Effectiveness of routine provision of feedback from patient-reported outcome measurements for cancer care improvement: a systematic review and meta-analysis.

BACKGROUND: Research shows that feeding back patient-reported outcome information to clinicians and/or patients could be associated with improved care processes and patient outcomes. Quantitative syntheses of intervention effects on oncology patient outcomes are lacking. OBJECTIVE: To determine the effects of patient-reported outcome measure (PROM) feedback intervention on oncology patient outcomes. DATA SOURCES: We identified relevant studies from 116 references included in our previous Cochrane review assessing the intervention for the general population. In May 2022, we conducted a systematic search in five bibliography databases using predefined keywords for additional studies published after the Cochrane review. STUDY SELECTION: We included randomized controlled trials evaluating the effects of PROM feedback intervention on processes and outcomes of care for oncology patients. DATA EXTRACTION AND SYNTHESIS: We used the meta-analytic approach to synthesize across studies measuring the same outcomes. We estimated pooled effects of the intervention on outcomes using Cohen's d for continuous data and risk ratio (RR) with a 95% confidence interval for dichotomous data. We used a descriptive approach to summarize studies which reported insufficient data for a meta-analysis. MAIN OUTCOME(S) AND MEASURES(S): Health-related quality of life (HRQL), symptoms, patient-healthcare provider communication, number of visits and hospitalizations, number of adverse events, and overall survival. RESULTS: We included 29 studies involving 7071 cancer participants. A small number of studies was available for each metanalysis (median = 3 studies, ranging from 2 to 9 studies) due to heterogeneity in the evaluation of the trials. We found that the intervention improved HRQL (Cohen's d = 0.23, 95% CI 0.11-0.34), mental functioning (Cohen's d = 0.14, 95% CI 0.02-0.26), patient-healthcare provider communication (Cohen's d = 0.41, 95% CI 0.20-0.62), and 1-year overall survival (OR = 0.64, 95% CI 0.48-0.86). The risk of bias across studies was considerable in the domains of allocation concealment, blinding, and intervention contamination. CONCLUSIONS AND RELEVANCE: Although we found evidence to support the intervention for highly relevant outcomes, our conclusions are tempered by the high risk of bias relating mainly to intervention design. PROM feedback for oncology patients may improve processes and outcomes for cancer patients but more high-quality evidence is required.

Development of a conceptual model for research on cyclical variation of patient reported outcome measurements (PROMs) in patients with chronic conditions: a scoping review.

BACKGROUND: Although circadian, seasonal, and other cycles have been observed for a number of chronic conditions, their impact on patient reported outcomes measurements (PROMs) has not been systematically explored, rendering our understanding of the effect of time of measurement on PROM scores very limited. The aim was to conduct a scoping review to determine what is known about how intra-individual cyclical variation might affect the way individuals with chronic conditions respond to patient-reported outcome measures. METHODS: A protocol of a systematic scoping review was registered on PROSPERO (CRD42017058365). We developed a search strategy based on previous relevant reviews and implemented it in: MEDLINE, Embase, PsycINFO, and CINAHL. No restrictions were placed on article types and backward and forward citation searches were conducted. Screening and data extraction were independently completed by up to four reviewers. An adapted version of CASP criteria was used to appraise the quality of included articles. Concepts that were important in understanding the impact of cyclical variation on PROM scores were elicited from the papers and iteratively refined through discussion amongst the authors. RESULTS: 2420 references resulted from the searches, with 33 articles meeting the inclusion criteria. Most study designs included observational research (particularly ecological momentary assessment), 2 were RCTs and 2 were systematic reviews. Studies mainly focused on specific health conditions: mental health, respiratory and musculoskeletal. There was a lack of qualitative research and theoretical framework to explore these concepts more fully. Five overarching concepts emerged: variation in outcomes, variation of scores, psychological status, individual factors, and environmental/situational factors. A conceptual model was developed outlining the relationships between these concepts. CONCLUSIONS: There is empirical evidence that supports cyclical variation in PROM scores across different chronic conditions, with potential very significant implications for administration and interpretation of PROMs. The proposed conceptual model can support further research in this area.

Predicting EQ-5D-5L crosswalk from the PROMIS-29 profile for the United Kingdom, France, and Germany.

BACKGROUND: EQ-5D health state utilities (HSU) are commonly used in health economics to compute quality-adjusted life years (QALYs). The EQ-5D, which is country-specific, can be derived directly or by mapping from self-reported health-related quality of life (HRQoL) scales such as the PROMIS-29 profile. The PROMIS-29 from the Patient Reported Outcome Measures Information System is a comprehensive assessment of self-reported health with excellent psychometric properties. We sought to find optimal models predicting the EQ-5D-5L crosswalk from the PROMIS-29 in the United Kingdom, France, and Germany and compared the prediction performances with that of a US model. METHODS: We collected EQ-5D-5L and PROMIS-29 profiles and three samples representative of the general populations in the UK (n = 1509), France (n = 1501), and Germany (n = 1502). We used stepwise regression with backward selection to find the best models to predict the EQ-5D-5L crosswalk from all seven PROMIS-29 domains. We investigated the agreement between the observed and predicted EQ-5D-5L crosswalk in all three countries using various indices for the prediction performance, including Bland-Altman plots to examine the performance along the HSU continuum. RESULTS: The EQ-5D-5L crosswalk was best predicted in France (nRMSEFRA = 0.075, nMAEFRA = 0.052), followed by the UK (nRMSEUK = 0.076, nMAEUK = 0.053) and Germany (nRMSEGER = 0.079, nMAEGER = 0.051). The Bland-Altman plots show that the inclusion of higher-order effects reduced the overprediction of low HSU scores. CONCLUSIONS: Our models provide a valid method to predict the EQ-5D-5L crosswalk from the PROMIS-29 for the UK, France, and Germany.

Quality of care assessment for people with multimorbidity.

Multimorbidity, the simultaneous presence of multiple health conditions in an individual, is an increasingly common phenomenon globally. The systematic assessment of the quality of care delivered to people with multimorbidity will be key to informing the organization of services for meeting their complex needs. Yet, current assessments tend to focus on single conditions and do not capture the complex processes that are required for providing care for people with multimorbidity. We conducted a scoping review on quality of care and multimorbidity in selected databases in June 2018 and identified 87 documents as eligible for review, predominantly original research and reviews from North America, Europe and Australasia and mostly frequently related to primary care settings. We synthesized data qualitatively in terms of perceived challenges, evidence and proposed metrics. Findings reveal that the association between quality of care and multimorbidity is complex and depends on the conditions involved (quality appears to be higher for those with concordant conditions, and lower in the presence of discordant conditions) and the approach used for measuring quality (quality appears to be higher in people with multimorbidity when measured using condition/drug-specific process or intermediate outcome indicators, and worse when using patient-centred reports of experiences of care). People with discordant multimorbidity may be disadvantaged by current approaches to quality assessment, particularly when they are linked to financial incentives. A better understanding of models of care that best meet the needs of this group is needed for developing appropriate quality assessment frameworks. Capturing patient preferences and values and incorporate patients' voices in the form of patient-reported experiences and outcomes of care will be critical towards the achievement of high-performing health systems that are responsive to the needs of people with multimorbidity.

Evidence supporting the best clinical management of patients with multimorbidity and polypharmacy: a systematic guideline review and expert consensus.

The complexity and heterogeneity of patients with multimorbidity and polypharmacy renders traditional disease-oriented guidelines often inadequate and complicates clinical decision making. To address this challenge, guidelines have been developed on multimorbidity or polypharmacy. To systematically analyse their recommendations, we conducted a systematic guideline review using the Ariadne principles for managing multimorbidity as analytical framework. The information synthesis included a multistep consensus process involving 18 multidisciplinary experts from seven countries. We included eight guidelines (four each on multimorbidity and polypharmacy) and extracted about 250 recommendations. The guideline addressed (i) the identification of the target population (risk factors); (ii) the assessment of interacting conditions and treatments: medical history, clinical and psychosocial assessment including physiological status and frailty, reviews of medication and encounters with healthcare providers highlighting informational continuity; (iii) the need to incorporate patient preferences and goal setting: eliciting preferences and expectations, the process of shared decision making in relation to treatment options and the level of involvement of patients and carers; (iv) individualized management: guiding principles on optimization of treatment benefits over possible harms, treatment communication and the information content of medication/care plans; (v) monitoring and follow-up: strategies in care planning, self-management and medication-related aspects, communication with patients including safety instructions and adherence, coordination of care regarding referral and discharge management, medication appropriateness and safety concerns. The spectrum of clinical and self-management issues varied from guiding principles to specific recommendations and tools providing actionable support. The limited availability of reliable risk prediction models, feasible interventions of proven effectiveness and decision aids, and limited consensus on appropriate outcomes of care highlight major research deficits. An integrated approach to both multimorbidity and polypharmacy should be considered in future guidelines.

The French PROMIS-29. Psychometric validation and population reference values.

BACKGROUND: PROMIS-29 is a new generic standardized questionnaire measuring self-reported health status. It was developed as part of the Patient Reported Outcome Measurement Information System (PROMIS) in the United States. The objective of this study was to carry out the psychometric validation of a French-language version of PROMIS-29 and to establish general population reference values for France. METHODS: Quota sampling was conducted by an independent polling company (Ipsos) to obtain a general population sample (n=1,501) representative with regards to: gender, age, occupation, region, and population density of the place of residence. Data collected included the results of the questionnaires PROMIS-29 and Short Form Health Survey (SF-36), the presence of selected chronic diseases, and socio-demographic information. RESULTS: The French PROMIS-29 demonstrated excellent factorial validity, confirming the 7-factor model of the original PROMIS-29. The use of modern measurement methods indicated that the PROMIS-29 scales satisfy the important characteristics of unidimensionality and, for five of the seven composite scales, invariance across age, educational level and gender. Gender and age specific (10-year intervals) reference values were generated for PROMIS-29 use in France. CONCLUSION: The French version of PROMIS-29 is a valid and reliable measure of self-reported health status in the French population. The instrument's sensitivity to change needs to be evaluated before its use in longitudinal studies can be recommended.

Patient-reported outcomes: pathways to better health, better services, and better societies.

While the use of PROs in research is well established, many challenges lie ahead as their use is extended to other applications. There is consensus that health outcome evaluations that include PROs along with clinician-reported outcomes and administrative data are necessary to inform clinical and policy decisions. The initiatives presented in this paper underline evolving recognition that PROs play a unique role in adding the patient perspective alongside clinical (e.g., blood pressure) and organizational (e.g., admission rates) indicators for evaluating the effects of new products, selecting treatments, evaluating quality of care, and monitoring the health of the population. In this paper, we first explore the use of PRO measures to support drug approval and labeling claims. We critically evaluate the evidence and challenges associated with using PRO measures to improve healthcare delivery at individual and population levels. We further discuss the challenges associated with selecting from the abundance of measures available, opportunities afforded by agreeing on common metrics for constructs of interest, and the importance of establishing an evidence base that supports integrating PRO measures across the healthcare system to improve outcomes. We conclude that the integration of PROs as a key end point within individual patient care, healthcare organization and program performance evaluations, and population surveillance will be essential for evaluating whether increased healthcare expenditure is translating into better health outcomes.

Using health status to measure NHS performance: another step into the dark for the health reform in England.

The National Health Service in England is moving away from targets based on processes of care and focusing on patient outcomes. This vision is operationalised in the recently published NHS Outcomes Framework, which includes the generalised use of Patient Reported Outcomes (health status and quality of life) as measures of population health at the provider level. This is the first time that such a bold initiative is attempted in the UK and it is not without risks. In this article we elaborate on our experience on the use of Patient Reported Outcomes and identify challenges and likely implications of this approach and suggest less disruptive alternatives.

Brief report: The KIDSCREEN follow-up study on Health-related Quality of Life (HRQoL) in Spanish children and adolescents. Pilot test and representativeness.

The Spanish KIDSCREEN follow-up study reassessed the Spanish baseline sample (n=840) of the European KIDSCREEN study 3 years later (2006). The aims of this paper were to describe the KIDSCREEN follow-up study and the pilot test, and to analyze participation rates and representativeness. Instruments included the KIDSCREEN-52 HRQoL measure and a set of scales including the possible explanatory variables. Focus groups and individual interviews were carried out in a pilot test. Participants were compared with non-participants at baseline, and also with Eurostat census data. Twenty-two out of 24 subjects were interviewed in the pilot test. Fifteen items needed to be modified after the pilot test. Participation rate reached 54% (n=454). Participants (mean age=12.71 years old) were on average 6 months younger than non-participants (p=0.03), and from more educated families. KIDSCREEN follow-up instrumentation seems adequate for collecting factors with potential influence on HRQoL. Follow-up respondents' representativeness seems to be acceptable.

Changes in health-related quality of life (HRQoL) in a population-based sample of children and adolescents after 3 years of follow-up.

OBJECTIVES: To assess changes in health-related quality of life (HRQoL) in children and adolescents over a 3-year period and to examine factors associated with change. METHODS: A representative sample of Spanish children and adolescents aged 8-18 years and their parents completed the KIDSCREEN-52 questionnaire at baseline and again after 3 years. Data were also collected on gender, pubertal development (PD), and family socio-economic status (SES). Change in HRQOL over time was evaluated using effect sizes (ES). Generalized estimating equations (GEE) were used to analyze associations among changes in KIDSCREEN scores, socio-demographic factors, and pubertal development. RESULTS: Response rate at follow-up was 54% (n = 454). Overall, HRQoL worsened in eight out of the ten KIDSCREEN dimensions, with ES ranging from -0.10 (Moods and Emotions) to -0.34 (Psychological Well-being). The decrease was most marked in the intermediate age group (13-17 years of age at follow-up) and in girls. In the GEE models, pubertal development more strongly impacted changes in girls than in boys. CONCLUSIONS: In this representative, population-based sample of children and adolescents, moderate decrements in HRQoL were observed after 3 years. Changes were particularly important among girls and in relation to pubertal development. These results could provide useful reference data for other longitudinal studies in population sub-groups.

The adaptation into Spanish of the Coddington Life Events Scales (CLES).

AIMS: To obtain a conceptually and psychometrically equivalent Spanish version of the Coddington Life Events Scales (CLES) for children and adolescents and to test their psychometric properties. METHODS: Forward and backward translations were performed. Comprehension, acceptability, and alternative translations were tested in focus groups and semi-structured interviews. An expert panel and the copyright holders of the original version were actively involved. Test-retest reliability [Intraclass Correlation Coefficient (ICC)] was assessed by administering the questionnaire on two occasions 3 months apart to children aged 12-14 years (n = 30). Construct validity was assessed by comparing children's responses with those of their parents (n = 19). The methods replicated those of the validation of the original version. RESULTS: Of the 53 CLES items translated, ten were found to be difficult to understand. Following back-translation, seven items were modified and a final version was obtained. Test-retest ICC reliability for total scores was 0.63. The ICC between children and parents was 0.42. Both results were very similar to those reported for the original version. CONCLUSIONS: These preliminary findings suggest that the Spanish version of the CLES is understandable and acceptable and that it is similar to the original in terms of validity and reliability. Although further validation is needed, it is recommended for use in research settings in Spain.

The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature.

OBJECTIVE: The purpose of this paper is to summarize the best evidence regarding the impact of providing patient-reported outcomes (PRO) information to health care professionals in daily clinical practice. METHODS: Systematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field). RESULTS: Out of 1,861 identified references published between 1978 and 2007, 34 articles corresponding to 28 original studies proved eligible. Most trials (19) were conducted in primary care settings performed in the USA (21) and assessed adult patients (25). Information provided to professionals included generic health status (10), mental health (14), and other (6). Most studies suffered from methodologic limitations, including analysis that did not correspond with the unit of allocation. In most trials, the impact of PRO was limited. Fifteen of 23 studies (65%) measuring process of care observed at least one significant result favoring the intervention, as did eight of 17 (47%) that measured outcomes of care. CONCLUSIONS: Methodological concerns limit the strength of inference regarding the impact of providing PRO information to clinicians. Results suggest great heterogeneity of impact; contexts and interventions that will yield important benefits remain to be clearly defined.

The impact of the VF-14 index, a perceived visual function measure, in the routine management of cataract patients.

BACKGROUND: Evidence about the impact of routine feedback of patient-reported outcomes is contradictory, and there is limited information regarding its use in the routine management of cataract patients. METHODS: The VF-14 Index was used to assess the visual function of 833 consecutive cataract patients, attending 19 ophthalmologists from public and private hospitals and primary care practices in Spain, in 1999-2000. In this before/after trial, the intervention included (1) an educational session, and (2) the provision of the VF-14 scores of all subsequent patients to the ophthalmologist. Mixed effects linear and logistic models were constructed to assess the effect on the process (correlation between patients' and physicians' assessments of visual function, appropriateness of surgery recommendation) and the outcome of care (satisfaction). RESULTS: The adjusted regression coefficient for the VF-14 score significantly increased after the intervention as a predictor of the ophthalmologist's assessment of visual function (beta coefficient: control 0.10 vs. intervention 0.35, p < 0.05). The intervention did not increase the probability of an appropriate medical decision (OR = 0.90; 95% CI: 0.42; 2,69) and it did not change patient satisfaction with care. CONCLUSIONS: Routine provision of education and feedback on the patient's VF-14 Index score significantly increases agreement between patients' and physicians' assessments of functional capacity. The lack of a beneficial effect on management or outcome suggests the need for a more intense intervention to change medical practice.

Comparative study between isolated intestinal perforation and necrotizing enterocolitis.

INTRODUCTION: Intestinal perforations in the neonatal period are usually related to necrotizing enterocolitis (NEC) or intestinal occlusion. Intestinal perforation in the absence of these conditions is called isolated perforation (IP). Several risk factors and pathogenic mechanisms have been suggested, and most of them are common to those classically attributed to NEC. AIM: To identify and compare the clinical and pathological features of IP and NEC. MATERIAL AND METHODS: We reviewed all cases of neonatal intestinal perforation and NEC in the last five years. Thirty-three patients were retrospectively classified into Group NEC: 24 cases, and Group IP: 9 cases. We collected multiple data as study variables: 1) General features; 2) Obstetric history; 3) Neonatal treatment; 4) Comorbidity; 5) Perforation features; 6) Treatment and outcome. RESULTS: Comparing the groups, we found statistical significant differences in isolated perforation cases with these risk factors: extreme prematurity, very low birth weight, abruptio placenta, intubation and neonatal mechanical ventilation, umbilical catheterization, precocious sepsis, and indomethacin therapy. A more precocious operation and a good prognosis also reached statistical significance. In the other hand, we found statistically significant differences in NEC with congenital cardiopathy (excluding isolated patent ductus arteriosus), with intestinal pneumatosis, with diffuse bowel involvement and a worse prognosis. Risk factors and pathologic findings seem to support an ischaemic pathogenesis in both diseases.

Content-based interpretation aids for health-related quality of life measures in clinical practice. An example for the visual function index (VF-14).

BACKGROUND: In spite of a well-established development of instruments, difficulty in interpreting health related quality of life scores may limit its use in clinical practice. OBJECTIVE: To develop generalizable interpretation aids for a measure of perceived functional visual status, the VF-14 index. DESIGN: Item Response Theory (Rasch analysis) was used to analyze the performance of VF-14 items. The 'ruler' aid was derived from the most difficult activity (item) a patient is able to do without difficulty; the 'clinical scenarios' aid, first identified all significantly different clusters of items within the index and then estimated the mean expected difficulty (responses) to perform a benchmark item in each cluster. SETTING: The study was conducted in four hospitals and six ambulatory cataract surgery centers in Barcelona, Spain. PATIENTS: One hundred and ninety-eight patients scheduled for first eye cataracts surgery. MEASUREMENTS: The self-reported VF-14 index and clinical measures were used. RESULTS: All VF-14 items were found unidimensional with three items showing only partial misfit. For a patient with a VF-14 Rasch score of 71, the 'ruler' aid indicated that 'doing fine handwork' would be the most requiring activity he/she would perform without difficulty. The 'clinical scenarios' aid estimated that such a patient would be unable to 'drive at night', would have some difficulty 'reading small print' and no difficulty 'doing fine handwork', 'watching TV' or 'recognizing people'. Concordance between modeled and observed responses was fair to substantial. CONCLUSIONS: Simple content-based interpretation aids for the VF-14 scores were developed that should facilitate its use in clinical practice. These aids should be easily generalizable to other quality of life instruments.

[Citizens opinions, experiences and perceptions about waiting lists for elective cataract surgery and hip and knee replacement. ]. / Opiniones, vivencias y percepciones de los ciudadanos en torno a las listas de espera para cirugía electiva de catarata y artroplastia de cadera y rodilla.

OBJECTIVES: The aim of this study is to describe the views, perceptions and personal experience around elective cataract and hip and knee replacement waiting lists in Catalonia in order to improve their management. DESIGN: Qualitative methodology: four focus groups for each procedure. PLACE: Conducted between February-March 2000 at the Catalan Health Services headquarters. PARTICIPANTS: Each focus group included consultants (ophtalmologists, orthopedic surgeons, rheumatologists, rehabilitators, GPs), other related health professionals (nurses, social workers, physiotherapists, opticians/optometrist, GPs), patients and relatives and general population. Participants were selected through researchers and the clinical scientific committees. All of them followed a pre-established inclusion criteria. MAIN MEASURES: The analysis of the information was performed using the content analysis technique (contents of sessions were transcripted and information classified according to themes). RESULTS: Ten themes were identified. Waiting lists were argued to be a consequence of lack of resources, bad management and conflict of interest among consultants. Overall, the health care authority responsibility for the solution was acknowledged, although some participants claim more citizen participation. Among proposed solutions, prevention and education, more resources and improved management were found. Furthermore, a better physician-patient communication was considered essential. All the groups disagreed with the implicit current prioritisation system, however none wanted to assume the responsibility. CONCLUSIONS: Citizen's perceptions and personal experiences point to a multifactorial approach to waiting lists management, which would ameliorate the problem and lead to a better social acceptance.

Provision of feedback on perceived health status to health care professionals: a systematic review of its impact.

OBJECTIVE: To assess the impact on the process and the outcomes of care of feeding back information on perceived health status to health care professionals in clinical practice. DESIGN: Systematic review of controlled trials. DATA IDENTIFICATION: Search in electronic databases (MEDLINE 1966-1997), manual searches, and requests to experts in the field. DATA ANALYSIS: Differences between intervention and control group were considered in process of care (use of health services, diagnosis, and treatment), patient outcomes (health status), and patient satisfaction. In a subgroup of 13 interventions that dealt with the provision of feedback about the patient's mental health, the impact on the process of care was subjected to meta-analysis. RESULTS: We identified 21 studies that satisfied the selection criteria. Eleven of 20 (55%) found significant differences (P <0.05) in at least 1 of the process indicators in favor of the intervention group. Of 11 trials that assessed patient outcomes, only 4 (36%) detected significant improvements. A similar trend but lower percentages were observed among the 8 interventions that provided general health status information. Eleven interventions that evaluated feedback information about the patient's mental health status showed a higher rate of diagnosis in the intervention group (combined odds ratio [OR]=1.91; 95% confidence interval [CI] 1.28 to 2.83). Seven of 9 studies evaluating treatment failed to show an effect on this indicator (combined OR=1.15; 95% CI 0.76 to 1.75). CONCLUSIONS: The provision of feedback on perceived health status to health professionals seems to have an effect on the process of care but not on patient functional or health status. This is especially true with regard to mental health status information. Nevertheless, there is still need for a more through evaluation of this type of intervention.

[Benedictus Textor and the teaching of Dioscorides' De materia medica]. / Benedictus Textor y la enseñanza de la "Materia Médica" de Dioscorides.

Exhaustive study of Benedictus Textor's Stirpium differentiae (1534), a work endeavouring at this time to convey systematically to students of medicine the Galenic properties of plants; a scientific adaptation of the meaning of Dioscorides' work.