Goal 2: Reduce Human Disease

Spirometry for diagnosis and treatment of COPD

1. What is the comparative effectiveness of different approaches to implementing use of spirometry in primary care to confirm the diagnosis of COPD (e.g., increased reimbursements, use of EMRs and other tools)
2. What is the comparative effectiveness of using symptoms vs. spirometry in increasing patient and adherence to COPD treatment guidelines?
3. What is the comparative effectiveness of using a fixed FEV1/FVC ratio... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Patient-reported outcomes include symptom frequency, activities of daily living, quality of life, sleep quality, exacerbations

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Goal 2: Reduce Human Disease

Management of COPD in the presence of comorbidity

Management of COPD in the presence of comorbidity

• Does a protocol-based screening for commonly occurring comorbid conditions in patients with COPD (eg. CAD, CHF, depression, sleep apnea) improve management and outcomes for patients with COPD?

• How should providers coordinate management strategies and treatment goals in patients with COPD and other co-existing chronic diseases?

• What is the comparative effectiveness... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

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Goal 3: Advance Translational Research

Effectiveness of pulmonary rehabilitation

1. Does pulmonary rehabilitation (PR) reduce mortality risk?

2. Does PR in the post-hospitalization period reduce subsequent health care utilization?

3. Can the principles of PR be applied more broadly across the disease spectrum to reduce morbidity, mortality, and health care expenditures in patients with COPD?

4. Does early PR following hospitalization for acute exacerbation reduce mortality and readmission rates... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Feasibility and challenges of addressing this CQ or CC

Does improved sleep following pulmonary rehabilitation contribute to improvement in symptoms and quality of life in these patients?

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Risk factors for sleep-disordered breathing in patients with COPD

What are the risk factors for sleep-disordered breathing in patients with COPD (the “overlap syndrome")?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

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Clinical Trials in Pediatric Sleep Disorders - Effect of adenotonsillectomy

Effect of adenotonsillectomy on behavioral and cardiovascular outcomes in children with primary snoring

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

The recent NHLBI Childhood Adenotonsillectomy (CHAT) study showed highly significant behavioral improvements in children with obstructive sleep apnea syndrome . This study included children with an apnea hypopnea index as low as 2/hr. Many small or suboptimally controlled studies suggest that even primary snoring can affect behavior. If large randomized controlled trials confirm this finding, it will radically affect the treatment of the estimated 10% of children who snore.

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Clinical Trials in Pediatric Sleep Disorders - Effect of adenotonsillectomy

Effect of adenotonsillectomy on neurocognitive and behavioral outcomes in infants and and toddlers with obstructive sleep apnea syndrome.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

The CHAT study showed few significant changes in cognitive outcomes in school-aged children with OSAS. However, these children (aged 5-9 years) may have suffered from OSAS too long to allow for reversibility of central nervous system damage. The peak prevalence of OSAS occurs in much younger children. Theoretically, these children are much more likely to show cognitive improvement after treatment, due to a shorter duration of OSAS (with its resultant hypoxemic damage) and increased plasticity of their nervous system. These young children are often not treated, due to either underdiagnosis or concern about the increased risks of adenotonsillectomy in very young children. Thus, if it is found that early treatment reverses cognitive damage, the clinical management of these children would be profoundly affected.

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Clinical Trials in Pediatric Sleep Disorders

Effectiveness of medications for cataplexy in children.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Pediatric sleep experts agree that there appears to be a mini-epidemic of narcolepsy in children currently, characterized by acute onset of disease with severe symptoms and difficult to control cataplexy, in very young children. No drugs are approved for treatment of cataplexy in children, and drugs typically used in adults are not FDA-approved for use in children. A multicenter trial would be needed in order to accumulate sufficient cases for a randomized controlled trial.

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Pulmonary Complications of Sickle Cell Disease

Does screening for pulmonary hypertension (PH) of sickle cell disease (SCD) alter disease outcomes?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

What is known about this topic:

  1. An elevated tricuspid regurgitant jet velocity (TRV) by echocardiography occurs in 1/3 of HbSS adults, 10-25% of HbSC adults and 10-20% of HbSS adolescents.

  2. An elevated TRV is associated with mortality risk in adults, but not children/adolescents

  3. Epidemiologically, associations of an elevated TRV with markers of hemolysis and other disease complications (leg ulcers, priapism, proteinuria, etc.) exist.

  4. Some patients with an elevated TRV have pulmonary hypertension but there is a high false positive rate.

Feasibility and challenges of addressing this CQ or CC

Areas of controversy:

  1. Does screening change outcomes? Currently, there is no established treatment for an elevated TRV. Are there either SCD related therapies (such as hydroxyurea) or treatments for disease associations (such as treatment for proteinuria) that change outcomes?

  2. Does an elevated TRV predict an increased risk of venous thromboembolic disease, obstructive sleep apnea, asthma or other pulmonary diseases with established treatment?

  3. What are the implications of an elevated TRV in the pediatric/adolescent population?

  4. If screening is beneficial, what is the optimal frequency?

  5. What is the best method of screening and what role does newer technologies such as genomics and proteomics play in identifying a higher risk group for whom screening would be more advantageous?

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Risk factors and treatment options for pulmonary hypertension in Sickle Cell Disease

What are the risk factors and treatment options for pulmonary hypertension related to diastolic dysfunction in Sickle Cell Disease (SCD)?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

What is known about this topic:

  1. Pulmonary venous hypertension (PVH) related primarily to left ventricular diastolic dysfunction accounts for at least 50% of cases of PH in SCD patients.

  2. PVH is an independent risk factor for mortality

  3. Etiology of diastolic dysfunction in this population is unknown as well as the contribution of relative systemic hypertension

  4. No specific therapies exist for this condition although traditional diastolic dysfunction CHF are at times eomployed. No standard of care exists.

Feasibility and challenges of addressing this CQ or CC

Areas of Controversy:

  1. What role, if any, does iron chelation play in disease prevention?

  2. What role does treatment of systemic hypertension play in prevention and treatment?

  3. Is obstructive sleep apnea a risk factor for diastolic dysfunction in this population?

  4. Is there increased risk of VTE in this population?

  5. Are SCD specific therapies (hydroxyurea, transfusions) beneficial in improving outcomes?

  6. What is the best means of diagnosing PVH of SCD? Are there ways non-invasively to predict PAH vs PVH in this population?

  7. Is cardiac MRI superior to echocardiography in evaluating diastolic function in this patient population?

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Clinical Trials in Pediatric Sleep Disorders

Effect of anti-inflammatory medications (including nasal steroids and leukotriene antagonists) in children with obstructive sleep apnea syndrome, stratified for severity of OSAS as well as presence of atopy.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Small studies suggest a therapeutic effect of anti-inflammatory medication in childhood OSAS. This may be especially useful in children with residual OSAS following adenotonsillectomy (as CPAP adherence tends to be low) or children who are poor candidates for surgery. Current studies have been limited to children with extremely mild OSAS, have not determined whether atopy plays a role in the response to therapy, and have been limited to very short-term trials.

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Clinical Trials in Pediatric Sleep Disorders

Long-term risk of recurrence of obstructive sleep apnea in children successfully treated with surgery during childhood.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Very small, incomplete, retrospective studies, and some new emerging data from Hong Kong, suggest that a significant number of children with obstructive sleep apnea syndrome will develop progressive symptoms later in life, or will develop recurrence of OSAS after adenotonsillectomy. Further studies are needed to determine the long-term risk of recurrence. Results of this trial will influence clinical management in regards to ongoing surveillance and secondary prevention techniques.

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