Individual quality of life is not correlated with health-related quality of life or physical function in patients with amyotrophic lateral sclerosis. Quality of life before and one year following stem cell transplantation using an individualized and a standardized instrument. Individual versus standard quality of life assessment in a phase II clinical trial in mesothelioma patients: feasibility and responsiveness to clinical changes. The experience of using the SEIQoL-DW with patients with advanced chronic obstructive pulmonary disease (COPD): issues of process and outcome Individual quality of life in long-term survivors of Hodgkin's lymphoma – a comparative study Pharmaceutical intervention in the care of cystic fibrosis patients. The feasibility of a single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease Determinants of Health-Related Quality of Life in Long-Term Survivors of Hodgkin's Lymphoma A pilot cluster randomized controlled trial of structured goal-setting following stroke Individual quality of life in patients undergoing hip replacement Response shift masks the treatment impact on patient reported outcomes (PROs): the example of individual quality of life in edentulous patients A multidisciplinary primary care team consultation in a socio-economically deprived community: An exploratory randomised controlled trial Comparison of two modes of administration of a personalized quality of life scale in a longitudinal study of total hip arthroplasty. Development of a brief measure to assess quality of life in obesity. Myometrial invasion in endometrial cancer: diagnostic accuracy of diffusion-weighted 3.0-T MR imaging--initial experience. Editorial: an author's checklist for measure development and validation manuscripts. Quality of descriptions of treatments: a review of published randomised controlled trials Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. Psychosocial Outcomes of Telemedicine Case Management for Elderly Patients With Diabetes The use of life review to enhance quality of life of people living with AIDS: A feasibility study Systematic Review: Inspiratory Muscle Training in Patients with Chronic Obstructive Pulmonary Disease: The State of the Evidence Multinational study of reliability and validity of the King's Health Questionnaire in patients with overactive bladder Effects of school-based interventions on mental health stigmatization: a systematic review
We compared the change over time of individual quality of life ( QOL ) versus health-related QOL ( HRQOL ) and functional status in palliative care patients with amyotrophic lateral sclerosis ( ALS ) . Forty-two patients with ALS performed the following assessment s : the ALS functional rating scale ( ALSFRS ) , the Sickness Impact Profile ( SIP ) , the Short Form 36 ( SF-36 ) , and the  Schedule for the Evaluation of Individual QOL-Direct Weighting  ( SEIQOL-DW ) . The SF-36 and the SEIQOL-DW were assigned at r and om . Patients were examined at least three times at 2-month intervals . There was a significant decrease from visit 1 to 3 ( 4-month period ) in the function-based values of the SIP , SF-36 , and ALSFRS . Despite this progressive decline of physical function and HRQOL , individual QOL as assessed by the SEIQOL-DW remained stable throughout the observation period . Correspondingly , there was a clear correlation between the ALSFRS , the SIP , and the SF-36 , but no correlation between these scales and the SEIQOL-DW . The QOL domains most often named in the SEIQOL-DW were family , friends/social life , health , and profession . Thus , individual QOL appears to be largely independent from physical function in severely ill patients with ALS . Because of the characteristics of the scale , assessment of individual QOL may have an interventional value in palliative care OBJECTIVE The aim was to prospect ively measure quality of life in patients with malignant blood disorders following stem cell transplantation ( SCT ) using an individualized and a st and ardized measure . METHODS Twenty-two consecutive patients were assessed before and one year following SCT , using a generic and disease-related version of the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting ( SEIQoL-DW ) and the EORTC QLQ-C30 . Results of the QLQ-C30 were compared with Swedish norm values . RESULTS A majority of the patients reported concerns related to health before as well as one year after SCT , recorded by both instruments . Mean scores produced by the SEIQoL-DW , and four scales of the EORTC QLQ-C30 , showed a change over time , indicating improved quality of life one year after SCT . In comparison with Swedish norm values for the EORTC QLQ-C30 , SCT recipients reported a worse functioning . CONCLUSIONS In addition to well-known disease and treatment-related problems , areas not typically included in st and ardized instruments were nominated in the disease-related SEIQoL-DW . Such areas included positive aspects , e.g. a changed view of life and oneself . The results support the use of the generic and disease-related SEIQoL-DW to achieve a comprehensive picture of patient 's clinical situation under treatment or when recovering from illness BACKGROUND In patients with malignant pleural mesothelioma undergoing a multimodality therapy , treatment toxicity may outweigh the benefit of progression-free survival . The subjective experience across different treatment phases is an important clinical outcome . This study compares a st and ard with an individual quality of life ( QoL ) measure used in a multi-center phase II trial . PATIENTS AND METHODS Sixty-one patients with stage I-III technically operable pleural mesothelioma were treated with preoperative chemotherapy , followed by pleuropneumonectomy and subsequent radiotherapy .  QoL was assessed at baseline , at day 1 of cycle 3 , and 1 , 3 and 6 months post-surgery by using the  Rotterdam Symptom Checklist  ( RSCL ) and the Schedule for the Evaluation of Quality of Life-Direct Weighting  ( SEIQoL-DW ) , a measure that is based on five individually nominated and weighted QoL-domains . RESULTS Completion rates were 98 % ( RSCL ) and 92 % ( SEIQoL ) at baseline and 98%/89 % at cycle 3 , respectively . Of the operated patients ( N=45 ) RSCL and SEIQoL were available from 86%/72 % , 93%/74 % , and 94%/76 % at months 1 , 3 , and 6 post-surgery . Average assessment time for the SEIQoL was 24min compared to 8min needed for the RSCL . Median changes from baseline indicate that both RSCL QoL overall score and SEIQoL index remained stable during chemotherapy with a clinical ly significant deterioration ( change > or=8 points ) 1 month after surgery ( median change of -66 and -14 for RSCL and SEIQoL , respectively ) . RSCL QoL overall scores improved thereafter , but remained beneath baseline level until 6 months after surgery . SEIQoL scores improved to baseline-level at month 3 after surgery , but worsened again at month 6 . RSCL QoL overall score and SEIQoL index were moderately correlated at baseline ( r=.30 ; p < or=.05 ) and at 6-month follow-up ( r=.42 ; p < or=.05 ) but not at the other time points . CONCLUSION The SEIQoL assessment seems to be feasible within a phase II clinical trial , but may require more effort from staff . More distinctive QoL changes in accordance with clinical changes were measured with the RSCL . Our findings suggest that the two measures are not interchangeable : the RSCL is to favor when mainly information related to the course of disease- and treatment is of interest Purpose To report the experience of using the SEIQoL-DW for the measurement of quality of life with patients with advanced COPD and consider its feasibility , acceptability and appropriateness for a Phase III r and omised controlled trial ( RCT ) . Methods The SEIQoL-DW was administered according to its instructions within a Phase II RCT 3–5 times per patient , across 13 patients and the process audio-recorded . Quantitative and qualitative criteria were used to assess feasibility , acceptability and appropriateness . Qualitative analysis of the transcripts and fieldwork notes was conducted using Framework Analysis . Results The SEIQoL-DW steps ( of identifying five quality of life cues , rating their functioning and importance ) were completed at 48/51 interviews . However , some respondents were overwhelmed by the scripted introduction , experienced difficulty with cue identification , and focused only on certain types of cues ( Step 1 ) ; some had difficulty interpreting and rating the concept of Step 2 ; and some had difficulty interpreting ‘ importance ’ and manipulating the SEIQoL-DW disc ( Step 3 ) . Conclusions Patients with advanced COPD were able to complete the SEIQoL-DW but analysis of its administration identified practical and conceptual concerns which question the validity of the results obtained . Suggestions for the development of the SEIQoL-DW and future feasibility studies are given This study aim ed to use an individual approach in evaluating QoL in long-term survivors of Hodgkin 's lymphoma ( HL ) and their view of what impact the disease has had on life using an extended version of the The Schedule for the Evaluation of the Individual quality of life-Direct Weighting ( SEIQoL-DW ) . Adult long-term survivors from HL ( n = 121 ) were compared with a r and omly selected sample of the general population in Stockholm ( n = 236 ) . The results showed that the most commonly nominated areas ( > 50 % of patients and controls ) important in life were family , personal health , work and relations to other people . The HL survivors mentioned leisure and finances less frequently than the controls . However , neither the current status in the different areas nor the QoL index score differed between survivors and controls . Thoughts and worries around disease , fatigue and loss of energy and late effects on skin and mucous membrane were the most commonly reported problems following HL . Sixty-six percent of the survivors reported a change in their view of life and of themselves . Demographic and disease characteristics did not influence the ratings of the chosen areas . In conclusion , long-term survivors of HL seem to have adapted well to the situation of having had a life-threatening disease and undergoing treatment , as measured with SEIQoL-DW . The extended Swedish version with a disease-specific module could be of great value when identifying specific issues that are important for the patient at time of evaluation In a prospect i ve , r and omised , cross-over study including cystic fibrosis patients with indications for HIVAT ( home intravenous antibiotic treatment ) the prospect of pharmaceutical intervention was investigated . A comparison between the use of disposable infusion devices with antibiotics from the pharmacy and when the patients prepared the drugs themselves was performed . During a first treatment course the patients received either infusion devices during 5 days or reconstituted the drugs themselves during 5 days , or vice versa . During a second treatment course the order was the reversed . Eight patients were included , out of which six completed the original design as a cross-over study , yielding a total of 550 doses of antibiotics . The patients preferred infusion devices from the pharmacy prepared according to GMP ( Good Manufacturing Practice ) as opposed to reconstituting the antibiotics themselves . Points of view presented included no anxiety over the correct dosage of drugs and less disruption of family and social life . In a practical sense , portable devices are more expensive than the preparation of the drugs by the patients themselves . However , when comparing with in-hospital treatment the direct costs for a hospital stay exceed that of the devices . Another part of the study evaluated the quality of life using a modified form of SEIQoL-DW ( Schedule for the Evaluation of Individual Quality of Life - Direct Weighting ) . Twenty patients took part in the study and the overall quality of life scores increased significantly when patients received infusion devices compared to reconstituting the drugs themselves Background The Breathlessness Intervention Service is a novel service for patients with intractable breathlessness regardless of aetiology . It is being evaluated using the Medical Research Council 's framework for the evaluation of complex interventions . This paper describes the feasibility results of Phase II : a single-blinded fast-track pragmatic r and omised controlled trial . Methods A single-blinded fast-track pragmatic r and omised controlled trial was conducted for patients with chronic obstructive pulmonary disease referred to the service . Patients were r and omised to either receive the intervention immediately for an eight-week period , or receive the intervention after an eight-week period on a waiting list during which time they received st and ard care . Outcomes examined included : response rates to the trial ; response rates to the individual question naires and items ; comments relating to the trial functioning made during interviews with patients , carers , referrers and service providers ; and , research er fieldwork notes . Results 16 of the 20 eligible patients agreed to participate in a recruitment visit ( 16/20 ) ; 14 respondents went on to complete a recruitment visit/baseline interview . The majority of those who completed a recruitment visit/baseline interview completed the RCT protocol ( 13/14 ) ; 12 of their carers were recruited and completed the protocol . An unblinding rate of 6/25 respondents ( patients and carers ) was identified . Missing data were minimal and only one patient was lost to follow up . The fast-track trial methodology proved feasible and acceptable . Two of the baseline/ outcome measures proved unsuitable : the WHO performance scale and the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting ( SEIQoL-DW ) . Conclusion This study adds to the evidence that fast-track r and omised controlled trials are feasible and acceptable in evaluations of palliative care interventions for patients with non-malignant conditions . Reasonable response rates and low attrition rates were achieved . Further , with adequate preparation of the research and r and omisation teams , clinicians , and responders , and effective liaison with the clinicians , single-blinding proved possible . Methods were identified to reduce unblinding through careful attention to the type of data collected at unblinded measurement points ; the content of interviews should be carefully considered when design ing blinded-trial protocol s . Trial registration Clinical Trials.gov In this study health-related quality of life ( HRQL ) in long-term survivors of Hodgkin 's lymphoma ( HL ) was evaluated and the findings were analyzed using a conceptual model developed by Wilson and Cleary . A better underst and ing of the relationships between the variables explaining HRQL may improve care and rehabilitation of HL patients . The population s were long-term survivors of HL ( n=121 ) and a control group ( n = 236 ) . Participants were approached with one semi-structured interview , an extended version of the Schedule for the Evaluation of Individual Quality of Life – Direct Weighting ( SEIQoL-DW ) and three st and ardized question naires : Hospital Anxiety and Depression ( HAD ) scale , Short Form 12 health survey question naire ( SF-12 ) and  Sense of Coherence ( SOC ) scale . No differences regarding the mean scores were found between the HL survivors and the controls except for the SF-12 , where the patients considered themselves to be in poorer physical health than the controls ( p < 0.01 ) . Even though physical health was diminished , patients did not evaluate overall QoL worse compared to the controls . The major determinants of perception of general QoL were self-rated physical and mental health as well as SOC . The HRQL of persons who have survived a median of 14years with HL is similar to that of controls Objective : To determine the feasibility , the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal - setting . Design : A cluster r and omized controlled trial . Setting : Inpatient rehabilitation facilities . Subjects : People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal - setting and complete the primary outcome measure . Interventions : Structured goal elicitation using the Canadian Occupational Performance Measure . Main measures : Quality of life at 12 weeks using the Schedule for Individualised Quality of Life ( SEIQOL-DW ) , Functional Independence Measure , Short Form 36 and Patient Perception of Rehabilitation ( measuring satisfaction with rehabilitation ) . Assessors were blinded to the intervention . Results : Four rehabilitation services and 41 patients were r and omized . We found high values of the intraclass correlation for the outcome measures ( ranging from 0.03 to 0.40 ) and high variance of the SEIQOL-DW ( SD 19.6 ) in relation to the minimally importance difference of 2.1 , leading to impractically large sample size requirements for a cluster r and omized design . Conclusions : A cluster r and omized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal - setting . Other techniques for coping with contamination effects are necessary Quality of life ( QoL ) assessment is becoming increasingly important for measuring the impact of illnesses , diseases , and their treatment and for deciding priorities when allocating re sources . We developed a novel method to measure QoL from the perspective of the individual patient . The schedule for the evaluation of individual quality of life ( SEIQoL ) was devised from the technique known as judgment analysis to measure patients ' level of functioning in five self-nominated facets of life and the relative weight or importance attached to these areas . We applied this method , together with traditional measures of health status , in a prospect i ve intervention study of 20 patients undergoing unilateral total hip-replacement surgery with six-month follow-up by comparison with matched , non-patient controls .  Health status was significantly improved by hip replacement on the McMaster health index question naire ( p less than 0.001 ) and the arthritis impact measurement scales ( p less than 0.001 ) . Individually measured QoL was significantly increased after surgery when measured by SEIQoL ( p less than 0.02 ) . The individual nature of QoL was reflected in the variety of life areas nominated as important by individual patients , the differences in relative weights attached to these areas , and the complex nature of the changes that occurred postoperatively . Our data not only highlight such individuality but also show that SEIQoL provides a means by which this can be assessed scientifically Background Quality of life ( QoL ) is now established as an important outcome for evaluating the impact of disease , and for assessing the efficacy of treatments . However , individuals change with time and the basis on which they make a QoL judgement may also change , a phenomenon increasingly referred to as response shift . Here , the individual may change his or her internal st and ards , values , and /or conceptualization on the target construct as a result of external factors such as a treatment or a change in health status . This has important implication s for assessing the effects of treatments as a change in QoL may reflect a response shift , a treatment effect , or a complex combination of both . In this study , we used an individualised quality of life ( IQoL ) measure , the SEIQoL  , together with a then-test to determine whether response shift would influence the measurement of treatment efficacy in edentulous patients . Methods Data are reported here for the first phase of a r and omised controlled clinical trial design ed to assess the impact , on IQoL , of implant supported dentures compared with high quality conventional dentures .  IQoL was measured using the  SEIQoL-DW  in 117 patients ( mean age 64.8 ; 32 % male ) at baseline ( T1 ) and 3 months ( T2 ) after receiving high quality conventional dentures . The work was carried out in dental teaching hospitals in Dublin and Belfast . Results Unadjusted SEIQoL index scores revealed no significant impact of treatment at three months ( baseline : 75.0 ; 3 months : 73.2 , p = .33 , n.s . ) . However , the then-test at 3 months revealed that patients retrospectively rated their baseline IQoL as significantly lower ( P < .001 ) than they had rated it at the time ( then-test baseline : 69.2 ) . Comparison of the 3 month scores with this readjusted baseline indicated a significant treatment effect ( then-test baseline : 69.2 ; 3 months : 73.2 , p = 0.016 ) . 81 % of patients nominated at least one different IQoL domain at 3 months . Conclusion The positive impact of denture treatment for edentulous patients on IQoL was seen only when response shifts were taken into consideration . The nature of the response shifts was highly complex but the data indicated a degree of re-conceptualisation and reprioritisation . Assessment of the impact of treatments using patient-generated reports must take account of the adaptive nature of patients Background Psychosocial problems in socioeconomically deprived communities are not always amenable to traditional medical approaches . Mothers living in these areas are a particularly vulnerable group . The objective of this study was to evaluate the effectiveness of a lengthened multi-disciplinary team consultation in primary care in reducing  anxiety and depression in mothers . Methods This was a prospect i ve r and omised controlled trial of a multidisciplinary team consultation against normal care .  94 mothers were recruited from three general practice s from an area of extreme socio-economic deprivation . Mothers r and omised into the intervention group attended a multidisciplinary consultation with up to four case-specific health care professionals . Consultations addressed medical , psychological and social problems and lasted up to one hour . Conventional primary care continued to be available to the intervention families . Control group families received normal primary care services . The outcomes measured were anxiety and depression as using the Hospital Anxiety and Depression Scale ( HADS ) , health status using SF36v2 , and quality of life using the abbreviated Schedule for the Evaluation of Individual Quality of Life ( SEIQoL-DW ) at baseline , 6 months and 12 months . Results Ordered logistic regression was used to analyse the data . There was no significant difference found between intervention and control groups after 6 months and 12 months in all of the measured outcomes . Conclusions The new lengthened multi-disciplinary team consultation did not have any impact on the mental health , general health , and quality of life of mothers after 6 and 12 months . Other methods of primary health care delivery in socio-economically deprived communities need to be evaluated UNLABELLED  Quality of life  scales are being increasingly used to evaluate patients . The earliest scales were st and ardized question naire that did not necessarily provide an optimal evaluation of the quality of life of each individual patient . A number of personalized scales are now available , including the SEIQoL , in which the patients nominate the five quality of life areas most important to them . The SEIQoL has been vali date d. We tested the SEIQoL in patients treated by total hip arthroplasty , a procedure that is expected to improve quality of life . OBJECTIVE To compare two methods of administration of the SEIQoL several months after total hip arthroplasty . METHODS The SEIQoL was administered before and after the arthroplasty . During the postoperative test session , the SEIQoL was administered twice , once using the items nominated preoperatively and once after allowing the patient to repeat the nomination procedure . RESULTS With both methods , significant improvements in quality of life were demonstrated ( P < 0.05 ) . There was no significant difference between the two methods . CONCLUSION Changing the items of the SEIQoL during prospect i ve studies does not modify the overall quality of life score . Keeping the same items throughout the study is nevertheless warranted OBJECTIVE Obesity research ers have a growing interest in measuring the impact of weight and weight reduction on quality of life . The Impact of Weight on  Quality of Life question naire ( IWQOL ) was the first self-report instrument specifically developed to assess the effect of obesity on quality of life . Although the IWQOL has demonstrated excellent psychometric properties , its length ( 74 items ) makes it somewhat cumbersome as an outcome measure in clinical research . This report describes the development of a 31-item version of the IWQOL ( IWQOL-Lite ) . RESEARCH METHODS AND PROCEDURES IWQOLs from 996 obese patients and controls were used to develop the IWQOL-Lite . Psychometric properties of the IWQOL-Lite were examined in a separate cross-validation sample of 991 patients and controls . RESULTS Confirmatory factor analysis provided strong support for the adequacy of the scale structure . The five identified scales of the IWQOL-Lite  ( Physical Function , Self-Esteem , Sexual Life , Public Distress , and Work ) and the total IWQOL-Lite score demonstrated excellent psychometric properties . The reliability of the IWQOL-Lite scales ranged from 0.90 to 0.94 and was 0.96 for the total score . Correlations between the IWQOL-Lite and collateral measures supported the construct validity of the IWQOL-Lite . Changes in  IWQOL-Lite scales over time correlated significantly with changes in weight , supporting its sensitivity to change . Significant differences in IWQOL-Lite scale and total scores were found among groups differing in body mass index , supporting the utility of the IWQOL-Lite across the body mass index spectrum . DISCUSSION The IWQOL-Lite appears to be a psychometrically sound and clinical ly sensitive brief measure of quality of life in obese persons PURPOSE To assess the diagnostic accuracy of fused T2-weighted and high-b-value diffusion-weighted ( DW ) magnetic resonance ( MR ) images at 3 T for evaluation of myometrial invasion in patients with endometrial cancer . MATERIAL S AND METHODS Institutional review board approval and informed consent were obtained . From May 2006 to October 2007 , 48 consecutive patients aged 25 - 80 years ( mean age , 57 years ) who had endometrial cancer were prospect ively enrolled for preoperative evaluation by using a 3-T MR unit .  Two radiologists interpreted the depth of myometrial invasion on T2-weighted images , dynamic contrast material -enhanced MR images , and fused T2-weighted and DW MR images ( b = 1000 sec/mm(2 ) ) . Statistical methods included kappa statistics for reader agreement , Pearson analysis for pathologic correlation , accuracy assessment , and receiver operating characteristic analysis for diagnostic performance comparison . Surgical pathologic findings were the reference st and ard . RESULTS Reader agreement was excellent for fused T2-weighted and DW images ( weighted kappa , 0.79 ) , with a significant pathologic correlation regarding the depth of myometrial invasion ( r = 0.94 , P < .0001 ) . For assessing any myometrial involvement , addition of fused T2-weighted and DW imaging to dynamic contrast-enhanced or dynamic contrast-enhanced and T2-weighted imaging was significantly better compared with dynamic contrast-enhanced imaging alone ( P < .001 ) or dynamic contrast-enhanced and T2-weighted ( P = .001 ) imaging ; T2-weighted imaging combined with fused T2-weighted and DW imaging also was better than dynamic contrast-enhanced and T2-weighted imaging ( P = .001 ) . Tumor apparent diffusion coefficients were 0.60 - 1.32 x 10(-3 ) mm(2)/sec ( median , 0.75 x 10(-3 ) mm(2)/sec ) , with no significant correlation with the depth of myometrial invasion ( P = .31 , r = -0.15 ) . CONCLUSION Fused T2-weighted and high-b-value DW images at 3 T can provide accurate information for preoperative evaluation of myometrial invasion A recent special issue of the Journal of Pediatric Psychology included papers focused on evidence -based assessment across several broad domains of assessment in pediatric psychology ( e.g. , adherence , pediatric pain , and quality of life ) . In one of these papers , Holmbeck et al. ( 2008 ) review ed strengths and limitations of existing measures of psychosocial adjustment and psychopathology , concluding that many measures lacked supporting psychometric data ( e.g. , basic indices of reliability and validity ) that would permit a complete evaluation of these measures . Given that measure development and validation papers are frequently published in JPP ( Brown , 2007 ) , it is important that we attend to guiding psychometric principles when developing and disseminating data on new measures to be employed with pediatric population s ( Nunnally & Bernstein , 1994 ) . Thus , the purpose of this paper is to present and describe a checklist for authors to use when su bmi tting measure development papers to JPP . This checklist is included in the Appendix and is also included at the following link on the JPP website : http://www.oxfordjournals.org/our_journals/jpepsy/for _ authors /measure%20development%20checklist.pdf Findings presented by Holmbeck et al. ( 2008 ) indicated that 34 of the 37 measures review ed met pre-established “ evidence -based assessment ” ( EBA ) criteria for “ well-established ” measures ( Cohen et al. , 2008 ) . To be considered “ well-established , ” a measure had to have been presented in at least two peer- review ed journal articles by different investigatory teams , have demonstrated adequate levels of reliability and validity , and be accompanied by supporting information ( e.g. , a measure manual ) . Although most measures that we review ed met these criteria , we also found that most of the 34 “ well-established ” measures were hampered by at least one major psychometric flaw and /or lacked important psychometric data . We concluded that a more fine-grained EBA classification system is needed . One important distinction in this literature relates to differences between empirically supported assessment and evidence -based assessment . This type of distinction was first discussed in the literature on clinical interventions ( e.g. , Spring , 2007 ) . An empirically supported intervention is one that has demonstrated efficacy in r and omized clinical trials or clinic-based effectiveness trials . An evidence -based intervention has empirical support in the manner just described , but also “ integrates research evidence , clinical expertise , and patient preferences and characteristics … empirically-supported treatments  ( ESTs )  are an important component of evidence -based practice ( EBP ) , but EBP can not be reduced to ESTs ” ( Spring , 2007 , p.611 ) . Applying these terms to the field of assessment and measure development efforts , an empirically supported assessment measure would be one that demonstrates satisfactory psychometric characteristics , broadly defined . To be evidence based , the measure should also demonstrate utility in clinical setting s , be useful in making diagnoses , be sensitive to treatment effects , and /or provide incremental validity above and beyond other similar measures . Although papers in the special issue of JPP frequently referred to “ evidence -based assessment ” ( Cohen et al. , 2009 ) , the articles included in the issue tended to evaluate the degree to which the measures were empirically-supported rather than evidence based . To be “ evidence -based , ” our review s would have needed to integrate an evaluation of clinical utility , diagnostic utility , and treatment sensitivity with the empirical psychometric data presented in each review . As noted , the published review s were more likely to focus on the latter rather than on the former . As suggested by Mash and Hunsley ( 2005 ) , detailed EBA profiles would provide a complete evaluation of evidence across each of several psychometric and clinical ly relevant dimensions , including : ( a ) internal consistency , ( b ) test – retest reliability , ( c ) the availability of normative data , ( d ) content validity , ( e ) construct validity , ( f ) convergent and discriminant validity , ( g ) criterion-related validity , ( h ) incremental validity , ( i ) clinical utility , ( j ) diagnostic utility , and ( k ) treatment sensitivity . The focus on incremental validity and clinical and diagnostic utility raises the bar from a focus on “ empirical support ” ( i.e. , where the focus would tend to be primarily on psychometric data ) to a broad focus on the “ evidence base ” for a measure . In developing the checklist that is the focus of this article , we attempted to provide a list of criteria relevant to establishing the evidence base ( and not just empirical support ) for a measure . In addition to shifting the focus from providing “ empirical support ” for a measure to providing an “ evidence base ” for our instruments , a checklist for measure development papers would permit JPP review ers to evaluate such papers in the same way that review ers of r and omized clinical trials make use of the Consoli date d St and ards of Reporting Trials ( CONSORT ) checklist and flowchart ( Altman et al. , 2001 ) . The CONSORT checklist contains reporting st and ards with respect to method ological features of and the manner in which results are reported in clinical trials . Moreover , authors are required to provide a flowchart that describes details of sample recruitment and attrition during the course of the study . Thus , a checklist for measure development papers would serve two interrelated purpose s : ( a ) it would provide guidance to authors as they embark on the measure development process and would provide a list of criteria authors can use as they develop an evidence base for their measures , and ( b ) it would begin to st and ardize the manner in which psychometric and other assessment -related data are presented in measure development papers for this journal . Before providing a more detailed overview of the checklist , it is important to note that this checklist is rather exhaustive ( see Appendix ) . As such , it represents what would “ ideally ” be expected for a measure development or validation manuscript rather than minimal criteria for such papers . No one paper can provide a complete evaluation of all important psychometric and clinical ly relevant dimensions that will establish once- and -for-all the evidence base for a measure . Instrument refinement is part of a measure development process that gradually builds an evidence base for a scale ( see Smith & McCarthy , 1995 , for suggestions on measure refinement ) . Indeed , the validation of any measure is a cumulative process that occurs across many different types of research studies and across research programs Objectives To be useable in clinical practise , treatments studied in trials must provide sufficient information to enable clinicians and research ers to replicate . We sought to assess the completeness of treatment descriptions in published r and omised controlled trials ( RCTs ) using a checklist and to determine the extent to which peer review ers and editors comment on the quality of reporting of treatments . Design A cross-sectional study . Setting Trials published in the BMJ , a general medical journal . Participants Fifty-one trials published in the BMJ were independently evaluated by two raters using a checklist . Review ers ’ and editors ’ comments were also assessed for statements on treatment descriptions . Primary and secondary outcome measures Proportion of trials rated as replicable ( primary outcome ) . Results For 57 % ( 29/51 ) of the papers , published treatment descriptions were not considered sufficient to allow replication . Most poorly described aspects were the actual procedures involved including the sequencing of the technique ( what happened and when ) and the physical or informational material s used ( eg , training material s ) : 53 % and 43 % not clear , respectively . For a third of treatments , the dose/ duration of individual sessions was not clear and for a quarter the schedule ( interval , frequency , duration or timing ) was not clear . Although the majority of problems were not picked up by review ers and editors , when they were detected only about two-thirds were fixed before publication . Conclusions Journals wanting to publish the research of use to practising healthcare professionals need to pay more attention to descriptions of treatments . Our checklist , may be useful for review ers , and editors and could help ensure that important details of treatments are provided before papers are in the public domain BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Diabetes case management ( DCM ) may improve medical outcomes ( 1,2 ) . Case managers coordinate care and often provide a mix of interventions , e.g. , telephone outreach , education , reminders . However , the efficacy of DCM is unclear . Three systematic review s lend only limited support for the efficacy of DCM for improving glycemic control but none for lipid , weight , or blood pressure benefits ( 3–5 ) . DCM studies typically target biomedical outcomes and ignore potential psychosocial effects . Yet , psychosocial variables ( e.g. , depression , anxiety , social support ) relate to hyperglycemia , complications , adherence , and quality of life ( 6–11 ) . Thus , a positive impact of DCM on these factors is important . Two studies did assess psychosocial outcomes of DCM and found improved self-efficacy and satisfaction ( cluster visit ) ( 12 ) and quality of life ( dietitian-led DCM group ) ( 13 ) . Because barriers ( e.g. , distance , weather ) limit DCM access , telemedicine can be used . A review of telemedicine versus face-to-face trials concluded that , while feasible and acceptable , there is little evidence that telemedicine has clinical benefits ( 14 ) . Our team published results of a trial of telemedicine DCM versus usual care for elderly diabetic patients ( 15 ) . The intervention result ed in significant improvements in glycemic control , blood pressure , and total and LDL cholesterol ( 16 ) . The purpose of the Informatics for Diabetes Education and Telemedicine ( IDEATel ) project , funded by the Centers for Medicare and Medicaid Services , is to evaluate the feasibility and effectiveness of telemedicine with a diverse , medically underserved , elderly diabetic sample . The purpose of this study is to assess the impact of the IDEATel intervention on secondary psychosocial outcomes . A detailed description of the IDEATel study design has been previously reported ( 15,16 ) . Medicare recipients were recruited if they were aged ≥55 years , diagnosed with diabetes , and without moderate/severe impairments or comorbidities . Research nurses blinded to the groups People living with AIDS ( PLWA ) are confronted with uncertainty and their own mortality at an earlier than expected age . Life review , an intervention that has the potential to increase life satisfaction in the elderly experiencing transition points in their lives , may have a similar effect when used with PLWA . Therefore , the purpose of this feasibility study was to explore the use of life review in a sample of 20 PLWA through a r and omized controlled trial of its effectiveness in decreasing depressive symptoms and in increasing self esteem , quality of life , and purpose in life . Compared to the control group , the treatment group had an improved overall quality of life and self-esteem over 12 months , less depressive symptoms over 12 months , and a greater purpose in life at 3 months . The effects that were seen were mainly small to medium effects . The findings from this feasibility study suggest the potential value of life review to enhance quality of life , purpose in life , and self-esteem , and to decrease depressive symptoms in PLWA . Further research is needed with a larger sample and with other groups such as PLWA experiencing virologic failure Purpose : The purpose of the present review was to assess the quality of evidence in the literature regarding the specific benefits of inspiratory muscle training ( IMT ) with an emphasis on training intensity and the relationships between changes in inspiratory muscle function and other clinical outcome measures . Methods : Articles were found by search ing CINAHL , PubMed , Medline via First Search , and ProQuest data bases . Articles used in the review were r and omized trials of IMT vs. sham IMT or no intervention  , published in English in a peer‐ review ed journal , included patients with chronic obstructive pulmonary disease ( COPD ) , and specified the intensity of training . The quality of the studies was evaluated by 2 independent review ers using the method ological rigor scale described by Medlicott and Harris as well as Sackett 's levels of evidence . Fifteen articles met the inclusion criteria and were used in this review . Results : Consistent improvements in maximal inspiratory pressures ( ranging from ‐11 to ‐30 cm H2O ) and inspiratory muscle endurance were found . Improvements in dyspnea and health‐related quality of life were also observed . Inspiratory muscle training may result in improved exercise tolerance as measured using walking tests . High‐intensity IMT result ed in improved training efficiency with respect to inspiratory muscle strength , but evidence of the effect of high‐intensity IMT on other clinical outcomes is lacking . Conclusion : Despite research spanning decades , there are numerous limitations in the literature regarding IMT . IMT appears to improve dyspnea , waking test distance , and health‐related quality of life in individuals with COPD , but it is not clear whether this improvement is mediated through improved inspiratory muscle strength and endurance . This review discussed several considerations critical to the design of future trials Objective : Overactive bladder ( OAB ) has substantial impact on health-related quality of life ( HRQoL ) . The purpose of this research was to evaluate the psychometric properties of the King 's Health Question naire ( KHQ ) . Methods : The  KHQ ( n = 1284 ) was administered at baseline and 12 weeks post-treatment in a multinational , double-blind , r and omized clinical trial of tolterodine  for treatment of OAB . Country-specific psychometric analyses of HRQoL instruments were performed . Countries demonstrating marginal psychometric properties on the KHQ were pooled with same- language countries , re-evaluated , and aggregate analysis performed on the pooled data . Results : Internal consistency of the KHQ was high , item characteristics were good , most assumptions of summed scales were met , and it is externally valid and consistent . Few problems with the KHQ were noted although the performance of the personal relationships domain was complicated by the ‘ not applicable ’ response category . Conclusions : Psychometric testing supports the reliability and validity of the KHQ as an OAB-specific measure of Stigmatizing , or discriminatory , perspectives and behaviour , which target individuals on the basis of their mental health , are observed in even the youngest school children . We conducted a systematic review of the published and unpublished , scientific literature concerning the benefits and harms of school-based interventions , which were directed at students 18 years of age or younger to prevent or eliminate such stigmatization . Forty relevant studies were identified , yet only a qualitative synthesis was deemed appropriate . Five limitations within the evidence base constituted barriers to drawing conclusive inferences about the effectiveness and harms of school-based interventions : poor reporting quality , a dearth of r and omized controlled trial evidence , poor methods quality for all research design s , considerable clinical heterogeneity , and inconsistent or null results . Nevertheless , certain suggestive evidence derived both from within and beyond our evidence base has allowed us to recommend the development , implementation and evaluation of a curriculum , which fosters the development of empathy and , in turn , an orientation toward social inclusion and inclusiveness . These effects may be achieved largely by bringing especially but not exclusively the youngest children into direct , structured contact with an infant , and likely only the oldest children and youth into direct contact with individuals experiencing mental health difficulties . The possible value of using educational activities , material s and contents to enhance hypothesized benefits accruing to direct contact also requires investigation . Overall , the curriculum might serve as primary prevention for some students and as secondary prevention for others
The results of convergent and discriminant validity support our hypotheses in which SEIQoL-DW was expected to correlate moderately to high with measures of global QoL , life satisfaction and mental health and weakly with measures of functional status and health .
Conclusion The SEIQoL-DW appears to be a feasible and valid instrument .
The lack of association between the Index score and health , functional status , demographic and clinical parameters may be explained by the instrument ’s focus on global QoL and by that of the idiographic measurement approach reflecting the capacity of a patient to value domains other than health in life , despite having health problems .
Purpose To review published studies regarding the use , feasibility and psychometric performance of the schedule for the evaluation of individual quality of life — direct weighting ( SEIQoL-DW ) in clinical research .