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Protocol - Disease Progression and Regression - 0-24 Months

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Description

The Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) and the Newcastle Mitochondrial Disease Adult Scale (NMDAS) can be used to evaluate the progression of mitochondrial disease. There are three versions of the NPMDS, each for a specific age range (0-24 months, 2-11 years, and 12-18 years). The NMDAS is for adult patients over 16 years.

The scales allow for standardization of patient assessment and to improve accurate data collection. The scales are composed of multiple domains: Current Function, System Specific Involvement, Current Clinical Assessment and Quality of Life. Almost all questions provide a score which ranges from 0 to 3, with the following representations: 0 is normal, 1 is mild, 2 is moderate, and 3 is severe. Examples of severity for each question are provided. Depending upon the domain, the questions are either self- or interviewer-administrated, based on a provider’s clinical assessment or medical records. There is a manual for each scale, which details the administration, process, and scoring instructions.

Specific Instructions

In order to maximize consistency, the authors of the scale state it is essential that clinicians adhere to the scale instructions. They also advise that the scales be administrated by clinicians with experience in the care of patients with mitochondrial disease and also that the scale be given every 6 months for children under 2 years of age and at 6- to 12-month intervals for older children and adults.

Availability

Available

Protocol

The Newcastle Paediatric Mitochondrial Disease Scale (NPMDS)

0 - 24 months

Date of assessment:

Age at assessment:

Parental consanguinity:

Age at presentation:

Age at clinical diagnosis:

Clinical diagnosis:

Genotype if known:

Biochemical phenotype if known:

Basis of clinical diagnosis e.g. MRI, blood / CSF lactate

Information regarding pregnancy

• reduced fetal movements _____Y___ N___ unknown_____

• cardiomyopathy on antenatal scans ___ Y___ N___ unknown________

• abnormalities on fetal anomaly scan ___ Y___ N___unknown________ Please specify_______________________________________________

• other:

Neonatal information:

• gestational age _______weeks

• delivery method (NVD vs instrumental vs C/S) _______

• birth weight _______kg

• resuscitation and ventilation ___ Y___ N___unknown__ _______

Please specify_______________________________________________

Scores: Sections I-III:

Section IV:

Section I: Current Function

Rate function during the preceding 2 week period only according to caregiver

interview. Indicate the score that best fits patient’s functional status independently of the nature of the signs.

1. Vision

  1. Normal. No parental concerns
  2. Mild. Limited eye or head movement to large objects or parental face in visual field
  3. Moderate. No response to large objects or parental face in the visual field
  4. Severe. No response to light

2. Hearing

  1. Normal
  2. Mild. Body, head or eye movement only to loud noise
  3. Moderate. No reaction to loud noise
  4. Severe. No hearing (even with aid)

3. Communication (assessed with appropriate regard for age)

  1. Normal. Age appropriate communication
  2. Mild. Delayed development of communication
  3. Moderate. Communication unintelligible to parents or completely reliant on non-verbal communication
  4. Severe. Not communicating effectively in any form

4. Feeding

  1. Normal
  2. Mild. Difficulties in sucking / coughing / anorexia / wheezy with feeds or occasional choking
  3. Moderate. Supplementary enteral feeding or recurrent aspiration pneumonia
  4. Severe. Exclusive enteral feeding (gastrostomy / NG tube). Nil by mouth

5. Mobility

  1. Normal. No concerns. Age appropriate mobility
  2. Mild. Clumsy age appropriate mode of mobility
  3. Moderate. Mobile but through age inappropriate mode
  4. Severe. Immobile

Section II: System Specific Involvement

Rate system specific involvement during the preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. Scores should be assigned according to caregiver interview, clinician’s knowledge of the patient and clinical notes.

1. Seizures

  1. None
  2. Mild. Myoclonic or absence seizures only or < 1 generalised tonic-clonic seizure/month
  3. Moderate. > 5 generalized tonic-clonic seizures/month or > 20 absence or myoclonic seizures/month
  4. Severe. Status epilepticus or intractable seizures

2. Encephalopathy

  1. None
  2. Mild. Abnormal sleepiness / lethargy. Waking only for feeds
  3. Moderate. Recurrent episodes of mild encephalopathy (> 2/year)
  4. Severe. Life threatening encephalopathy - requires artificial ventilation

3. Gastrointestinal

  1. Normal.
  2. Mild. Constipation or unexplained vomiting / diarrhoea > 3/week
  3. Moderate. Severe constipation (no relief with laxative treatment) or unexplained vomiting / diarrhoea every day or surgical intervention for dysmotility
  4. Severe Malabsorption / Failure to thrive

4. Endocrine

  1. Normal.
  2. Mild. Biochemical evidence of impaired function
  3. Moderate. Endocrine failure requiring replacement therapy
  4. Severe. Endocrine decompensation (e.g. diabetic ketoacidosis, Addisonian crisis)

5. Respiratory

  1. Normal
  2. Mild. Abnormal respiratory pattern not requiring therapy / hospitalization
  3. Moderate. Abnormal respiration requiring oxygen flow or hospitalisation but not ventilation
  4. Severe. Abnormal respiration requiring artificial ventilation

6. Cardiovascular- over preceding 12 months

  1. Normal
  2. Mild. Asymptomatic ECG change
  3. Moderate. Abnormal echocardiogram (e.g. cardiomegaly) or sustained / symptomatic arrhythmia on ECG
  4. Severe. Decompensated cardiomyopathy or requiring pacing device / defibrillator / ablation

7. Renal

  1. Normal
  2. Mild. Impaired function but no change in diet or therapy required
  3. Moderate. Impaired function requiring restricted protein diet
  4. Severe. Failure requiring transplant / dialysis

8. Liver

  1. Normal
  2. Mild. Mildly impaired Liver Function Tests (LFTs). Normal albumin and coagulation. No symptoms of hepatic failure
  3. Moderate. Impaired LFTs with symptoms (e.g. jaundice, coagulation anomalies, oedema)
  4. Severe. Failure requiring hospitalisation and / or transplantation

9. Blood

  1. Normal
  2. Mild. Anaemia only
  3. Moderate. Asymptomatic pancytopenia
  4. Severe. Pancytopenia requiring regular transfusion / transplantation

Section III: Current Clinical Assessment

Rate current status according to the clinician’s examination at the time of assessment unless otherwise stated in the question.

1. Growth (weight) over preceding 6 months

  1. Normal. Following normal growth trajectory
  2. Mild. Weight less than second centile but growing parallel to it
  3. Moderate. Weight crossing one centile
  4. Severe. Weight crossing ≥ 2 centiles or less than 2nd centile with divergent trajectory

2. Development over preceding 4 months Score: ____

3. Vision

  1. Normal. Normal fixation and tracking
  2. Mild. Impaired fixation and / or tracking of small objects
  3. Moderate. Impaired fixation and / or tracking of familiar faces
  4. Severe. No response to light or registered blind

4. Ptosis and Eye Movement

  1. Normal
  2. Mild. Gaze evoked nystagmus or unilateral ptosis or impaired eye movement at extremities
  3. Moderate. Intermittent nystagmus at rest or bilateral ptosis not obscuring pupils or restriction of >50% eye movement
  4. Severe. Continuous nystagmus at rest or bilateral ptosis obscuring pupils or only a flicker of eye movement

5. Myopathy

  1. Normal
  2. Mild. Mild symmetrical weakness of hip and / or shoulder girdle only
  3. Moderate. Moderate symmetrical weakness (proximal > distal) limiting functional movement
  4. Severe. Wheelchair / carrier dependent or respiratory compromise due to myopathy.

6. Pyramidal

  1. Normal
  2. Mild. Unilateral pyramidal signs but retaining functional movement
  3. Moderate. Dense hemiplegia with little movement of affected side
  4. Severe. Bilateral pyramidal weakness with little or no movement

7. Extrapyramidal

  1. Normal.
  2. Mild. Unilateral extrapyramidal posturing and increased tone
  3. Moderate. Bilateral extrapyramidal posturing and increased tone
  4. Severe. Severe extrapyramidal posturing resulting in very little movement

8. Neuropathy

  1. Normal.
  2. Mild. Areflexia only
  3. Moderate. Sensory ataxia or motor impairment (distal weakness) but mobile
  4. Severe. Reliant on mobility aids primarily due to neuropathy

Section IV: Quality of Life

This survey asks for your views about your child’s recent health. Please answer every question by marking an ‘x’ in the box next to the phrase which best describes your answer.

1) During the past 4 weeks, how would you rate your child’s overall health?

[ ] Very poor

[ ] Poor

[ ] Fair

[ ] Good

[ ] Very good

2) During the past 4 weeks, how much did your child’s physical health problems limit their physical activities (such as moving or playing)?

[ ] Very much

[ ] Quite a lot

[ ] Somewhat

[ ] A little

[ ] Not at all

3) During the past 4 weeks, how much energy did your child have?

[ ] None

[ ] A little

[ ] Some

[ ] Quite a lot

[ ] Very much

4) During the past 4 weeks, how much bodily pain / discomfort did your child have?

[ ] Very much

[ ] Quite a lot

[ ] Some

[ ] A little

[ ] None

5) During the past 4 weeks, how would you rate your child’s behaviour compared with other children his / her age?

[ ] Very poor

[ ] Poor

[ ] Fair

[ ] Good

[ ] Very good

6) During the past 4 weeks, how would you rate your child’s ability to interact with other people (e.g. with you, siblings or other children his / her age) compared with other children his / her age?

[ ] Very poor

[ ] Poor

[ ] Fair

[ ] Good

[ ] Very good

7) During the past 4 weeks, how much were you (the parent / carer) bothered by emotional problems (e.g. feelings of anxiety, sadness) as a result of your child’s illness?

[ ] Very

[ ] Quite a lot

[ ] Somewhat

[ ] A little

[ ] Not at all

8) During the past 4 weeks, how much was your time limited as a result of your child’s illness?

[ ] Very

[ ] Quite a lot

[ ] Somewhat

[ ] A little

[ ] Not at all

9) During the past 4 weeks, how much were your family’s activities limited or interrupted as a result of your child’s illness?

[ ] Very

[ ] Quite a lot

[ ] Somewhat

[ ] A little

[ ] Not at all

10) During the past 6 months, what has been the financial cost of your child’s illness?

[ ] Very expensive

[ ] Quite expensive

[ ] Moderately expensive

[ ] Little additional cost

[ ] No additional cost

11) During the past 4 weeks, how would you rate your family’s ability to get along with one another?

[ ] Very poor

[ ] Poor

[ ] Fair

[ ] Good

[ ] Very good

12) During the past 4 weeks, how often did your child’s illness have a positive effect on your child, you or your family (e.g. being treated well due to illness, meeting new people)?

[ ] Never

[ ] Occasionally

[ ] Sometimes

[ ] Quite a lot

[ ] Most of the time

Personnel and Training Required

The Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) and the Newcastle Mitochondrial Disease Adult Scale (NMDAS) should be administered by clinicians, preferably with experience in caring for patients with mitochondrial disease or other rare genetic conditions.

Equipment Needs

None.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training Yes
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual Yes
Mode of Administration

Proxy-administered questionnaire

Lifestage

Infant, Toddler

Participants

Children ages 0-24 months

Selection Rationale

The Rare Genetic Conditions Working Group (WG) selected the Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) and the Newcastle Mitochondrial Disease Adult Scale (NMDAS) because mitochondrial disorders have a wide array of symptoms making this measure potentially extensible to other progressive disorders. In addition, rare genetic disorders can be associated with secondary mitochondrial dysfunction and overlapping symptoms. Although these scales were developed for mitochondrial diseases, the WG acknowledges data from these scales can be beneficial for other rare genetic conditions, such as inborn errors of metabolism, storage disorders, and nonmitochondrial myopathies.

Language

English

Standards
StandardNameIDSource
Human Phenotype Ontology Pace of progression HP:0003679 HPO
caDSR Form PhenX PX220701 - Disease Progression And Regression 0-24 Months 6201956 caDSR Form
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

Newcastle Paediatric Mitochondrial Disease Scale (NPMDS), 0-24 months

Source

Newcastle University. Newcastle Paediatric Mitochondrial Disease Scale (NPMDS)

0-24 months.

Available at bsu.ncl.ac.uk/pdfs/0-2_paed.pdf.

General References

Enns, G. M., Moore, T., Le, A., Atkuri, K., Shah, M. K., Cusmano-Ozog, K., Niemi, A. K., & Cowan, T. M. (2014). Degree of glutathione deficiency and redox imbalance depend on subtype of mitochondrial disease and clinical status. PLoS One, 9(6), e100001. doi:10.1371/journal.pone.0100001

Phoenix, C., Schaefer, A. M., Elson, J. L., Morava, E., Bugiani, M., Uziel, G., Smeitink, J. A., Turnbull, D. M., & McFarland, R. (2006). A scale to monitor progression and treatment of mitochondrial disease in children. Neuromuscular disorders: NMD, 16(12), 814-820.

Protocol ID

220701

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX220701_Disease_ProgressionRegression_024Mo_Abnormalities_FetalScan
PX220701110000 abnormalities on fetal anomaly scan N/A
PX220701_Disease_ProgressionRegression_024Mo_Abnormalities_Specify
PX220701120000 Please specify N/A
PX220701_Disease_ProgressionRegression_024Mo_Age
PX220701020000 Age at assessment: N/A
PX220701_Disease_ProgressionRegression_024Mo_Basis_Diagnosis
PX220701080000 Basis of clinical diagnosis e.g. MRI, blood more
/ CSF lactate show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_Biochemical_Phenotype
PX220701070000 Biochemical phenotype if known: N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Development
PX220701360000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Development over preceding 4 months __ Score show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Extrapyramidal
PX220701410000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Extrapyramidal show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_GrowthWeight
PX220701350000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Growth (weight) over preceding 6 months show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Myopathy
PX220701390000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Myopathy show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Neuropathy
PX220701420000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Neuropathy show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_PtosisEyeMovement
PX220701380000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Ptosis and Eye Movement show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Pyramidal
PX220701400000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. - Pyramidal show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentClinical_Vision
PX220701370000 Rate current status according to the more
clinician's examination at the time of assessment unless otherwise stated in the question. -Vision show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentFunction_Communication
PX220701230000 Rate function during the preceding 2 week more
period only according to caregiver - communication (assessed with appropriate regard for age) show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentFunction_Feeding
PX220701240000 Rate function during the preceding 2 week more
period only according to caregiver - Feeding show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentFunction_Hearing
PX220701220000 Rate function during the preceding 2 week more
period only according to caregiver - Hearing show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentFunction_Mobility
PX220701250000 Rate function during the preceding 2 week more
period only according to caregiver - Mobility show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_CurrentFunction_Vision
PX220701210000 Rate function during the preceding 2 week more
period only according to caregiver - Vision show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_Date
PX220701010000 Date of assessment: N/A
PX220701_Disease_ProgressionRegression_024Mo_Genotype
PX220701060000 Genotype if known: N/A
PX220701_Disease_ProgressionRegression_024Mo_Neonatal_BirthWeight
PX220701160000 birth weight in kg N/A
PX220701_Disease_ProgressionRegression_024Mo_Neonatal_DeliveryMethod
PX220701150000 delivery method (NVD vs instrumental vs C/S) N/A
PX220701_Disease_ProgressionRegression_024Mo_Neonatal_GestationalAge
PX220701140000 gestational age ____weeks N/A
PX220701_Disease_ProgressionRegression_024Mo_Neonatal_ResuscitationVentilation
PX220701170000 Resuscitation and ventilation N/A
PX220701_Disease_ProgressionRegression_024Mo_Neonatal_Specify
PX220701180000 Specify N/A
PX220701_Disease_ProgressionRegression_024Mo_ParentalAge_AgeDx
PX220701050000 Age at clinical diagnosis: N/A
PX220701_Disease_ProgressionRegression_024Mo_Parental_AgePresentation
PX220701040000 Age at presentation: N/A
PX220701_Disease_ProgressionRegression_024Mo_Parental_Consanguinity
PX220701030000 Parental consanguinity: N/A
PX220701_Disease_ProgressionRegression_024Mo_Pregnancy_Cardiomyopathy_Antenatal
PX220701100000 cardiomyopathy on antenatal scans N/A
PX220701_Disease_ProgressionRegression_024Mo_Pregnancy_Cardiomyopathy_PregnancyOther
PX220701130000 Other N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_ActivitiesLimited
PX220701510000 During the past 4 weeks, how much were your more
family's activities limited or interrupted as a result of your child's illness? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_Behavior
PX220701470000 During the past 4 weeks, how would you rate more
your child's behaviour compared with other children his / her age? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_EmotionalProblems
PX220701490000 During the past 4 weeks, how much were you more
(the parent / carer) bothered by emotional problems (e.g. feelings of anxiety, sadness) as a result of your child's illness? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_Energy
PX220701450000 During the past 4 weeks, how much energy did more
your child have? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_FinancialCost
PX220701520000 During the past 6 months, what has been the more
financial cost of your child's illness? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_GetAlong
PX220701530000 During the past 4 weeks, how would you rate more
your family's ability to get along with one another? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_Interactions
PX220701480000 During the past 4 weeks, how would you rate more
your child's ability to interact with other people (e.g. with you, siblings or other children his / her age) compared with other children his / her age? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_OverallHealth
PX220701430000 During the past 4 weeks, how would you rate more
your child's overall health? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_Pain
PX220701460000 During the past 4 weeks, how much bodily more
pain / discomfort did your child have? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_PhsyicalActivities
PX220701440000 During the past 4 weeks, how much did your more
child's physical health problems limit their physical activities (such as moving or playing)? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_PositiveEffects
PX220701540000 During the past 4 weeks, how often did your more
child's illness have a positive effect on your child, you or your family (e.g. being treated well due to illness, meeting new people)? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_QOL_TimeLimited
PX220701500000 During the past 4 weeks, how much was your more
time limited as a result of your child's illness? show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_Reduced_FetalMovement
PX220701090000 reduced fetal movements N/A
PX220701_Disease_ProgressionRegression_024Mo_Score_SectionIV
PX220701200000 Score Section IV: N/A
PX220701_Disease_ProgressionRegression_024Mo_Score_SectionsI_III
PX220701190000 Score Sections I-III N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Blood
PX220701340000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - blood show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Cardiovascular
PX220701310000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - cardiovascular show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Encephalopathy
PX220701270000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Encephalopathy show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Endocrine
PX220701290000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Endocrine show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Gastrointestinal
PX220701280000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Gastrointestinal show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Liver
PX220701330000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Liver show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Renal
PX220701320000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Renal show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Respiratory
PX220701300000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - respiratory show less
N/A
PX220701_Disease_ProgressionRegression_024Mo_SystemInvolvement_Seizures
PX220701260000 Rate system specific involvement during the more
preceding 6 month period only (or since birth if the child is less than 6 months old) unless otherwise stated in the question. - Seisures show less
N/A
Rare Genetic Conditions
Measure Name

Disease Progression and Regression

Release Date

April 30, 2015

Definition

This measure determines the impact of disease on an individual over time.

Purpose

This measure is used to assess the presence and degree of symptoms over time. Rare genetic diseases, such as mitochondrial disorders and mucopolysaccharidosis (MPS), can be associated with symptoms that become more severe over time and may result in a regression of some physical abilities. This measure can be used to quantify such changes to determine the natural course of disease(s) as well as contribute to longitudinal or therapeutic intervention studies.

Keywords

Newcastle Paediatric Mitochondrial Disease Scale, NPMDS, Newcastle Mitochondrial Disease Adult Scale, NMDAS, mitochondria, Developmental Delay, Intellectual Delay, disease, disease scale, progression, regression

Measure Protocols
Protocol ID Protocol Name
220701 Disease Progression and Regression - 0-24 Months
220702 Disease Progression and Regression - 2-11 Years
220703 Disease Progression and Regression - 12-18 Years
220704 Disease Progression and Regression - Adult
Publications

There are no publications listed for this protocol.