In silico validation of the Autoinflammatory Disease Damage Index.

INTRODUCTION: Autoinflammatory diseases can cause irreversible tissue damage due to systemic inflammation. Recently, the Autoinflammatory Disease Damage Index (ADDI) was developed. The ADDI is the first instrument to quantify damage in familial Mediterranean fever, cryopyrin-associated periodic syndromes, mevalonate kinase deficiency and tumour necrosis factor receptor-associated periodic syndrome. The aim of this study was to validate this tool for its intended use in a clinical/research setting. METHODS: The ADDI was scored on paper clinical cases by at least three physicians per case, independently of each other. Face and content validity were assessed by requesting comments on the ADDI. Reliability was tested by calculating the intraclass correlation coefficient (ICC) using an 'observer-nested-within-subject' design. Construct validity was determined by correlating the ADDI score to the Physician Global Assessment (PGA) of damage and disease activity. Redundancy of individual items was determined with Cronbach's alpha. RESULTS: The ADDI was validated on a total of 110 paper clinical cases by 37 experts in autoinflammatory diseases. This yielded an ICC of 0.84 (95% CI 0.78 to 0.89). The ADDI score correlated strongly with PGA-damage (r=0.92, 95% CI 0.88 to 0.95) and was not strongly influenced by disease activity (r=0.395, 95% CI 0.21 to 0.55). After comments from disease experts, some item definitions were refined. The interitem correlation in all different categories was lower than 0.7, indicating that there was no redundancy between individual damage items. CONCLUSION: The ADDI is a reliable and valid instrument to quantify damage in individual patients and can be used to compare disease outcomes in clinical studies.

Validity and reliability of a medical record review method identifying transitional patient safety incidents in merged primary and secondary care patients' records.

OBJECTIVE: Inadequate information transfer during transitions in healthcare is a major patient safety issue. Aim of this study was to pilot a review of medical records to identify transitional safety incidents (TSIs) for use in a large intervention study and assess its reliability and validity. DESIGN: A retrospective medical record review study. SETTINGS AND PARTICIPANTS: Combined primary and secondary care medical records of 301 patients who had visited their general practitioner and the University Medical Center Utrecht, the Netherlands, in 2013 were randomly selected. Six trained reviewers assessed these medical records for presence of TSIs. OUTCOMES: To assess inter-rater reliability, 10% of medical records were independently reviewed twice. To assess validity, the identified TSIs were compared with a reference standard of three objectively identifiable TSIs. RESULTS: The reviewers identified TSIs in 52 (17.3%) of all transitional medical records. Variation between reviewers was high (range: 3-28 per 50 medical records). Positive agreement for finding a TSI between reviewers was 0%, negative agreement 80% and the Cohen's kappa -0.15. The reviewers identified 43 (22%) of 194 objectively identifiable TSIs. CONCLUSION: The reliability of our measurement tool for identifying TSIs in transitional medical record performed by clinicians was low. Although the TSIs that were identified by clinicians were valid, they missed 80% of them. Restructuring the record review procedure is necessary.

Actively preparing for pregnancy is associated with healthier lifestyle of women during the preconception period.

OBJECTIVE: To assess whether actively preparing for pregnancy by women is associated with lifestyle changes during the preconception period. DESIGN: retrospective cross-sectional study. SETTING: primary care community midwifery practice in the Netherlands. PARTICIPANTS: convenience sample of 283 women who received antenatal care. MEASUREMENTS AND FINDINGS: the association between pregnancy preparation (defined as searching for information and/or consulting a healthcare provider) and preconception lifestyle changes (healthier diet, folic acid, alcohol and tobacco cessation) was measured and adjusted for age, body mass index and educational level. Almost 60% (n=160) of women acquired preconception information themselves and 25% (n=68) consulted a healthcare provider regarding their pregnancy wish. The former group was significantly more likely to quit drinking (adjusted OR 5.46 (95% CI 1.76-16.96)), improve their diet (adjusted OR 7.84 (95% CI 3.03-20.30)) and use folic acid (adjusted OR 3.90 (95% CI 2.00-7.62)) compared with women who did not prepare for pregnancy. Effect sizes were even larger for women who (also) consulted a healthcare provider with regard to folic acid use, healthier diet and smoking cessation. KEY CONCLUSIONS: gathering preconception information, either by women themselves or by means of a PCC consult, is associated with women positively changing lifestyles during the preconception period. IMPLICATIONS FOR PRACTICE: we recommend to not solely focus interventions on increasing the uptake of PCC consults, yet providing a suitable offer of preconception health information, which enables women to properly inform themselves.

The Value of a Checklist for Child Abuse in Out-of-Hours Primary Care: To Screen or Not to Screen.

OBJECTIVES: To assess the diagnostic value of the screening instrument SPUTOVAMO-R2 (checklist, 5 questions) for child abuse at Out-of-hours Primary Care locations (OPC), by comparing the test outcome with information from Child Protection Services (CPS). Secondary, to determine whether reducing the length of the checklist compromises diagnostic value. METHODS: All children (<18 years) attending one of the participating OPCs in the region of Utrecht, the Netherlands, in a year time, were included. The checklist is an obligatory field in the electronic patient file. CPS provided data on all checklist positives and a sample of 5500 checklist negatives (dataset). The checklist outcome was compared with a report to CPS in 10 months follow up after the OPC visit. RESULTS: The checklist was filled in for 50671 children; 108 (0.2%) checklists were positive. Within the dataset, 61 children were reported to CPS, with emotional neglect as the most frequent type of abuse (32.8%). The positive predictive value (PPV) of the checklist for child abuse was 8.3 (95% CI 3.9-15.2). The negative predictive value (NPV) was 99.1 (98.8-99.3), with 52 false negatives. When the length of the checklist was reduced to two questions closely related to the medical process (SPUTOVAMO-R3), the PPV was 9.1 (3.7-17.8) and the NPV 99.1 (98.7-99.3). These two questions are on the injury in relation to the history, and the interaction between child and parents. CONCLUSIONS: The checklist SPUTOVAMO-R2 has a low detection rate of child abuse within the OPC setting, and a high false positive rate. Therefore, we recommend to use the shortened checklist only as a tool to increase the awareness of child abuse and not as a diagnostic instrument.

A screening protocol for child abuse at out-of-hours primary care locations: a descriptive study.

BACKGROUND: Child abuse is often unrecognized at out-of-hours primary care (OOH-PC) services. The aim of our study was to evaluate the clinical outcome of the screening instrument SPUTOVAMO-R2 for child abuse (checklist), followed by a structured approach (reporting code), at OOH-PC services. The reporting code with five steps should ensure consistent action in case of a suspicion. METHODS: All children attending one of the five participating OOH-PC services in the region of Utrecht, the Netherlands, in a year time, were included. The checklist is an obligatory field in the electronic patient file and was filled in for all children. In case of a positive checklist, the steps in the reporting code were followed. Additionally, the case was evaluated in a multidisciplinary team to determine the probability of child abuse. RESULTS: The checklist was filled in for 50671 children; 108 (0.2 %) were positive. The multidisciplinary team diagnosed child abuse in 24 (22 %) of the 108 positive checklists, and no child abuse in 36 (33 %). Emotional neglect was the most frequent type of abuse diagnosed. For all abused children, care was implemented according to the protocol. The most frequent care given was a referral to the hospital (N = 7) or contact with child's own general practitioner (N = 6). CONCLUSION: A checklist followed by a reporting code guarantees consistent actions and care for children with a suspicion of child abuse. The percentage of positive checklists is lower than expected. Validity of the checklist should be assessed in a diagnostic study.

Pilot study on identification of incidents in healthcare transitions and concordance between medical records and patient interview data.

OBJECTIVE: To investigate whether transitional incidents can be identified from the medical records of the general practitioners and the hospital and to assess the concordance of transitional incidents between medical records and patient interviews. DESIGN: A pilot study. SETTING: The study was conducted in 2 regions in the Netherlands: a rural and an urban region. PARTICIPANTS: A purposeful sample of patients who experienced a transitional incident or are at high risk of experiencing transitional incidents. MAIN OUTCOME MEASURES: Transitional incidents were identified from both the interviews with patients and medical records and concordance was assessed. We also classified the transitional incidents according to type, severity, estimated cause and preventability. RESULTS: We identified 28 transitional incidents within 78 transitions of which 3 could not be found in the medical records and another 5 could have been missed without the patient as information source. To summarise, 8 (29%) incidents could have been missed using solely medical records, and 7 (25%) using the patients' information exclusively. Concordance in transitional incidents between patient interviews and medical records was 64% (18/28). The majority of the transitional incidents were unsafe situations; however, 43% (12/28) of the incidents reached the patient and 18% (5/28) caused temporary patient harm. Over half of the incidents were potentially preventable. CONCLUSIONS: This pilot study suggests that the majority of transitional incidents can be identified from medical records of the general practitioner and hospital. With this information, we aim to develop a measurement tool for transitional incidents in the medical record of general practitioner and hospital.

Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.

DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative treatment. A multicenter randomised clinical trial.

BACKGROUND: Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses.Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management.We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. METHODS/DESIGN: The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years) presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management). Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used.The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. DISCUSSION: Considering the high incidence and the multicenter design of this study, it may be assumed that the number of patients needed for this study (n = 214), may be gathered within one and a half year.Depending on the expertise and available equipment, we prefer to perform a laparoscopic resection on patients randomised for elective surgery. Should this be impossible, an open technique may be used as this also reflects the current situation. TRIAL REGISTRATION: (Trial register number: NTR1478).

Comparison of the SF-6D and the EQ-5D in patients with coronary heart disease.

BACKGROUND: The SF-6D was derived from the SF-36. A single summary score is obtained allegedly preserving the descriptive richness and sensitivity to change of the SF-36 into utility measurement. We compared the SF-6D and EQ-5D on domain content, scoring distribution, pre-treatment and change scores. METHODS: The SF-6D and the EQ-5D were completed prior to intervention and 1, 3, 6 and 12 months post-intervention in a study enrolling 561 patients with symptomatic coronary stenosis. Patients were randomized to off-pump coronary artery bypass surgery (CABG), standard on-pump CABG, or percutaneous transluminal coronary angioplasty (PTCA). Baseline and change over time scores were compared using parametric and non-parametric tests. RESULTS: The relative contribution of similar domains measuring daily functioning to the utility scores differed substantially. SF-6D focused more on social functioning, while EQ-5D gave more weight to physical functioning. Pain and mental health had similar contributions. The scoring range of the EQ-5D was twice the range of the SF-6D. Before treatment, EQ-5D and SF-6D mean scores appeared similar (0.64 versus 0.63, p = 0.09). Median scores, however, differed substantially (0.69 versus 0.60), a difference exceeding the minimal important difference of both instruments. Agreement was low, with an intra-class correlation of 0.45.Finally, we found large differences in measuring change over time. The SF-6D recorded greater intra-subject change in the PTCA-group. Only the EQ-5D recorded significant change in the CABG-groups. In the latter groups changes in SF-6D domains cancelled each other out. CONCLUSION: Although both instruments appear to measure similar constructs, the EQ-5D and SF-6D are quite different. The low agreement and the differences in median values, scoring range and sensitivity to change after intervention show that the EQ-5D and SF-6D yield incomparable scores in patients with coronary heart disease.

Validation of the Dutch cystic fibrosis questionnaire (CFQ) in adolescents and adults.

BACKGROUND: This study assesses the reliability and validity of the Dutch version of a disease-specific measure of health-related quality of life (HRQOL) for adolescents and adults with CF (CFQ-14+). The 47-item CFQ-14+ covers nine domains, three symptom scales and one health perception scale. METHODS: To assess psychometric characteristics of the CFQ-14+, cross-sectional (homogeneity, discriminative and construct validity) and test-retest designs were used. Eighty-four adolescents and adults with CF (mean age: 21.4 years, range 14.0-46.5 years) and a wide range of lung function (mean FEV1: 59.9% predicted, range 15-121%) completed the questionnaire during a routine visit. RESULTS: Internal consistency was acceptable for most domains of the CFQ-14+ (alpha = 0.43-0.92) and test-retest reliability was high for all domain scores (0.72-0.98). Several domains of the CFQ-14+ were able to differentiate between individuals with varying disease severity and between nourished and malnourished patients. Construct validity of the questionnaire was fair, with moderate to strong correlation between physically orientated domains and pulmonary function (rs = 0.36-0.62). CONCLUSION: The results demonstrate that the CFQ-14+ questionnaire is a well-validated measure of HRQOL assessment in adolescents and adults with CF.

Waiting for total hip arthroplasty: avoidable loss in quality time and preventable deterioration.

This study was conducted to determine the effect of waiting times for total hip arthroplasty in terms of loss in quality-adjusted life years and additional burden perceived. A second goal was to study the effect of waiting times and preoperative function scores on postoperative outcome scores. Data were collected prospectively from a cohort of 161 patients waiting for total hip arthroplasty. The Oxford Hip score, Western Ontario and McMaster Universities Osteoarthritis Index, SF-36, and the EuroQol health status instruments were administered when the patient was placed on the waiting list, preoperatively, and 3 and 12 months after surgery. The disease-specific scores especially showed a significant deterioration during the waiting time. Moreover, a considerable loss of quality-adjusted life years occurred simply by postponing surgery. Although we found no direct effect of waiting time on postoperative outcomes, patients in a later phase of the disease process did not improve to the level achieved by patients with better preoperative function.