MedicalResearch.comExclusive Interviews with Medical Research and

Health Care ResearchersEditor: Marie Benz, MD info@Hemodialysis.com

December 23 2013

For Informational Purposes Only: Not for Specific Medical Advice.

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Diabetes: Effect of Lifestyle Intervention on Weight ChangeMedicalResearch.com Interview with: Prof. Raj S BhopalBruce and John Usher Professor of Public HealthEdinburgh Ethnicity and Health Research Group,Centre for Population Health Sciences,University of Edinburgh, Teviot Place, Edinburgh EH89AG

• MedicalResearch.com: What are the main findings of the study?• Prof. Bhopal: In a randomised controlled trial, a tailored, family orientated intervention whereby

dietitians worked in the family home to provide diet and exercise advice in people at high risk of developing diabetes, had a modest but potentially important effect in reducing weight at the end of the three-year intervention, by 1.6 kg more than in the control group.

MedicalResearch.com: Were any of the findings unexpected?• Prof. Bhopal: More than one fifth of the study population, including those in the intervention group,

increased their weight by 2.5 kg or more over three years. A remarkable 98% of the study population of 171 people completed the three-year trial-that may well be a record in the context of trials of this kind.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Bhopal: If people at high risk of developing diabetes e.g. because of impaired glucose tolerance

or impaired fasting glucose, family orientated health promotion provided by trained health professionals would be a reasonable addition to the normal armamentarium of actions.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Prof. Bhopal: This is one of the first trials of its kind i.e. focused on ethnic minority populations in Europe. It shows that such trials are feasible, and the very high retention rates are promising. We need to improve the impact of such interventions and then evaluate how they work in routine clinical care.

• Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial

• Prof Raj S Bhopal DSc,Anne Douglas MA,Sunita Wallia MSc,Prof John F Forbes PhD,Prof Michael E J Lean MD,Jason M R Gill PhD,John A McKnight MD,Prof Naveed Sattar FRCP,Prof Aziz Sheikh MD,Prof Sarah H Wild PhD,Prof Jaakko Tuomilehto MD,Anu Sharma MSc,Ruby Bhopal BSc,Joel B E Smith PhD,Isabella Butcher PhD,Prof Gordon D Murray PhD

• The Lancet Diabetes & Endocrinology – 23 December 2013• DOI: 10.1016/S2213-8587(13)70204-3

Read the rest of the interview on MedicalResearch.com

Patient-Relevant Research Outcomes from Published vs Non-Published DataMedical Research.com Interview with: Dr. Beate WieselerHead of Department Dept. Drug AssessmentInstitute for Quality and Efficiency in Health Care (IQWiG) Im Mediapark

Köln Germany

• MedicalResearch.com: What are the main findings of the study?• Dr. Wieseler: Our study shows that unpublished clinical study reports, i.e. reports submitted to

regulatory authorities during the approval procedure for a drug, provide substantially more information on patient-relevant outcomes than publicly available sources, i.e. articles published in medical journals and reports published in online clinical trial registries. (A “patient-relevant outcome” is an outcome describing morbidity, mortality or health-related quality of life.)In detail, we analysed 101 trials with clinical study reports; 86 trials had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The clinical study reports provided complete information on a considerably higher proportion of patient-relevant outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), clinical study reports provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). They also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between clinical study reports and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes [1].

• References• Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of

Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013 349 Oct 8;10(10):e1001526

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Patient-Relevant Research Outcomes from Published vs Non-Published DataMedical Research.com Interview with: Dr. Beate WieselerHead of Department Dept. Drug AssessmentInstitute for Quality and Efficiency in Health Care (IQWiG) Im Mediapark

Köln Germany

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Wieseler: Previous research on the antidepressant reboxetine and the antiviral oseltamivir (Tamiflu) showed

that inclusion of unpublished data from clinical study reports changed previous conclusions about the benefits and harms of these drugs [1,2]. Our previous study on the issue of information gain from clinical study reports showed that this document type provided substantially more information on study methods and selected study outcomes (primary outcomes and adverse events) [3]. We therefore expected similar results in our current study. However, in our current study, the information gain from clinical study reports was even greater for patient-relevant outcomes (regardless of whether primary or not): While in the previous study the proportion of completely reported primary outcomes and adverse events was 91% for clinical study reports, 52% for journal publications, and 71% for registry reports, the corresponding values for the full range of (primary and non-primary) patient-relevant outcomes investigated in the current study were 86%, 23%, and 22%, respectively [3,4].

• References• Doshi P, Jefferson T, Del Mar C (2012) The imperative to share clinical study reports: recommendations from the

Tamiflu experience. PLoS Med 9: e1001201 doi:10.1371/journal.pmed.1001201.• Eyding D, Lelgemann M, Grouven U, Harter M, Kromp M, et al. (2010) Reboxetine for acute treatment of major

depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 341: c4737.

• Wieseler B, Kerekes MF, Vervoelgyi V, McGauran N, Kaiser T (2012) Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 344: d8141

• Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013 349 Oct 8;10(10):e1001526

Read the rest of the interview on MedicalResearch.com

Patient-Relevant Research Outcomes from Published vs Non-Published DataMedical Research.com Interview with: Dr. Beate WieselerHead of Department Dept. Drug AssessmentInstitute for Quality and Efficiency in Health Care (IQWiG) Im Mediapark

Köln Germany

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Wieseler: Clinicians and patients should be aware that information obtained from

published evidence alone may be biased. For instance, the benefits of a drug may be exaggerated and harms may be underestimated.

• Clinical study reports should be made publicly available as they may substantially influence conclusions concerning the actual position of an individual drug in a therapeutic area.

• MedicalResearch.com: What[NMG1] recommendations do you have for future research as a result of this study?

• Dr. Wieseler: Future research could include a more detailed comparison of information reported in unpublished clinical study reports and information reported in journal publications to further investigate the reasons for selective reporting (“outcome reporting bias”).

• • Citation:• • Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpubl

ished Clinical Study Reports with Publicly Available Data • Beate Wieseler, Natalia Wolfram, Natalie McGauran, Michaela F. Kerekes, Volker Vervölgyi, Pet

ra Kohlepp, Marloes Kamphuis, Ulrich Grouven• Published: October 08, 2013

DOI: 10.1371/journal.pmed.1001526Read the rest of the interview on MedicalResearch.com

Is Robotic Surgery Better than Traditional Colectomy?MedicalResearch.com Interview with:Nita Ahuja, MDDepartments of Surgery and Oncology,Johns Hopkins University School of Medicine Baltimore, Maryland

• MedicalResearch.com: What are the main findings of the study?• Dr. Ahuja: Across the nation, laparoscopic colectomy is performed about as frequently as open colectomy, despite

being associated with a lower complication rate and a lower overall hospital cost. On the other hand, an exponentially growing prevalence was found with robotic colectomy, a procedure that has so far demonstrated only equivalent outcomes with laparoscopic colectomy but a higher overall cost.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Ahuja: Yes, one would expect that robotic colectomy, offering better ergonomics, instrument articulation,

visualization, and ease of use, to be associated with a better outcome profile in comparison with traditional laparoscopic colectomy. However, only equivalent outcomes were found between robotic and laparoscopic colectomy yet robotic surgery costs more.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Ahuja: For clinicians, judicious selection of patient for each surgical approach should be employed in order to

optimize outcome. For patients, each surgical approach has its advantages and disadvantages for each individual patient, a newer or pricier approach isn’t necessarily the best choice for every patient.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ahuja: Other aspects of robot’s potential advantages over traditional laparoscopic surgery such as decreased

postoperative pain, shorter learning curve, or facilitation of single-incision techniques, should be explored.• Citation:• Is Minimally Invasive Colon Resection Better Than Traditional Approaches?

First Comprehensive National Examination With Propensity Score Matching• Juo Y, Hyder O, Haider AH, Camp M, Lidor A, Ahuja N. Is Minimally Invasive Colon Resection Better Than Traditional

Approaches?: First Comprehensive National Examination With Propensity Score Matching. JAMA Surg. 2013;():. doi:10.1001/jamasurg.2013.3660.

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Breast Cancer Risk: Effects of Tomato and SoyMedicalResearch.com Interview with:Adana A.M. Llanos, PhD, MPHAssistant Professor, Department of Epidemiology RBHS-School of Public HealthRutgers, The State University of New

Jersey Piscataway, NJ 08854

• MedicalResearch.com: What are the main findings of the study?Dr. Llanos: Our longitudinal study examined the effects of both tomato-rich and soy-rich diets in a group of 70 postmenopausal women who participated in the study at The Ohio State University Comprehensive Cancer Center. For 10 weeks, women ate tomato products containing at least 25 milligrams of lycopene daily. For a separate 10-week period, the participants consumed at least 40 grams of soy protein daily. Before each test period began, the women were instructed to abstain from eating both tomato and soy products for two weeks. We examined the dietary intervention effects on hormone biomarkers known to be associated with obesity, namely adiponectin and leptin. After the tomato-rich diet participants’ levels of adiponectin climbed nine percent. The effect was slightly stronger in women who had a lower body mass index.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Llanos: The soy diet was linked to a reduction in study participants’ adiponectin levels. We originally hypothesized that a diet containing large amounts of soy could also have beneficial effects on adiponectin (specifically increasing adiponectin levels). But it may be that the protective effects of soy are limited to certain subgroups of women, such as those who regularly consume soy-rich diets and/or those who began consuming such diets earlier in life.

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Breast Cancer Risk: Effects of Tomato and SoyMedicalResearch.com Interview with:Adana A.M. Llanos, PhD, MPHAssistant Professor, Department of Epidemiology RBHS-School of Public HealthRutgers, The State University of New

Jersey Piscataway, NJ 08854

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Llanos: The main take away message from our study’s preliminary findings is that the

beneficial effects of a diet high in lycopene on adiponectin may explain WHY tomatoes might be effective at reducing the risk of breast cancer in some women.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Dr. Llanos: While our findings are very preliminary, we believe regular consumption of at least the daily recommended servings of lycopene-containing fruits and vegetables would promote breast cancer prevention in a population at risk for breast cancer. Further, the findings demonstrate the importance of obesity prevention, given that the diet rich in tomatoes had a stronger impact on adiponectin levels in women with a lower body mass index.

• Citation: • Llanos AA, Peng J, Pennell ML, et al. Effects of Tomato and Soy on Serum Adipokine Concentra

tions in Postmenopausal Women at Increased Breast Cancer Risk: A Cross-Over Dietary Intervention Trial. J Clin Endocrinol Metab. 2013;doi:10.1210/jc.2013-3222.

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Parkinson’s Disease: Effect of Deep Brain Stimuation on DrivingMedicalResearch.com Interview with:Priv. Doz. Dr. Carsten BuhmannDepartment of NeurologyUniversity Medical Center Hamburg-Eppendorf Hamburg, Germany.

• MedicalResearch.com: What are the main findings of the study?• Answer: Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has no negative but rather a beneficial effect on driving

in patients with Parkinsons´s disease (PD). Driving not only was superior in even more clinically affected PD patients with DBS compared with PD patients without DBS but also patients with DBS drove better with stimulation than with levodopa.

• This might reflect favorable driving-relevant nonmotor effects due to STN-DBS.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Unexpectedly, PD patients with DBS and controls drove comparably well. The driving course was demanding but short

and patients reported lower annual mileage. Driving of longer distances might be worse in patients because of problems with sustained attention. Therefore, the present results might be limited to shorter driving distances, such as inner-city or neighborhood driving.MedicalResearch.com: What should clinicians and patients take away from your report?

• Answer: • Regaining a better driving ability in PD might be one aspect of improved quality of life with DBS in comparison to medical

treatment alone• Driving permission for DBS-treated patients with PD should not be handled more restrictively than permissions for patients with

PD in general• The study results should not bring PD patients to undergo DBS just to get back behind the wheel.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: A prospective study investigating driving ability of PD patients before and after DBS operation should be done.• Citation:• Effect of subthalamic nucleus deep brain stimulation on driving in Parkinson disease• Carsten Buhmann, MD, Lea Maintz, Jonas Hierling, Eik Vettorazzi, Christian K.E. Moll, MD, Andreas K. Engel, MD, Christian Gerlo

ff, MD, Wolfgang Hamel, MD and Wolfgang H. Zangemeister, MD• Published online before print December 18, 2013, doi: 10.1212/01.wnl.0000438223.17976.fb

Neurology 10.1212/01.wnl.0000438223.17976.fb

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Anxiety Associated With Increased Stroke RiskMedicalResearch.com Interview with: Maya J. Lambiase, PhDDepartment of Psychiatry University of Pittsburgh School of MedicinePittsburgh, PA 15213

• MedicalResearch.com: What are the main findings of the study?• Dr. Lambiase: Higher levels of anxiety were associated with a greater risk for stroke.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Lambiase: Even moderate increases in anxiety were associated with an increase in stroke risk,

independent from other risk factors such as depression.• MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Lambiase: Anxiety symptoms, which include feeling unusually worried, stressed, nervous, or

tense, are very common. Although everyone has some anxiety now and then, if it is elevated and/or chronic, it may have an effect on your vasculature years down the road. Thus, assessment and treatment of anxiety has the potential to not only improve overall quality of life, but all reduce the risk of cardiovascular diseases, such as stroke, later in life.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Dr. Lambiase: Future research is needed to determine the mechanisms whereby greater levels of anxiety increase a person’s risk for stroke. Also, it will be important for studies to assess the effect of anxiety treatment on long-term cardiovascular health.

• Citation:• Prospective Study of Anxiety and Incident Stroke• Maya J. Lambiase, Laura D. Kubzansky, and Rebecca C. Thurston• Stroke. 2013;STROKEAHA.113.003741published online before print December 19 2013, doi:10.1161/

STROKEAHA.113.003741Read the rest of the interview on MedicalResearch.com

Anonymous Sperm Donation and Consanguinity RiskMedicalResearch.com Interview with: Jean-Louis SerreEA 2493 ‘Pathologie Cellulaire and Génétique, de la Conception à la Naissance’, Université de Versailles, Saint Quentin en Yvelines, and Jean-Pierre

Siffroi, Commission de Génétique, Fédération Française des CECOS,UMR S933 INSERM/Université Pierre et Marie Curie (UPMC), Paris, France

• MedicalResearch.com: What are the main findings of the study?• Answers:• Anonymous sperm donation may lead to unions between relatives, especially between half-

siblings and to an increase of both consanguinity and the frequencies of recessive diseases. We made an evaluation of the actual consequences of anonymous sperm donation in France and we concluded that they can be considered as negligible when compared to those due to false paternities, four times higher.

• The risk of inadvertent unions between half-sibs is often advocated and we showed that it may be estimated to as few as one case every 10 years. Consequently, the main level of consanguinity in the French population is not modified and unions between first cousins within the sub-population from Mediterranean origin remain the main source of consanguinity.

•MedicalResearch.com: Were any of the findings unexpected?

• Answers:• The marginal consequences of anonymous sperm donation on unions between relatives and on

consanguinity were expected. However, its precise estimation is useful for the debate initiated in several European countries about the access to gamete donor identity.

• The actual effect of false paternities versus anonymous sperm donation was quite unexpected.

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Anonymous Sperm Donation and Consanguinity RiskMedicalResearch.com Interview with: Jean-Louis SerreEA 2493 ‘Pathologie Cellulaire and Génétique, de la Conception à la Naissance’, Université de Versailles, Saint Quentin en Yvelines, and Jean-Pierre

Siffroi, Commission de Génétique, Fédération Française des CECOS,UMR S933 INSERM/Université Pierre et Marie Curie (UPMC), Paris, France

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answers:• According to the legal rules in France, AID (in a medical context, limited to an offspring of ten per donor) has

no major consequences on public health.• All the estimations and calculations reported in this article are useful for refuting the assertion that AID

increases the risk of inadvertent unions between relatives and the level of consanguinity.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answers:• If sperm donation evolves in the future, either towards a limitation of the offspring or, more probably,

towards non-medical indications, one would reconsider calculations in order to define a new strategy for CECOS which could maintain this marginal effect of anonymous sperm donation.

• For example, one way to limit the risk of inadvertent unions and consanguinity is to decrease the number of sperm donation centres, allowing them to work in large populations or geographic areas.

• Moreover, children born after AID should be aware of their mode of conception in order to ask for genetic tests when adults if they want to exclude any inadvertent union with a relative.

• Citation:• Does anonymous sperm donation increase the risk for unions between

relatives and the incidence of autosomal recessive diseases due to consanguinity?Serre JL, Leutenegger AL, Bernheim A, Fellous M, Rouen A, Siffroi JP.

• Hum Reprod. 2013 Dec 16. [Epub ahead of print]

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Fluctuating Cognitive Impairment and Dementia Risk\MedicalResearch.com Interview with:Dr. Alan B. Zonderman PhDCognition Section Laboratory of Personality and Cognition, NIAGerontology Research Center Baltimore, MD 21224-6825

• MedicalResearch.com: What are the main findings of the study?• Dr. Zonderman: In a prospective population-based 5-year follow-up study the authors examined the rate at which participants converted

from mild cognitive impairment to dementia or reverted from mild cognitive impairment to normal cognitive performance. As has been common, they found elevated risk for dementia associated with mild cognitive impairment, but also found elevated risk for dementia among those who reverted (temporarily) to normal cognitive performance.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Zonderman: Until these data it’s been unclear whether changes in status were due to inconsistent diagnostic procedures or whether

they were true changes in cognitive performance. Additionally, the clinical significance of such intra-individual variations was unclear if these changes were not just unreliability in diagnostic procedures. What was surprising was that the risk for dementia was so large (hazard ratio = 6.6) that the effect is unlikely to have been just a trivial finding.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Zonderman: These results suggest that although the time course of dementia is usually unpredictable for any individual, a temporary

reversion from mild cognitive impairment to unimpaired cognitive performance is unlikely to signal the absence of the disease.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Zonderman: Although the authors suggest that individuals who revert from mild cognitive impairment are candidates for intervention

trials, we should temper this by the likelihood that such individuals may already have the disease. It is most likely that only the manifestation of the disease reverted, probably not the underlying brain pathology. This suggests that we should begin studies of dementia before any manifestation of the disease occurs.

• Individuals who revert to unimpaired cognitive performance from mild cognitive impairment may be candidates for treatment interventions that might delay reversion to dementia. Such interventions might include pharmacological therapeutics, but may also include other treatments such as physical exercise.

• Citation:• Risk of dementia after fluctuating mild cognitive impairment:

When the yo-yoing stopsAlan B. Zonderman, PhD and; Gregory A. Dore, PhD.Journal NeurologyPublished ahead of print: December 18 2013

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Obstructive Sleep Apnea: Value of Being Elbowed by Bed-PartnerMedicalResearch.com Interview InvitationM.E. Fenton MD MSc FRCPC FCCPAssociate Professor Program Director, Respirology Training ProgramDivision of Respirology

, Critical Care and Sleep Medicine University of Saskatchewan

• MedicalResearch.com: What are the main findings of the study?• Dr. Fenton: This study demonstrates that asking a simple question in the outpatient clinic – Does your bed-

partner ever poke or elbow you because you have stopped breathing? – has significant predictive value for a diagnosis of obstructive sleep apnea.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Fenton: Prior to doing this study, we had observed that many patients being evaluated for obstructive sleep

apnea (OSA) report this phenomenon in the outpatient clinic, so we were not surprised that the Elbow Sign has predictive value in diagnosing OSA. However, we were pleasantly surprised at the high specificity (96.6%) demonstrated in men who have a body mass index of 31 or higher. This is the most common demographic being assessed for OSA and the possibility of making a diagnosis without a polysomnogram is exciting, as there are long wait times for such testing in many jurisdictions.

• MedicalResearch.com: What should clinicians take away from your report?• Dr. Fenton: The primary message is that in a Sleep Disorders Clinic a positive Elbow Sign has high predictive value

for a diagnosis of OSA, particularly in obese men. The other, more controversial, message is that this study suggests that not all patients being evaluated for OSA need a diagnostic test (e.g. polysomnogram) to make the diagnosis.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Fenton: This is a single center study and needs to be validated more broadly.• Citation:• The Utility of the Elbow Sign in the diagnosis of Obstructive Sleep Apnea• Mark E. Fenton, MD, FCCP; Karen Heathcote, MD; Rhonda Bryce, MD; Robert Skomro, MD, FCCP; John K. Reid, M

D, FCCP; John Gjevre, MD, FCCP; David Cotton, MD, FCCP

Chest. 2013. doi:10.1378/chest.13-1046Read the rest of the interview on MedicalResearch.com

Breast Cancer: PIK3CA Mutation to Predict Chemotherapy ResistanceMedicalResearch.com Interview with:Prof. Dr. med. Sibylle Loibl MDUnit Head of Medicine & Research Member of Management BoardAssociate Professor University Frankfurt Neu

-Isenburg

• MedicalResearch.com: What are the main findings of the study?• Dr. Loibl: We could demonstrate that patients with a HER2+ primary breast cancer harbouring a PIK3CA mutation are less

likely to achieve a pathological complete response after treatment with an anthracycline/taxane containing therapy in combination with trastuzumab and lapatinib, than patients whose tumours does not harbour the mutation (so called wild type). This difference was largest in the group with HER2+, HR + tumours. The pCR rate in this cohort was as low as 6.3%.

• Looking at the differences in another study with either trastuzumab or lapatinib anti-HER2 treatment is seems as patients with a PIK3CA mutated tumour have a low pCR rate irrespective of the antiHER2 treatment, whereas the patients with a wild type tumour benefit from trastuzumab and the double blockade.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Loibl: Other investigations from the Neo-Altto study, the Neosphere study and the TRBRC 006 study showed basically

similar results and report on pCR rates below 10% for the HER2+, HR+, PIK3CA mutated tumours.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Loibl: I would not yet recommend to test all HER2+ tumours for PIK3CA mutation status as the data need to be

confirmed and alternative treatment options for these patients have not yet been investigated. But I am confident that this will be implemented into clinical practice soon. Current running clinical trials are already stratifying for the PIK3CA mutation status.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Loibl: We need to further look into the PIK3CA mutation and need to address this issue in prospective clinical trials,

trying to optimize the systemic treatment for patients whose tumour harbour a PIK3CA mutation.• Citation:• PIK3CA mutation predicts resistance to anti-HER2/chemotherapy in primary HER2-positive/hormone receptor-positive br

east cancer• Prospective analysis of 737 participants of the GeparSixto and GeparQuinto studies• San Antonio Breast Symposium 2013

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Mild Cognitive Impairment: Progression to Dementia RiskMedicalResearch.com Interview with:Dr. Ronald C. Petersen M.D., Ph.D. Division of EpidemiologyDepartment of Health Sciences Research; Department of NeurologyMayo Clinic, Rochester, MN

• MedicalResearch.com: What are the main findings of the study?

Dr. Petersen: The diagnosis of mild cognitive impairment increases the likelihood of developing dementia.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Petersen: Even in those subjects diagnosed with MCI who return to normal on a subsequent occasion still have an increased risk of developing dementia.

• MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Petersen: Mild cognitive impairment is important to recognize to determine if any causes might be treatable and to plan for the future.

• Dr. Petersen: We need to know if biomarkers will help sort out who will progress and who will not.

• Citation:• Higher risk of progression to dementia in mild cognitive impairment cases who revert to nor

mal• Rosebud O. Roberts, MB, ChB, David S. Knopman, MD, Michelle M. Mielke, PhD, Ruth H. Cha,

MS, V. Shane Pankratz, PhD, Teresa J.H. Christianson, BSc, E. Geda, MD, MSc, Bradley F. Boeve, MD, Robert J. Ivnik, PhD, LP, Eric G. Tangalos, MD, Walter A. Rocca, MD, MPH and Ronald C. Petersen, MD, PhD

• Published online before print December 18, 2013, doi: 10.1212/WNLNeurology 10.1212/WNL.0000000000000055

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Systemic Sclerosis: Chemokine CXCL4 as a Biomarker of Progression and PhenotypeMedicalResearch.com Interview with:Prof. Dr. T.R.D.J. Radstake, MD, PhDStaff Rheumatologist / head translational Immunology

Department of Rheumatology & Clinical Immunology EULAR Center of ExcellenceUniversity Medical Center Utrecht, The Netherlands

• MedicalResearch.com: What are the main findings of the study?• Prof. Radstake: We observed that the chemokine CXCL4 is highly produced by so-called

plasmacytoid dendritic cells in systemic sclerosis (Ssc). CXCL4 is associated with the progression and clinical phenotype of Ssc and thus provides a tool for clinicians to identify those patients in need for aggressive therapy and on the other hand, avoid unnecessary side-effects for those who have mild disease. Moreover, the identified roles for CXCL4 in SSc sparks our knowledge on the pathogenic pathways at hand in this terrible conditions. Now, we and other groups will have to further unravel the precise roles for CXCL4 in SSc and possibly other fibrotic and immune mediated conditions that cover the spectrum of medicine.

MedicalResearch.com: Were any of the findings unexpected?• Prof. Radstake: The role of plasmacytoid dendritic cells was already suggested by their

production of various inflammatory mediators such as type I Interferon which has been shown to play a role in this condition. That CXCL4 is made in large quantities is completely new. This suggests an important role for pDC other than the expected production if type I IFNs and one that need to be unravelled further.

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Systemic Sclerosis: Chemokine CXCL4 as a Biomarker of Progression and PhenotypeMedicalResearch.com Interview with:Prof. Dr. T.R.D.J. Radstake, MD, PhDStaff Rheumatologist / head translational Immunology

Department of Rheumatology & Clinical Immunology EULAR Center of ExcellenceUniversity Medical Center Utrecht, The Netherlands

• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Radstake: The clinical relevance of this work is pretty high as there is no current effective

therapy available for Ssc. Also, there are no biomakers who are able to predict which patient will have severe disease or those who will not. This is utterly important since therapy that is available as kind of last resort for these patients eg. Cyclophosphamide or autologous stem cell transplantation has a high rate of mortality and/or morbidity. Not lastly, the role of CXCL4 we show in the paper provides more insights into the possible pathogenesis of disease. We are now following up onto these observations were we focus onto a better understanding of the precise roles of CXCL4 in the diverse pathological hallmarks of Scleroderma but also to develop CXCL4 as a candidate for future therapeutic targeting.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Prof. Radstake: I believe we should further focus on the precise role of CXCL4 in the pathological circuitry in Ssc which is complex. We now only revealed a tip of the veil. Furthermore, we should focus on CXCL4 as a potential therapeutic target for this condition as well as other medical conditions typified by fibrosis and/or chronic inflammation

• Citation:• Proteome-wide Analysis and CXCL4 as a Biomarker in Systemic Sclerosis• Lenny van Bon, M.D., Alsya J. Affandi, M.Sc., Jasper Broen, M.D., Ph.D., Romy B. Christmann, M.D., P

h.D., Renoud J. Marijnissen, Ph.D., Lukasz Stawski, M.Sc., Giuseppina A. Farina, M.D., Ph.D., Giuseppina Stifano, M.D., Allison L. Mathes, Ph.D., Marta Cossu, M.D., Michael York, M.D., Cindy Collins, M.A., Mark Wenink, M.D., Richard Huijbens, M.Sc., Roger Hesselstrand, M.D., Ph.D., Tore Saxne, M.D., Ph.D., Mike DiMarzio, M.Sc., Dirk Wuttge, M.D., Ph.D., Sandeep K. Agarwal, M.D., Ph.D., John D. Reveille, M.D., Ph.D., Shervin Assassi, M.D., Maureen Mayes, M.D., M.P.H., Yanhui Deng, Ph.D., Joost P.H. Drenth, M.D., Ph.D., Jacqueline de Graaf, M.D., Ph.D., Martin den Heijer, M.D., Ph.D., Cees G.M. Kallenberg, M.D., Ph.D., Marc Bijl, M.D., Ph.D., Arnoud Loof, M.Sc., Wim B. van den Berg, Ph.D., Leo A.B. Joosten, Ph.D., Vanessa Smith, M.D., Ph.D., Filip de Keyser, M.D., Ph.D., Rafaella Scorza, M.D., Ph.D., Claudio Lunardi, M.D., Ph.D., Piet L.C.M. van Riel, M.D., Ph.D., Madelon Vonk, M.D., Ph.D., Waander van Heerde, Ph.D., Stephan Meller, M.D., Bernhard Homey, M.D., Lorenzo Beretta, M.D., Ph.D., Mark Roest, Ph.D., Maria Trojanowska, Ph.D., Robert Lafyatis, M.D., and Timothy R.D.J. Radstake, M.D., Ph.D.

• December 18, 2013DOI: 10.1056/NEJMoa1114576

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Postpartum Health and Maternity Leave DurationMedicalResearch.com Interview with:Rada K. Dagher, Ph.D.Assistant Professor, University of Maryland School of Public HealthDepartment of Health Services Administration

College Park, MD 20742

• MedicalResearch.com: What are the main findings of the study?• Dr. Dagher: The main finding of this study is that taking leave from work up to six months after

childbirth is associated with a decrease in maternal postpartum depressive symptoms; thus longer maternity leaves may protect against the risk of postpartum depression. We conclude that the 12 week leave duration provided by the Family and Medical Leave Act (FMLA) of 1993 may not be sufficient for women who are at risk or experiencing postpartum depression. Moreover, the unpaid nature of the FMLA makes it harder for mothers with limited financial means to take longer leaves; thus, many of these mothers may have to take leaves that are much shorter in duration than 12 weeks.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Dagher: We did not expect that additional leave days after 6 months postpartum will be

associated with an increase in postpartum depressive symptoms. This reversal in the relationship between leave duration and postpartum depressive symptoms at six months after childbirth may be related to women’s feelings of low control over housework and infant-related tasks at home, and missing the supportive relationships at their workplaces and the sense of accomplishment derived from the achievements and rewards of paid work. However, we caution that in our sample of women, 87% were back to work by 6 months postpartum and 92% were back to work by 12 months. Thus, it is difficult to accurately estimate the impact of leave durations that are longer than 6 months on women’s postpartum depressive symptoms.

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Postpartum Health and Maternity Leave DurationMedicalResearch.com Interview with:Rada K. Dagher, Ph.D.Assistant Professor, University of Maryland School of Public HealthDepartment of Health Services Administration

College Park, MD 20742

• MedicalResearch.com: What should clinicians and patients take away from your report?

• Dr. Dagher: Our findings point to the possibility of a protective effect of maternity leave up to six months after childbirth on the risk of postpartum depression. Expectant and new mothers should discuss their plans to return to work after childbirth with their primary care and occupational health providers. Some women may need intermittent leave a benefit provided by the FMLA that allows mothers the opportunity to return to work on a gradual, part-time basis. However, this benefit is only provided with medical certification that a woman is incapacitated by a serious health condition by law and it is the role of primary care and occupational health providers to assess women and discuss with them their eligibility for this benefit.

• Expectant and new mothers who have to return to work soon after childbirth (for e.g., due to financial reasons) should explore with their employers the possibility of using flex-time and telecommuting options, including reduced hours upon re-entry to work. Moreover, expectant and new mothers should actively seek social support from their families, friends, and those experiencing depressive symptoms should seek mental health counseling. Moreover, they can join local postpartum support groups and seek support from postpartum support organizations such as postpartum support international (www.postpartum.net<http://www.postpartum.net>), which has volunteers in every state in the U.S.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Dr. Dagher: Taking time off from work after childbirth provides time for mothers to rest and recover from pregnancy, labor, and delivery. Research has consistently found an association between postpartum fatigue and postpartum depression; therefore, it may be that taking leave from work after childbirth helps mothers attend to their fatigue symptoms which may in turn decrease their risk for postpartum depression. Future studies should examine the mechanisms through which taking time off after childbirth influences postpartum depressive symptoms, one potential mechanism being postpartum fatigue.

• Citation:• Maternity Leave Duration and Postpartum Mental and Physical Health: Implications for Leave Policies • Dagher RK, McGovern PM, Dowd BE.

J Health Polit Policy Law. 2013 Dec 4. [Epub ahead of print]

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Costs of Health Care: Teaching Medical Residents How to Provide Cost-Conscious CareMedicalResearch.com Interview with:Mitesh Patel, MD, MBARWJF Clinical Scholar, University of PennsylvaniaMitesh

Patel, MD, MBA is a Robert Wood Johnson Clinical Scholar the University of Pennsylvania and primary care physician at the Philadelphia VA Medical Center

• MedicalResearch.com: What are the main findings of the study?• Dr. Patel: We evaluated survey responses from nearly 300 internal medicine residency programs directors to assess whether residency programs were

teaching residents the fundamental concepts of practicing high-value, cost-conscious care. We found that 85% of program directors feel that graduate medical education has a responsibility to help curtail the rising costs of health care. Despite this, about 6 out of every 7 internal medicine residency programs have not yet adopted a formal curriculum teaching new physicians these important concepts.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Patel: About half of the programs did not agree that their faculty members consistently role-modeled cost-conscious care. Since these faculty are the

ones responsible for teaching concepts and assessing competency, this is a concerning finding that needs more attention. However, we did find some hope in that 50% of programs stated they are actively working on ways to improve and adopt a more formal curriculum.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Patel: There is a lot of opportunity to continue to improve upon current cost-conscious care curricula. An ideal curriculum would need to incorporate

multiple forms of teaching and assessment methods that are well integrated into residency training and clinical practice. This could include core lectures and didactic sessions, making resources available on the costs of tests and treatments, and to be most impactful be integrated within provider discussions related to clinical care. Clinicians and patients should look for ways to integrate questions and discussions around the value of care into the clinical setting.

• MedicalResearch.com: What resources are available to help improve the practice of high-value, cost conscious care?• Dr. Patel: In my prior research, we created the VALUE Framework, which is a mnemonic for a simple and concise tool that clinicians can use at the point of

care to evaluate whether a test or treatment will provide value to their patient. This publication also has over 20 recommendations for residency programs to integrate training on these concepts into their current structure.

• For medical schools, we’ve proposed a national curriculum in health policy that can help teach the fundamental concepts that a future physicians will need to effectively translate new health policy into clinical care.

• Health systems and hospitals can look for ways to leverage concepts from behavioral economics to impact change in provider behavior and improve the practice of high-value, cost-conscious care.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Patel: There is a significant need for further research and evaluation on this important topic. We encourage programs or health care settings that have

implemented curricula or methods to help improve the practice of high-value, cost-conscious care to help evaluate and study their outcomes so impactful changes can be disseminated and adopted more broadly.

• Citation:• Teaching Residents to Provide Cost-Conscious Care: A National Survey of Residency Program Directors• Patel MS, Reed DA, Loertscher L, McDonald FS, Arora VM. Teaching Residents to Provide Cost-Conscious Care: A National Survey of Residency Program Direc

tors. JAMA Intern Med. 2013;():-. doi:10.1001/jamainternmed.2013.13222.

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Diabetes: Complications and Mortality in Older PatientsMedicalResearch.com Interview with:Elbert S. Huang, MD MPH FACPAssociate Professor of MedicineUniversity of Chicago5841 S. Maryland Ave., MC 2007 Chicago, IL 60637

• MedicalResearch.com: What did you find most surprising in these results?• Dr. Huang: We did not expect hypoglycemia to rank as highly as it did among the diabetes complications.• We were also surprised to find that the rates of cardiovascular and microvascular complications are all

dramatically lower than they were in the 1990s.

MedicalResearch.com: What factors do you consider in individualizing the treatment plan for a given patient?

• Dr. Huang: Apart from age and duration of diabetes, it is important to consider the overall health status of the patient including their comorbid illnesses and functional status. These variables affect the likelihood that a patient will benefit from intensive glucose control and affect their ability to carry out the treatment plan. And of course, you have to consider the goals and preferences of the patient. Are they someone already bothered by the burdens of polypharmacy? Are they someone willing to do anything possible to prevent the complications of diabetes?

• MedicalResearch.com: What main message would you hope for physicians to take away from this research?• Dr. Huang: When you meet an older patient with diabetes for the first time, the course of the disease will be

different depending on their age and how long they have had the disease. Patients over 80 with longstanding diabetes are at the highest risk for experiencing the complications of diabetes as well as the side effects of treatment. Take time to ensure that hypoglycemia is avoided.

• Citation:• Rates of Complications and Mortality in Older Patients With Diabetes Mellitus: The Diabetes and Aging Study

.• Huang ES, Laiteerapong N, Liu JY, John PM, Moffet HH, Karter AJ.

JAMA Intern Med. 2013 Dec 9. doi: 10.1001/jamainternmed.2013.12956. [Epub ahead of print]

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Traumatic Brain Injury Increases Risk of PTSDMedicalResearch.com Interview with: Dewleen G. Baker, MD Department of PsychiatrySchool of Medicine, University of California, Veterans Affairs San Diego Healthcare System

Veterans Affairs Center of Excellence for Stress and Mental HealthSan Diego, California• MedicalResearch.com: What are the main findings of the study?• Dr. Baker: Pre-deployment psychiatric symptoms, combat intensity, and traumatic brain injury (TBI) were significant

predictors of post-deployment PTSD symptom severity. However, the strongest predictor was deployment-related TBI; mild TBI increased symptom scores by 23%, and moderate to severe injuries increased scores by 71%.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Baker: Prior research has shown that symptoms from TBI and PTSD may overlap considerably, and that the two disorders may often co-occur in combat veterans. Our study takes these associations one step further and suggests that TBI may be an important risk factor for PTSD.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Baker: Based on our findings, clinicians should be alerted to the likelihood that individuals who have sustained

deployment-related brain injuries may be at higher risk for PTSD, and that their patients with PTSD may have had had significant head injury events that may impact their functioning and recovery. Patients should be alerted to report both events, both emotional traumas and head injury to their physician, as well as persistent symptoms, and to work closely with their clinicians.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Baker: Future research will be important in order to discern causes of the increase in PTSD symptoms in

combatants with, versus those with deployment-related TBI. It is unknown to what extent factors, such as the emotional salience of the head injury event or neuronal damage associated with the head injury event contribute to the higher rates of post-deployment PTSD. Future research that includes high-resolution neuroimaging is needed to determine whether the head injury causes persistent neural tissue damage that impedes emotional recovery from emotionally stressful events.

• Citation:• Yurgil KA, Barkauskas DA, Vasterling JJ, et al. Association Between Traumatic Brain Injury and Risk of Posttraumatic St

ress Disorder in Active-Duty Marines. JAMA Psychiatry. 2013;():-. doi:10.1001/jamapsychiatry.2013.3080.

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racking: Chemicals In Process May Disrupt HormonesMedicalResearch.com Interview with:Christopher D Kassotis (MU-Student)

Department of Obstetrics, Gynecology and Women’s Health and Division of Biological Sciences University of Missouri, Columbia, MO 65211;

• MedicalResearch.com: What are the main findings of the study?• Answer: The main findings of our study are twofold:• First, we found that 12 chemicals used in the fracking process disrupt hormone action. Specifically, we found that they inhibited the action of estrogens

such as estradiol and androgens such as testosterone; classes of reproductive hormones that are critical for normal development and reproductive maturation.

• Second, we found that surface and ground water from a drilling-dense area in Colorado has much greater hormonal activity than samples from areas with limited drilling. Specifically, ground water had elevated estrogenic activity (mimicking the effects of estrogens), while surface water exhibited anti-estrogenic and anti-androgenic activities, similar to the chemicals we tested.

MedicalResearch.com: Were any of the findings unexpected?• Answer: I would say that most of the results were unexpected. This was designed as a proof of concept study, so we selected sites that were both in

drilling-dense regions and that had spills related to this industry. We weren’t sure that we would see any difference in activity across sites.• I was also surprised at the antagonist activity that we measured both in the 12 fracking chemicals we tested as well as the surface water in Garfield

County. In several cases we saw chemicals or water samples that were able to completely block the binding of estradiol to the estrogen receptor.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: I am not a medical doctor, but I hope that this study will inform both patients and clinicians to the potential for human exposure to these

endocrine disrupting chemicals (EDCs) in drilling-dense regions. Over the last twenty years, numerous laboratory studies have shown adverse health effects in animals exposed to endocrine disrupting chemicals and epidemiological studies have found correlations between exposure and human disease. We did not assess any health outcomes from the chemicals used in drilling, but show that there may be cause for concern for people living nearby and certainly a need for additional research.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: The current research on this topic is decidedly lacking. Very little is known about the fracturing process, the identities of many of the chemicals

used in the process, and the potential health effects of exposure to these chemicals.• Going forward, I think we need to gain a better understanding of how fracturing fluids enter water sources, which chemicals are used in the process (the

identity of many chemicals used remains proprietary information), and whether there may be any resulting adverse health outcomes for humans and animals living near fracking operations.

• Citation:• Estrogen and Androgen Receptor Activities of Hydraulic Fracturing Chemicals and Surface and Ground Water in a Drilling-Dense Region

Endocrinology en.2013-1697; doi:10.1210/en.2013-1697• Christopher D. Kassotis, Donald E. Tillitt, J. Wade Davis, Annette M. Hormann,

and Susan C. Nagel

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Osteoarthritis: Increased Risk of Cardiovascular DiseaseMedicalResearch.com Interview with:

M Mushfiqur Rahman, MSc. PhD candidateSchool of Population and Public Health

University of British Columbia, Statistical Analyst Arthritis Research Centre of CanadaBC, Canada, V6X 2C7;

• MedicalResearch.com: What are the main findings of the study?• Author’s response: Using 18 years of administrative health records from British Columbia,

Canada, our aim was to determine whether osteoarthritis increases the risk of cardiovascular disease in a longitudinal study. We also examined the risks of specific cardiovascular conditions such as, myocardial infarction, ischemic heart disease, congestive heart failure, and stroke after adjusting for age, sex, socio-economic status, diabetes, hypertension, hyperlipidemia, chronic obstructive pulmonary disease, and a co-morbidity score.

• We observed a significant increase in the risk of cardiovascular disease, ischemic heart disease, and congestive heart failure among individuals with osteoarthritis compared with age-sex matched non-osteoarthritis individuals. Our data suggests that adult women and men aged 65 years and older with osteoarthritis had higher risks of developing these conditions. The risks were also higher among severe osteoarthritis patients who had undergone total joint replacement surgeries. Men aged between 20-64 years with osteoarthritis did not show higher risks of developing these conditions. MedicalResearch.com: Were any of the findings unexpected?

• Author’s response: Yes, in our study, individuals with osteoarthritis did not show a significant association with myocardial infarction or stroke. This may have happened due to some factors unknown at this point and data limitations. Our administrative database did not include records of hospital patients treated at emergency care units. Some deaths from acute myocardial infarction or stroke occurred in the hospital emergency care units or at home were not captured in our study.

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Osteoarthritis: Increased Risk of Cardiovascular DiseaseMedicalResearch.com Interview with:

M Mushfiqur Rahman, MSc. PhD candidateSchool of Population and Public Health

University of British Columbia, Statistical Analyst Arthritis Research Centre of CanadaBC, Canada, V6X 2C7;

• MedicalResearch.com: What should clinicians and patients take away from your report?• Author’s response: These findings can inform both clinicians and patients to develop additional

strategies to build cardiac awareness campaigns. Although these results are conditional on further confirmation, the goal could be to increase knowledge of cardiovascular disease risks among men and women with osteoarthritis. The causal mechanism of this relationship is unknown at this point, however, patients should be aware of the adverse impact of factors such as chronic inflammation, obesity and metabolic syndromes, immobility (or less physical activity), muscle weakness, non-steroidal anti-inflammatory drugs use.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Author’s response: To the best of our knowledge, this is the first prospective longitudinal study of the relationship between osteoarthritis and incident cardiovascular disease. Therefore, we recommend more population-based studies to confirm these relationships in different databases. In addition, we were not able to adjust for all possible confounding factors in these relationships, future studies may include them. The impact of osteoarthritis on acute myocardial infarction or stroke related mortality prior to hospital admission could be another potential future area of research.

• Citation:• Risk of Cardiovascular Disease in Patients With Osteoarthritis: A Prospective Longitudinal Study• Rahman MM, Kopec JA, Anis AH, Cibere J, Goldsmith CH.• Arthritis Care Res (Hoboken). 2013 Dec;65(12):1951-8. doi: 10.1002/acr.22092.

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Alzheimer’s: Distinct Cognitive Deficits Associated with Regional Brain AtrophyMedicalResearch.com Interview with:Lieke Smits drs. L.L. SmitsVU University Medical CenterDepartment of Neurology – Alzheimer Center 1081

HV Amsterdam, The Netherlands

• MedicalResearch.com: What are the main findings of the study?• Answer: In this study we used two visual ratings scales to estimate atrophy of the medial temporal lobe (MTA) and posterior

atrophy (PA) on MRI in patients with Alzheimer’s disease. We assessed associations between MTA and PA with cognitive impairment. We found that MTA was associated with worse performance in memory, language and attention, while PA was associated with worse performance in viuso-spatial functioning and executive functioning.

• Further stratification for age at diagnosis revealed that in late onset (>65 years old) MTA was associated with impairment in memory, language, visuo-spatial functioning and attention. In early onset patients (<65 years old), worse performance on visuo-spatial functioning almost reached significance.

MedicalResearch.com: Were any of the findings unexpected?• Answer: Based on dichotomized MRI ratings we found that 27% of patients had no atrophy and 17% had only PA. For a disease

where MTA is traditionally regarded as a hallmark, the number of patients without appreciable MTA is quite high. An explanation could be that our cohort was relatively young and in patients with an early onset we found less MTA.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: The visual rating scale for MTA has been used over two decades, the rating scale for PA has recently been developed. With

those easy to use scales we observed the heterogeneity of atrophy in Alzheimer’s disease. Clinicians should be aware that patients with Alzheimer’s disease can have PA in absence of MTA or show no atrophy at all. Finally, relations between atrophy and cognition are not set in stone, as a substantial proportion of patients had no atrophy, even when there was clear cognitive impairment.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Future research should further correlate the PA rating scale with clinical heterogeneity in Alzheimer’s disease. And it

would be of interest to validate the scale for other types of dementia, for example Dementia with Lewy bodies. Finally, an important research question is whether pattern of atrophy is a determinant for rate of progression.

• Citation:Regional atrophy is associated with impairment in distinct cognitive domains in Alzheimer’s disease

• Smits LL, Tijms BM, Benedictus MR, Koedam EL, Koene T, Reuling IE, Barkhof F, Scheltens P, Pijnenburg YA, Wattjes MP, van der Flier WM.

• Alzheimers Dement. 2013 Nov 6. pii: S1552-5260(13)02494-1. doi: 10.1016/j.jalz.2013.06.007. [Epub ahead of print]

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Hospice Care: Discussed Earlier by Physicians Who Would Enroll Themselves if Terminally IllMedicalResearch.com Interview with:Garrett M. Chinn, MD, MS

Division of General Medicine, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston

• MedicalResearch.com: What are the main findings of this study:• Dr. Chinn: Despite the desire of most Americans facing terminal illness to spend their remaining time at home, only 24% of those aged 65 and

older do so. Many spend their final days in an institutional setting such as an acute care hospital, often receiving aggressive care.• In the case of patients facing stage 4 lung cancer, many who would prefer to emphasize pain relief over extending life report not having discussed

hospice with a physician. More than 25% indicate that they had not addressed advanced care directives such as do-not-resuscitate orders with their doctors but wanted to do so. This tells us that patients wish to better understand their illness and prognosis and might be interested in learning about hospice. And although the general trend for hospice utilization has increased over the past decade, a high percentage of hospice enrollment occurs quite late in the course of illness, often during an acute hospitalization.

In an effort to identify factors which might affect timely discussions about hospice, we wondered whether or not physicians who had more positive attitudes toward hospice themselves were more likely to have early discussions about hospice with their cancer patients. Women, primary care physicians, and those working in managed-care settings or who worked with more terminally-ill and managed-care patients were more likely to strongly agree with the statement:

• If I were terminally ill with cancer, I would enroll in hospice? • Physicians who strongly agreed with that statement were more likely to have earlier, timely discussions about hospice with a terminally-ill cancer

patient with a prognosis of 4-6 months, compared to other physicians with less positive attitudes toward hospice.• MedicalResearch.com: Were any of the findings unexpected?• Dr. Chinn: Although physicians who would strongly agree to hospice themselves if terminally ill were more likely to have timely discussions about

hospice with their cancer patients compared to other physicians, less than 30% did so.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Chinn: While end-of-life care discussions with terminally ill cancer patients can be difficult, initiating them early on may increase patient

understanding about prognosis, clarify the extent to which treatment can help, demystify what hospice is and can offer, and best help patients maintain a high quality of life that is consistent with their values. For physicians with less positive attitudes toward hospice, education on the benefits of how hospice can help their patients may increase rates of timely end-of-life care discussions. For instance, palliative care rotations for medical students and residents may help.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Chinn: Further research should address the extent to which other factors might act as barriers to timely end-of-life care discussions.• Citation:• Chinn GM, Liu P, Klabunde CN, Kahn KL, Keating NL. Physicians’ Preferences for Hospice if They Were Terminally Ill and the Timing of Hospice Discus

sions With Their Patients. JAMA Intern Med. 2013;():-. doi:10.1001/jamainternmed.2013.12825.

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Cannabis: Heavy Use Associated with Working Memory DeficitsMedicalResearch.com Interview with:Dr. Matthew J. Smith PhDDepartment of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, 710 N. Lake Shore Drive, 13th Floor, Abbott Hall, Chicago, IL 60611

• MedicalResearch.com Interview with:Dr. Matthew J. Smith PhDDepartment of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, 710 N. Lake Shore Drive, 13th Floor, Abbott Hall, Chicago, IL 60611

• MedicalResearch.com: What are the main findings of the study?• Dr. Smith: We observed that the shapes of brain structures involved in a working memory brain circuit seemed to collapse inward in a similar

fashion among both of the groups that had a history of daily cannabis use. These cannabis-related changes in shape were directly related to the participants’ poor performance on working memory tasks. Some of the shape abnormalities were more severe in the group with schizophrenia and the history of daily cannabis use. We also found that participants with an earlier age of daily cannabis use had more abnormal brain shapes.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Smith: We didn’t expect that the cannabis-related shape would be correlated with the age of onset of daily cannabis use. This finding suggests

that the younger someone was when they started using daily, the more abnormal the shape of the brain structures. Although this finding is not direct evidence of causation, it appears to be consistent with a causal hypothesis.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Smith: Among adolescence, working memory is a significant predictor of academic achievement. Hence, heavy cannabis use during

adolescence may have negative implications for working memory, and in turn, academic achievement.• Among individuals with schizophrenia, working memory is a significant contributor to community-based functioning (e.g., social functioning,

completing everyday living activities). Hence, the evidence from this study suggests that long-term cannabis use may have negative implications for working memory, and in turn, community-based functioning.

• Additional research would be needed to examine whether heavy cannabis use directly or indirectly impacts academic achievement among adolescents or community-based functioning among individuals with schizophrenia.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Smith: Based on the cross-sectional nature of this study, the observed brain abnormalities could have predated the onset of cannabis use.

Hence, the observed abnormalities could represent a biological vulnerability to substance misuse. Future research is needed to evaluate whether cannabis use contributes to brain changes over time.

• Citation:• Matthew J. Smith, Derin J. Cobia, Lei Wang, Kathryn I. Alpert, Will J. Cronenwett, Morris B. Goldman, Daniel Mamah, Deanna M. Barch, Hans C. Brei

ter, and John G. Csernansky• Cannabis-Related Working Memory Deficits and Associated Subcortical Morphological Differences in Healthy Individuals and Schizophrenia Subjec

ts Schizophr Bull sbt176 first published online December 15, 2013 doi:10.1093/schbul/sbt176Read the rest of the interview on MedicalResearch.com

Blood Pressure: Effect of CPAP in Patients with Obstructive Sleep ApneaMedicalResearch.com Interview with:Dr. Miguel-Ángel Martínez-GarcíaRespiratory Department, Hospital Universitario y Politécnico La FeValencia, Spain

• MedicalResearch.com: What are the main findings of this study:• Answer: The main findings of the study are:• 1. The treatment with CPAP

(continuous positive airway pressure) achieves a clinically andstatistically significant reduction of blood pressure in patients withresistant hypertension (blood pressure that remains above goal in spite ofthe use of at least three antihypertensive drugs) and obstructive sleepapnea.

• 2. This treatment increases the probability of recovering the normalnocturnal blood pressure pattern (dipper pattern) or reversing the riserpattern.

• 3. The prevalence of sleep apnea in patients with resistant hypertension is very high (more than 80%).• The main implication of this study is very clear. Patients with

resistant hypertension must undergo a sleep study to rule out obstructivesleep apnea. If the patient have an apnea-hypopnea index >15 (at leastmoderate sleep apnea) should be treated with CPAP and undergo a bloodpressure monitorization.

• MedicalResearch.com: What are the Take-Home messages for patients and health care providers?• Answer:

-1. The prevalence of sleep apnea in patients with resistant hypertension is very high.-2. Treatment with CPAP is effective in decrease in a clinically significant way the blood pressure in these patients.-3. Patients with resistant hypertension must undergo a sleep study independently of the presence of sleep apnea symptoms) daytime hypersomnolence).

• Effect of CPAP on Blood Pressure in Patients With Obstructive Sleep Apneaand Resistant HypertensionThe HIPARCO Randomized Clinical Trial

• Citation:• Martínez-García M, Capote F, Campos-Rodríguez F, et al. Effect of CPAP on Blood Pressure in Patients With Obstructive Sleep Apnea and Resistan

t Hypertension: The HIPARCO Randomized Clinical Trial. JAMA. 2013;310(22):2407-2415. doi:10.1001/jama.2013.281250.

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Chemotherapy: Adherence Increased with Generic, Lower Cost MedicationsMedicalResearch.com Interview with:Dawn L. Hershman, MD MSAssociate Professor of Medicine and EpidemiologyLeader, Breast Cancer Program Herbert

Irving Comprehensive Cancer Center Columbia University Medical Center

• MedicalResearch.com: What are the main findings of the study?• Dr. Hershman: We have found in the past that compliance to 5 years of hormone therapy for the adjuvant

treatment of breast cancer is low. While toxicity is a main reason, other factors are also important. Recent studies suggest out of pocket costs are high among cancer patients. We evaluated the change in adherence to hormone therapy after the introduction of generic Aromatase inhibitors. We found that discontinuation decreased and adherence increased with generic aromatase inhibitors compared to brand name. we found that higher co-payments were associated with decreased adherence and increased discontinuation. We also found that patients in the highest income group were more likely to be adherent to hormone therapy.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Hershman: We were surprised that even after controlling for average co-payment amount, there was

still more adherence with generic aromatase inhibitors than brand name or tamoxifen.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Hershman: Clinicians should be aware that out of pocket costs may be a barrier to optimal treatment

and should discuss ask patients if they are having a difficult time getting these life saving medications.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Hershman: With newer oral chemotherapy medications approaching up to $10,000 a month, research

needs to focus on compliance and access to these drugs.• Citation:• Source reference: Hershman DL, et al “The change from brand-name to generic aromatase inhibitors and

hormone therapy adherence for early stage breast cancer” SABCS 20131; Abstract S3-04.

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