Mireia Espallargues

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

ObjectiveThe 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.MethodsSystematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field).ResultsOut 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.ConclusionsMethodological 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.

Identifying Bone-Mass-Related Risk Factors for Fracture to Guide Bone Densitometry Measurements: A Systematic Review of the Literature

Abstract: Available evidence suggests that fracture prediction with bone densitometry may improve when used on people at high risk of osteoporotic fractures. The objectives of this literature review were: (1) to identify risk factors for fracture that are associated with the development of a low bone mass for both men and women; (2) to describe and assess the relationship between these factors and the risk of fracture; and (3) to classify them according to the strength of their association with fracture incidence. Studies were identified from MEDLINE (1982–1997), HealthSTAR (1975–1997) and The Cochrane Library (1997) databases. Pre-stated inclusion criteria (original analytic studies assessing risk factors for osteoporotic fractures in men and women) and methodologic quality were assessed by two independent investigators. Information on the study design and analysis, characteristics of participants, exposure (risk factor) and outcome measures (relative risk and odds ratios for fracture incidence), control for potential confounding factors and risk estimates was extracted using a standardized protocol. Qualitative and meta-analytic techniques were used for data synthesis. As a result, risk factors were classified into three groups according to their strength of association with fracture: high risk (RR≥2), moderate risk (1<RR<2) and no risk or protective (RR≤1). Of approximately 80 risk factors identified from 94 cohort and 72 case-control studies, 15% were classified in the high-risk group, including low body weight, loss of weight, physical inactivity, the consumption of corticosteroids or anticonvulsants, primary hyperparathyroidism, diabetes mellitus type I, anorexia nervosa, gastrectomy, pernicious anemia, and aging (>70–80 years). Eighteen percent and 8% of risk factors were classified in the moderate and no risk group respectively, whereas 60% showed either a lack of scientific evidence confirming their association with fracture or contradictory results. An efficient strategy for bone densitometry provision may thus be its selective use in those individuals who present with several strong or moderate risk factors for fracture related to bone mass loss.

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 patients 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 patients 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.

Intraoperative clinical practice and risk of early complications after cataract extraction in the United States, Canada, Denmark, and Spain

OBJECTIVE To examine variation in intraoperative clinical practice and rates of adverse events after cataract surgery across four different healthcare systems. DESIGN Multicenter cohort study. PARTICIPANTS Patients were recruited from ophthalmic clinics in the United States (n = 75); in the Province of Manitoba, Canada (n = 12); in Denmark (n = 17); and the City of Barcelona, Spain (n = 10). In all, 1420 patients undergoing first eye cataract surgery were enrolled, with preoperative, perioperative, and postoperative clinical data collected on 1344 patients (95%). MAIN OUTCOME MEASURES Occurrence of 23 specified intraoperative and early postoperative adverse events was measured. Four-month postoperative visual acuity outcome also was measured. RESULTS Phacoemulsification was performed in two thirds of the extractions in the United States and Manitoba, in one third in Denmark, and in 3% in Barcelona (P < 0.001). More than 96% of extractions in North America and Denmark were performed with the patient under local anesthesia, whereas general anesthesia was used for 38% of extractions in Barcelona (P < 0.001). Rates of intraoperative adverse events were 11% to 12.8% in Manitoba, Denmark, and Barcelona and significantly lower in the United States (6%), mainly because of a lower rate of capsular rupture (P < 0.01). Significantly higher rates of early postoperative events were seen in the United States (18.8%) and Manitoba (20.4%) compared to Denmark (7.9%) and Barcelona (5%) (P < 0.001). The differences among sites in rates of events could not be explained by differences in recorded patient characteristics or surgical techniques. The occurrence of perioperative events was significantly associated with a worse 4-month visual outcome. CONCLUSION The observed variation in clinical practice might represent a general trend of a slower diffusion of new medical technology in Europe compared with that of North America. Rates of intraoperative and early postoperative events varied significantly across sites.

Arthroplasty registers: A review of international experiences

OBJECTIVES Registers have proven to be a valuable instrument in the evaluation of arthroplasty procedures and the performance of implants. The aim of this study was to describe the structure, functioning, and content of arthroplasty registers in Europe and other parts of the world. METHODS A search of technical reports was carried out through the Internet and in Medline/PubMed. The exhaustiveness of the information was confirmed using the links to Web pages of other registers and contacts with key people. Aims, methods in data collection and evaluation, internal structure and organization, participants, validity of the data, and other variables were assessed for each arthroplasty register using a qualitative content analysis of the texts. RESULTS Fifteen arthroplasty registers were identified which published sufficient information to conduct a comparative analysis. Eight additional registers were identified but no information was available on the Internet or in English. Most registers were initiatives of an orthopaedic society receiving governmental funding. Data were collected using standardized clinical forms and additional information from clinical-administrative datasets or other registers (mortality, implant costs, hip fractures). The main outcome measure of these registers is survival of the prostheses. Registers use the Internet and their annual reports as the main strategy for the dissemination and feed-back of their results. CONCLUSIONS Scientific or professional societies and the public health administration should collaborate in the development of arthroplasty registers. To adequately assess the results of observational data information on the structure, the process of arthroplasty interventions and patients characteristics should be collected.

Variation in indications for cataract surgery in the United States, Denmark, Canada, and Spain: results from the International Cataract Surgery Outcomes Study

BACKGROUND/AIMS International comparisons of clinical practice may help in assessing the magnitude and possible causes of variation in cross national healthcare utilisation. With this aim, the indications for cataract surgery in the United States, Denmark, the province of Manitoba (Canada), and the city of Barcelona (Spain) were compared. METHODS In a prospective multicentre study, patients scheduled for first eye cataract surgery and aged 50 years or older were enrolled consecutively. From the United States 766 patients were enrolled; from Denmark 291; from Manitoba 152; and from Barcelona 200. Indication for surgery was measured as preoperative visual status of patients enlisted for cataract surgery. Main variables were preoperative visual acuity in operative eye, the VF-14 score (an index of functional impairment in patients with cataract) and ocular comorbidity. RESULTS Mean visual acuity were 0.23 (USA), 0.17 (Denmark), 0.15 (Manitoba), and 0.07 (Barcelona) (p<0.001). When restricting the sample to eyes with normal retina and macula, no significant difference between United States and Denmark was observed (p>0.05). Mean VF-14 scores were 76 (USA), 76 (Denmark), 71 (Manitoba), and 64 (Barcelona) (p<0.001). CONCLUSION Similar indications for cataract surgery were found in the United States and Denmark. Significantly more restricted indications were observed in Manitoba and Barcelona. Possible explanations for the results are discussed, including differences in sociodemographic characteristics, access to care, surgeons’ willingness to operate, and patient demand.

Efficacy and safety of viscosupplementation with Hylan G-F 20 for the treatment of knee osteoarthritis: a systematic review.

OBJECTIVES To review the scientific evidence on the efficacy, effectiveness, and safety of intra-articular injections of Hylan G-F 20 for the treatment of knee osteoarthritis. METHODS Systematic review of experimental and observational studies performed in humans up to December 1999. Qualitative and quantitative (meta-analytic) techniques were used for data synthesis. RESULTS A single course of intra-articular Hylan G-F 20 provides a statistically significant and clinically relevant short-term decrease of the painful symptomatology of knee osteoarthritis and improves joint function. It also seems to delay the need for knee replacement, if results observed in noncontrolled studies are confirmed. Hylan G-F 20 has a comparable efficacy to that of oral NSAID, and a smaller risk of gastrointestinal adverse effects. It seems to be well tolerated and safe, but the short follow-up in most studies limits any extrapolation of the effectiveness and safety over the longer term. There is also scarce evidence on the effect of multiple courses of Hylan G-F 20, and the scientific rigor of both experimental and nonexperimental studies reviewed is somewhat limited. CONCLUSIONS Whereas there is good quality scientific evidence showing that Hylan G-F 20 is a safe and well-tolerated therapy providing a short-term decrease of the pain symptoms while improving joint function, the delay of the need for knee replacement as well as the durability of the effect over the longer term have only been demonstrated in noncontrolled clinical series. The available evidence is not sufficient to reach firm conclusions on the effect of multiple courses of intra-articular injections of Hylan G-F 20 on health outcomes.

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.

Wide Social Participation in Prioritizing Patients on Waiting Lists for Joint Replacement: A Conjoint Analysis

Objective. The aim was to develop a priority scoring system for patients on waiting lists for joint replacement based on a wide social participation, and to analyze the differences among participants. Methods. Conjoint analysis. Focus groups in combination with a nominal technique were employed to identify the priority criteria (N=36). A rank-ordered logit model was then applied for scoring estimations. Participants (N=860) represented: consultants, allied-health professionals, patients and their relatives, and the general population of Catalonia. Results. Clinical and social criteria were selected, and their relative importance (over 100 points) was: pain (33), difficulty in doing activities of daily living (21), disease severity (18), limitations on ability to work (10), having someone to look after the patient (9), being a caregiver (6), and recovery probability (4). Estimated criteria coefficients had the expected positive sign and all were statistically significant (P < 0.001). There were differences between groups; pain was rated higher by patients/relatives, and difficulty in doing activities was rated lower by patients/relatives and the general public. Most interaction terms for these criteria and groups were significant (P < 0.001). Consultants and allied-health professionals had the most similar prioritization pattern (r=0.97). Conclusion. Both clinical and social criteria are considered for prioritization of joint replacement surgery from a wide social perspective. The preference among professional and social groups varies and this might impact the result of patient prioritization. A wide social participation for obtaining adequate prioritizing systems for patients on waiting lists is desirable.

Artroplastias de cadera y rodilla en Cataluña desde 1994 a 2005

Objetivo: Las artroplastias de cadera y rodilla estan entre los procedimientos quirurgicos mas frecuentes en Cataluna. El objetivo de este estudio fue describir su evolucion y los cambios en sus caracteristicas entre 1994 y 2005. Metodos: Estudio transversal de altas por artroplastias totales primarias de cadera (ATC) o rodilla (ATR) y de revision seleccionadas del Conjunto Minimo Basico de Datos al Alta Hospitalaria: codigos 81.51, 81.53, 81.54 y 81.55 (CIE-9-MC). Se calcularon las tasas de ATC y ATR estandarizadas por edad y sexo, y la carga de revision, analizando su evolucion mediante la regresion de joinpoint. Se definieron 4 periodos y se analizaron las caracteristicas de los pacientes y de los episodios asistenciales comparando los periodos 4 y 1 a partir de modelos de regresion logistica. Resultados: Las tasas por 10.000 habitantes se incrementaron entre 1994 y 2000 en ATC, pasando de 4,1 a 6,6, y entre 1994 y 2005 en ATR, pasando de 2,6 a 15,5. La carga de revision aumento en la cadera hasta 2001 y en la rodilla durante todo el periodo de estudio. El principal motivo de artroplastia primaria fue la artrosis. Los pacientes de 75 anos o mayores y la comorbilidad aumentaron en ATC y ATR. Conclusiones: El incremento de las tasas y el cambio del perfil de los pacientes reflejan una posible ampliacion de los criterios de indicacion. El previsible aumento de la cirugia de revision se podria reducir mediante sistemas de evaluacion de la supervivencia de las protesis y el desarrollo de guias de practica clinica.