Evaluation of the Quality of Prognosis Studies in Systematic Reviews Positive affect, anhedonia, and compliance with self-care in patients with chronic heart failure. Cognitive impairment and self-care in heart failure The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials Patient participation in patients with heart failure receiving structured home care - a prospective longitudinal study Effect of a medication-taking behavior feedback theory-based intervention on outcomes in patients with heart failure. Predictors of Better Self-Care in Patients with Heart Failure after Six Months of Follow-Up Home Visits Telephone Follow-Up of Self-Care Behaviour after a Single Session Education of Patients with Heart Failure in Primary Health Care Trajectories of heart failure self-care management and changes in quality of life
Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items OBJECTIVE Optimal self-care is crucial in patients with chronic heart failure ( HF ) . While the focus of research has been on negative mood states , adequate psychological re sources may be required to successfully engage in HF self-care . Therefore , the longitudinal associations of multiple positive affect measures in explaining HF self-care including consulting behavior were examined while adjusting for depressive symptoms and potential covariates ( e.g. , disease severity ) . METHODS In this prospect i ve cohort study , 238 patients ( mean age : 66.9 ± 8.6 years , 78 % men ) , with chronic HF completed question naires at baseline and 1-year follow-up .  Positive affect was assessed with the Positive and Negative Affect Schedule ( PANAS ) and the Global Mood Scale ( GMS ) . Anhedonia , i.e. diminished interest or pleasure , was assessed with a subscale of the Hospital Anxiety and Depression Scale ( HADS ) . The 9-item European Heart Failure Self-care Behaviour scale  was completed to assess HF self-care including consultation behavior . RESULTS Linear mixed modeling results showed that anhedonia was most strongly associated with both poor self-care ( estimate=-.72 , P<.001 ) and consulting behavior ( estimate=-.44 , P<.001 ) over time , after adjustment for covariates and depressive symptoms . GMS positive affect was related to better HF self-care adjusting for st and ard depressive symptoms but not when adjusting for anhedonia . PANAS positive affect was not independently related to self-care . CONCLUSION Anhedonia was associated with worse compliance with self-care among chronic HF patients over time , irrespective of disease severity and depression . Associations between positive affect and self-care were dependent on the measures used in multivariable analyses Background Heart failure ( HF ) is a prevalent chronic disease in older adults that requires extensive self-care to prevent decompensation and hospitalization . Cognitive impairment may impact the ability to perform HF self-care activities . We examined the association between cognitive impairment and adherence to self-care in patients hospitalized for acute HF . Design Prospect i ve cohort study . Setting and participants A total of 577 patients ( mean age = 71 years , 44 % female ) hospitalized for HF at five medical centers in the United States and Canada . Measurements and methods Participants were interviewed for information on self-reported adherence to self-care using the European Heart Failure Self-care Behaviour Scale . We assessed cognitive impairment in three domains ( memory , processing speed , and executive function ) using st and ardized measures . Patients ’ demographic and clinical characteristics were obtained through medical record review . Multivariable linear regression was used to examine the association between cognitive impairment and self-care practice s adjusting for demographic and clinical factors . Results A total of 453 patients ( 79 % ) were impaired in at least one cognitive domain . Average adherence to self-care activities among patients with global cognitive impairment did not differ significantly from those without cognitive impairment ( 30.5 versus 29.6 ; 45-point scale ) . However , impaired memory was associated with lower self-care scores ( P = 0.006 ) in multivariable models . Conclusion Cognitive impairment is highly prevalent among older patients hospitalized for HF .  Memory impairment is associated with poorer adherence to self-care practice s. Screening for memory impairment in patients with HF may help to identify patients at risk for poor self-care who may benefit from tailored disease management programs Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background Patient participation is important for improving outcomes , respect for self-determination and legal aspects in care . However , how patients with heart failure view participation and which factors may be associated with participation is not known . The aim of this study was therefore to describe the influence of structured home care on patient participation over time in patients diagnosed with heart failure , and to explore factors associated with participation in care . Methods The study had a prospect i ve pre-post longitudinal design evaluating the influence of structured home care on participation in patients at four different home care units . Patient participation was measured using 3 scales and 1 single item . Self-care behavior , knowledge , symptoms of depression , socio- demographic and clinical characteristics were measured to explore factors associated with patient participation . Repeated measure ANOVA was used to describe change over time , and stepwise regression analyses were used to explore factors associated with patient participation . Results One hundred patients receiving structured heart failure home care were included . Mean age was 82 years , 38 were women and 80 were in New York Heart Association functional class III . One aspect of participation , received information , showed a significant change over time and had increased at both six and twelve months . Better self-care behavior was associated with all four scales measuring different aspects of participation . Experiencing lower degree of symptoms of depression , having better knowledge , being of male sex , being of lower age , cohabiting and having home help services were associated with one or two of the four scales measuring different aspects of participation . Conclusion Patients experienced a fairly high level of satisfaction with participation in care at baseline , and there was a significant improvement over time for participation with regard to received information after being admitted to structured home care . Higher level of patient participation was consistently associated with better self-care behavior . This study shows that patient participation may need to be further focused upon , and that the association with self-care may be interesting to target in future interventions BACKGROUND Medication nonadherence contributes to hospitalization and mortality , yet there have been few interventions tested that improve adherence and reduce hospitalization and mortality in heart failure ( HF ) . Our objective was to determine whether an education intervention improved medication adherence and cardiac event-free survival . METHODS AND RESULTS A r and omized controlled trial was conducted on 82 HF patients . The intervention was based on the theory of planned behavior ( TPB ) and included feedback of medication-taking behavior using the Medication Event Monitoring System ( MEMS ) . Patients were assigned to one of three groups : 1 ) theory-based education plus MEMS feedback ; 2 ) theory-based education only ; or 3 ) usual care ( control ) . Cardiac events were collected for 9 months . Patients in both intervention groups were more adherent over follow-up compared with the control group . In Cox regression , patients in either intervention group had a longer event-free survival compared with those in the control group before and after controlling age , marital status , financial status , ejection fraction , New York Heart Association functional class , angiotensin-converting enzyme inhibitor use , and presence or absence of a significant other during the intervention ( P < .05 ) . CONCLUSIONS Use of an intervention based on the TPB improves medication adherence and outcomes in patients with HF and therefore offers promise as a clinical ly applicable intervention to help patients with HF to adhere to their prescribed regimen This study aim ed to examine the predictors of better self-care behavior in patients with heart failure ( HF ) in a home visiting program .  This is a longitudinal study nested in a r and omized controlled trial ( IS RCT N01213862 ) in which the home-based educational intervention consisted of a six-month followup that included four home visits by a nurse , interspersed with four telephone calls .  The self-care score was measured at baseline and at six months using the Brazilian version of the European Heart Failure Self-Care Behaviour Scale . The associations included eight variables : age , sex , schooling , having received the intervention , social support , income , comorbidities , and symptom severity . A simple linear regression model was developed using significant variables ( P ≤ 0.20 ) , followed by a multivariate model to determine the predictors of better self-care .  One hundred eighty-eight patients completed the study . A better self-care behavior was associated with patients who received intervention ( P < 0.001 ) , had more years of schooling ( P = 0.016 ) , and had more comorbidities ( P = 0.008 ) . Having received the intervention ( P < 0.001 ) and having a greater number of comorbidities ( P = 0.038 ) were predictors of better self-care . In the multivariate regression model , being in the intervention group and having more comorbidities were a predictor of better self-care Background : Improved self-care behaviour is a goal in educational programmes for patients with heart failure , especially in regard to daily self-weighing and salt and fluid restriction . Aims : The objectives of the present study were to : ( 1 ) describe self-care with special regard to daily self-weighing and salt and fluid restriction in patients with heart failure in primary health care , during one year of monthly telephone follow-up after a single session education , ( 2 ) to describe gender differences in regard to self-care and ( 3 ) to investigate if self-care was associated with health-related quality of life . Methods : The present analysis is a subgroup analysis of a larger r and omised trial . After one intensive educational session , a primary health care nurse evaluated 60 patients ( mean age 79 years , 52 % males , 60 % in New York Heart Association class III – IV ) by monthly telephone follow-up during 12 months . Results : The intervention had no effect on quality of life measured by EuroQol 5D and no significant associations were found between quality of life and self-care behaviour . Self-care behaviour measured by The European Self-care Behaviour Scale remained unchanged throughout the study period . No significant gender differences were shown but women had a tendency to improve adherence to daily weight control between 3- and 12 months . Conclusion : The self-care behaviour and quality of life in patients with heart failure did not change during one year of monthly telephone follow-up after a single session education and this indicates a need for more extensive interventions to obtain improved self-care behaviour in these patients Introduction : Heart failure patients vary considerably in their self-care management behaviors ( i.e. recognizing and responding to symptoms ) . The goal of this study was to identify unique patterns of change in heart failure self-care management and quantify associations between self-care management and quality of life ( HRQOL ) over time . Methods : A prospect i ve cohort study among adults with symptomatic heart failure was design ed to measure changes in  self-care management ( Self-care of Heart Failure Index ) and HRQOL ( Kansas City Cardiomyopathy Question naire ) over six months . Growth mixture modeling was used to identify unique trajectories of change in self-care management . Results : The mean age ( n=146 ) was 57 years , 70 % were male , and 41 % had class II heart failure . Two trajectories of self-care management were identified ( entropy = 0.88 ) . The larger trajectory ( 73.3 % ) was characterized by a significant decline in self-care management over time and no change in HRQOL . The smaller trajectory ( 26.7 % ) was characterized by marked improvements in self-care management and HRQOL . Changes in heart failure self-care management occurred in the absence of change in routine self-care maintenance behaviors , functional classification , and physical and psychological symptoms . Patients with greater physical symptoms at enrollment ( odds ratio ( OR ) = 1.04 , p=0.037 ) , larger left ventricles ( OR=1.50 , p=0.044 ) , and ischemic heart failure ( OR=3.84 , p=0.014 ) were more likely to have the declining trajectory of self-care management . Higher levels of depression at enrollment were associated with reduced odds of having a decline in self-care management over time ( OR=0.85 , p<0.001 ) . Conclusions : There are unique and clinical ly-relevant trajectories of change in heart failure self-care management that are associated with differences in HRQOL
Background : Self-care is an important element in the comprehensive management of patients with heart failure .
The European Heart Failure Self-Care Behaviour Scale ( EHFScBS ) was developed and tested to measure behaviours performed by the heart failure patients to maintain life , healthy functioning , and wellbeing .
Aims : The purpose of this review was to evaluate the importance of factors associated with heart failure self-care behaviours as measured by the EHFScBS .