Core Set of Patient-Reported Outcome Measures for Measuring Quality of Life in Clinical Obesity Care.

PURPOSE: The focus of measuring success in obesity treatment is shifting from weight loss to patients' health and quality of life. The objective of this study was to select a core set of patient-reported outcomes and patient-reported outcome measures to be used in clinical obesity care. MATERIALS AND METHODS: The Standardizing Quality of Life in Obesity Treatment III, face-to-face hybrid consensus meeting, including people living with obesity as well as healthcare providers, was held in Maastricht, the Netherlands, in 2022. It was preceded by two prior multinational consensus meetings and a systematic review. RESULTS: The meeting was attended by 27 participants, representing twelve countries from five continents. The participants included healthcare providers, such as surgeons, endocrinologists, dietitians, psychologists, researchers, and people living with obesity, most of whom were involved in patient representative networks. Three patient-reported outcome measures (patient-reported outcomes) were selected: the Impact of Weight on Quality of Life-Lite (self-esteem) measure, the BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), and the Quality of Life for Obesity Surgery questionnaire (excess skin). No patient-reported outcome measure was selected for stigma. CONCLUSION: A core set of patient-reported outcomes and patient-reported outcome measures for measuring quality of life in clinical obesity care is established incorporating patients' and experts' opinions. This set should be used as a minimum for measuring quality of life in routine clinical practice. It is essential that individual patient-reported outcome measure scores are shared with people living with obesity in order to enhance patient engagement and shared decision-making.

The minimal important change is not a universal fixed value across diagnoses when using the FAOS and FAAM in patients undergoing elective foot and ankle surgery.

PURPOSE: This study aimed to calculate region and diagnosis-specific minimal important changes (MICs) of the Foot and Ankle Outcome Score (FAOS) and the Foot and Ankle Ability Measure (FAAM) in patients requiring foot and ankle surgery and to assess their variability across different foot and ankle diagnoses. METHODS: The study used routinely collected data from patients undergoing elective foot and ankle surgery. Patients had been invited to complete the FAOS and FAAM preoperatively and at 3-6 months after surgery, along with two anchor questions encompassing change in pain and daily function. Patients were categorised according to region of pathology and subsequent diagnoses. MICs were calculated using predictive modelling (MICPRED) and receiver operating characteristic curve (MICROC) method and evaluated according to strict credibility criteria. RESULTS: Substantial variability of the MICs between forefoot and ankle/hindfoot region was observed, as well as among specific foot and ankle diagnoses, with MICPRED and MICROC values ranging from 7.8 to 25.5 points and 9.4 to 27.8, respectively. Despite differences between MICROC and MICPRED estimates, both calculation methods exhibited largely consistent patterns of variation across subgroups, with forefoot conditions systematically showing smaller MICs than ankle/hindfoot conditions. Most MICs demonstrated high credibility; however, the majority of the MICs for the FAOS symptoms subscale and forefoot conditions exhibited insufficient or low credibility. CONCLUSION: The MICs of the FAOS and FAAM vary across foot and ankle diagnoses in patients undergoing elective foot and ankle surgery and should not be used as a universal fixed value, but recognised as contextual parameters. This can help clinicians and researchers in more accurate interpretation of the FAOS and FAAM change scores. LEVEL OF EVIDENCE: Level IV.

Validation of the Dutch Version of the BODY-Q Measuring Appearance, Health-Related Quality of Life, and Experience of Healthcare in Patients Undergoing Bariatric and Body Contouring Surgery.

BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.

Validity and reliability of the Patient-Reported Outcomes Measurement Information System (PROMIS®) using computerized adaptive testing in patients with advanced chronic kidney disease.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has been recommended for computerized adaptive testing (CAT) of health-related quality of life. This study compared the content, validity, and reliability of seven PROMIS CATs to the 12-item Short-Form Health Survey (SF-12) in patients with advanced chronic kidney disease. METHODS: Adult patients with chronic kidney disease and an estimated glomerular filtration rate under 30 mL/min/1.73 m2 who were not receiving dialysis treatment completed seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and the ability to participate in social roles and activities), the SF-12, and the PROMIS Pain Intensity single item and Dialysis Symptom Index at inclusion and 2 weeks. A content comparison was performed between PROMIS CATs and the SF-12. Construct validity of PROMIS CATs was assessed using Pearson's correlations. We assessed the test-retest reliability of all patient-reported outcome measures by calculating the intraclass correlation coefficient and minimal detectable change. RESULTS: In total, 207 patients participated in the study. A median of 45 items (10 minutes) were completed for PROMIS CATs. All PROMIS CATs showed evidence of sufficient construct validity. PROMIS CATs, most SF-12 domains and summary scores, and Dialysis Symptom Index showed sufficient test-retest reliability (intraclass correlation coefficient ≥ 0.70). PROMIS CATs had a lower minimal detectable change compared with the SF-12 (range, 5.7-7.4 compared with 11.3-21.7 across domains, respectively). CONCLUSION: PROMIS CATs showed sufficient construct validity and test-retest reliability in patients with advanced chronic kidney disease. PROMIS CATs required more items but showed better reliability than the SF-12. Future research is needed to investigate the feasibility of PROMIS CATs for routine nephrology care.

Is There An Association Between Bundled Payments and "Cherry Picking" and "Lemon Dropping" in Orthopaedic Surgery? A Systematic Review.

BACKGROUND: The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure that incentivizes improved value for patients. There is concern that such a payment mechanism may lead to patient screening and denying or providing orthopaedic care to patients based on the number and severity of comorbid conditions present associated with complications after surgery. Currently, however, there is no clear consensus about whether such an association exists. QUESTIONS/PURPOSES: In this systematic review, we asked: (1) Is the implementation of a bundled payment model associated with a change in the sociodemographic characteristics of patients undergoing an orthopaedic procedure? (2) Is the implementation of a bundled payment model associated with a change in the comorbidities and/or case-complexity characteristics of patients undergoing an orthopaedic procedure? (3) Is the implementation of a bundled payment model associated with a change in the recent use of healthcare resources characteristics of patients undergoing an orthopaedic procedure? METHODS: This systematic review was registered in PROSPERO before data collection (CRD42020189416). Our systematic review included scientific manuscripts published in MEDLINE, Embase, Web of Science, Econlit, Policyfile, and Google Scholar through March 2020. Of the 30 studies undergoing full-text review, 20 were excluded because they did not evaluate the outcome of interest (patient selection) (n = 8); were editorial, commentary, or review articles (n = 5); did not evaluate the appropriate intervention (introduction of a bundled payment program) (n = 4); or assessed the wrong patient population (not orthopaedic surgery patients) (n = 3). This led to 10 studies included in this systematic review. For each study, patient factors analyzed in the included studies were grouped into the following three categories: sociodemographics, comorbidities and/or case complexity, or recent use of healthcare resources characteristics. Next, each patient factor falling into one of these three categories was examined to evaluate for changes from before to after implementation of a bundled payment initiative. In most cases, studies utilized a difference-in-difference (DID) statistical technique to assess for changes. Determination of whether the bundled payment initiative required mandatory participation or not was also noted. Scientific quality using the Adapted Newcastle-Ottawa Scale had a median (range) score of 8 (7 to 8; highest possible score: 9), and the quality of the total body of evidence for each patient characteristic group was found to be low using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. We could not assess the likelihood of publication using funnel plots because of the variation of patient factors analyzed in each study and the heterogeneity of data precluded a meta-analysis. RESULTS: Of the nine included studies that reported on the sociodemographic characteristics of patients selected for care, seven showed no change with the implementation of bundled payments, and two demonstrated a difference. Most notably, the studies identified a decrease in the percentage of patients undergoing an orthopaedic operative intervention who were dual-eligible (range DID estimate -0.4% [95% CI -0.75% to -0.1%]; p < 0.05 to DID estimate -1.0% [95% CI -1.7% to -0.2%]; p = 0.01), which means they qualified for both Medicare and Medicaid insurance coverage. Of the 10 included studies that reported on comorbidities and case-complexity characteristics, six reported no change in such characteristics with the implementation of bundled payments, and four studies noted differences. Most notably, one study showed a decrease in the number of treated patients with disabilities (DID estimate -0.6% [95% CI -0.97% to -0.18%]; p < 0.05) compared with before bundled payment implementation, while another demonstrated a lower number of Elixhauser comorbidities for those treated as part of a bundled payment program (before: score of 0-1 in 63.6%, 2-3 in 27.9%, > 3 in 8.5% versus after: score of 0-1 in 50.1%, 2-3 in 38.7%, > 3 in 11.2%; p = 0.033). Of the three included studies that reported on the recent use of healthcare resources of patients, one study found no difference in the use of healthcare resources with the implementation of bundled payments, and two studies did find differences. Both studies found a decrease in patients undergoing operative management who recently received care at a skilled nursing facility (range DID estimate -0.50% [95% CI -1.0% to 0.0%]; p = 0.04 to DID estimate: -0.53% [95% CI -0.96% to -0.10%]; p = 0.01), while one of the studies also found a decrease in patients undergoing operative management who recently received care at an acute care hospital (DID estimate -0.8% [95% CI -1.6% to -0.1%]; p = 0.03) or as part of home healthcare (DID estimate -1.3% [95% CI -2.0% to -0.6%]; p < 0.001). CONCLUSION: In six of 10 studies in which differences in patient characteristics were detected among those undergoing operative orthopaedic intervention once a bundled payment program was initiated, the effect was found to be minimal (approximately 1% or less). However, our findings still suggest some level of adverse patient selection, potentially worsening health inequities when considered on a large scale. It is also possible that our findings reflect better care, whereby the financial incentives lead to fewer patients with a high risk of complications undergoing surgical intervention and vice versa for patients with a low risk of complications postoperatively. However, this is a fine line, and it may also be that patients with a high risk of complications postoperatively are not being offered surgery enough, while patients at low risk of complications postoperatively are being offered surgery too frequently. Evaluation of the longer-term effect of these preliminary bundled payment programs on patient selection is warranted to determine whether adverse patient selection changes over time as health systems and orthopaedic surgeons become accustomed to such reimbursement models.

Measuring health-related quality of life in colorectal cancer patients: systematic review of measurement properties of the EORTC QLQ-CR29.

INTRODUCTION: The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice. The aim of this systematic review was to investigate whether the initial positive results regarding the measurement properties of the QLQ-CR29 are confirmed in subsequent studies. METHODS: A systematic search of Embase, Medline, PsycINFO, and Web of Science was conducted to identify studies investigating the measurement properties of the QLQ-CR29 published up to January 2019. For the 11 included studies, data were extracted, methodological quality was assessed, results were synthesized, and evidence was graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on the measurement properties: structural validity, internal consistency, reliability, measurement error, construct validity (hypothesis testing, including known-group comparison, convergent and divergent validity), cross-cultural validity, and responsiveness. RESULTS: Internal consistency was rated as "sufficient," with low evidence. Reliability was rated as "insufficient," with moderate evidence. Construct validity (hypothesis testing; known-group comparison, convergent and divergent validity) was rated as "inconsistent," with moderate evidence. Structural validity, measurement error, and responsiveness were rated as "indeterminate" and could therefore not be graded. CONCLUSION: This review indicates that current evidence supporting the measurement properties of the QLQ-CR29 is limited. Additionally, better quality research is needed, taking into account the COSMIN methodology.

Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

BACKGROUND: Instructing and guiding patients after surgery is essential for successful recovery. However, the time that health-care professionals can spend with their patients postoperatively has been reduced because of efficiency-driven, shortened hospital stays. We evaluated the effect of a personalised e-health-care programme on return to normal activities after surgery. METHODS: A multicentre, single-blind, randomised controlled trial was done at seven teaching hospitals in the Netherlands. Patients aged 18-75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication were recruited. An independent researcher randomly allocated participants to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital. Participants in the intervention group had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient. The control group received usual care and access to a placebo website containing standard general recovery advice. Participants were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery. The primary outcome was time between surgery and return to normal activities, measured using personalised patient-reported outcome measures. Intention-to-treat and per-protocol analyses were done. This trial is registered in the Netherlands National Trial Register, number NTR4699. FINDINGS: Between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group. 14 participants (4%) were lost to follow-up, with 330 participants included in the primary outcome analysis. Median time until return to normal activities was 21 days (95% CI 17-25) in the intervention group and 26 days (20-32) in the control group (hazard ratio 1·38, 95% CI 1·09-1·73; p=0·007). Complications did not differ between groups. INTERPRETATION: A personalised e-health intervention after abdominal surgery speeds up the return to normal activities compared with usual care. Implementation of this e-health programme is recommended in patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures. FUNDING: ZonMw.

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

PURPOSE: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies. METHODS: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. RESULTS: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate. CONCLUSION: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.

A systematic review of the measurement properties of the Body Image Scale (BIS) in cancer patients.

INTRODUCTION: Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients. METHODS: A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate. RESULTS: Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity. CONCLUSION: The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies.

Meaningful Change Scores in the Knee Injury and Osteoarthritis Outcome Score in Patients Undergoing Anterior Cruciate Ligament Reconstruction.

BACKGROUND: Meaningful change scores in the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing anterior cruciate ligament (ACL) reconstruction have not yet been established. PURPOSE: To define the minimal important change (MIC) for the KOOS after ACL reconstruction. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: KOOS and anchor questions with 7-point scales ranging from "better, an important improvement" to "worse, an important worsening" were completed postoperatively by randomly chosen participants from the Norwegian Knee Ligament Registry. Presurgery KOOS scores were retrieved from the registry. The MIC for improvement was calculated with anchor-based approaches using the predictive modeling method adjusted for the proportion of improved patients, the mean change method, and the receiver operating characteristic (ROC) method. RESULTS: Complete data for at least one of the KOOS subscales were obtained from 542 (45.3%) participants. Predictive modeling MIC values were 12.1 for the KOOS subscales of Sport and Recreational Function and 18.3 for Knee-Related Quality of Life. These values aid in interpreting within-group improvement over time and can be used as responder criteria when comparing groups. The corresponding and much lower values for the subscales of Pain (2.5), Symptoms (-1.2), and Activities of Daily Living (2.4) are the results from patients reporting, on average, only mild problems with these domains preoperatively. Although 4% to 10% of patients reported subscale-specific worsening, MIC deterioration calculations were not possible. The ROC MIC values were associated with high degrees of misclassification. Values obtained by the mean change method were considered less reliable because these estimates are derived from subgroups of patients. Average KOOS change scores were approximately similar for patients reporting acceptable symptoms postoperatively and patients reporting important improvements on the anchor items after surgery. CONCLUSION: KOOS users should apply subscale-specific cutoffs for meaningful improvement. Our results confirm using the subscales of Sport and Recreational Function and Knee-Related Quality of Life as primary patient-reported outcomes after ACL reconstruction. The predictive modeling approach gave the most robust estimates of MIC values. Our data suggest that reporting acceptable symptoms postoperatively corresponds to reporting an important improvement after ACL reconstruction.

Using PROMIS for measuring recovery after abdominal surgery: a pilot study.

BACKGROUND: To assess the construct validity and responsiveness of the PROMIS Physical Function v1.2 short form 8b (PROMIS-PF), and the PROMIS Ability to Participate in Social Roles and Activities v2.0 short form 8a (PROMIS-APS) in postoperative recovery. METHODS: An observational pilot study was conducted in which 30 patients participated, undergoing various forms of abdominal surgery. Patients completed the PROMIS-PF and PROMIS-APS, the Short Form 36 Health Survey (SF-36) and the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) at several time points before and after surgery. The construct validity and responsiveness of the two PROMIS short forms were evaluated by testing pre-defined hypotheses and were considered adequate when at least 75% of the data was consistent with the hypotheses. Construct validity was evaluated by calculating Spearman correlations and the responsiveness by calculating effect sizes. RESULTS: 6/7 (85.7%) of the results were consistent with the hypotheses supporting the construct validity of the PROMIS-PF. For the PROMIS-APS this was the case in 7/15 (46.7%) of the results. For the PROMIS-PF, 6/7 (85.7%) of the results were consistent with the hypotheses, supporting responsiveness. Regarding the responsiveness of the PROMIS-APS, only 7 out of 13 (53.8%) of these results were consistent with the hypotheses. CONCLUSIONS: This study supported the construct validity and the responsiveness of the PROMIS-PF v1.2 short form 8b for measuring recovery in abdominal surgery. Considering the major advantages of PROMIS, we recommend the use of the PROMIS-PF in abdominal surgery.

A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

BACKGROUND: An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. OBJECTIVES: To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. METHODS: A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. RESULTS: Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. CONCLUSIONS: At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS.

Breast-conserving therapy for breast cancer: Cosmetic results and options for delayed reconstruction.

OBJECTIVES: Optimisation of the cosmetic outcome after breast-conserving therapy (BCT) is important. We aimed to determine the cosmetic outcome following BCT and factors influencing this cosmesis and identify the most favourable options for delayed breast reconstruction. MATERIALS AND METHODS: Four reconstructive surgeons evaluated the cosmetic outcome of 109 patients after BCT. Additionally, the surgeons indicated which patients were amenable for delayed reconstruction and the preferred type of reconstruction. The inter- and intra-observer agreement of the surgeons was rated. RESULTS: The mean overall cosmetic outcome was rated as fair (2.7/4.0, SD 0.9, 1.0-4.0). Risk factors for a poor cosmesis were larger breast size (OR 3.81, p = 0.040), larger tumour (OR 1.63, p = 0.028) and axillary lymph node dissection (ALND) (OR 3.09, p = 0.013). Reconstruction of the ipsilateral side was recommended in 55.6% and 94.5% and contralateral reconstruction in 16.7% and 73.3% of patients with good and poor cosmesis, respectively. Flap reconstruction and lipofilling were most commonly reported for the ipsilateral, and breast reduction for the contralateral breast, with reasonable improvement expected (2.2/4.0, SD 0.5, 1.08-3.3). The inter- (0.5-0.7) and intra-observer (0.63-0.79) agreement of the cosmesis was moderate to good, however, poor regarding the recommended reconstruction techniques (mainly < 0.50). CONCLUSION: Cosmetic outcome after BCT is influenced by breast and tumour size and ALND. Although several reconstructive options are available, the optimal method for revision surgery has not yet been determined. Future studies are necessary to obtain evidence-based guidelines for reconstructive surgery after BCT.

Spearman-Brown prophecy formula and Cronbach's alpha: different faces of reliability and opportunities for new applications.

OBJECTIVES: There are similarities between the different forms of reliability, such as internal consistency (internal reliability) and interrater and intrarater reliability. Reliability coefficients that are based on classical test theory can be expressed as intraclass correlation coefficients (ICCs), such as Cronbach's alpha. The Spearman-Brown prophecy formula (SB formula) is used to calculate the reliability when the number of items in a questionnaire is changed. This paper aims to increase insight into reliability studies by pointing to the assumptions of reliability coefficients, similarities between various coefficients, and the subsequent new applications of reliability coefficients. DESIGN, SETTINGS AND RESULTS: The origin and assumptions of Cronbach's alpha and the SB formula are discussed. Cronbach's alpha is written as an ICC formula, using the well-known property that taking the average value of a number of ratings increases the reliability of a measurement. We illustrate with an example that the ICC formulas for average measurements of multiple raters and the SB formula give similar results. This implies that the SB formula can be used to decide on the number of measurements to be averaged and thus on the number of raters required, for obtaining measurements with acceptable reliability, even if the variance components of the ICC formula are not known. Using the same example, we illustrate the principle of "Cronbach's alpha if item deleted" to decide on the poorest performing raters in a set of raters. CONCLUSION: These applications have different assumptions: the principle of "Cronbach's alpha if item deleted" is based on the assumption of a fixed set of items/raters and the SB formula is based on the assumption of random raters. The example also emphasizes the need for more raters in the design of the reliability study to obtain a robust estimation of reliability.

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

BACKGROUND: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. OBJECTIVE: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. METHODS: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. RESULTS: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. CONCLUSIONS: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. CLINICALTRIAL: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).

Comment on "Should we reframe how we think about physical activity and sedentary behavior measurement? Validity and reliability reconsidered".

With great interest we read the article by Kelly et al. on the measurement of physical activity (PA) and sedentary behavior (SB) (Kelly P et al. Int J Behav Nutr Phys Act 13:(1) 32, 2016). We appreciate the invitation of the authors to provide feedback on their ideas and we take this opportunity to contribute to the discussion. Our main proposition is that this field can learn much from the field of quality of life research and the methodology developed for validating quality of life questionnaires.

The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and how to select an outcome measurement instrument

Background: COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) is an initiative of an international multidisciplinary team of researchers who aim to improve the selection of outcome measurement instruments both in research and in clinical practice by developing tools for selecting the most appropriate available instrument. Method: In this paper these tools are described, i.e. the COSMIN taxonomy and definition of measurement properties; the COSMIN checklist to evaluate the methodological quality of studies on measurement properties; a search filter for finding studies on measurement properties; a protocol for systematic reviews of outcome measurement instruments; a database of systematic reviews of outcome measurement instruments; and a guideline for selecting outcome measurement instruments for Core Outcome Sets in clinical trials. Currently, we are updating the COSMIN checklist, particularly the standards for content validity studies. Also new standards for studies using Item Response Theory methods will be developed. Additionally, in the future we want to develop standards for studies on the quality of non-patient reported outcome measures, such as clinician-reported outcomes and performance-based outcomes. Conclusions: In summary, we plea for more standardization in the use of outcome measurement instruments, for conducting high quality systematic reviews on measurement instruments in which the best available outcome measurement instrument is recommended, and for stopping the use of poor outcome measurement instruments.

Assessment of patient-reported outcome measures in the surgical treatment of patients with gastric cancer.

BACKGROUND: Gastric cancer is responsible for 10 % of all cancer-related deaths worldwide. With improved operative techniques and neo-adjuvant therapy, survival rates are increasing. Outcomes of interest are shifting to quality of life (QOL), with many different tools available. The aim of this study was to assess which patient-reported outcome measures (PROMs) are used to measure QOL after a gastrectomy for cancer. METHODS: A comprehensive search was conducted for original articles investigating QOL after gastrectomy. Two authors independently selected relevant articles, conducted clinical appraisal and extracted data (P.J. and J.S.). RESULTS: Out of 3414 articles, 26 studies were included, including a total of 4690 patients. These studies included ten different PROMs, which could be divided into generic, symptom-specific and disease-specific questionnaires. The EORTC and the FACT questionnaires use an oncological overall QOL module and an organ-specific module. Only one validation study regarding the use of the EORTC after surgery for gastric cancer was available, demonstrating good psychometric properties and clinical validity. CONCLUSIONS: A great variety of PROMs are being used in the measurement of QOL after surgery for gastric cancer. A questionnaire with a general module along with a disease-specific module for the assessment of QOL seems most desirable, such as the EORTC and the FACT with their specific modules. Both are developed in different treatment modalities, such as in surgical patients. EORTC is the most widely used questionnaire and therefore allows for comparison of new studies to existing data. Future studies are needed to assess content validity in surgical gastric cancer patients.

The Oxford Shoulder Instability Score; validation in Dutch and first-time assessment of its smallest detectable change.

BACKGROUND: The Oxford Shoulder Instability Score (OSIS) is a short, self-reported outcome measurement for patients with shoulder instability. In this study, the OSIS was validated in Dutch by testing the internal consistency, reliability, measurement error, validity and the floor and ceiling effects, and its smallest detectable change (SDC) was calculated. METHODS: A total of 138 patients were included. Internal consistency was calculated with Cronbach's α. Reliability (test-retest) was calculated with the intraclass correlation coefficient (ICC). The measurement error was calculated (SEM), and the SDC was estimated in a subgroup of 99 patients that completed the re-test after a mean of 13 days (5-30 days). Construct validity was evaluated by comparing the OSIS with the Western Ontario Shoulder Instability index (WOSI), the Simple Shoulder Test (SST), the Oxford Shoulder Score (OSS), the Disability of the Arm, Shoulder, and Hand assessment (DASH), and the Short Form-36 (SF-36). RESULTS: Internal consistency was good, with a Cronbach's α of 0.88. The reliability was excellent, with an ICC of 0.87. The SEM was 3.3 and the SDC was 9 points (on a scale of 0-48). Regarding the construct validity, 80% of the results were in accordance with the hypotheses, including a high correlation (0.82) with the WOSI. No floor or ceiling effects were found. CONCLUSIONS: The Dutch version of the OSIS showed good reliability and validity in a cohort of patients with shoulder instability.