Recombinant ADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura.

BACKGROUND: Congenital thrombotic thrombocytopenic purpura (TTP) results from severe hereditary deficiency of ADAMTS13. The efficacy and safety of recombinant ADAMTS13 and standard therapy (plasma-derived products) administered as routine prophylaxis or on-demand treatment in patients with congenital TTP is not known. METHODS: In this phase 3, open-label, crossover trial, we randomly assigned patients in a 1:1 ratio to two 6-month periods of prophylaxis with recombinant ADAMTS13 (40 IU per kilogram of body weight, administered intravenously) or standard therapy, followed by the alternate treatment; thereafter, all the patients received recombinant ADAMTS13 for an additional 6 months. The trigger for this interim analysis was trial completion by at least 30 patients. The primary outcome was acute TTP events. Manifestations of TTP, safety, and pharmacokinetics were assessed. Patients who had an acute TTP event could receive on-demand treatment. RESULTS: A total of 48 patients underwent randomization; 32 completed the trial. No acute TTP event occurred during prophylaxis with recombinant ADAMTS13, whereas 1 patient had an acute TTP event during prophylaxis with standard therapy (mean annualized event rate, 0.05). Thrombocytopenia was the most frequent TTP manifestation (annualized event rate, 0.74 with recombinant ADAMTS13 and 1.73 with standard therapy). Adverse events occurred in 71% of the patients with recombinant ADAMTS13 and in 84% with standard therapy. Adverse events that were considered by investigators to be related to the trial drug occurred in 9% of the patients with recombinant ADAMTS13 and in 48% with standard therapy. Trial-drug interruption or discontinuation due to adverse events occurred in no patients with recombinant ADAMTS13 and in 8 patients with standard therapy. No neutralizing antibodies developed during recombinant ADAMTS13 treatment. The mean maximum ADAMTS13 activity after recombinant ADAMTS13 treatment was 101%, as compared with 19% after standard therapy. CONCLUSIONS: During prophylaxis with recombinant ADAMTS13 in patients with congenital TTP, ADAMTS13 activity reached approximately 100% of normal levels, adverse events were generally mild or moderate in severity, and TTP events and manifestations were rare. (Funded by Takeda Development Center Americas and Baxalta Innovations; ClinicalTrials.gov number, NCT03393975.).

Modifiable risk factors for inpatient violence in psychiatric hospital: prospective study and prediction model.

BACKGROUND: Violence perpetrated by psychiatric inpatients is associated with modifiable factors. Current structured approaches to assess inpatient violence risk lack predictive validity and linkage to interventions. METHODS: Adult psychiatric inpatients on forensic and general wards in three psychiatric hospitals were recruited and followed up prospectively for 6 months. Information on modifiable (dynamic) risk factors were collected every 1-4 weeks, and baseline background factors. Data were transferred to a web-based monitoring system (FOxWeb) to calculate a total dynamic risk score. Outcomes were extracted from an incident-reporting system recording aggression and interpersonal violence. The association between total dynamic score and violent incidents was assessed by multilevel logistic regression and compared with dynamic score excluded. RESULTS: We recruited 89 patients and conducted 624 separate assessments (median 5/patient). Mean age was 39 (s.d. 12.5) years with 20% (n = 18) female. Common diagnoses were schizophrenia-spectrum disorders (70%, n = 62) and personality disorders (20%, n = 18). There were 93 violent incidents. Factors contributing to violence risk were a total dynamic score of ⩾1 (OR 3.39, 95% CI 1.25-9.20), 10-year increase in age (OR 0.67, 0.47-0.96), and female sex (OR 2.78, 1.04-7.40). Non-significant associations with schizophrenia-spectrum disorder were found (OR 0.50, 0.20-1.21). In a fixed-effect model using all covariates, AUC was 0.77 (0.72-0.82) and 0.75 (0.70-0.80) when the dynamic score was excluded. CONCLUSIONS: In predicting violence risk in individuals with psychiatric disorders, modifiable factors added little incremental value beyond static ones in a psychiatric inpatient setting. Future work should make a clear distinction between risk factors that assist in prediction and those linked to needs.

Psychiatric comorbidity and risk of premature mortality and suicide among those with chronic respiratory diseases, cardiovascular diseases, and diabetes in Sweden: A nationwide matched cohort study of over 1 million patients and their unaffected siblings.

BACKGROUND: Persons with noncommunicable diseases have elevated rates of premature mortality. The contribution of psychiatric comorbidity to this is uncertain. We aimed to determine the risks of premature mortality and suicide in people with common noncommunicable diseases, with and without psychiatric disorder comorbidity. METHODS AND FINDINGS: We used nationwide registries to study all individuals born in Sweden between 1932 and 1995 with inpatient and outpatient diagnoses of chronic respiratory diseases (n = 249,825), cardiovascular diseases (n = 568,818), and diabetes (n = 255,579) for risks of premature mortality (≤age 65 years) and suicide until 31 December 2013. Patients diagnosed with either chronic respiratory diseases, cardiovascular diseases, or diabetes were compared with age and sex-matched population controls (n = 10,345,758) and unaffected biological full siblings (n = 1,119,543). Comorbidity with any psychiatric disorder, and by major psychiatric categories, was examined using diagnoses from patient registers. Associations were quantified using stratified Cox regression models that accounted for time at risk, measured sociodemographic factors, and unmeasured familial confounders via sibling comparisons. Within 5 years of diagnosis, at least 7% (range 7.4% to 10.8%; P < 0.001) of patients with respiratory diseases, cardiovascular diseases, or diabetes (median age at diagnosis: 48 to 54 years) had died from any cause, and 0.3% (0.3% to 0.3%; P < 0.001) had died from suicide, 25% to 32% of people with these medical conditions had co-occurring lifetime diagnoses of any psychiatric disorder, most of which antedated the medical diagnosis. Comorbid psychiatric disorders were associated with higher all-cause mortality (15.4% to 21.1%) when compared to those without such conditions (5.5% to 9.1%). Suicide mortality was also elevated (1.2% to 1.6% in comorbid patients versus 0.1% to 0.1% without comorbidity). When we compared relative risks with siblings without noncommunicable diseases and psychiatric disorders, the comorbidity with any psychiatric disorder was associated with substantially increased mortality rates (adjusted HR range: aHRCR = 7.2 [95% CI: 6.8 to 7.7; P < 0.001] to aHRCV = 8.9 [95% CI: 8.5 to 9.4; P < 0.001]). Notably, comorbid substance use disorders were associated with a higher mortality rate (aHR range: aHRCR = 8.3 [95% CI: 7.6 to 9.1; P < 0.001] to aHRCV = 9.9 [95% CI: 9.3 to 10.6; P < 0.001]) than depression (aHR range: aHRCR = 5.3 [95% CI: 4.7 to 5.9; P < 0.001] to aHRCV = 7.4 [95% CI: 7.0 to 7.9; P < 0.001]), but risks of suicide were similar for these 2 psychiatric comorbidities. One limitation is that we relied on secondary care data to assess psychiatric comorbidities, which may have led to missing some patients with less severe comorbidities. Residual genetic confounding is another limitation, given that biological full siblings share an average of half of their cosegregating genes. However, the reported associations remained large even after adjustment for shared and unmeasured familial confounders. CONCLUSIONS: In this longitudinal study of over 1 million patients with chronic health diseases, we observed increased risks of all-cause and suicide mortality in individuals with psychiatric comorbidities. Improving assessment, treatment, and follow-up of people with comorbid psychiatric disorders may reduce the risk of mortality in people with chronic noncommunicable diseases.

Feasibility of using Clinical Practice Research Datalink data to identify patients with chronic obstructive pulmonary disease to enrol into real-world trials.

PURPOSE: To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial. METHODS: A retrospective multidatabase cohort study using CPRD primary care and linked secondary care data to describe the characteristics of populations of patients with COPD. Patients' demographic and lifestyle factors, comorbidity profile, spirometry measurements and treatment changes were evaluated, as was the distribution of follow-up time and types of losses during follow-up. Characteristics were evaluated using descriptive statistics. RESULTS: A total of 322 991 patients from 1148 primary care practices in the United Kingdom across two CPRD primary care databases, CPRD GOLD and CPRD Aurum, were potentially eligible to participate in a hypothetical trial using CPRD, starting on 31 December 2017. Patients with COPD in CPRD GOLD and CPRD Aurum were comparable in terms of age (median age 70 vs. 68 years), gender (50% vs. 52% male), disease severity (e.g., 25% vs. 24% Medical Research Council [MRC] dyspnoea score grades 3-5) and history of respiratory conditions (e.g., 43% vs. 38% asthma). High proportions of patients with COPD in CPRD GOLD and CPRD Aurum were available on 31 December 2012 for follow-up at 1, 2, and 5 years (92%, 85% and 67%, respectively). CONCLUSIONS: Patients and data from CPRD GOLD and CPRD Aurum were comparable across key aspects relevant to COPD trials. A pragmatic trial using CPRD to recruit patients with COPD is scientifically feasible.

Survivin and XIAP: two valuable biomarkers in medullary thyroid carcinoma.

BACKGROUND: Medullary thyroid carcinoma (MTC) accounts for ∼5% of all thyroid malignancies. To date, surgery is the first-line therapy with curative intention. However, for advanced MTC, conventional chemotherapeutic agents do not provide convincing results. Therefore, the identification of biomarkers that can be antagonised by small-molecule therapeutics may lead to novel encouraging treatment options. METHODS: Seventy-nine patients with surgically resected and histologically confirmed MTC were included in this study. Tissue microarrays were constructed to assess the relationship between inhibitor of apoptosis proteins (IAPs) survivin or XIAP expression levels and clinicopathological variables as well as overall survival. RESULTS: High survivin or XIAP expression was associated with an advanced T-stage and metastatic disease. Whereas tissue expression levels of survivin correlated with serum calcitonin levels, XIAP was overexpressed in the subgroup of patients with sporadic MTC. Both IAPs were negatively associated with patient survival in the multivariate Cox regressions analysis (survivin: hazard ratio (HR) 1.62; 95% confidence interval (CI): 1.21-2.16; P=0.001; XIAP: HR 1.78; 95% CI: 1.16-2.72; P=0.008). CONCLUSIONS: Survivin and XIAP demonstrate distinct expression patterns in MTCs, which are associated with advanced disease and poor prognosis. We thus provide first evidence that both IAPs might serve as viable targets in patients with MTC.

Premature mortality in epilepsy and the role of psychiatric comorbidity: a total population study.

BACKGROUND: Epilepsy is associated with high rates of premature mortality, but the contribution of psychiatric comorbidity is uncertain. We assessed the prevalence and risks of premature mortality from external causes such as suicide, accidents, and assaults in people with epilepsy with and without psychiatric comorbidity. METHODS: We studied all individuals born in Sweden between 1954 and 2009 with inpatient and outpatient diagnoses of epilepsy (n=69,995) for risks and causes of premature mortality. Patients were compared with age-matched and sex-matched general population controls (n=660,869) and unaffected siblings (n=81,396). Sensitivity analyses were done to investigate whether these odds differed by sex, age, seizure types, comorbid psychiatric diagnosis, and different time periods after epilepsy diagnosis. RESULTS: 6155 (8.8%) people with epilepsy died during follow-up, at a median age of 34·5 (IQR 21·0-44·0) years with substantially elevated odds of premature mortality (adjusted odds ratio [aOR] of 11·1 [95% CI 10·6-11·6] compared with general population controls, and 11·4 [10·4-12·5] compared with unaffected siblings). Of those deaths, 15·8% (n=972) were from external causes, with high odds for non-vehicle accidents (aOR 5·5, 95 % CI 4·7-6·5) and suicide (3·7, 3·3-4·2). Of those who died from external causes, 75·2% had comorbid psychiatric disorders, with strong associations in individuals with co-occurring depression (13·0, 10·3-16·6) and substance misuse (22·4, 18·3-27·3), compared with patients with no epilepsy and no psychiatric comorbidity. INTERPRETATION: Reducing premature mortality from external causes of death should be a priority in epilepsy management. Psychiatric comorbidity plays an important part in the premature mortality seen in epilepsy. The ability of health services and public health measures to prevent such deaths requires review. FUNDING: Wellcome Trust, the Swedish Prison and Probation Service, and the Swedish Research Council.

Inherited thrombotic thrombocytopenic purpura in children.

Congenital thrombotic thrombocytopenic purpura (TTP) or Upshaw-Schulman syndrome is caused by homozygous or compound heterozygous mutations in the ADAMTS-13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) gene. We investigated 30 patients with congenital TTP and analyzed clinical data and underlying ADAMTS-13 mutations. All patients showed virtually no ADAMTS-13 activity in plasma. Individual disease burden ranged from mild courses with rare episodes of mild thrombocytopenia to severe courses with chronic kidney disease and central nervous system (CNS) lesions. Two patients died due to complications of TTP. If initiated in a timely manner, plasma transfusions offer a reliable treatment to prevent organ damage. We identified 30 different causative mutations in the ADAMTS-13 gene. Our data do not support the idea of a tight correlation between ADAMTS-13 genotype and severity of disease. The type and magnitude of exogenous triggers for acute bouts of TTP as well as endogenous individual factors participating in the inflammatory response likely represent the foremost determinants of individual clinical courses. Future developments should aim at improving early diagnosis of TTP. To improve feasibility of prophylaxis and treatment of congenital TTP, recombinant ADAMTS-13 therapeutics are highly anticipated.

Effectiveness of Violence Prevention Interventions: Umbrella Review of Research in the General Population.

To address the societal harms of violence, many violence prevention interventions have been developed, tested, and implemented in the general population. These have been reported in systematic reviews and meta-analyses, which have typically focused on one type of intervention or outcome. We aimed to provide a comprehensive overview of the current evidence regarding the effectiveness of different psychosocial interventions in reducing all forms of violence toward others. We have conducted an umbrella review of previous meta-analyses using standard approaches and converted findings on effectiveness into odds ratios. We tested for the underlying quality of the meta-analytic evidence by examining heterogeneity, excess statistical significance, prediction intervals, and small study effects. We identified 16 meta-analyses, including nine investigating psychosocial interventions, and five legislative and policy changes. Most meta-analyses reported positive effects of tested interventions. The strongest effects were found for sports-based initiatives, and the weakest for general population programs aimed at early childhood, youth development, and reducing sexual assault perpetration by men. Legislative changes had varying effectiveness. We conclude that simple, scalable, and cost-efficient programs, such as sport-based initiatives, have the clearest empirical support as population-based approaches to violence prevention.

Suicide in prisoners with bipolar disorder and other psychiatric disorders: a systematic review.

OBJECTIVES: To examine the risk of suicide and suicide attempts in prisoners with bipolar disorder and other psychiatric disorders compared with prisoners without psychiatric disorders. METHODS: We conducted a systematic review and meta-analysis of observational studies comparing suicide outcomes in prisoners with bipolar disorder and other psychiatric disorders to other prisoners. RESULTS: Five studies reported the risk of suicidal outcomes in prisoners with bipolar disorder compared with other prisoners, with a random effects pooled odds ratio of 2.4 (95% confidence interval: 1.6-3.7; I(2) = 0%). This appeared to be lower than the risk of suicidal outcomes for all psychiatric disorders and for depression, specifically, and, in meta-regression, significantly lower (p = 0.03) than for schizophrenia-spectrum disorders. CONCLUSIONS: Although bipolar disorder is associated with suicide and non-fatal suicidal behavior in prisoners, further research is necessary to confirm any associations and mediating mechanisms.

Fossil traces of the bone-eating worm Osedax in early Oligocene whale bones.

Osedax is a recently discovered group of siboglinid annelids that consume bones on the seafloor and whose evolutionary origins have been linked with Cretaceous marine reptiles or to the post-Cretaceous rise of whales. Here we present whale bones from early Oligocene bathyal sediments exposed in Washington State, which show traces similar to those made by Osedax today. The geologic age of these trace fossils ( approximately 30 million years) coincides with the first major radiation of whales, consistent with the hypothesis of an evolutionary link between Osedax and its main food source, although older fossils should certainly be studied. Osedax has been destroying bones for most of the evolutionary history of whales and the possible significance of this "Osedax effect" in relation to the quality and quantity of their fossils is only now recognized.

Trends in adrenal surgery: institutional review of 528 consecutive adrenalectomies.

PURPOSE: The increasing detection of adrenal tumors and the availability of a more sophisticated biochemical work-up leading to rising numbers of sub-clinical Conn's and Cushing's syndromes coincide with a rising number of adrenalectomies worldwide. The aim of our study was to report a single institution's experience with adrenal surgery. METHODS: We report data of 528 adrenalectomies, operated at our institution before and after the onset of minimally invasive endoscopic surgery (1986-1994, 1995-2008). Gender, age, indication, imaging, surgical approach, operating time, histology, tumor size, hospital stay, and complications were analyzed retrospectively. RESULTS: A total of 478 patients underwent adrenal surgery during the time observed. The average number of yearly adrenalectomies increased from 14 to 21 (p = 0.001) after the onset of laparoscopic surgery. Imaging techniques showed a significant shift towards magnetic resonance imaging (p < 0.001) and preoperative assessment of tumor size was significantly correlated to malignancy: 10.8 % (11/102) and 42 % (21/50) of tumors measuring 4-6 cm and ≥6 cm, respectively, were malignant in the final histology report (p < 0.001). Patients operated by minimally invasive endoscopy were significantly younger (mean 49.4 years, p = 0.046), had significantly shorter operating times (mean 118 min, p < 0.001), had shorter hospital stays (mean 7.1 days, p < 0.001), and had less complications (6.9 %, p = 0.004) compared to patients resected through open procedures. CONCLUSION: Although adrenalectomy rates increased and minimally invasive endoscopic surgery reduced hospital stay and complications at our institution, the yearly number of procedures was still low with often high surgical complexity. We therefore believe that adrenal surgery remains a highly specialized procedure that should preferably be performed at endocrine surgery centers.

Osedax borings in fossil marine bird bones.

The bone-eating marine annelid Osedax consumes mainly whale bones on the deep-sea floor, but recent colonization experiments with cow bones and molecular age estimates suggesting a possible Cretaceous origin of Osedax indicate that this worm might be able grow on a wider range of substrates. The suggested Cretaceous origin was thought to imply that Osedax could colonize marine reptile or fish bones, but there is currently no evidence that Osedax consumes bones other than those of mammals. We provide the first evidence that Osedax was, and most likely still is, able to consume non-mammalian bones, namely bird bones. Borings resembling those produced by living Osedax were found in bones of early Oligocene marine flightless diving birds (family Plotopteridae). The species that produced these boreholes had a branching filiform root that grew to a length of at least 3 mm, and lived in densities of up to 40 individuals per square centimeter. The inclusion of bird bones into the diet of Osedax has interesting implications for the recent suggestion of a Cretaceous origin of this worm because marine birds have existed continuously since the Cretaceous. Bird bones could have enabled this worm to survive times in the Earth's history when large marine vertebrates other than fish were rare, specifically after the disappearance of large marine reptiles at the end-Cretaceous mass extinction event and before the rise of whales in the Eocene.

Recidivism rates in individuals receiving community sentences: A systematic review.

OBJECTIVE: We aimed to systematically review recidivism rates in individuals given community sentences internationally. We sought to explore sources of variation between these rates and how reporting practices may limit their comparability across jurisdictions. Finally, we aimed to adapt previously published guidelines on recidivism reporting to include community sentenced populations. METHODS: We searched MEDLINE, PsycINFO, SAGE and Google Scholar for reports and studies of recidivism rates using non-specific and targeted searches for the 20 countries with the largest prison populations worldwide. We identified 28 studies with data from 19 countries. Of the 20 countries with the largest prison populations, only 2 reported recidivism rates for individuals given community sentences. RESULTS: The most commonly reported recidivism information between countries was for 2-year reconviction, which ranged widely from 14% to 43% in men, and 9% to 35% in women. Explanations for recidivism rate variations between countries include when the follow-up period started and whether technical violations were taken into account. CONCLUSION: Recidivism rates in individuals receiving community sentences are typically lower in comparison to those reported in released prisoners, although these two populations differ in terms of their baseline characteristics. Direct comparisons of the recidivism rates in community sentenced cohorts across jurisdictions are currently not possible, but simple changes to existing reporting practices can facilitate these. We propose recommendations to improve reporting practices.

The prediction of suicide in severe mental illness: development and validation of a clinical prediction rule (OxMIS).

Assessment of suicide risk in individuals with severe mental illness is currently inconsistent, and based on clinical decision-making with or without tools developed for other purposes. We aimed to develop and validate a predictive model for suicide using data from linked population-based registers in individuals with severe mental illness. A national cohort of 75,158 Swedish individuals aged 15-65 with a diagnosis of severe mental illness (schizophrenia-spectrum disorders, and bipolar disorder) with 574,018 clinical patient episodes between 2001 and 2008, split into development (58,771 patients, 494 suicides) and external validation (16,387 patients, 139 suicides) samples. A multivariable derivation model was developed to determine the strength of pre-specified routinely collected socio-demographic and clinical risk factors, and then tested in external validation. We measured discrimination and calibration for prediction of suicide at 1 year using specified risk cut-offs. A 17-item clinical risk prediction model for suicide was developed and showed moderately good measures of discrimination (c-index 0.71) and calibration. For risk of suicide at 1 year, using a pre-specified 1% cut-off, sensitivity was 55% (95% confidence interval [CI] 47-63%) and specificity was 75% (95% CI 74-75%). Positive and negative predictive values were 2% and 99%, respectively. The model was used to generate a simple freely available web-based probability-based risk calculator (Oxford Mental Illness and Suicide tool or OxMIS) without categorical cut-offs. A scalable prediction score for suicide in individuals with severe mental illness is feasible. If validated in other samples and linked to effective interventions, using a probability score may assist clinical decision-making.

Prediction of violent reoffending in prisoners and individuals on probation: a Dutch validation study (OxRec).

Scalable and transparent methods for risk assessment are increasingly required in criminal justice to inform decisions about sentencing, release, parole, and probation. However, few such approaches exist and their validation in external settings is typically lacking. A total national sample of all offenders (9072 released from prisoners and 6329 individuals on probation) from 2011-2012 in the Netherlands were followed up for violent and any reoffending over 2 years. The sample was mostly male (n = 574 [6%] were female prisoners and n = 784 [12%] were female probationers), and median ages were 30 in the prison sample and 34 in those on probation. Predictors for a scalable risk assessment tool (OxRec) were extracted from a routinely collected dataset used by criminal justice agencies, and outcomes from official criminal registers. OxRec's predictive performance in terms of discrimination and calibration was tested. Reoffending rates in the Dutch prisoner cohort were 16% for 2-year violent reoffending and 44% for 2-year any reoffending, with lower rates in the probation sample. Discrimination as measured by the c-index was moderate, at 0.68 (95% CI: 0.66-0.70) for 2-year violent reoffending in prisoners and between 0.65 and 0.68 for other outcomes and the probation sample. The model required recalibration, after which calibration performance was adequate (e.g. calibration in the large was 1.0 for all scenarios). A recalibrated model for OxRec can be used in the Netherlands for individuals released from prison and individuals on probation to stratify their risk of future violent and any reoffending. The approach that we outline can be considered for external validations of criminal justice and clinical risk models.

A left nonrecurrent inferior laryngeal nerve in a patient with right-sided aorta, truncus arteriosus communis, and an aberrant left innominate artery.

The identification and prevention of injury to the inferior laryngeal nerve is one of the main issues in thyroid surgery. Sound knowledge of anatomic variants of the nerve is of major importance. In rare cases the nerve does not run the recurrent way and it is therefore difficult to identify the nerve. Abnormal developments of the aortic arch during embryogenesis include malformation of the great vessels and can be the reason for anatomic abnormalities. A cause for a nonrecurrent nerve on the right side is the so-called lusorian artery, a right retroesophageal subclavian artery. Left-sided nonrecurrent nerves are seldom if ever documented. Only two cases have been published so far of patients with situs inversus viscerum, where left nonrecurrent nerves were associated with inverse, left-sided lusorian arteries.

Selecting a risk assessment tool to use in practice:a 10-point guide.

With the increase in the number of risk assessment tools and clinical algorithms in many areas of science and medicine, this Perspective article provides an overview of research findings that can assist in informing the choice of an instrument for practical use. We take the example of violence risk assessment tools in criminal justice and forensic psychiatry, where there are more than 200 such instruments and their use is typically mandated. We outline 10 key questions that researchers, clinicians and other professionals should ask when deciding what tool to use, which are also relevant for public policy and commissioners of services. These questions are based on two elements: research underpinning the external validation, and derivation or development of a particular instrument. We also recommend some guidelines for reporting drawn from consensus guidelines for research in prognostic models.