How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations? Assessing the performance of the EQ-VAS in the NHS PROMs programme Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol Qualitative analysis of patients’ feedback from a PROMs survey of cancer patients in England Accurately measuring the quality and effectiveness of cervical spine surgery in registry efforts: determining the most valid and responsive instruments. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial Composing a new song for trials: the Standardized Outcomes in Nephrology (SONG) initiative. Criteria for Success after Surgery for Cervical Radiculopathy; Estimates for a Substantial Amount of Improvement in Core Outcome Measures. Outcome scores in spinal surgery quantified: excellent, good, fair and poor in terms of patient-completed tools INFANT GROWTH AND HUMAN MILK REQUIREMENTS: A Fresh Approach A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. Conducting experimental research in marginalised populations: clinical and methodological implications from a mixed-methods randomised controlled trial in Kenya Driving up the Quality and Relevance of Research Through the Use of Agreed Core Outcomes The PROMIS of Better Outcome Assessment: Responsiveness, Floor and Ceiling Effects, and Internet Administration Determining the quality and effectiveness of surgical spine care: patient satisfaction is not a valid proxy.
Purpose We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how  patient-reported outcome measures ( PROMs ) data were referred to in the process of ( 1 ) eliciting and exploring patients ’ concerns ; ( 2 ) making decisions about supportive treatment and ( 3 ) making decisions about chemotherapy and other systemic treatments . Methods We purposively sample d audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK r and omised controlled trial of the feedback of PROMs data to doctors ( Velikova et al. in J Clin Oncol 22(4):714–724 [ 1 ] ) . We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management . Findings Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy . High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy . Symptomatic treatment was more often offered for problems like nausea , constipation , pain and depression but much less so for fatigue . Doctors discussed fatigue by providing a cause for the fatigue ( e.g. the chemotherapy ) , presenting this as ‘ something to be expected ’ , minimising its impact or moving on to another topic . Chemotherapy regimens were not changed on the basis of the PROMs data alone , but PROMs data were sometimes used to legitimise changes . Conclusions Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems , but doctors may not always know how to do this . Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation Objectives The study aims to increase knowledge about the performance of the EuroQol-visual analogue scales ( EQ-VAS ) in the UK NHS patient-reported outcome measures ( PROMs ) programme , which covers groin hernia , hip and knee replacement and varicose vein surgery , and make suggestions for improved collection , coding and analysis of data . Methods Four hundred scanned images of matched before- and -after EQ-VAS PROMs responses were selected at r and om . These were classified according to the different ways in which they were completed . Patient-level PROMs programme data linked to Hospital Episode Statistics for all patients from April 2009 to February 2011 were used to analyse the relationship between the EQ-VAS and the EQ-5D profile , index-weighted profile and condition-specific instruments . The linked PROMs and HES data comprise 331,951 anonymised patient records . Results A large majority ( 95 % ) of EQ-VAS responses were completed in an unambiguous way , but only a minority ( 45 % ) conformed strictly to the instructions given , posing challenges for data coding . The EQ-VAS data have a predictable and consistent relationship with the EQ-5D profile , although the correlations between the EQ-VAS and other measures of patient-reported health , both before and after surgery and in the change between them , are weak . Conclusions EQ-VAS data might be improved by providing better guidance on collection and coding . It is argued that the observed differences in results from EQ-VAS and other measures of health reflect the fact that it measures a broader underlying construct of health , arguably providing a means of summarising overall health that is closer to the patient ’s perspective Background UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment . However , as part of this 6-month assessment little information is gathered from the patient ’s perspective . The means of collecting this patient-centred information might be served best by a patient-reported outcome measure ( PROM ) at the 6-month assessment time point . Currently , four different methods of 6-month follow-up assessment occur ; the most common being face-to-face interview followed by telephone interview , postal question naire and online question naire . Therefore , this study will investigate if the acceptability of telephone , online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration . Methods / design A UK multicentre , blinded ( analyst and research er ) , pragmatic , non-inferiority study , with 80 % power using a 2.5 % non-inferiority margin was design ed to compare the acceptability of three modes of administration ( telephone interview , postal question naire and online question naire ) compared with face-to-face interview administration of a PROM . We plan to approach and r and omise a minimum of 808 potentially eligible participants , 202 participants per group . Discussion The aim of this ongoing research is to underst and if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors . In utilising a pragmatic design , it is believed that this study will offer UK wide generalisable results , of the acceptability of the methods under investigation , to inform clinicians and commissioners of stroke services . Trials registration Clinical Trials.gov : NCT03177161 . Registered on 6 June 2017 Objective This study examined how free-text comments from cancer survivors  could complement formal patient-reported outcome measures ( PROMs ) , as part of the Engl and PROMs survey programme for cancer . Design A qualitative content analysis was conducted of responses to a single open-ended free-text question placed at the end of the cross-sectional population -based postal question naire . Setting Individuals were identified through three UK Cancer Registries and question naires were posted to their home addresses . Participants A r and om sample of individuals ( n=4992 ) diagnosed with breast , colorectal , non-Hodgkins lymphoma or prostate cancer at 1 , 2 , 3 and 5 years earlier . Results 3300 participants completed the survey ( 68 % response rate ) . Of these 1056 ( 32 % ) completed the free-text comments box , indicating a high level of commitment to provide written feedback on patient experience . Almost a fifth ( 19 % ) related experiences of excellent care during the treatment phase , with only 8 % reporting negative experiences . This contrasted with experiences of care after primary cancer treatment where the majority were negative . Factors impacting negatively upon patient-reported outcomes included the emotional impact of cancer ; poor experiences of treatment and care ; comorbidities , treatment side effects , social difficulties and inadequate preparation for a wide range of sometimes long-lasting on-going physical and psychological problems . Mediating factors assisting recovery incorporated both professional-led factors , such as quality of preparation for anticipated problems and aftercare services , and participant-led factors , such as learning from other cancer survivors and self-learning through trial and error . The support of friends and family was also a factor in participants ' outcomes . Conclusions This analysis of free-text comments complements quantitative analysis of PROMs measure 's by illuminating relationships between factors that impact on quality of life ( QoL ) and indicate why cancer patients may experience significantly worse QoL than the general population . The data suggest more systematic preparation and aftercare for individuals to self-manage post-treatment problems might improve QoL outcomes among cancer survivors BACKGROUND CONTEXT There is a growing dem and to measure the real-world effectiveness and value of care across all specialties and disease states . Prospect i ve registries have emerged as a feasible way to capture real-world care across large patient population s. However , the proven validity of more robust and cumbersome patient-reported outcome instruments ( PROi ) must be balanced with what is feasible to apply in large-scale registry efforts . Hence , commercial registry efforts that measure quality and effectiveness of care in an attempt to guide quality improvement , pay for performance , or value-based purchasing should incorporate measures that most accurately represent patient-centered improvement . PURPOSE We set out to establish the relative validity and responsiveness of common PROi in accurately determining effectiveness of cervical surgery for neck and arm pain in registry efforts . STUDY DESIGN Prospect i ve cohort study . PATIENT SAMPLE Eighty-eight patients undergoing primary anterior cervical discectomy and fusion ( ACDF ) for neck and arm pain . OUTCOME MEASURES Patient-reported outcome measures for pain ( numeric rating scale for neck pain [ NRS-NP ] and arm pain [ NRS-AP ] ) , disability ( neck disability index [ NDI ] ) , general health ( short-form 12-item survey physical component summary [ SF-12 PCS ] and mental component summary [ SF-12 MCS ] ) , and quality of life ( Euro-Qol-5D [ EQ-5D ] ) were assessed . METHODS Eighty-eight patients undergoing primary ACDF for neck and arm pain were entered into a Web-based prospect i ve registry . Baseline and 12-month patient-reported outcomes ( NRS-NP , NRS-AP , NDI , SF-12 PCS , SF-12 MCS , and EQ-5D ) were assessed . Patients were also asked whether they experienced a level of improvement after ACDF that met their expectation ( meaningful improvement ) . To assess the validity of NRS-NP , NRS-AP , and NDI ( measures of pain and disability ) to discriminate between meaningful and nonmeaningful improvement and the validity of SF-12 PCS , SF-12 MCS , and EQ-5D ( measures of general health and quality of life ) to discriminate between meaningful and nonmeaningful improvement , receiver-operating characteristic curves were generated for each outcome instrument . The greater the area under the curve ( AUC ) , the more valid the discriminator . The difference between st and ardized response means ( SRMs ) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each outcome instrument to changes in  pain and QOL after surgery . RESULTS For pain and disability , both NDI ( AUC=0.75 ) and NRS-AP ( AUC=0.74 ) were valid discriminators of meaningful improvement . Numeric rating scale for neck pain ( AUC=0.69 ) was a poor discriminator . Neck disability index was also most responsive to postoperative improvement ( SRM difference 0.78 ) , followed by NRS-AP ( SRM difference 0.59 ) and NRS-NP ( SRM difference 0.46 ) . For general health and quality of life , SF-12 PCS ( AUC=0.79 ) was the only valid discriminator of meaningful improvement . Euro-Qol-5D ( AUC=0.68 ) and SF-12 MCS ( AUC=0.44 ) were poor discriminators . Short-form 12 physical component summary ( SRM difference 1.08 ) was also most responsive compared with EQ-5D ( SRM difference 0.89 ) and SF-12 MCS ( SRM difference 0.01 ) . CONCLUSIONS For pain and disability , NDI is the most valid and responsive measure of improvement after surgery for neck and arm pain . Numeric rating scale for neck pain and NRS-AP are poor substitutes for NDI when measuring effectiveness of care in registry efforts . For health-related quality of life , only SF-12 PCS could accurately discriminate meaningful improvement after cervical surgery and was found to be most valid and responsive . Large-scale registry efforts aim ed at measuring effectiveness of cervical spine surgery should use NDI and SF-12 to accurately assess improvements in pain , disability , and quality of life OBJECTIVE To assess reliability , validity , and responsiveness of a 29-item short-form version of the Patient Reported Outcomes Measurement Information System ( PROMIS ) and a novel “ impact score ” calculated from those measures . DESIGN Prospect i ve cohort study . SETTING Rural primary care practice s. SUBJECTS Adults aged ≥ 55 years with chronic musculoskeletal pain , not currently receiving prescription opioids . METHODS Subjects completed the PROMIS short form at baseline and after 3 months . Patient subsets were compared to assess reliability and responsiveness . Construct validity was tested by comparing baseline scores among patients who were or were not applying for Worker 's Compensation ; those with higher or lower catastrophizing scores ; and those with or without recent falls . Responsiveness was assessed with mean score changes , effect sizes , and st and ardized response means . RESULTS Internal consistency was good to excellent , with Cronbach 's alpha between 0.81 and 0.95 for all scales . Among patients who rated their pain as stable , test-retest scores at 3 months were around 0.70 for most scales . PROMIS scores were worse among patients seeking or receiving worker 's compensation , those with high catastrophizing scores , and those with recent falls . Among patients rating pain as “ much less ” at 3 months , absolute effect sizes for the various scales ranged from 0.24 ( Depression ) to 1.93 ( Pain Intensity ) . CONCLUSIONS Results indicate that the PROMIS short 29-item form may be useful for the study of patients with chronic musculoskeletal pain . Our findings also support use of the novel “ impact score ” recommended by the National Institutes of Health ( NIH ) Task Force on Research St and ards for Chronic Low Back Pain OBJECTIVES : The National Institutes of Health ( NIH ) created the Patient Reported Outcomes Measurement Information System ( PROMIS ) to allow efficient , online measurement of patient-reported outcomes ( PROs ) , but it remains untested whether PROMIS improves outcomes . Here , we aim ed to compare the impact of gastrointestinal ( GI ) PROMIS measures vs. usual care on patient outcomes . METHODS : We performed a pragmatic clinical trial with an off-on study design alternating weekly between  intervention ( GI PROMIS )  and control arms at one Veterans Affairs and three university-affiliated specialty clinics . Adults with GI symptoms were eligible . Intervention patients  completed GI PROMIS symptom question naires on an e-portal 1 week before their visit ; PROs were available for review by patients and their providers before and during the clinic visit . Usual care patients were managed according to customary practice s. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems question naire . Secondary outcomes included provider interpersonal skills ( Doctors ’ Interpersonal Skills Question naire ( DISQ ) ) and shared decision-making ( 9-item Shared Decision Making Question naire ( SDM-Q-9 ) ) . RESULTS : There were 217 and 154 patients in the GI PROMIS and control arms , respectively . Patient satisfaction was similar between groups ( P>0.05 ) . Intervention patients had similar assessment s of their providers ’ interpersonal skills ( DISQ 89.4±11.7 vs. 89.8±16.0 , P=0.79 ) and shared decision-making ( SDM-Q-9 79.3±12.4 vs. 79.0±22.0 , P=0.85 ) vs. controls . CONCLUSIONS : This is the first controlled trial examining the impact of NIH PROMIS in clinical practice . One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making . Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption R and omized trials provide the most reliable evidence about the safety and effectiveness of interventions to improve health care and patient outcomes . Unfortunately , the potential for trials to inform treatment decisions remains limited because the outcomes reported often do not resonate with what is directly meaningful and relevant to patients and their clinicians [ 1–3 ] . Further , inconsistent reporting of outcomes across trials prevents assessment of the comparative effect of interventions [ 4 ] . Outcome reporting bias , whereby authors cherry-pick the outcomes they report on the basis of favourable results , may also occur when there is not a st and ardized list of outcomes measured and reported [ 5 , 6 ] . Collectively these problems may undermine the reliability of published trials , leading to inefficient use of scarce research and health care re sources and unintended harm to patients [ 6 ] . Such dissonance in outcomes reported in trials is widespread and evident across all medical specialties . The growing recognition of the problem has prompted large-scale efforts to establish core outcome sets . Core outcome sets are an agreed st and ardized set of outcomes for a specific clinical area that are to be reported as a minimum in all trials in that area [ 7 ] . Outcomes are selected because they are critically important to all stakeholders — namely patients , their clinicians and policymakers— for decision making . Core outcome sets are not design ed to be comprehensive or exclusive . Typically they include only three to five outcomes . Other outcomes that are identified to be important ( i.e. to some stakeholder groups ) may also be recommended for some trials ( Figure 1 ) . The design ated primary outcome of any given trial may be outside the core outcome set and research ers may also opt to add other , trial-specific outcomes , chosen for reasons including responsiveness to the intervention and feasibility . Attempts to st and ardize outcomes began 50 years ago when the World Health Organization published recommendations for the minimum requirements for data collection in cancer trials [ 8 ] . In the 1990s , the Outcome Measures in Rheumatology ( OMERACT ) initiative was formed , and is perhaps the most widely recognized and largest initiative in the field of core outcome development . OMERACT engages patients and health professionals to st and ardize outcome measures for trials in rheumatology [ 9 ] and has pioneered method ologies for developing core outcome sets . The uptake of the OMERACT core outcome sets has improved the consistency of outcomes reported in trials [ 10 ] . In the past decade , core outcome sets in diverse medical specialties , including cardiology , dermatology , surgery , oncology , women ’s health and respiratory disease , have progressively been developed [ 7 , 9–11 ] . The use of core outcome sets is also increasingly being advocated by funders to ensure the relevance and potential impact of research . In the UK , funding organizations , including the National Institute for Health Research and the Health Research Board ( Irel and ) , advise research ers to include core outcome sets if they are available and highlight the  Core Outcome Measures in Effectiveness ( COMET ) data base of core outcomes as a key re source [ 7 ] . The COMET initiative was recently launched to facilitate the development , implementation and evaluation of core outcome sets [ 7 ] . There has been a long-st and ing need in nephrology to develop core outcomes [ 12–14 ] . More than 14 000 r and omized trials are available in the Cochrane Kidney and Transplant Specialised Register [ 15 ] and a search of Clinical Trials.gov trials for ‘ kidney disease ’ yields > 3000 ongoing trials . Despite this considerable investment in trials in nephrology , improvements in outcomes for patients with kidney disease have been modest at best . Across all stages of chronic kidney disease ( CKD ) , patients still have a markedly higher risk of mortality and serious comorbidities , including cardiovascular disease , diabetes , cancer and infection , compared with the general population [ 16–18 ] . Patients with CKD have poor quality of life , particularly if they are on dialysis , to the extent that many patients || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || || IMPORTANCE Defining clinical ly meaningful success criteria from patient-reported outcome measures ( PROMs ) is crucial for clinical audits , research and decision-making . PURPOSE We aim ed to define criteria for a successful outcome 3 and 12 months after surgery for cervical degenerative radiculopathy ( CDR ) on recommended PROMs . STUDY DESIGN Prospect i ve cohort study with 12 months follow-up . PATIENT SAMPLE Patients operated at one or two levels for cervical radiculopathy included in the Norwegian Registry for Spine Surgery ( NORspine ) from 2011 to 2016 . OUTCOME MEASURES Neck Disability Index ( NDI ) , Numeric Rating Scale for neck pain ( NRS-NP ) and arm pain ( NRS-AP ) , health-related quality -of-life EuroQol 3L ( EQ-5D ) , general health status ( EQ-VAS ) . METHODS We included 2868 consecutive CDR patients operated for cervical radiculopathy in one or two levels and included in the Norwegian Registry for Spine Surgery ( NORspine ) . External criterion to determine accuracy and optimal cut-off values for success in the PROMs was the Global Perceived Effect Scale ( GPE ) . Success was defined as " much better " or " completely recovered " . Cut-off values were assessed by analyzing the area under the receiver operating curves ( ROC ) for follow-up scores , mean change scores , and percentage change scores . RESULTS All PROMs showed high accuracy in defining success and non-success and only minor differences were found between 3- and 12-month scores . At 12 months , the area under the ROC for follow-up scores were 0.86 - 0.91 , change scores were 0.74 - 0.87 , and percentage change scores were 0.74 - 0.91 . Percentage scores of NDI and NRS-AP showed the best accuracy . The optimal cut-off values for each PROM showed considerable overlap across those operated due to disc herniation and spondylotic foraminal stenosis . CONCLUSIONS All PROMs , especially NDI and NRS-AP , showed good to excellent discriminative ability in distinguishing between a successful and non-successful outcome after surgery due to cervical radiculopathy . Percentage change scores are recommended for use in research and clinical practice Outcome scores are very useful tools in the field of spinal surgery as they allow us to assess a patient ’s progress and the effect of various treatments . The clinical importance of a score change is not so clear . Although previous studies have looked at the minimum clinical ly important score change , the degree of score change varies considerably . Our study is a prospect i ve cohort study of 193 patients undergoing discectomy , decompression and fusion procedures with minimum 2-year follow-up . We have used three st and ard outcome measures in common usage , the oswestry disability index ( ODI ) , the  low back outcome score ( LBOS ) and the visual analogue score ( VAS ) . We have defined each of these scores according to a global measure of outcome grade d by the patient as excellent , good , fair or poor . We have also grade d patient perception and classified excellent and good as success and fair and poor as failure . Our results suggest that a median 24-point change in the ODI equates with a good outcome or is the minimum change needed for success . We have also found that different surgical disorders have very different minimal clinical ly important differences as perceived by patient perception . We found that for a discectomy a minimum 27-point change in the ODI would be classed as a success , for a decompression the change in ODI needed to class it as a success would be 16 points , whereas for a fusion the change in the ODI would be only 13 points . We believe that patient-rated global measures of outcome are of value and we have quantified them in terms of the st and ard outcome measures used in spinal surgery Abstract The relationship between growth and the breast-milk plus complementary food intake of a group of British babies has been studied prospect ively up to 8 months . From the data the human milk needs of  solely breast-fed children to grow along the 5th , 50th , and 95th Gentile of the NCHS st and ard have been predicted using multiple regression analysis . The values obtained are substantially lower than previous estimates and they may form a more practical guideline for the evaluation of lactational adequacy within a community . Individual variation is important . It is futile to identify a single age when breast-feeding becomes inadequate as the sole source of food BACKGROUND Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity . R and omised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures . Such variation contributes to an inability to compare , contrast , and combine individual studies , limiting the usefulness of research to inform clinical practice . The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders , including patients , will be collected and reported in a st and ardised fashion . METHODS An international steering group including healthcare professionals , research ers , and patients , has been formed to guide the development of this core outcome set . Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients . Potential core outcomes will be entered into an international , multi-perspective online Delphi survey . All key stakeholders , including healthcare professionals , research ers , and patients will be invited to participate . The modified Delphi method encourages whole and stakeholder group convergence towards consensus ' core ' outcomes . Once core outcomes have been agreed upon it is important to determine how they should be measured . The truth , discrimination , and feasibility assessment framework will assess the quality of potential outcome measures . High quality outcome measures will be associated with core outcomes . Mechanisms exist to disseminate and implement the result ing core outcome set within an international context . DISCUSSION Embedding the core outcome set within future clinical trials , systematic review s , and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice , enhance patient care , and improve maternal and offspring outcomes . The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other setting s , for example selecting research priorities and clinical practice guideline development . PROSPECT IVE REGISTRATION : [ 1 ] Core Outcome Measures in Effectiveness Trials ( COMET ) registration number : 588 . [ 2 ] International Prospect i ve Register of Systematic Review s ( PROSPERO ) registration number : CRD42015015529 The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care ABSTRACT Experimental studies to test interventions for people living with HIV in low- and middle-income countries are essential to ensure appropriate and effective clinical care . The implication s of study participation on outcome data in such population s have been discussed theoretically , but rarely empirically examined . We aim ed to explore the effects of participating in a r and omised controlled trial conducted in an HIV clinic in Mombasa , Kenya . We report qualitative data from the Treatment Outcomes in Palliative Care trial , which evaluated the impact of a nurse-led palliative care intervention for HIV positive adults on antiretroviral therapy compared to st and ard care . Participants in both arms attended five monthly quantitative data collection appointments . Post-trial exit , 10 control and 20 intervention patients participated in semi-structured qualitative interviews , analysed using thematic analysis . We found benefit attributed to the compassion of the research team , social support , communication , completion of patient reported outcome measures ( PROMs ) and material support ( transport reimbursement ) . Being treated with compassion and receiving social support enabled participants to build positive relationships with the research team , which improved mental health and well-being . Open and non-judgmental communication made participants feel accepted . Participants described how repeated completion of the PROMs was a prompt for reflection , through which they began to help themselves and self-care . Participant reimbursements relieved financial hardship and enabled them to fulfil their social responsibilities , enhancing self-worth . These findings emphasise the importance of compassion , support and effective communication in the clinical encounter , particularly in stigmatised and isolated population s , and the potential of the integration of simple PROMs to improve patient outcomes . Participation in research has unexpected positive benefits for participants , which should be taken into account when design ing research in similar population s. Research ers should be aware of the effects of financial reimbursement and contact with research ers in isolated and impoverished communities There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure  patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered Objective . Use of item response theory ( IRT ) and , subsequently , computerized adaptive testing ( CAT ) , under the umbrella of the NIH-PROMIS initiative ( National Institutes of Health – Patient-Reported Outcomes Measurement Information System ) , to bring strong new assets to the development of more sensitive , more widely applicable , and more efficiently administered patient-reported outcome ( PRO ) instruments . We present data on current progress in 3 crucial areas : floor and ceiling effects , responsiveness to change , and interactive computer-based administration over the Internet . Methods . We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change ; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments ; performed a r and omized head-to-head trial of 4 modes of item administration ; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes . Results . IRT-based PROMIS instruments are more sensitive to change , result ing in the potential to reduce sample size requirements substantially by up to a factor of 4 . The modes of administration tested did not differ from each other in any instance by more than one-tenth of a st and ard deviation . Floor and ceiling effects greatly reduce the number of available subjects , particularly at the ceiling . Conclusion . Failure to adequately address floor and ceiling effects , which determine the range of an instrument , can result in suboptimal assessment of many patients . Improved items , improved instruments , and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research BACKGROUND CONTEXT Given the unsustainable costs of the US health-care system , health-care purchasers , payers , and hospital systems are adopting the concept of value-based purchasing by shifting care away from low- quality providers or hospitals . Legislation now allows public reporting of these quality rankings . True measures of quality , such as surgical morbidity and vali date d question naires of effectiveness , are burdensome and costly to collect . Hence , patients ' satisfaction with care has emerged as a commonly used metric as a proxy for quality because of its feasibility of collection . However , patient satisfaction metrics have yet to be vali date d as a measure of overall quality of surgical spine care . PURPOSE We set out to determine whether patient satisfaction is a valid measure of safety and effectiveness of care in a prospect i ve longitudinal spine registry . STUDY DESIGN Prospect i ve longitudinal cohort study . PATIENT POPULATION All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center . OUTCOME MEASURES Patient-reported outcome instruments ( numeric rating scale [ NRS ] , Oswestry disability index [ ODI ] , neck disability index [ NDI ] , short-form 12-item survey [ SF-12 ] , Euro-Qol-5D [ EQ-5D ] , Zung depression scale , and Modified Somatic Perception Question naire [ MSPQ ] anxiety scale ) , return to work , patient satisfaction with outcome , and patient satisfaction with provider care . METHODS All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center were enrolled into a prospect i ve longitudinal registry . Data collected on all patients included demographics , disease characteristics , treatment variables , readmissions/reoperations , and all 90-day surgical morbidity . Patient-reported outcome instruments ( NRS , ODI , NDI , SF-12 , EQ-5D , Zung depression scale , and MSPQ anxiety scale ) , return to work , patient satisfaction with outcome , and patient satisfaction with provider care were recorded at baseline and 3 months after treatment . Receiver-operating characteristic ( ROC ) curve analysis was performed to determine whether extent of improvement in quality of life ( SF-12 physical component summary [ PCS ] ) and disability ( ODI/NDI ) accurately predicted patient satisfaction versus dissatisfaction . St and ard interpretation of area under the curve ( AUC ) was used : less than 0.7 , poor ; 0.7 to 0.8 , fair ; and greater than 0.8 , good accuracy . Multivariate logistic regression analysis was performed to determine if surgical morbidity ( quality ) or improvement in disability and quality of life ( effectiveness of care ) were independently associated with patient satisfaction . RESULTS Four hundred twenty-two ( 84 % ) patients completed all question naires 3 months after surgery during the review ed time period ( mean age 55±14 years ) . Lumbar surgery was performed in 287 ( 68 % ) and cervical surgery in 135 ( 32 % ) patients . There were 51 ( 12.1 % ) 90-day complications , including 21 ( 5.0 % ) readmissions and 12 ( 2.8 % ) return to operating room . Three hundred fifty-eight ( 84.8 % ) patients were satisfied with provider care and 288 ( 68.2 % ) with their outcome . Satisfaction with provider care : In ROC analyses , extent of improvement in quality of life ( SF-12 ) and disability ( ODI/NDI ) differentiated satisfaction versus dissatisfaction with care with very poor accuracy ( AUC 0.49 - 0.69 ) . In regression analysis , 3-month morbidity ( odds ratio [ 95 % confidence interval ] : 1.45 [ 0.79 - 2.66 ] ) , readmission ( 0.66 [ 0.24 - 1.80 ] ) , improvement in quality of life ( SF-12 PCS ) , or improvement in general health ( health transition index ) were not associated with satisfaction with care . Satisfaction with outcome : In ROC analyses , improvement in quality of life ( SF-12 ) and disability ( ODI/NDI ) failed to differentiate satisfaction with good accuracy ( AUC 0.76 ) . Neither 90-day morbidity ( 1.05 [ 0.46 - 2.34 ] ) nor 90-day readmission ( 0.27 [ 0.04 - 2.04 ] ) was associated with satisfaction with outcome in regression analysis . CONCLUSIONS Patient satisfaction is not a valid measure of overall quality or effectiveness of surgical spine care . Patient satisfaction metrics likely represent the patient 's subjective contentment with health-care service , a distinct aspect of care . Satisfaction metrics are important patient-centered measures of health-care service but should not be used as a proxy for overall quality , safety , or effectiveness of surgical spine care
Conclusion Our findings suggest that people with low literacy skills or learning disabilities are left out of the development of PROMs .
Background  Patient-reported outcome measures ( PROMs ) are intended to reflect outcomes relevant to patients .
They are increasingly used for healthcare quality improvement .
To produce valid measures , patients should be involved in the development process but it is unclear whether this usually includes people with low literacy skills or learning disabilities .