the course of LBP. The purpose of this study is to investigate the association of the STarT Back Screening Tool (SBST) risk score and the type of leg pain (non-radiating LBP, referred non-radicular, and radicular radiating leg pain) with the disability trajectory (at baseline, the slope, and recovery at one year) in adults with low back pain. METHODS: This is a prospective cohort study in 347 patients with low back pain who sought physiotherapy care at three primary care practices in the Netherlands. Linear mixed models were estimated to describe the association of the SBST risk score and the type of leg pain with disability at baseline, the slope in the disability trajectory, and at twelve months follow-up. RESULTS: A medium/high risk score on the SBST is associated with higher baseline disability scores on the Oswestry Disability Index (ODI), faster initial recovery, and still a higher disability ODI score at 12 months follow-up. Non-radicular referred and radicular radiating leg pain were associated with worse baseline disability ODI scores in LBP. This association was not present for the initial recovery or at the 12 months follow-up. CONCLUSION: The SBST is associated with the LBP recovery trajectory. The SBST might be a useful tool to predict the disability trajectory in a heterogeneous group of people with low back pain in primary care and might, therefore, be recommended in future clinical practice guidelines. The type of leg pain was not associated with the recovery trajectory of LBP. Future research might focus on evaluating different types of leg pain. TRIAL REGISTRATION: Clinicaltrials.gov: 109,643.

Patients' Needs Regarding Work-Focused Healthcare: A Qualitative Evidence Synthesis.

PURPOSE: To identify, appraise, and synthesize qualitative research evidence exploring patients' needs regarding work-focused healthcare. METHODS: A systematic review was conducted in accordance with the PRISMA statement guidelines to identify studies reporting patients' needs regarding work-focused healthcare. Four databases (MEDLINE, Embase, PsychInfo and Web of Science) were systematically searched from January 2000 until May 2023 and screened in duplicate by pairs of two reviewers. Inclusion criteria were qualitative data collection method, and patients' perspectives regarding healthcare focusing on work when experiencing work-related problems due to chronic medical conditions. Data extraction and synthesis was executed by means of an inductive thematic analysis approach. The quality of the included studies was assessed using the CASP Qualitative Study checklist. Confidence in the review findings was assessed through the Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach. RESULTS: Out of 23,677 records, 97 qualitative studies were included. Needs regarding four main themes were identified: (1) Substantive guidance, which comprises the specific content of work-focused healthcare; (2) Clear and continuous process, which comprises clarification and optimization of the work-focused healthcare process; (3) Supportive attitude and behavior, which comprises a positive and supportive attitude and behavior from professionals towards the patients; and (4) Tailored approach, which comprises the delivery of tailored care to the individuals' needs. 17 subthemes were identified. CONCLUSION: The broader insight in patients' needs in work-focused healthcare can help (occupational) healthcare professionals adopt a more patient-centred approach in practice.

The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.

BACKGROUND AND PURPOSE: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences. METHODS AND ANALYSES: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

Work-focused healthcare from the perspective of employees living with cardiovascular disease: a patient experience journey mapping study.

BACKGROUND: People living with cardiovascular diseases (CVD) often experience work participation problems. Good work-focused healthcare, defined as the received advice, treatment, and guidance focusing on work participation, can support the patient and work place. However, experiences with work-focused healthcare are generally not always positive which is a barrier for work participation. Therefore, the objective of this study is to gain insight into the work-focused healthcare journey from the perspective of patients with work participation problems due to CVD, to understand their experiences and needs, and to derive opportunities for improving work-focused healthcare service at a system level. METHODS: Semi-structured interviews, preceded by preparatory assignments, were conducted with 17 patients who experience(d) work participation problems due to CVD. The patient experience journey map (PEJM) approach was used to visualize the patients' work-focused healthcare journey, including experiences and needs over time and place, from which opportunities to improve work-focused healthcare from the patient's perspective were derived. RESULTS: An aggregated PEJM consisting of six phases was composed and graphically mapped. The first phase, working, represents a period in which CVD health problems and subsequent functional limitations occur. The next two phases, short- and long-term sick leave, represent a period of full sick leave. The last three phases, start-, partial-, and full vocational reintegration, focus on the process of return to work that takes place ranging from a few months up to several years after sick-listing. For each phase the touchpoints, timespan, stakeholders, activities, experiences and needs from the perspective of the patients were identified. Finally, for better work-focused healthcare nine opportunities for improvement were derived from the PEJM, e.g. emphasize the need for work adjustment prior to the medical intervention, provide more personalized advice on handling work limitations, and putting more compelling pressure on the employer to create suitable work positions for their employees. DISCUSSION/CONCLUSION: This paper contributes insights to provide a more patient-centered work-focused healthcare trajectory for patients employed in paid jobs when living with CVD. The PEJM provides an understanding of the patients' perspectives throughout their work-focused healthcare journey and highlights opportunities for improvement towards a better suited and seamless patient journey, Although this research was conducted within the Dutch healthcare system, it can be assumed that the findings on integrated work-focused healthcare are largly transferable to other healthcare systems.

A framework to improve quality of hospital-based physiotherapy: a design-based research study.

BACKGROUND: A quality framework for hospital-based physiotherapy is lacking. This study aims to design a framework, building on the currently available literature, to improve the quality of hospital-based physiotherapy. METHODS: A multidisciplinary panel of six representatives of hospital-based physiotherapy and their key stakeholders (patients, medical specialists, hospital management and professional association) was set up. We used brainwriting to sample ideas and the 'decision-matrix' to select the best ideas. RESULTS: The first round of brainwriting with an online panel of six experienced participants yielded consensus on seven possible methods for quality improvement of hospital-based physiotherapy [1]: continuing education [2] ,feedback on patient reported experience measures and patient reported outcome measures [3] ,a quality portfolio [4] ,peer observation and feedback [5] ,360 degree feedback [6] ,a management information system, and [7] intervision with intercollegiate evaluation. Placing these methods in a decision matrix against four criteria (measurability, acceptability, impact, accessibility) resulted in a slight preference for a management information system, with almost equal preference for five other methods immediately thereafter. The least preference was given to a 360-degree feedback. CONCLUSIONS: In the design of a framework for improving the quality of hospital-based physiotherapy, all seven suggested methods were perceived as relevant but differed in terms of advantages and disadvantages. This suggests that, within the framework, a mixture of these methods may be desirable to even out respective advantages and disadvantages.

Personalised Outcomes Forecasts of Supervised Exercise Therapy in Intermittent Claudication: An Application of Neighbours Based Prediction Methods with Routinely Collected Clinical Data.

OBJECTIVE: Insights regarding individual patient prognosis may improve exercise therapy by informing patient expectations, promoting exercise adherence, and facilitating tailored care. Therefore, the aim was to develop and evaluate personalised outcomes forecasts for functional claudication distance over six months of supervised exercise therapy for patients with intermittent claudication. METHODS: Data of 5 940 patients were eligible for analysis. Neighbours based predictions were generated via an adaptation of predictive mean matching. Data from the nearest 223 matches (a.k.a. neighbours) for an index patient were modelled via Generalised Additive Model for Location Scale and Shape (GAMLSS). The realised outcome measures were then evaluated against the GAMLSS model, and the average bias, coverage, and precision were calculated. Model calibration was analysed via within sample and of sample analyses. RESULTS: Neighbours based predictions demonstrated small average bias (- 0.04 standard deviations; ideal = 0) and accurate average coverage (48.7% of realised data within 50% prediction interval; ideal = 50%). Moreover, neighbours based predictions improved prediction precision by 24%, compared with estimates derived from the whole sample. Both within sample and of sample testing showed predictions to be well calibrated. CONCLUSION: Neighbours based prediction is a method for generating accurate personalised outcomes forecasts for patients with intermittent claudication undertaking supervised exercise therapy. Future work should examine the influence of personalised outcomes forecasts on clinical decisions and patient outcomes.

Roles of general practitioners in shared decision-making for patients with cancer: A qualitative study.

OBJECTIVE: The shared decision-making (SDM) process for the treatment of pancreatic and oesophageal cancer primarily takes place with healthcare professionals (HCPs) in the hospital setting. This study aims to explore the perspectives of general practitioners (GPs) on their possible roles during this SDM process, their added value and their requirements for involvement in SDM. METHODS: Semi-structured interviews were conducted with 12 GPs about their views on SDM for patients with cancer. The interviews were analysed by two researchers using an inductive open coding approach. RESULTS: Five potential roles in SDM were described by the interviewed GPs, of which the role as 'coach' of the patient was mentioned by all. GPs see their main added value as their long-standing relationship with the patient. To be able to participate optimally in SDM, GPs indicated that they need to be kept up to date during the patient's care process and should receive enough medical information about treatment options and contextual information. CONCLUSION: GPs see different potential roles for themselves when involved in SDM. Hospital HCPs that want to facilitate GP involvement should take the initiative, provide the GPs with enough and timely information and must be easy to consult.

Longing for homelikeness: A hermeneutic phenomenological analysis of patients' lived experiences in recovery from COVID-19-associated intensive care unit acquired weakness.

AIMS: To explore lived experiences of patients recovering from COVID-19-associated intensive care unit acquired weakness and to provide phenomenological descriptions of their recovery. DESIGN: A qualitative study following hermeneutic phenomenology. METHODS: Through purposeful sampling, 13 participants with COVID-19-associated intensive care unit acquired weakness were recruited with diversity in age, sex, duration of hospitalization and severity of muscle weakness. Semi-structured in-depth interviews were conducted from 4 to 8 months after hospital discharge, between July 2020 and January 2021. Interviews were transcribed verbatim and analysed using hermeneutic phenomenological analysis. RESULTS: The analysis yielded five themes: 'waking up in alienation', 'valuing human contact in isolation', 'making progress by being challenged', 'coming home but still recovering' and 'finding a new balance'. The phenomenological descriptions reflect a recovery process that does not follow a linear build-up, but comes with moments of success, setbacks, trying new steps and breakthrough moments of achieving mobilizing milestones. CONCLUSION: Recovery from COVID-19-associated intensive care unit acquired weakness starts from a situation of alienation. Patients long for familiarity, for security and for recognition. Patients want to return to the familiar situation, back to the old, balanced, bodily self. It seems possible for patients to feel homelike again, not only by changing their outer circumstances but also by changing the understanding of themselves and finding a new balance in the altered situation. IMPACT: Muscle weakness impacts many different aspects of ICU recovery in critically ill patients with COVID-19-associated intensive care unit acquired weakness. Their narratives can help nurses and other healthcare professionals, both inside and outside of the intensive care unit, to empathize with patient experiences. When healthcare professionals connect to the lifeworld of patients, they will start to act and communicate differently. These insights could lead to optimized care delivery and meeting patients' needs in this pandemic or a possible next.

Development of a patient-reported outcome measure for patients who have recovered from a subarachnoid hemorrhage: the "questionnaire for the screening of symptoms in aneurysmal subarachnoid hemorrhage" (SOS-SAH).

BACKGROUND: Patients who have been successfully treated for an aneurysmal subarachnoid hemorrhage (aSAH) often retain multiple health complaints, including mood disorders, cognitive complaints, fatigue, and problems with social participation. These problems are not always fully addressed during hospital visits or in current outcome measures, such as the modified Rankin score and the Glasgow Outcome Scale. Here, we present the development of the "Questionnaire for the Screening of Symptoms in aneurysmal Subarachnoid Hemorrhage" (SOS-SAH), which screens for the self-reported symptoms of patients with mild disabilities. METHODS: During the development of the SOS-SAH we adhered to the PROM-cycle framework for the selection and implementation of patient-reported outcome measures (PROMs). The SOS-SAH was developed in an iterative process informed by a literature study. Patients and healthcare professionals were involved in the development process through participating in a working group, interviews, and a cognitive validation study. RESULTS AND CONCLUSIONS: Relevant patient-reported outcomes (PROs) were identified for patients with aSAH. The SOS-SAH was developed primarily using domains and items from existing PROMs and, if necessary, by developing new items. The SOS-SAH consists of 40 items and covers 14 domains: cognitive abilities, hypersensitivity to stimuli, anxiety, depression, fatigue, social roles, personality change, language, vision, taste, smell, hearing, headache, and sexual function. It also includes a proxy measurement for use by family members to assess cognitive functioning and personality change.

Measurement properties of the Dutch-Flemish patient-reported outcomes measurement information system (PROMIS) physical function item bank and instruments: a systematic review.

BACKGROUND: Limitations in physical functioning are a big concern especially for patients with chronic or musculoskeletal diseases. Therefore, physical functioning is often used as a core outcome of treatments. The generic patient-reported outcomes information system (PROMIS) physical function (PF) item bank has shown potential to measure PF with better precision, interpretability and lower respondent burden compared with traditional patient-reported outcome measures. This study provides an overview of the current evidence on the quality of the measurement properties of the translated Dutch-Flemish PROMIS-PF item bank and its subdomains, and their derived short forms and computer adaptive tests (CATs). METHODS: PubMed was searched up to June 17th 2020 for validation studies of Dutch-Flemish PROMIS-PF in Dutch and Flemish adults. Quality assessment of the included studies was conducted using the COSMIN Risk of bias checklist. The COSMIN criteria for good measurement properties were used to judge the results of the studies, which were adjusted and added to where needed for this review, in the context of IRT instruments and item banks. The quality of evidence was summarized for each measurement property based on the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Eleven studies were included, evaluating the PROMIS-PF item bank, the Upper Extremity (UE) subdomain, and/or their derived short forms and CATs in different clinical populations. There is evidence for sufficient structural validity, measurement precision, construct validity, and cross-cultural validity of the Dutch-Flemish PROMIS-PF item bank. The upper extremity subdomain item bank shows high quality evidence for structural validity and measurement precision. Content validity of these item banks has not been thoroughly demonstrated in a Dutch-Flemish population. Furthermore, the derived instruments have far less robust evidence: there are fewer validation studies available and none examined their performance as stand-alone administered instruments. CONCLUSIONS: The first studies into the Dutch-Flemish PROMIS-PF item bank and the UE subdomain show promising results, with especially high quality evidence for sufficient structural validity and measurement precision. However, more studies, and with higher methodological quality, are needed to study the instruments derived from these item banks. These studies should also evaluate content validity, reliability and responsiveness.

Clinical adhesion score (CLAS): development of a novel clinical score for adhesion-related complications in abdominal and pelvic surgery.

BACKGROUND: Adhesions are a major cause of long-term postsurgical complications in abdominal and pelvic surgery. Existing adhesion scores primarily measure morphological characteristics of adhesions that do not necessarily correlate with morbidity. The aim of this study was to develop a clinical adhesion score (CLAS) measuring overall clinical morbidity of adhesion-related complications in abdominal and pelvic surgery. METHODS: An international Delphi study was performed to identify relevant score items for adhesion-related complications, including small bowel obstruction, female infertility, chronic abdominal or pelvic pain, and difficulties at reoperation. The CLAS includes clinical outcomes, related to morbidity of adhesions, and weight factors, to correct the outcome scores for the likelihood that symptoms are truly caused by adhesions. In a pilot study, two independent researchers retrospectively scored the CLAS in 51 patients to evaluate inter-observer reliability, by calculating the Intraclass correlation coefficient. During a feasibility assessment, we evaluated whether the CLAS completely covered different clinical scenarios of adhesion-related morbidity. RESULTS: Three Delphi rounds were performed. 43 experts agreed to participate, 38(88%) completed the first round, and 32 (74%) the third round. Consensus was reached on 83.4% of items. Inter-observer reliability for the CLAS was 0.95 (95% CI 0.91-0.97). During feasibility assessment, six items were included. As a result, the CLAS includes 22 outcomes and 23 weight factors. CONCLUSION: The CLAS represents a promising scoring system to measure and monitor the clinical morbidity of adhesion-related complications. Further studies are needed to confirm its utility in clinical practice.

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

Guideline-based quality assurance: a conceptual framework for the definition of key elements.

BACKGROUND: In 2017, the European Commission's Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). METHODS: A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. RESULTS: Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. CONCLUSIONS: The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

Selecting interventions to improve patient-relevant outcomes in health care for aortic valve disease - the Intervention Selection Toolbox.

BACKGROUND: Measuring and improving outcomes is a central element of value-based health care. However, selecting improvement interventions based on outcome measures is complex and tools to support the selection process are lacking. The goal was to present strategies for the systematic identification and selection of improvement interventions applied to the case of aortic valve disease and to combine various methods of process and outcome assessment into one integrated approach for quality improvement. METHODS: For this case study a concept-driven mixed-method approach was applied for the identification of improvement intervention clusters including: (1) benchmarking outcomes, (2) data exploration, (3) care delivery process analysis, and (4) monitoring of ongoing improvements. The main outcome measures were long-term survival and 30-day mortality. For the selection of an improvement intervention, the causal relations between the potential improvement interventions and outcome measures were quantified followed by a team selection based on consensus from a multidisciplinary team of professionals. RESULTS: The study resulted in a toolbox: the Intervention Selection Toolbox (IST). The toolbox comprises two phases: (a) identifying potential for improvement, and (b) selecting an effective intervention from the four clusters expected to lead to the desired improvement in outcomes. The improvements identified for the case of aortic valve disease with impact on long-term survival in the context of the studied hospital in 2015 include: anticoagulation policy, increased attention to nutritional status of patients and determining frailty of patients before the treatment decision. CONCLUSIONS: Identifying potential for improvement and carefully selecting improvement interventions based on (clinical) outcome data demands a multifaceted approach. Our toolbox integrates both care delivery process analyses and outcome analyses. The toolbox is recommended for use in hospital care for the selection of high-impact improvement interventions.

Approaches of integrating the development of guidelines and quality indicators: a systematic review.

BACKGROUND: Guidelines and quality indicators (for example as part of a quality assurance scheme) aim to improve health care delivery and health outcomes. Ideally, the development of quality indicators should be grounded in evidence-based, trustworthy guideline recommendations. However, anecdotally, guidelines and quality assurance schemes are developed independently, by different groups of experts who employ different methodologies. We conducted an extension and update of a previous systematic review to identify, describe and evaluate approaches to the integrated development of guidelines and related quality indicators. METHODS: On May 24th, 2019 we searched in Medline, Embase and CINAHL and included studies if they reported a methodological approach to guideline-based quality indicator development and were published in English, French, or German. RESULTS: Out of 16,034 identified records, we included 17 articles that described a method to integrate guideline recommendations development and quality indicator development. Added to the 13 method articles from original systematic review we included a total 30 method articles. We did not find any evaluation studies. In most approaches, guidelines were a source of evidence to inform the quality indicator development. The criteria to select recommendations (e.g. level of evidence or strength of the recommendation) and to generate, select and assess quality indicators varied widely. We found methodological approaches that linked guidelines and quality indicator development explicitly, however none of the articles reported a conceptual framework that fully integrated quality indicator development into the guideline process or where quality indicator development was part of the question formulation for developing the guideline recommendations. CONCLUSIONS: In our systematic review we found approaches which explicitly linked guidelines with quality indicator development, nevertheless none of the articles reported a comprehensive and well-defined conceptual framework which integrated quality indicator development fully into the guideline development process.

Reliability and Responsiveness of the Observable Movement Quality Scale for Children with Mild to Moderate Motor Impairments.

AIM: The Observable Movement Quality (OMQ) scale measures generic movement quality and is used alongside standardized age-adequate motor performance tests. The scale consists of 15 items, each focusing on a different aspect; together, the entire construct of movement quality is assessed. This study aimed to determine interrater and intrarater reliability, and responsiveness of the OMQ scale. METHODS: A prospective intervention study with pre-post design in pediatric physical therapy practices. For interrater reliability, 3 physical therapists observed video-recorded motor assessments of 30 children with mild to moderate motor impairments -aged 4 to 12 years-using the OMQ scale. One therapist scored baseline assessment a second time for intrarater reliability, and to calculate smallest detectable change (SDC). Responsiveness (n = 28) was tested by comparing outcomes before and after intervention. RESULTS: Interrater reliability was moderate to good (ICC2,1: 0.79); intrarater reliability was high (ICC2,1: 0.97). Responsiveness results revealed an SDC of 2.4 and a minimal important change of 2.5; indicating sufficient validity in differentiating groups of children showing improved versus unchanged movement quality. CONCLUSION: The OMQ scale is reliable and responsive to change when used to assess movement quality in clinical practice for children with mild to moderate motor impairments, aged 4-12 year.

Development of a Patient-Reported Outcome Measure for Geriatric Care: The Older Persons and Informal Caregivers Survey Short Form.

BACKGROUND: The Older Persons and Informal Caregivers Minimum Data Set (TOPICS-MDS) is a standardized data set that was developed to evaluate the quality of multidimensional geriatric care. There is an inherent need to reduce the number of TOPICS-MDS survey items to core outcomes to allow it to be more easily applied as a patient-reported outcome measure in clinical settings. OBJECTIVES: To create a TOPICS-short form (TOPICS-SF) and examine its validity. METHODS: Data in the TOPICS-MDS from persons aged 65 years and older in the Netherlands were used for the following analyses. Multiple linear regression analyses were performed to select the items and to derive domain weights of TOPICS-SF. A priori hypotheses were made on the basis of psychometric properties of the full-length TOPICS-MDS preference-weighted score (TOPICS-CEP). The validity of TOPICS-SF was evaluated by 1) examining the meta-correlation of the TOPICS-SF score with TOPICS-CEP and two quality-of-life measures, that is, the Cantril Ladder score and the EuroQol five-dimensional questionnaire utility index, and 2) performing mixed multiple regression of TOPICS-SF scores across key sociodemographic characteristics. RESULTS: TOPICS-SF scores were strongly correlated with the TOPICS-CEP (r = 0.96) and had stronger correlation with the EuroQol five-dimensional questionnaire utility index compared with the Cantril Ladder (r = 0.61 and 0.38, respectively). TOPICS-SF scores were higher among older persons who were married, living independently, and having higher levels of education. CONCLUSIONS: We have developed the 22-item TOPICS-SF and demonstrated its validity, supporting its use as a patient-reported outcome measure in geriatric care.

Instrument completion and validation of the patient-reported apnea questionnaire (PRAQ).

BACKGROUND: We previously developed the preliminary version of the Patient-Reported Apnea Questionnaire (PRAQ), a questionnaire measuring health-related quality of life in patients with (suspected) obstructive sleep apnea (OSA). This questionnaire was developed for clinical practice, where it can potentially serve two goals: use on an individual patient level to improve patient care, and use on an aggregate level to measure outcomes for quality improvement at a sleep center. In this study we aim to finalize the PRAQ, make a subselection of items and domains specifically for outcome measurement, and assess the validity, reliability and responsiveness of the PRAQ. METHODS: Patients with suspected OSA were included and asked to complete the PRAQ and additional questionnaires one or more times. The collected data was used to perform the final item selection for clinical practice and for outcome measurement, create the domains for outcome measurement, and assess the measurement properties internal consistency, test-retest reliability, convergent validity and responsiveness. RESULTS: 180 patients were included in the study. The final version of the PRAQ for use in clinical practice contains 40 items and 10 domains. A subselection of 33 items in 5 domains was selected for optimal outcome measurement with the PRAQ. The results for the outcome measurement domains were: Cronbach's alpha 0.88-0.95, ICC 0.81-0.88, and > 75% of hypotheses correct for convergent validity and responsiveness. CONCLUSIONS: The PRAQ shows good measurement properties in patients with (suspected) OSA.