Assessing the content validity of the Manchester-Oxford Foot Questionnaire in surgically treated ankle fracture patients: a qualitative study.

BACKGROUND: Roughly 10% of fractures in adults are ankle fractures. These injuries are found in both sexes and present with different fracture characteristics. The treatment varies with the patients' biology and fracture type, and the goals are to restore stability, prevent pain and maintain ankle function. Clinicians generally use outcomes like assessment of radiography, pain level, or function. The use of patient-reported outcome measures is increasing, and the Manchester-Oxford Foot Questionnaire (MOXFQ) has been shown to have good measurement properties when validated in patients with foot and ankle disorders. However, the instrument has not been validated for ankle fracture patients. This study aims to assess the content validity of the items in MOXFQ in surgically treated ankle fracture patients. METHODS: A qualitative deductive design was used to investigate patients' response process of the MOXFQ. Individual interviews were conducted using cognitive interviewing based on the theoretical framework of the 4-step model by Tourangeau. Adult patients that were surgically treated for an ankle fracture between four weeks and 18 months were purposively sampled, and interviews followed a semi-structured interview guide. The predetermined categories were comprehension, retrieval, judgement, and response. RESULTS: Seventeen respondents (65% females) were interviewed. Respondents' age ranged from 27 to 76 years. Some of the respondents in the early recovery phase were limited by post-operative restrictions and did not find the items in the walking/standing domain relevant. Respondents that were allowed weight-bearing as tolerated (WBAT) were able to recall relevant information for most items. Respondents with time since surgery more than 12 months had less pain and remembered fewer relevant episodes in the recall period. Items in the social interaction domain contained ambiguous questions and were generally considered less important by respondents. The summary index score lacked important concepts in measuring overall quality of life. CONCLUSIONS: Pain was a central concept in the post-operative recovery of ankle fracture patients. The MOXFQ-subscales for pain and walking/standing had acceptable content validity in patients that were allowed WBAT. The social interaction-subscale and the summary index score had insufficient content validity for this patient population.

Improving the quality of the fracture liaison service through the implementation of a structured health record.

OBJECTIVE: According to the best practice framework for secondary fracture prevention, all patients aged ≥50 years with a fracture should be assessed for osteoporosis within the fracture liaison service (FLS). The framework includes an FLS quality registry database to ensure quality. The input of data into our FLS registry was time-consuming and required entering data twice: into both the journal record and the registry. A '3-in-1' solution was required: (1) developing a structured health record (SHR) to provide decision-support to FLS nurses during patient consultations; (2) making a structured journal record from the SHR and (3) exporting data to the quality registry database. The SHR needed to be web based, secure and available for use all over the world. DESIGN: One provider at Stavanger University Hospital met all the criteria for further development of the record (CheckWare). An interdisciplinary working group was established, following the Plan-Do-Study-Act working model. Depending on the answers given, the FLS nurses were provided decision-making support. A significant loss of height (≥4 cm) was highlighted as one of the process quality indicators. All clinically relevant data were summarised in a report, which was exported to the health record software. Data were exported to the FLS quality registry. RESULTS: All fracture patients in need of a dual-energy X-ray absorptiometry scan received an appointment at the FLS outpatient clinic and 96% attended. The minimum standard was met for the three quality indicators 1-3). In particular, the use of SHRs increased the number of patients investigated for vertebral fractures with a height loss ≥4 cm from 67% to 93%. CONCLUSION: The SHR was successful in regard to the '3-in-1' solution: providing decision support to FLS nurses, developing structured journal records and exporting data to the FLS quality registry. After implementation, all FLS registry quality indicators improved.

Ankle fractures: a systematic review of patient-reported outcome measures and their measurement properties.

PURPOSE: Ankle fractures are commonly occurring fractures, especially in the aging population, where they often present as fragility fractures. The disease burden and economic costs to the patient and society are considerable. Choosing accurate outcome measures for the evaluation of the management of ankle fractures in clinical trials facilitates better decision-making. This systematic review assesses the evidence for the measurement properties of patient-reported outcome measures (PROMs) used in the evaluation of adult patients with ankle fractures. METHODS: Searches were performed in CINAHL, EMBASE, Medline and Google Scholar from the date of inception to July 2021. Studies that assessed the measurement properties of a PROM in an adult ankle fracture population were included. The included studies were assessed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of PROMs. RESULTS: In total, 13 different PROMs were identified in the 23 included articles. Only the Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) presented some evidence on content validity. The Olerud-Molander Ankle Score (OMAS) and Self-reported Foot and Ankle Score (SEFAS) displayed good evidence of construct validity and internal consistency. The measurement properties of the OMAS, LEFS and SEFAS were most studied. CONCLUSION: The absence of validation studies covering all measurement properties of PROMs used in the adult ankle fracture population precludes the recommendation of a specific PROM to be used in the evaluation of this population. Further research should focus on validation of the content validity of the instruments used in patients with ankle fractures.

Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)-a study protocol for a pragmatic randomized controlled trial.

BACKGROUND: The outcome of non-surgical treatment is generally good, but the treatment course can be long and painful with approximately a quarter of the patients acquiring a nonunion. Both surgical and non-surgical treatment can have disabling consequences such as nerve injury, infection, and nonunion. The purpose of the study is to compare patient-reported outcomes after surgical and non-surgical treatment for humeral shaft fractures. METHODS: A pragmatic randomized controlled trial (RCT) is planned with two study groups (SHAFT-Young and SHAFT-Elderly). A total of 287 eligible acute humeral shaft fractures are scheduled to be recruited and randomly allocated to surgical or non-surgical treatment with the option of early crossover due to delayed union. The surgical method within the allocation is decided by the surgeon. The primary outcome is the Disability of Arm, Shoulder, and Hand (DASH) score at 52 weeks, and is assessor blinded. The secondary outcomes are DASH score, EQ-5D-5L, pain assessed by visual analog score, Constant-Murley score including elbow range of motion, and anchor questions collected at all timepoints throughout the trial. All complications will be reported including; infection, nerve or vascular injury, surgical revisions (implant malpositioning, hardware failure, aseptic loosening, and peri-implant fracture), major adverse cardiovascular events, and mortality. DISCUSSION: The SHAFT trial is a pragmatic multicenter RCT, that will compare the effectiveness of the main strategies in humeral shaft fracture treatment. This will include a variety of fracture morphologies, while taking the dilemmas within the population into account by splitting the population by age and providing the orthopedic society with an interval for early crossover surgery. TRIAL REGISTRATION: Clinicaltrials.gov NCT04574336 . Registered on 5 October 2020.

Excellent PROM results after fast-track hip and knee arthroplasty with no postoperative restrictions: a cohort study validation of fast-track surgery without postoperative restrictions.

BACKGROUND: Fast-track hip and knee arthroplasty (HA and KA) has been increasingly common over the last decade. In the same time period, there was a strong trend toward less restrictive mobilization. However, few reports have been published on combining these novel programs while measuring the postoperative results by patient-reported outcome measures (PROMs). Descriptions of fast-track surgery programs and their results are warranted. METHODS: The aim of this retrospective cohort study was to examine if it is possible to achieve excellent PROM results for hip and knee arthroplasty patients in a fast-track pathway without postoperative restrictions. During 2014-2017, the stepwise introduction of a PROM program was implemented at Stavanger University Hospital for all scheduled HA and KA patients, with preoperative assessments and postoperative follow-ups at the outpatient clinic. Standardized information with a focus on early mobilization and no postoperative restrictions was also initiated for the same patients. The generic EuroQol questionnaire (EQ-5D) and either the Hip or Knee disability/injury and Osteoarthritis Outcome Score (HOOS or KOOS) were used. RESULTS: PROM response rates varied from 80 to 99%. The median (interquartile range) change from preoperative to one-year postoperative results were as follows for HA and KA patients, respectively: pain, 55 (43-68) and 47 (31-61); other symptoms, 50 (40-65) and 36 (19-50); function in daily living, 54 (41-65) and 44 (31-55); function in sports and recreation, 56 (38-75) and 40 (15-64); joint-related quality of life, 69 (50-81) and 56 (38-75). The length of stay (LOS) was reduced by 1.9 days (mean), corresponding to a 40% reduction for HA patients and a 37% reduction for KA patients. CONCLUSIONS: We found excellent PROM results after fast-track HA and KA with no postoperative restrictions. We believe that a fast-track program focusing on mobilization without any postoperative restrictions is superior for most patients, but further comparative studies are warranted.

Pragmatic trials - what are they? / Pragmatiske studier ­ hva er det?

Pragmatic clinical trials are based on data from unselected patients recruited from common clinical practice. These trials therefore bridge the gap between evidence-based medicine and clinical practice.

Improving osteoarthritis management in primary healthcare: results from a quasi-experimental study.

BACKGROUND: To improve quality of care for patients with hip and knee osteoarthritis (OA), general practitioners (GPs) and physiotherapists (PTs) in a Norwegian municipality initiated an intervention. The intervention aimed to increase provision of core OA treatment (information, exercise, and weight control) prior to referral for surgery, rational use of imaging for assessing OA and improve communication between healthcare professionals. This study assessed the effectiveness of this intervention. METHODS: Forty-eight PTs and one hundred one GPs were invited to the intervention that included two interactive workshops outlining best practice and an accompanying template for PT discharge reports. Using interrupted time series research design, the study period was divided into three: pre-implementation, transition (implementation) and post-implementation. Comparing the change between pre- and post-implementation, the primary outcome was patient-reported quality of OA care measured with the OsteoArthritis Quality Indicator questionnaire. Secondary outcomes were number of PT discharge reports, information included in GP referral letters to orthopaedic surgeon, the proportion of GP referral letters indicating use of core treatment, and the use of imaging within OA assessment. Analyses involved linear mixed and logistic regression models. RESULTS: The PT workshop had 30 attendees, and 31 PTs and 33 GPs attended the multidisciplinary workshop. Two hundred eight and one hundred twenty-five patients completed the questionnaire during pre- and post-implementation, respectively. The adjusted model showed a small, statistically non-significant, increase in mean total score for quality of OA care (mean change = 4.96, 95% CI -0.18, 10.12, p:0.057), which was mainly related to items on OA core treatment. Patients had higher odds of reporting receipt of information on treatment alternatives (odds ratio (OR) 1.9, 95% CI 1.08, 3.24) and on self-management (OR 2.4, 95% CI 1.33, 4.32) in the post-implementation phase. There was a small, statistically non-significant, increase in the proportion of GP referral letters indicating prior use of core treatment modalities. There were negligible changes in the number of PT discharge reports, in the information included in the GP referral letters, and in the use of imaging for OA assessment. CONCLUSION: This study suggests that a primary care intervention including two inter-active workshops can shift the quality of care towards best practice recommendations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02876120 .

Data entry quality of double data entry vs automated form processing technologies: A cohort study validation of optical mark recognition and intelligent character recognition in a clinical setting.

BACKGROUND AND AIMS: Patient-reported outcome measures (PROMs) are increasingly used in health services. Paper forms are still often used to register such data. Manual double data entry (DDE) has been defined as the gold standard for transferring data to an electronic format but is laborious and costly. Automated form processing (AFP) is an alternative, but validation in a clinical context is warranted. The study objective was to examine and validate a local hospital AFP setup. METHODS: Patients over 18 years of age who were scheduled for knee or hip replacement at Stavanger University Hospital from 2014 to 2017 who answered PROMs were included in the study and contributed PROM data. All paper PROMs were scanned using the AFP techniques of optical mark recognition (OMR) and intelligent character recognition (ICR) and were processed by DDE by health secretaries using a data entry program. OMR and ICR were used to capture different types of data. The main outcome was the proportion of correctly entered numbers, defined as the same response recorded in AFP and DDE or by consulting the original paper questionnaire at the data field, item, and PROM level. RESULTS: A total of 448 questionnaires from 255 patients were analyzed. There was no statistically significant difference in error proportions per 10 000 data fields between OMR and DDE for data from check boxes (3.52 95% confidence interval (CI) 2.17 to 5.72 and 4.18 (95% CI 2.68-6.53), respectively P = .61). The error proportion for ICR (nine errors) was statistically significantly higher than that for DDE (two errors), that is, 3.53 (95% CI 1.87-6.57) vs 0.78 (95% CI 0.22-2.81) per 100 data fields/items/questionnaires; P = .033. OMR (0.04% errors) outperformed ICR (3.51% errors; P < .001), Fisher's exact test. CONCLUSIONS: OMR can produce an error rate that is comparable to that of DDE. In our setup, ICR is still problematic and is highly dependent on manual validation. When AFP is used, data quality should be tested and documented.

Patient reported outcomes in hip arthroplasty registries.

PROs are used increasingly in orthopedics and in joint registries, but still many aspects of use in this area have not been examined in depth. To be able to introduce PROs in the DHR in a scientific fashion, my studies were warranted; the feasibility of four often used PROs (OHS, HOOS, EQ-5D and SF-12) was examined in a registry context. Having the PROs in the target language is an absolute necessity, so I translated, cross-culturally adapted and validated a Danish language version of an often used PRO (OHS), since this PRO had no properly developed Danish language version. To minimize data loss and to maximize the data quality I validated our data capture procedure, an up to date AFP system, by comparing scannable, paper-based PROs, with manual single-key- and double-key entered data. To help further registry-PRO studies, I calculated the number of patients needed to discriminate between subgroups of age, sex, diagnosis, and prosthesis type for each of four often used PROs (OHS, HOOS, EQ-5D and SF-12), and to simplify the clinical interpretation of PRO scores and PRO change scores in PRO studies, I estimated MCII and PASS for two often used PROs (EQ-5D and HOOS). The feasibility study included 5,747 THA patients registered in the DHR, and I found only minor differences between the disease-specific and the generic PROs regarding ceiling and floor effects as well as discarded items. The HOOS, the OHS, the SF-12, and the EQ-5D are all appropriate PROs for administration in a hip registry. I found that group sizes from 51 to 1,566 were needed for subgroup analysis, depending on descriptive factors and choice of PRO. The AFP study included 200 THA patients (398 PROs, 4,875 items and 21,887 data fields), and gave excellent results provided use of highly structured questionnaires. OMR performed equally as well as manual double-key entering, and better than single-key entering. The PRO translation and validation study included 2,278 patients (and 212 patients for the test-retest). I found that the translated PRO had good feasibility, an excellent response rate, no floor effect, but a high ceiling effect (as was expected with our postoperative patients) and few patients missed too many items to calculate a sum score. The translated PRO had high test-retest reliability and very high internal consistency, and appears to be a valid and reliable tool for outcome studies on THA patients in a hip registry setting. The MCII and PASS study included 1,335 patients, and I estimated that one year after THA, an improvement of 38-55% from mean baseline PRO score and absolute follow-up scores of 57-91% of the maximum score correspond to a minimal important improvement and acceptable symptom state, respectively.

Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively.

BACKGROUND AND PURPOSE: The increased use of patient-reported outcomes (PROs) in orthopedics requires data on estimated minimal clinically important improvements (MCIIs) and patient-acceptable symptom states (PASSs). We wanted to find cut-points corresponding to minimal clinically important PRO change score and the acceptable postoperative PRO score, by estimating MCII and PASS 1 year after total hip arthroplasty (THA) for the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) and the EQ-5D. PATIENTS AND METHODS: THA patients from 16 different departments received 2 PROs and additional questions preoperatively and 1 year postoperatively. The PROs included were the HOOS subscales pain (HOOS Pain), physical function short form (HOOS-PS), and hip-related quality of life (HOOS QoL), and the EQ-5D. MCII and PASS were estimated using multiple anchor-based approaches. RESULTS: Of 1,837 patients available, 1,335 answered the preoperative PROs, and 1,288 of them answered the 1-year follow-up. The MCIIs and PASSs were estimated to be: 24 and 91 (HOOS Pain), 23 and 88 (HOOS-PS), 17 and 83 (HOOS QoL), 0.31 and 0.92 (EQ-5D Index), and 23 and 85 (EQ-VAS), respectively. MCIIs corresponded to a 38-55% improvement from mean baseline PRO score and PASSs corresponded to absolute follow-up scores of 57-91% of the maximum score in THA patients 1 year after surgery. INTERPRETATION: This study improves the interpretability of PRO scores. The different estimation approaches presented may serve as a guide for future MCII and PASS estimations in other contexts. The cutoff points may serve as reference values in registry settings.

Factors influencing health-related quality of life after total hip replacement--a comparison of data from the Swedish and Danish hip arthroplasty registers.

BACKGROUND: There is an increasing focus on measuring patient-reported outcomes (PROs) as part of routine medical practice, particularly in fields such as joint replacement surgery where pain relief and improvement in health-related quality of life (HRQoL) are primary outcomes. Between-country comparisons of PROs may present difficulties due to cultural differences and differences in the provision of health care. However, in order to understand how these differences affect PROs, common predictors for poor and good outcomes need to be investigated. This cross-sectional study investigates factors influencing health-related quality of life (HRQoL) one year after total hip replacement (THR) surgery in Sweden and in Denmark. METHODS: Data was retrieved from the Swedish (n = 14,560 patients) and Danish (n = 632 patients) Hip Arthroplasty Registers according to preset selection criteria. Using linear regression models, we examined how sex, age, comorbidity and country of surgery were associated with different aspects of HRQoL as measured by the EQ-5D index and EQ VAS. RESULTS: Danish patients had an overall higher EQ-5D index and EQ VAS than Swedish patients (p < 0.001). After regression analysis, the estimated coefficients for sex, age, or the Charlson score did not differ between countries for either the EQ-5D index (p = 0.83) or EQ VAS (p = 0.41) one year after THR. CONCLUSIONS: We conclude that there are clear similarities in how basic predictors influence patient-reported outcomes (PROs) in patients with THR in Sweden and Denmark and these known predictors of good or poor HRQoL outcomes are not specific for each country.

Feasibility of 4 patient-reported outcome measures in a registry setting.

BACKGROUND AND PURPOSE: Feasibility is an important parameter when choosing which patient-reported outcomes (PRO) to use in a study. We assessed the feasibility of PROs in a hip registry setting. METHODS: Primary total hip arthroplasty (THA) patients (n = 5,747) who had been operated on 1-2, 5-6, or 10-11 years previously were randomly selected from the Danish Hip Arthroplasty Register and sent 2 PRO questionnaires: 1 generic (EuroQoL-5D or SF-12 health survey) and 1 disease-specific (hip dysfunction and osteoarthritis outcome score (HOOS) or Oxford 12-item hip score). We compared response rates, floor and ceiling effects, missing items, and the need for manual validation of forms. RESULTS: 4,784 patients (mean age 71 years, 57% females) were included (83%). The response rates ranged from 82-84%. Statistically significantly different floor and ceiling effects ranged from 0% to 0.5% and from 6.1% to 46%, respectively. Missing items ranged from 1.2% to 3.4%, and 0.8-4.3% required manual validation (p < 0.009). A hypothetical repeat study found that group sizes from 51 to 1,566 are needed for subgroup analysis, depending on descriptive factor and choice of PRO. INTERPRETATION: All 4 PROs fulfilled a priori set criteria, with the exception of ceiling effects. The high ceiling effects were attributed to postoperative administration and good outcome for THA. We conclude that all 4 PROs are appropriate for administration in a hip registry.

Quality of data entry using single entry, double entry and automated forms processing--an example based on a study of patient-reported outcomes.

BACKGROUND: The clinical and scientific usage of patient-reported outcome measures is increasing in the health services. Often paper forms are used. Manual double entry of data is defined as the definitive gold standard for transferring data to an electronic format, but the process is laborious. Automated forms processing may be an alternative, but further validation is warranted. METHODS: 200 patients were randomly selected from a cohort of 5777 patients who had previously answered two different questionnaires. The questionnaires were scanned using an automated forms processing technique, as well as processed by single and double manual data entry, using the EpiData Entry data entry program. The main outcome measure was the proportion of correctly entered numbers at question, form and study level. RESULTS: Manual double-key data entry (error proportion per 1000 fields = 0.046 (95% CI: 0.001-0.258)) performed better than single-key data entry (error proportion per 1000 fields = 0.370 (95% CI: 0.160-0.729), (p = 0.020)). There was no statistical difference between Optical Mark Recognition (error proportion per 1000 fields = 0.046 (95% CI: 0.001-0.258)) and double-key data entry (p = 1.000). With the Intelligent Character Recognition method, there was no statistical difference compared to single-key data entry (error proportion per 1000 fields = 6.734 (95% CI: 0.817-24.113), (p = 0.656)), as well as double-key data entry (error proportion per 1000 fields = 3.367 (95% CI: 0.085-18.616)), (p = 0.319)). CONCLUSIONS: Automated forms processing is a valid alternative to double manual data entry for highly structured forms containing only check boxes, numerical codes and no dates. Automated forms processing can be superior to single manual data entry through a data entry program, depending on the method chosen.

Effect of hydroxyapatite coating on risk of revision after primary total hip arthroplasty in younger patients: findings from the Danish Hip Arthroplasty Registry.

BACKGROUND: The effect of hydroxyapatite (HA) on implant survival in the medium and long term is uncertain. We studied the effect of HA coating of uncemented implants on the risk of cup and stem revision in primary total hip arthroplasty (THA). PATIENTS AND METHODS: Using the Danish Hip Arthroplasty Registry (DHR), we identified patients less than 70 years old who had undergone uncemented primary THA during 1997-2005. 4,125 HA-coated and 7,737 non-HA-coated cups and 3,158 HA-coated and 4,749 non-HA-coated stems were available for analysis. The mean follow-up time was 3.4 years for cups and 3.2 years for stems. We estimated the relative risk (RR) of revision due to aseptic loosening or any cause, and adjusted for possible confounders (age, sex, fixation of opposite implant part, and diagnosis for primary THA) using multivariate Cox regression analysis. RESULTS: The adjusted RRs for revision of HA-coated cups and stems due to aseptic loosening were 0.89 (95%CI: 0.37-2.2) and 0.71 (95%CI: 0.27-1.9) with up to 9 years of follow-up, compared to non-HA-coated implants. When taking all causes of revision into consideration, the risk estimates were 0.85 (95%CI: 0.68-1.1) and 0.81 (95%CI: 0.61-1.1) for HA-coated cups and stems, respectively. INTERPRETATION: In this medium-term follow-up study, the use of HA-coated implants was not associated with any clearly reduced overall risk of revision compared to non-HA-coated implants.