Assessment of Iodine Deficiency Disorders and Monitoring their Elimination :

A guide for programme managers, Second Edition. ICCIDD/UNCF/ WHO, 2001

 

 
 

 

 

 

 

 


Introduction

 

About this manual

The importance of iodine deficiency disorders (IDD)

 

Iodine deficiency, through its effects on the developing brain, has condemned millions of people to a life of  few  prospectus  and continued   underdevelopment.   On  a  worldwide  basis,   iodine deficiency  is  the single most important  preventable  cause  of brain damage.

 

People  living  in  areas  affected by severe  IDD  may  have  an intelligence quotient (IQ) of up to about 13.5 points below  that of  those from comparable communities in areas where there is  no iodine  deficiency (1).  This mental deficiency has an  immediate effect on child learning capacity, women's health, the quality of life of communities, and economic productivity.

 

On the other hand, IDD are among the easiest and cheapest of  all disorders  to prevent.  The addition of a small, constant  amount of  iodine to the salt that people consume every day is all  that

is  needed.   The elimination of IDD is  a  critical  development issue,  and should be given the highest priority  by  governments and international agencies.

 

Recognizing  the importance of preventing IDD, the  World  Health Assembly   adopted  in  1991  the  goal  of  eliminating   iodine deficiency as a public health problem by the year 2000.  In 1990, the  world's leaders had endorsed this goal when they met at  the World  Summit  for  Children  at  the  United  Nations.   It  was reaffirmed by the International Conference on Nutrition in  1992. In  1993,  WHO and UNICEF recommended universal  salt  iodization (USI) as the main strategy to achieve elimination of IDD.

 

Since 1990, there has been tremendous progress in increasing the amount  of salt which is adequately iodized.  As a  result,  many countries  are now on the threshold of acieving IDD  elimination.  In those countries, the emphasis will shift to ensuring that  the achievements are sustained for all time.

 

 

Objectives of this manual

Progress towards the elimination of IDD can only be  demonstrated if  it is measured.  This requires the selection  of  appropriate indicators of both process and impact (what is measured and why).

 

Techniques are then needed to measure these indicators (how  they are  measured).   These  techniques  have  to  be  applied  using suitable epidemiological methods (who, where, and when).

 

Finally, the results have to be presented in a digestible format, comparable with those from other regions or countries.

 

 

Specifically, the objectives of this manual are to describe:

 

*  the indicators used in assessing the baseline severity of IDD, and  in monitoring and evaluating salt iodization and its  impact on the target populations;

 

*  how to use and apply these indicators in practice;

 

*  how to assess whether iodine deficiency has been  successfully eliminated; and

 

*   how  to  judge  whether achievements  can  be  sustained  and maintained for the decades to come.

 

Target audiance

 

This book is aimed primarily at IDD programme managers and others in  government  who  are involved in the  implementation  of  IDD control programms.  It is also aimed at the salt industry and  all others involved in IDD elimination.

 

 

Origins of this book

This  is  a revised version of the original document,  which  was entitled  "indicators for assessing Iodine  Deficiency  Disorders and  their control through salt iodization" (2).   That  document was produced following a consultation held in Geneva in  November 1992.

 

Since the consultation, a considerable body of new information on the  identification,  prevention  and control  of  IDD  has  been generated, and the public health focus regarding this significant problem  has shifted to emphasize the importance of  the  process indicators.   To  continue the battle against IDD  into  the  new millennium,  these  new  concepts  have  been  incorporated  into

international  guidelines  for assessing  and  eliminating  these disorders.

 

The  Consultation on which this book is based was held in  Geneva from 4 to 6 May 1999.  It involved experts on IDD from all  three partner  organizations, WHO, UNICEF and ICCIDD, representing  all regions of the world (see Annex 7).

 

 

Definitions

Iodine  Deficiency Disorders refer to all of the  ill-effects  of iodine  deficiency  in  a population, that can  be  prevented  by ensuring  that the population has an adequate intake  of  iodine.  For further details, see section 2.

 

An  indicator is used to help describe a situation  that  exists, and  can  be used to track changes in the  situation  over  time.  Indicators  are  usually quantitative (i.e.  measurable  in  some way), but they may also be qualitative.

 

Monitoring  is  the  process of collecting, and  analysing  on  a regular  basis, information about a programme for the purpose  of identifying   problems,  such  as  non-compliance,   and   taking corrective action so as to fulfil stated objectives.

 

Evaluation   is   a  process  that  attempts  to   determine   as systematically   and  objectively  as  possible  the   relevance, effectiveness,  and  impact of activities in the light  of  their objectives (3).

 

 

Monitoring and evaluating IDD control programmes

Monitoring of any health intervention is essential, to check that it  is  functioning  as planned and to  provide  the  information needed  to  take  corrective action if  necessary.   In  additon, periodic  evalution of health programmes is necessary  to  ensure that overall goals and objectives are being met.

 

Salt  iodizatio programmes, like any other health  interventions, therefore   require  an  effective  system  for  monitoring   and evaluation.   The challenge is to apply the IDD indicators  using valid and reliable methods while keeping costs to a minimum.   To this  end, it is essential to formulate clearly the questions  to which  answers are needed, since the methods used to gather  data may be very different.  Important questions that will need to  be answered include:

 

*  Is all the salt that is being produced or imported iodized  to the country's requirements?

 

*  Is the salt adequately iodized?

 

*  Is adequately iodized salt reaching the target population?

 

*  What impact is salt iodization having on the iodine status  of the population?

 

*  Have IDD been eliminated as a public health problem?

 

In  some countries there is still inadequate information on  IDD, and programmes have not yet been implemented.  Here the questions may be:

 

*  Is there a significant IDD problem?

 

*  What is the prevalence of IDD in a given population?

 

*  Where does the salt come from that people buy?

 

Answering  these  questions  requires  different  approaches   to gathering data.  It is therefore very important to be quite clear about the purpose of a particular survey.

 

 

Indicators described in this manual

 

This  manual describes the various indicators which are  used  in monitoring and evaluating IDD control programmes.  The indicators are divided into three main groups:

 

*  Indicators to monitor and evaluate the salt iodization process (process indicators)

 

These  indicators involve salt iodine content at  the  production site,  point  of packaging, wholesale and retail levels,  and  in households.

 

*   Indicators to assess baseline IDD status and to  monitor  and evaluate  the impact of salt iodization on the target     population (impact indicators)

 

Once  a  salt  iodication  programme  has  been  initiated,   the prinicipal  impact indicator recommended involves urinary  iodine levels.   Changes  in  goitre prevalence lag  behing  changes  in iodine  status  and therefore cannot be relied  upon  to  reflect accurately current iodine intake, although they may be useful  in following trends.

 

Goitre assessment, by palpation or by ultrasound, shoulf remain a component  of surveys to establish the baseline severity of  IDD.  Neonatal thyroid stimulating hormone (TSH) levels may also play a role here if a country already has in place a screening programme for hypothyroidism.

 

*   Indicators  to  assess whether  iodine  deficiency  has  been successfully eliminated and to judge whether achievements can  be sustained and maintained for the decades to come  (sustainability indicators)

 

This  involves a combination of median urinary iodine  levels  in the target population, availability of adequately iodized salt at the  household level, and a set of programmatic indicators  which are regarded as evidence of sustainability.

 

 

IDD  and  their  control,  and  global  progress  in  their elimination

 

The Iodine Deficiency Disorders

 

Recommended iodine intake

 

WHO, UNICEF, and ICCIDD (4) recommended that the daily intake  of iodine should be as follows:

 

*  90 ug for preschool children (0 to 59 months);

 

*  120 ug for school children (6 to 12 years);

 

*  150 ug for adults (above 12 years); and

 

*  200 ug for pregnant and lactating women.

 

 

The Iodine Deficiency Disorders

Iodine   deficiency  occurs  when  iodine  intake   falls   below recommended  levels.  It is a natural ecological phenomenon  that occurs  in  many  parts of the world.  The erosion  of  soils  in riverine  areas  due  to loss of  vegetation  from  clearing  for agricultural  production,  overgrazing  by  livestock  and  tree-cutting  for firewood, results in a continued and increasing loss of  iodine from the soil. Groundwater and foods grown locally  in these areas lack iodine.

 

When  iodine intake falls below recommended levels,  the  thyroid may  no  longer  be  able to  synthesize  sufficient  amounts  of thyroid hormone.  The resulting low level of thyroid hormones  in the  blood (hypothyroidism) is the principal  factor  responsible for the damage done to the developing brain and the other harmful effects  known  collectively as the Iodine  Deficiency  Disorders (5).   The  adoption  of this term emphasized  that  the  problem  extended far beyond simply goitre and cretinism (see Table 1).

 

 

Table 1:  The spectrum of the Iodine Deficiency Disorders (IDD)

 

FETUS                  Abortions

                                Stillbirths

                                Congenital anomalies

                                Increased perinatal mortality

                                Increased infant mortality

                                Neurological cretinism:

                                mental deficiency, deaf mutism,

                                spastic Diplegia squint

                                Myxoedematous cretinism:

                                mental deficiency, dwarfism, hypothyroidism

                                Psychomotor defects

   

NEONATE            Neonatal hypothyroidism

 

CHILD &   Retarded mental and physical development

 

ADOLESCENT    

 

ADULT                  Goitre and its complications

                                Iodine-included hyperthyroidism (IIH)

 

ALL AGES           Goitre

                                Hypothyroidism

                                Impaired mental function

                                Increased susceptibility to nuclear radiation

 

The  most  critical  period  is  from  the  second  trimester  of pregnancy to the third year after birth (6,7).  Normal levels  of thyroid  hormones  are required for optimal  development  of  the brain.   In  areas of iodine deficiency,  where  thyroid  hormone levels are low, brain development is impaired.

 

In its most extreme form, this results in cretinism, but of  much greater  public health importance are the more subtle degrees  of brain  damage  and reduced cognitive capacity  which  affect  the entire population.  As a result, the mental ability of ostensibly normal  children and adults living in areas of iodine  deficiency is reduced compared to what it would otherwise be.

 

Thus,  the  potential of a whole community is reduced  by  iodine deficiency.    There  is  little  chance  of   achievement,   and underdevelopment  is perpetuated.  Indeed, everybody may seem  to

be  slow  and rather sleepy.  The quality of life  is  poor,  and ambition blunted.

 

The community becomes trapped in a self-perpetuating cycle.  Even the  domestic  animals, such as the village dogs,  are  affected.  Livestock productivity is also dramatically reduced (8).

 

 

Identification of the occurrence of IDD

In  the  past, the likely occurrence of IDD is  given  region  was regarded    as   being   signaled   by   certain    geographical characteristics.   These  include mountain  ranges  and  alluvial plains,  particularly  at  high  attitude  and  at   considerable distance  from the sea.  This occurrence is confirmed by  a  high prevalence of goitre in the resident population.

 

However, the greater availability of urinary iodine estimation and other  methods for assessing iodine deficiency  has  demonstrated that  IDD  can  and do occur in many areas where  none  of  these  conditions  are met.  Indeed, significant iodine  deficiency  has been found:

 

*   where  the prevalence of goitre, as based  on  palpation,  is normal;

 

*  in coastal areas;

 

*  in large cities;

 

*  in highly developed countries; and

 

*  where IDD have been considered to have been eliminated, either by prophylactic programmes or general dietary changes.

 

In  recognition  of  the  much  wider  occurrence  of  IDD   than previously  thought,  certain countries have come to  regard  the whole country as being at risk of iodine deficiency and therefore the entire population as a target of IDD control by iodized salt.  The  need  for  continued  vigilance is  underlined,  as  is  the importance of all countries carrying out periodic urinary  iodine

surveys.

 

 

Correction of iodine deficiency

An  iodine deficient environment requires the continued  addition of iodine, which is most conveniently and cheaply achieved by the addition  of iodine to the salt supply.  Most humans eat salt  in roughly the same amount each day.

 

A  decrease in salt intake can be readily met by  increasing  the iodine content.  Where a significant amount of processed food  is consumed, it is important that the salt used by the food industry is  preparing such food - as well as the salt used in the home  - is iodized.

 

Universal salt iodization, which ensures that all salt for  human and animal consumption is adequately iodized, has been remarkably successful   in   many  countries.   At  this   stage,   however, sustainability of this successful coorection of iodine deficiency becomes the challenge, as iodine deficiency may recur at any time (9).

 

In some regions, iodization of salt may not be a practical option for  the  sustainable elimination of IDD, at least in  the  short term.  This is particularly likely to be the case in remote areas where  communications are poor or where there are  numerous  very small-scale salt producers.

 

In such areas, other options for correction of IDD may have to be considered such as:

 

*  administration of iodized oil capsules every 6-18 months (10);

 

*   direct  administration of iodine solutions, such  as  Lugol's iodine, at regular intervals (once a month is sufficient); or

 

*   iodization  of water supplies by direct  addition  of  iodine solution or via a special delivery mechanism.

 

There  is much evidence that correction of iodine deficiency  has been followed by a "coming to life" of a community suffering from the  effects  on  the  brain  of  hypothyroidism  due  to  iodine deficiency.   Such  as increase in vitality  is  responsible  for improved  learning by school children, improved work  performance of   adults,  and  a  better  quality  of  life.   The   economic significance  of  the prevention of iodine  deficiency  disorders needs to be clearly understood (11).

 

Education  about these basic facts has to be repeated,  with  the inevitable  changes over time in Ministries of Health  and  among technocrats   and  salt  producers.   Otherwise,   a   successful programme will lapse, as has occurred in a number of countries.

 

 

Universal salt iodization

In nearly all countries where iodine deficiency occurs, it is now well  recognized  that  the most effective  way  to  achieve  the virtual  elimination of IDD is through universal salt  iodization (USI).

 

USI  involves  the iodization of all human  and  livestock  salt, including salt used in the food industry.  Adequate iodization of all  salt will deliver iodine in the required quantities  to  the population on a continuous and self-sustaining basis.

 

National  salt iodization programmes are now  applied  worldwide, and  have followed a common pattern of evolution, which  includes the following phases.

 

*   Decision phase:  the purposes of this phase are to  enable  a decision  on  universal  salt iodization  supported  by  industry mobilization, standards and regulation, and to prepare a plan for

implementation.

 

*   Implementation phase:  the phase ensures  infrastructure  for iodization  and  packaging of all human and livestock  salt,  and supports    that   infrastructure   with    quality    assurance, communications, regulation, and enforcement.

 

*  Consolidation phase:  once the goal of universal iodization is achieved,  it needs to be sustained through ongoing  process  and impact monitoring and periodic evaluation; the latter may include international multidisciplinary teams.

 

A  successful  salt iodization programme at  the  national  level depends upon the implementation of a set of activities by various sectors:

 

*   government  ministries  (legislation  and  justice,   health, industry, agriculture, education, communication, and finance);

 

*   salt  procedures,  salt  importers  and  distributions,  food manufacturers;

 

*   concerned civic groups; and

 

*  nutrition, food and medicial scientists, and other key opinion makers.

 

Opening the channels of communication and maintaining  commitment and  cooperation  across  these various  groups  is  perhpas  the greatest  challenge  to  reaching the IDD  elimination  goal  and sustaining it forever.

 

Salt producers and distributios are instrumental in ensuring that IDD   is  eliminated.   Protecting  consumers  requires  that   a framework   be  established  to  ensure  the   distributions   of adequately packaged, labelled, iodized salt.  The setting of this framework  is the main responsibility of the government.

 

Ensuring  a demand for the product and understanding  the  reason for  insisting upon only iodized salt is a shared  responsibility of  the private salt marketing system, the government, and  civic society.   The establishment and maintenance of such an  alliance and  all of the associated programme elements will determine  the success and sustainability of the programme.

 

A guideline has been developed as a useful tool to aid the review of all aspects of a comprehensive salt iodization programme (12).  This  guideline, however, will need to be modified  according  to the particular country situation.

 

 

Sustainability

The  remarkable  progress  of universal salt  iodization  in  the current  decade  poses  the  issue  of  sustainability.   Indeed, sustainability is absolutely critical.

 

IDD cannot be eradicated in one great global effort like smallpox and,  hopefully  poliomyelitis.  Smallpox and  poliomyelitis  are infectious  diseases with only one host - man.  Once  eliminated,

they cannot come back.

 

By  contrast, IDD is a nutritional deficiency that  is  primarily the  result of deficiency of iodine in soil and water.   IDD  can therefore  return at any time after their elimination if  control  programmes   fail.   Indeed,  there  is  evidence   that   iodine deficiency  is  returning  to some countries where  it  had  been eliminated in the past (13).

 

IDD  can  only  be  elimination  once  and  for  all  if  control programmes are constantly maintained. In other words, iodine must be provided permanently to populations living in iodine deficient environments or where no iodized food is imported.

 

Whether  countries  are  deemed IDD-free, close to  the  goal  of universal salt iodization, or still have some distance to go, the vital  message  is clear.  All efforts must  be  maintained,  and programmes must be sustained.  Where they are weak, they must  be strengthened.

 

Three   major   components  are  required  to   consolidate   the elimination of IDD and to sustain it permanently:

 

*  Political support

 

*  Administrative arrangements

 

*  Assessment and monitoring system

 

 

Political support

This  refers primarily to support at govrnmental  level,  through the  Minister  of Health and the executive  group  of  government (Cabinet  or equivalent).  Political support for the  elimination of  IDD depends on community awareness and understanding  of  the problem.

 

Without this community awareness, politicians are unlikely either to  be aware or willing to act.  Political support  is  essential for the passage of laws or regulations on salt iodization through the legislature.

 

 

Administrative arrangements

The  National  Body  responsible for the management  of  the  IDD control  programme should operate with a process model. A  useful example  of such a process model is known as the "wheel"  (Figure 1, following page).

 

This  model shows the social process involved in a  national  IDD control  programme.  The successful achievement of  this  process requires the establishment of a national IDD control  commission, with  full political and legislative authority to carry  it  out.  This model, which is described in detail on the opposite page, is being followed in a number of countries.

 

 

The social process involves six components, clockwise in the  hub of the wheel.

 

1.  Assessment of the situation requires baseline IDD  prevalence surveys,  including measurement of urinary iodine levels  and  an analysis of the salt situation.

 

2.   Dissemination  of findings implies communication  to  health professionals and the public, so that there is full understanding of the IDD problem and the potential benefits of elimination.

 

3.  Development of a plan of action includes the  establishment of  an intersectoral task force on IDD and the formulation  of  a strategy documet on achieving the elimination of IDD.

 

4.   Achieving  political will requires intensive  education  and lobbying of politicians and other opinion leaders.

 

5.   Implementation  needs  the  full  involvement  of  the  salt industry.  Special measures, such as negotiations for  monitoring and  quality control of imported iodized salt, will be  required.  It  will also be necessary to ensure that iodized  salt  delivery systems  reach all affected populations, including the  neediest.  In   addition,  the  establishment  of  cooperatives  for   small producers, or restructuring to larger units of production, may be needed.   Implementation will require training at all  levels  in management,    salt   technology,   laboratory    methods,    and communication.

 

6.   Monitoring and evaluation requires the establishment  of  an efficient  system for the collection of relevant scientific  data on salt iodine content and urinary iodine levels.

 

The  multidisciplinary  orientation  required  for  a  successful programme   poses   special   difficulties   in   implementation.  Experience indicates that particular problems often arise between

health professionals and the salt industry - with their different professional  orientations.  There is need for  mutual  education about  the health and development problems of IDD, and about  the problems  encountered  by  the salt  industry  in  the  continued production  of  high  quality  iodized  salt.   Such  team work  is required for sustainability to be achieved.

 

The  additional  cost of iodine fortification in the  process  of salt  production  (less than 5 US cents per person  per  year  in 1999) should eventually be borne by an educated community.   This will greatly assist sustainability.

 

 

Assessment and monitoring system

It  is  necessary to provide adequate dietary iodine  to  prevent brain damage in the fetus and in the young infant when the  brain is  growing  rapidly.   Whether or not a  national  programme  is providing  an adequate amount of iodine to the target  population is  reliably assessed by reference to measurements of salt  iodine (at the factor, retail, and household levels) and urinary  iodine (measured in casual samples from school children or  households).  Additional  contributive measurements are estimation  of  thyroid size and blood tests.

 

Measurements  of  salt  and urinary iodine  thereby  provide  the essential   elements   for  monitoring  whether  IDD   is   being successfully eliminated.  These measurements must be carried  out regularly, according to the procedures described in this manual.

 

Accordingly, appropriate measures can be taken, if necessary,  to ensure  the  normal  range  of  intake  of  iodine.   All   these procedures   require  internal and external  quality  control  in order to ensure reliability of the data collected.

 

 

In order to be effective, the surveillance system needs:

*   Laboratories,  for  measurement of salt  iodine  and  urinary iodine,  which are available at the country and  regional  levels with  some  support from international laboratories  for  quality control:   regional  reference  laboratories  are  important  for sample exchange to ensure external quality control; and

 

*   production  quality  assurance charts  and  database  at  the country   level,  for  recording  the  results  of  the   regular monitoring  procedures  - particularly for salt  iodine,  urinary iodine, thyroid size and, when available, neonatal TSH.

 

These  facilities must be backed up by the provision of  adequate resources.  Money, trained manpower, eqipment, and materials  are also  required to support the implementation of  salt  iodization and the establishment of monitoring systems.

 

Global progress in the elimination of IDD

In  1999, WHO estimated that of its 191 Member States, 130 had  a significant  IDD problem.  A total of approximately  740  million people  were  affected  by  goitre - 13%  of  the  world's  total

population (14).  Given that goitre represents the tip of the IDD iceberg  (5), it is likely that a much greater proportion of  the population suffers from IDD and, in particular, from some  degree of mental retardation.

 

While  the struggle to conquer IDD started in the early years  of the  twentieth  century, the last decades has seen  the  greatest progress.  That progress has been particularly rapid in Asia  and

Africa.

 

In  spite of the progress, however, the estimated number  of  the total  affected  population at the global level has  not  changed substantially  compared with the figure previously  published  in 1993  (15).   The  reason  lies in the  fact  that  in  1993  the magnitude of the problem had been underestimated because some  of the information was not yet available.

 

          Table 2:  Current magnitude of IDD by goitre

                      by WHO Region (1999)

 

WHO Region

Population

in millions*

Population affected by goiter in millions      

% of the Region

 

 

 

 

Africa

612

124

20%

The Americas

788

39

5%

South-East Asia

1477

172

12%

Europe Eastern

869

130

15%

Mediterranean

473

152

32%

Western Pacific

1639

124

8%

Total

5858

741

13%

 

Source: WHO Global IDD Database (to be published).*Based on UN Population Division estimates, 1997.

 

In 1999, WHO in collaboration with UNICEF and ICCIDD reviewed the IDD  global  situation (14).  Of the 130 countries with  IDD,  98 (75%)  now  have legislation on salt iodization in place,  and  a further 12 have it in draft form.

 

Following  the  promulgation  of  legislation  on  salt,  and  the sensitization  of the salt industry, there has been  an  enormous increase in the consumption of iodized salt.  The latest data for each of WHO's Regions are summarized in Table 3.

 

      Table 3:  Current status of salt iodization coverage

                      by WHO Region (1999)

 

WHO Region

Percentage of households

with access to iodized salt*

Africa

63%

The Americas

90%

South-East Asia

70%

Europe

27%

Eastern Mediterranean

66%

Western Pacific

76%

Overall

68%

 

Source:   adapted  from  WHO, UNICEF,  ICCIDD.  Progress  towards elimination of iodine deficiency disorders (14).

 

*Total population of each country multiplied by the percentage of households  with access to iodized salt.  Numbers  then  totalled for  each  Region  and divided by the total  population  of  that

Region.

 

This  report  (14) emphasizes the importance  of  monitoring  for ensuring  the  sustainability  of IDD  control  programmes.   The latest  data  from  the same report,  concerning  the  status  of monitoring programmes in the various WHO Regions, are  summarized in Table 4.

 

      Table 4:  Current status of monitoring activities and 

     laboratory facilities in IDD-affected countries (1999)

 

WHO Regions

Number of

IDD-affected

countries

Number of IDD-affected countries

 

Monitoring salt quality

Monitoring Iodine

status

With laboratory facilities

Africa

44

29

24

28

The Americas

19

19

19

19

South-East Asia

9

8

7

6

Europe Eastern

32

17

13

23

Mediterranean

17

14

10

11

Western Pacific

9

8

 

6

7

Total

130

95

79

84

Per cent

100%

73%

 

61%

65%

 

 

*These  figures  reflect  countries with the  capacity  for  both urinary  iodine and/or salt iodine level analyses.   Standard  of laboratories  and expertise for each of these, however,  is  very different.

 

 

Challenges for the future: consolidating the achievement

It  is clear that, despite the great success in  many  countries, there remain challenges for the future.

 

*   Continued  and strong government commitment  and  motivation, with  appropriate  annual budgetary allocations to  maintain  the process, are essential to eliminate IDD.

 

*   The salt industrly should have the mandate and the access  to resources  to ensure effective iodization.  Producer  compliance, quality assurance, logistical problems, and bottlenecks needs  to

be addressed through effective advocacy and social communications.

 

*  Monitoring systems should be in place to ensure specified salt iodine   content,  and  should  be  coordinated  with   effective regulation and enforcement.

 

*  Small-scale producers need to be included in this process,  to ensure  that their products are also brought up to  standard  and that  they deliver the right amount of iodine to the  population.  This  is often best achieved by the formation of cooperatives  or through working with a common distributor, thus reducing the need for many small iodization units.

 

*   In some countries, salt for animal consumption has  not  been included  in  the  iodization programme and  is  not  covered  by legislation.  Animal productivity is also enhanced by elimination of  IDD.   Ensuring this salt is iodized also  means  eliminating leakage   of  uniodized  salt  into  the  market  and   resultant consumption by the general population.

 

*   There  are still numerous places in the world  where  iodized salt is not available.  Identifying these areas and developing in them  a  market for iodized salt is critical  to  successful  IDD elimintion.   This process includes creating  consumer  awareness and demand.

 

Esuring  the required daily intake of iodine to  maintain  normal brain  function is an important as the provision of clean  water.  There is adequate knowledge and expertise to ensure the sustained elimination of IDD from the entire world.

 

Thus,  an ancient scourge of mankind can be eliminated  with  the application  of  existing  technology.  The  achievement  of  the sustained  elimination  of IDD will constitute one of  the  major public health triumphs of our time.                             

 

 

Indicators of the salt iodization process

 

Factors that determine salt iodine content

Iodization  may  take  place  inside  the  country  at  the  main production or packing sites, or outside the country by  importing salt  which  has already been iodized.  Salt is  iodized  by  the addition  of fixed amounts of potassium iodate, as either  a  dry solid or an aqueous solution, at the point of production.

 

Iodate is recommended in preference to iodine because it is  much more  stable  (16,  17).  The stability of iodine  in  salt   and levels  of  iodization  are questions of  crucial  importance  to national  health  authorities and salt producers,  as  they  have implications for programme effectiveness, safety, and cost.

 

The  actual  availability  of iodine from  iodized  salt  at  the consumer level can vary over a wide range as a result of:

 

*   variability  in  the  amount  of  iodine  added  during   the iodization process;

 

*   uneven  distribution  of iodine in the  iodized  salt  within batches and individual bags;

 

*   the  extent  of  loss  of  iodine  due  to  salt  impurities, packaging,  and  environmental conditions during  a  storage  and distribution; and

 

*  loss of iodine due to food processing, and washing and cooking processes in the household.

 

In  order  to  determine appropriate  levels  of  iodization,  an accurate  estimate is required of the losses of iodine  occurring between  the  tie  of iodization and  the  time  of  consumption. Control   of   moisture  content  in  iodized   salt   throughout manufacturig   and   distributions,   by   improved   processing, packaging, and storage, is critical to the stability of the added iodine.

 

A  recent laboratory study (18) examined the effects of  humidity and packaging materialson the stabiliyt of iodine in typical salt samples  from countries with tropical and  subtropical  climates.  The  study  showed  that  high  humiditym  coupled  with   porous packaging,  resulted in 30-80% loss of iodine within a period  of six months.

 

The  study  also determined that losses  could  be  significantly reduced  (in the range of 10-15%) by using packaging with a  good moisture  barrier, such as low-density polyethylene (LDPE)  bags. 

However, longer storage - beyond six months - aggravated losses.  Therefore,   it  is  recommended  that  the  time  required   for distribution,  sale and consumption of iodized salt be  minimized as far as possible, to ensure effective use of the added iodine.

 

Additional measures can be taken to retain the storage efficiency of low-density polyethylene films, in a system of high mechanical strength   and  resistance  to  puncture.    Woven   high-density polyethylene  (HDPE)  bags,  with a  continuous  film  insert  or laminate of low density polyethylene, should be considered as  an effective low-cost packaging method for iodized salt.

 

Recommendations

WHO/UNICEF/ICCIDD    recommended    (19)   that,    in    typical circumstances, where:

 

*   iodine  lost  from  salt  is  20%  from  production  site  to household,

 

*  another 20% is lost during cooking before consumption, and

 

*  average salt intake is 10 g per person per day,

 

Iodine concentration in salt at the point of production should be within the range of 20-40 mg of iodine per kg of salt (i.e. 20-40 ppm  of iodine) in order to provide 150 ug of iodine  per  person per  day.   The iodine should be added as potassium  (or  sodium) iodate.   Under these circumstances median urinary iodine  levels will vary from 100-200 ug/l.

 

However,  in some instances the quality of iodized salt is  poor, or the salt is incorrectly packaged, or the salt deteriorates due to   excessive   long-term  exposure  to  moisture,   heat,   and contaminants.    Iodine  losses  from  point  of  production   to consumption can then be well in excess of 50%.  In addition, salt consumption is sometimes much less than 10 g per person per  day. 

As  a  result,  actual iodine consumption  may  fall  well  below recommended levels.

 

Regular surveys of median iodine urinary levels should  therefore be  carried  out  in  a  representative  sample  of  the  at-risk population,   to  ensure  that  those  levels  are   within   the recommended   range  (100-200  ug/l).   If  not,  the  level   of iodization  of  salt, and factors affecting  the  utilization  of iodized salt, should be reassessed focusing on:

 

*  salt quality and the iodization process;

 

*  factors affecting iodine losses from salt, such as  packaging, transport, and storage; and

 

*  food habits in relation to salt intake and cooking practices.

 

National   authorities  should  establish  initial   levels   for iodization  in consultation with the salt industry,  taking  into account  expected  losses  and  local  salt  consumption.    Once iodization has commenced, regular surveys of salt iodine  content and  urinary iodine levels should be carried out to determine  if the programme is having the desired effect.

 

Discussions  and  regulations about iodine levels  in  salt  must clearly  specify  whether they refer to total content  of  iodine alone or to content of iodine compound (KIO3 or KI).

 

It  is  recommended  that the level be expressed  as  content  of iodine   alone.   This  approach  emphasizes  the   physiological important  component (iodine) and facilitates comparison  of  its different forms.

 

3.2  Determining salt iodine levels

 

The iodine content of salt can be determined quantitatively  with the titration method, and qualitatively using rapid test kits.

 

 

Titration method

The iodine content of salt can be determined by liberating iodine from salt and titrating the iodine with sodium thiosulphate using starch as an external indicator.  The method od liberating iodine

from  salt  differs  depending on whether salt  is  iodized  with iodate  or iodide.  Details of the method are given in  Annex  1.  Facilities for titration are usually available in a public health or  food  standards  laboratory.  Large-  and  medium-scale  salt producers should carry out titration on site.

 

Titration  is  preferred  for accurate testing  of  salt  batches produced  in factories orupon their arrival in a country, and  in cases  of doubt, contestation, etc.  This method  is  recommended for  determination  of  the concentration of iodine  in  salt  at various  levels  of the distribution system where  such  accurate testing  is  required.   Once the method is  established,  it  is necessary  to  adhere  to proper internal  and  external  quality control  measures.   However,  the  titration  method  is   time-consuming, and is not recommended for routine monitoring purposes througout the country.

 

Rapid test kits

These  are  small bottles of 10-50 ml, containing  a  stablilized starch-based  solution.  One drop of the solution placed on  salt containing  iodine (in the form of potassium iodate)  produces  a blue/purple coloration.  These kits should therefore be  regarded as qualitative rather than quantitative.

 

Coloration   indicates   that   iodine  is   present,   but   the concentration  cannot  be reliably determined.   In  cases  where there  is suspicion of alkalinity in the salt sample, a  drop  of the  `recheck solution' may be used and the test may  be  dropped over  the  drop of recheck solution to indicate the  presence  of iodine (see Annex 1 for further details).

 

An  advantage of rapid test kits is that they can be used in  the field to give an immediate result.  They are therefore useful  to health  inspectors  and others who are involved in  carrying  out spot checks on food quality or household surveys.

 

They  may  also play a valuable educational role,  in  that  they provide  a  visible  indication that salt  actually  is  iodized.  Accordingly,  they  can  be used for  demonstration  purposes  in schools and other institutions.  However, because rapid test kits do  not  give  a reliable estimate of iodine  content  (20,  21), results must be backed up by titration.

 

There  are a large number of test kits available on  the  market; moreover,  many  countries  are currently  producing  their  own.  UNICEF  also  supplies  countries with  test  kits.   However,  a comprehensive review to assess these kits is still needed.

 

Monitoring systems

External monitoring systems by governments

 

This  system  is  based upon the establishment  of  a  law  which mandates that all salt for human and - in most countries,  animal - consumption is iodized.  Details of implementation, inspection, and  enforcement are set out in the regulations.  Guidelines  for developing regulations are available (23), and a good example  of such  a law is the ASIN law in the Philippines (Annex 6).  It  is crucial  to  state  in the regulations the  amount  of  potassium iodate to be added at the point of production.

 

Other legal requirements should include packaging in polyethylene bags,  labelling  to identify the iodine level and the  name  and address  of the company packaging the salt.  The regulation  also needs  to designate a government agency or department which  will be  responsible for a system of licensing  producers,  importers, and distributors, and inspecting their facilities.

 

That  agency must also be responsible for  periodically  checking the  quality  assurance records that must be kept, and  for  spot checking the salt for iodate content.  Although monitoring at the production and household level is considered extremely important, retail outlets also need to be checked periodically to  determine what  is  happening  in the salt market and to  ensure  that  all sources  of  salt have been identified.  Several  monitoring  and inspection systems have emerged in different countries.

 

Often  this monitoring becomes a function of the Food  and  Drugs Bureau of the Health Ministry.  In other countries, the  Ministry of  Industry, or Mines, or Agriculture has  this  responsibility.  In  the  case of importation of salt, the  Customs  Authority  is often in charge of checking the specifications in the importation document, and in some circumstances taking samples to  check  the iodate level in the salt.

 

As indicated above, the salt testing kits that are used by  these government  agencies should not be used in enforcement,  as  they often give both false positive and false negative results and the colour  does  not always accord well with  titration.   Government inspection  systems  need  to  have access to  and  use  of  salt

titration in a standardized laboratory on a regular basis.

 

When   countries  first  began  to  introduce  salt   iodization, inspection  systems were used largely to guide   salt  iodization programme managers in identifying problems with salt  iodization, and  were  rarely used for enforcement  purposes.   As  countries increase the coverage to 50%, these systems should be  strengthen and  used  for enforcement against those producers  who  fail  to comply with the law.

 

It is often the less expensive uniodized salt in the market  that prevents  the realization of elimination of IDD. Indeed,  as  the coverage  of iodized salt increases, special efforts need  to  be made  to  identify  the  non-complaint  importer,  producer   and distributor and systematically eliminate that problem.

 

Salt  must be iodized indefinitely, or until it  is  demonstrated that  an adequate iodine intake is available from other  sources.  The  infrastructure, together with the annual  budget to  support the government inspecion system, must be permanently established.  In  order to guarantee this, it is essential that  inspection  of iodized  salt  be integrated into the  existing  food  inspection system in the country.

 

Internal monitoring systems by producers and distributors

For  each  type  of salt production, and for each  type  of  salt iodization system, there must be established a set of  guidelines for  best manufacturing processes.  It is the  responsibility  of the  producer  to  have  such a set of  guidelines  for  his  own facility, as each has its own unique characteristics.

 

The  Ministry  of  Industry, the Bureau of  Standards,  or  Codex Alimentarius  are useful reference sources for guiding  producers in  the process of iodization salt.  They can also esatblish  the ultimate standards expected in the production of iodized salt.

 

Adherence  to these manufacturing standards is perhaps  the  most important  issue  in  the elimination  of  IDD.   Therefore,  the producer  plays a pivotal role both in improving the accuracy  of the   iodization  process  and  in  reducing   the   considerable variations observed in iodine concentration in many countries.

 

Among  the areas of greatest concern (24) is the  very  important mixing or spraying step.  This area includes not only the  actual iodization  method chosen by a production or packaging  facility,

but  also the assurance that the producer closely adheres to  the amount of time for mixing.

 

Repid  test kits should be used frequently during shifts and,  in addition,  samples should be taken on a periodic basis  for  salt titration.   The  iodine concentration of each  batch  should  be checked at least once.

 

For  this  reason, it is recommended that  whenever  possible  at least  two  persons at a production plant should be  trained  and their  skills  standardized to determine  accurately  the  iodine concentration  using  the  tiration  method.   Furthermore,   key persons   at  each  production  site  should  be  aware  of   the detrimental conseqences of iodine deficiency and excess, as  well as the health benefits of correctly iodized salt.

 

Results  should  be recorded and plotted in a  quality  assurance chart.   When levels are not satisfactory,  immediate  corrective action  should be taken and that action entered into  the  record

book.

 

Because  production methods and factory sizes vary so widely,  it is beyond the scope of this manual to define this process in  any greater detail.  Whatever the method adopted, it should result in salt that has an iodate level that corresponds to that  indicated on  the label.  That level should, of course, correspond  to  the level allowed for under the law.

 

When  importers  and  distributors procure salt,  they  have  the responsibility  either to ensure that it meets specifications  as stipulated  in the requirements, or to ensure that these are  met before  salt  goes out to the wholesale or retail  market.   This implies  that  they should have a quality assurance  system  that includes salt iodine titration measurements.

 

If the salt they receive is not up to standard, they will need to have   their  own  iodization  facility.   All  salt  should   be distributed  in  polyethylene bags, with  appropriate  labels  as described above.

 

Monitoring at the household level

There are two basic methods for obtaining household-level data:

 

*  Cross-sectional surveys; and

 

*  Community-based monitoring.

 

Cross-sectional surveys

Cross-sectional  surveys are conducted infrequently (see  Chapter 5: Survey methods).  A household questionnaire concerning the use of iodized salt and qualitative testing of that salt using a salt testing  kit has been employed successfully to determine  overall coverage  of iodized salt and to identify geographic gaps in  the programme.

 

This questionnaire was included in the UNICEF Multiple  Indicator Household Cluster Survey (MIHCS) in 1996, and will be repeated in the  next  round.   Some countries have  successfully  added  the questionnaire   to  other  national  surveys,  e.g.,  to   either nutrition surveys or surveys that collect key economic and census data.   These surveys provide estimates of the proportion of  the population  using  adequately iodized salt, and  identify   areas where there is low use of iodized salt and/or where all the  salt is uniodized.

 

The  results  allow for visual representations of  variations  of coverage and provide a basis for targeting resources and focusing interventions in areas where they are most needed.  This type  of

monitoring  should  then  be  followed   by  specific  action  to identify  further  the  reason for low iodized  salt  usage,  and should  result  in  a range of actions to  correct  the  problem.  Survey  approaches  that  have  been  successfully  used  include Cluster  Sampling, Lot Quality Assurance Sampling,  and  sentinel sample sites (25).

 

Community-based monitoring

Ongoing  household-level monitoring is used more frequently  than periodic  surveys.   This  approach  may  be  organized  in   the community or through the schools, particularly in areas with high rates  of  school  enrolment.  Providing  salt  testing  kits  to environmental  health  officers,  community  midwives,  nutrition officers,  schoolteachers, mayors, and other  government  workers

responsible  for  community  health, has  been  helpful  in  this process.

 

These  approaches are very effective communication and  awareness creation  tools,  particularly when this awareness is  linked  to action.  This action could involve approaching the salt producers

or  distributors, and directly requesting them to supply  iodized salt.

 

Finally, the occurrence of parallel markets in uniodized salt has frequently been a barrier to achieving universal salt iodization.  National   cross-sectional   household  surveys   and   community monitoring have often been useful in identifying such salt and in developing strategies to address the problem.

 

Figure  2  illustrates  graphically  the  components  of  a   USI monitoring system.  General standards and specific practices  can be  checked  by inspections, tests, and records  to  assure  that

responsible  producers  comply with the  standards,  and  various actions can be taken according to the level of that compliance.

 

Figure  3  demonstrates a double loop which  can  be  effectively established   among   national  or  provincial   programmes   and community-level monitoring, through their respective actions  and the resultant feedback.  Programmes take actions, which result in feedback, which aids and reinforces their activities.  Similarly, monitoring   enables  actions,  providing  feedback  to   enhance monitoring.

 

Once  begun, the process is continuous and self-reinforcing.   By their  activities, IDD programmes enable certain  assessment  and corrective  actions.   These actions can result  in  the  desired effects,   which  will  in  turn  assist  programmes  in   better performing their respective tasks, and so on around the loops.

 

Indicators of impact

Overview

Assessment  of  thyroid size by palpation  is  the  time-honored method of assessing IDD prevalence.  However, because of the long response  time  after iodine supplementation is  introduced  this method  is  of  limited usefulness in  assessing  the  impact  of programmes  once  salt iodization has commenced.  In  this  case, urinary iodine is the most useful indicator because it is  highly sensitive to recent changes in iodine intake.

 

Since  most countries have now started to implement  IDD  control programmes, urinary iodine rather than thyroid size is emphasized in  this  manual as the principal indicator of  impact.   Thyroid size is more useful in the baseline assessment of the severity of IDD,  and  also  has a role in the assessment  of  the  long-term impact of control programmes.

 

The introduction of ultrasonography for the precise assessment of thyroid  size has been a significant development.  However,  this approach requires costly equipment and a source of electricity in the  field.   Moreover, there are as yet  no  generally  accepted standards for thyroid size in iodine-replete populations.

 

Two  other  indicators are included in this  discussion:  thyroid stimulating  hormone (TSH) and thyroglobulin (Tg).  While TSH  in neonates  are  particularly  sensitive   to  iodine   deficiency, difficulties in interpretation remain.  Furthermore, the cost  of implementing   a  screening  programme  is  too  high  for   most developing countries.  The value of thyroglobulin as an indicator of  IDD  status  has yet to be fully explored and  to  gain  wide acceptance.

 

Urinary Iodine

Biological features

Most iodine absorbed in the body eventually appears in the urine.  Therefore,  urinary  iodine excretion is a good  marker  of  very recent  dietary iodine intake. In individuals, urinary  excretion

can  vary somewhat from day to day and even within a  given  day.  However, this variation tends to even out among populations.

 

Studies  have convincingly demonstrated that a profile of  iodine concentrations in morning or other casual urine specimens  (child or  adult)  provides  an adequate assessment  of  a  population's

iodine  nutrition, provided a  sufficient number of specimens  is collected.  Twenty-four hour samples are difficult to obtain  and are not necessary.

 

Relating  urinary iodine to creatinine is cumbersome,  expensive, and  unnecessary.   Indeed, urinary iodine/ceatinine  ratios  are unreliable,  particularly when protein intake - and  consequently

creatinine excretion - is low.

 

Feasibility

Acceptance  of this  indicator  is  very  high,  and  spot  urine specimens  are easy to obtain.  Urinary iodine assay methods  are not  difficult  to  learn  or use  (see  below),  but  meticulous attention  is required to avoid contamination with iodine at  all stages.  Special laboratory areas, glassware, and reagents should be set aside solely for this determination.

 

In  general,  only  small  amounts  (0.5-1.0 ml)   of  urine  are required, although the exact volume depends on the method.   Some urine  should also be kept in reserve.  Samples are collected  in tubes,  which should be tightly sealed with screw tops.  They  do not require refrigeration, addition of preservative, or immediate determination  in  most  methods.   They  can  be  kept  in   the laboratory  for months for more, preferably in a refrigerator  to avoid unpleasent odour.

 

Evaporation should be avoided, because this process artifactually increases  the concentration.  Samples may safely be  frozen  and refrozen,  but must be completely defrosted before  aliquots  are taken for analysis.

 

Many  analytical  techniques  exist, varying  from  very  precise measurement  with  highly  sophisticated  instruments,  to  semi-quantitative  `low  tech' methods that can be used  in  regional,

country  or local laboratories. Most methods depend  on  iodide's role  as  a catalyst in the reduction of ceric  ammonium  sulfate  (yellow  colour) to the cerous from (colourless) in the  presence of  arsenious acid (the Sandell-Kolthoff reaction).  A  digestion or  other purification step using ammonium persulfat  or  chloric acid  is necessary before carrying out this reaction, to rid  the urine of interfering contaminants.

 

A  brief  description of some of the methods introduced  in  this section is presented in the following pages.

 

*  Methods with ammonium persulfate (Method A)

 

Small  samples of urine (250-500 ml) are digested  with  ammonium persulfate at 90-110 C; arsenious acid and ceric ammonium sulfate are then added.  The decrease in yellow colour over a fixed  time period  is  then  measured by  a  spectrophotometer  and  plotted against a standard curve constructed with known amounts of iodine (26).    This   method   requires   a   heating   block   and   a spectrophotometer, which are both inexpensive instruments.  About 100-150  unknown samples can be run in a day by  one  experienced technician.   Several versions of this method exist:  details  of one of these are given in Annex 3.

 

*  Methods with chloric acid (Method B)

 

Chloric  acid can be substituted for ammonium persulfate  in  the digestion step, and the colorimetric determination carried out as for method A (27).  A disadvantage is the safety concern, because the  chemical  mixture  can  be  explosive  if  residues  dry  in ventilating sytems.  Handlings these chemicals in a fume cupboard and using a chloric acid trap when performing sample digestion is strongly recommended (see Annex 3).

 

*  Other methods

 

A modification of Method B uses the rebox indicator ferroin and a stopwatch instead of a spectrophotometer to measure colour change (28).  Urine is digested with chloric acid and colour changes  in batches of samples measured relative to standards of known iodine content.   This  places  samples in categories  (e.g.,  below  50 ug/litre,  100-200  ug/l, etc.) that can be adjusted  to  desired levels.   This  method  is currently being  adapted  to  ammonium persulfate digestion.

 

Another semi-quantitative method is based on the iodide-catalyzed oxidation   of   3,3`,5,5`-tetramethylbenzidine   by    peracetic acid/H202  to  yield coloured products that are recognized  on  a colour  strip indicating three ranges: <100 ug/l,  100-300  ug/l, and  >300 ug/l (22).  Interfering substances are removed by  pre-packaged  columns with activated charcoal.  Analyses must be  run

within  two hours, and the procedure requires the  manufacturer's pre-packed columns.

 

*  Other methods (continued)

 

In  still  another  method, samples are  digested  with  ammonium persulfate  on microplates enclosed in specially designed  sealed cassettes and heated to 110 C (29).  Samples are then transferred to  another microplate and the ceric ammonium  sulfate  reduction reaction  carried  out and reach on a microplate  reader.   Field tests  are promising: up to 400 urine samples can be analysed  in one day, depending on manufacturers' supplies.

 

Choice of method

Criteria  for assessing urinary iodine methods  are  reliability, speed,   technical   demands,  complexity   of   instrumentation, independence  from sole-source suppliers, safety, and cost.   The

choice  among the above and other methods depends on local  needs and  resources.   Large  central  laboratories  processing   many samples may prefer `high-tech' methods, while smaller  operations

closer to the field may find the simplest methods more practical.

 

Due  to  the potential hazards of chloric acid,  Method  A  using ammonium persulfate is currently recommended.  It can  adequately replace the chloric acid method, since the main differnce is  the substitution  of  ammonium  persulfate for chloric  acid  in  the digestion step (see Annex 3).  Results are comparable.

 

The  other methods described above show promise but are  not  yet fully tested.

 

 

Quality control and reference laboratories

All  laboratories  should have clearly defined  internal  quality control  procedures  in  place, and should be  open  to  external audit.   In addition, all laboratories should participate  in  an external   quality  control  programme  in  conjunction  with   a recognized reference laboratory.

 

Active  efforts are now in progress, both to  define  performance criteria  for  laboratories  and to develop a  global  system  of reference   laboratories.   These  reference  laboratories   will provide reliable measurements of urinary iodine, and will conduct technical  training and supervision. This initiative is  a  major priority for ensuring sustainability of iodine sufficiency.

 

Performance

Most of the above methods perform reliably, although some of  the newer  ones  need  further testing as of this  date.   All  these methods routinely recognize urinary iodine concentrations in  the

range of 50-200 ug/l.

 

With  appropriate  dilutions,  they can  be  extended  upward  to examine whatever range is desired.  The coefficient of  variation is  generally  under  10% for all methods.   Proper  training  is necessary but not complicated.

 

Since  casual  specimens are used, it is desirable to  measure  a sufficient  number from a given population to allow  for  varying degrees  of  subject hydration and  other  biological  variations among  individuals,  as  well as to obtain  a  reasonably  narrow confidence  interval  (see  Annex  4).   In  general,  30   urine determinations from a defined sampling group are sufficient.

 

Interpretation

Simple modern methods make it feasible to process large number of samples at low cost and to characterize the distribution according to  different cut-off points and intervals.  The  cut-off  points

proposed for classifying iodine nutrition into different  degrees of public health significance are shown in Table 5.

 

Frequency   distribution   curves   are   necessary   for    full interpretation.   Urinary  iodine  values  from  populations  are usually  not normally distributed.  Therefore, the median  rather than the mean should be used as the measure of central  tendency.  Likewise,  percentiles rather than standard deviations should  be used as measures of spread.

 

Median urinary iodine concentrations of 100 ug/l and above define a population which has no iodine deficiency, i.e. at least 50% of the sample should be above 100 ug/l.  In addition, not more  than 20% of samples should be below 50 ug/l.

 

Alternatively, the first quintile (20th percentile) should be  at least 50 ug/l.  In adults, a urinary iodine concentration of  100 ug/l corresponds roughly to a daily iodine intake of about 150 ug under steady-state conditions.

 

Urinary  iodine  concentration is currently  the  most  practical biochemical  marker for iodine nutrition, when carried  out  with appropriate  technology  and sampling.   This  approach  assesses

iodine nutrition only at the time of measurement, whereas thyroid size reflects iodine nutrition over months or years.   Therefore, even  though populations may have attained iodine sufficiency  by median urinary iodine concentration, goitre may persist, even  in children.

 

With  rapid  global  progress in  correcting  iodine  deficiency, examples  of  iodine excess are  being  recognized,  particularly when  salt  iodization is excessive and  poorly  monitored  (21).  Tolerance  to  high doses of iodine is quite variable,  and  many individuals ingest amounts of several milligrams or more per  day without apparent problems.

 

The  major  epidemiological  consequences  of  iodine  excess  is iodine-included hyperthyroidism (IIH) (30, 31).  This occurs more commonly in older subjects with pre-existing nodular goitres, and

may occur even when iodine intake is within the normal range.

 

Iodine  intakes  above  300  ug/l per  day  should  generally  be discouraged,  particularly in areas where iodine  deficiency  has previously existed.  In these situations, more individuals may be vulnerable  to  adverse health  consequences,  including  iodine-included hyperthyroidism and autoimmune thyroid diseases.

 

In  populations characterized by longstanding  iodine  deficiency and rapid increment in iodine intake, median value(s) for urinary iodine above 200 ug/l are not recommended because of the risk  of iodine-included  hyperthyroidism.   This  adverse  condition  can occur  during  the 5 to 10 years following  the  introduction  of iodized salt (30, 31).  Beyond this period of time, median values up  to 300 ug/l have not demonstrated side-effects, at least  not in populations with adequately iodized salt.

 

Thyroid size

The traditional method for determining thyroid size is inspection and  palpation.   Ultrasonography  provides a  more  precise  and objective  method.  However, there is no agreement  on  reference values.

 

Both methods are described below.  Issues common to palpation and ultrasound are not repeated in the section on ultrasound.

 

Thyroid size by palpation

The  size of the thyroid gland changes inversely in  response  to alterations  in  iodine intake, with a lag interval  that  varies from  a few months to several years, depending on  many  factors.  These include the severity and duration of iodine deficiency, the type  and effectiveness of iodine supplementation, age, sex,  and possible additional goitrogenic factors.

 

The  term  "goitre" refers to a thyroid gland that  is  enlarged.  The  statement that "a thyroid gland each of whose lobes  have  a volume  greater than the terminal phalanges of the thumb  of  the person examined will be considered goitrous" is empirical but has been  used in most epidemiological studies of endemic goitre  and is still recommended (see Table 6).

 

Feasibility

Palpation  of  the thyroid is particularly  useful  in  assessing goitre  prevalence,  but  much less so  in  determining  impactl.  Costs are associated with mounting a survey, which is  relatively easy  to  conduct, and training of personnel.  These  costs  will vary  depending  upon the availability of health  care  personnel accessibility of the populations, and samples size.   Feasibility and performance vary according to target groups, as follows:

 

Neonates:  It is neither feasible nor practical to assess  goitre among neonates, whether by palpation or ultrasound.   Performance is poor.

 

School-aged children (6-12 years):  This is the preferred  group, as  it  is  usually  easily  accessible.   However,  the  highest prevalence of goitre occurs during puberty and childbearing  age.  Some studies have focused on 8-10 years.

 

There  is  a practical reason for not measuring  very  young  age groups.  The smaller the child, the smaller the thyroid, and  the more difficult it is to perform palpation.

 

If the proportion of children attending school is less than  50%, school children may not be representative.  In these cases,  spot surveys  should  be conducted among those who attend  school  and those  who  do  not, to ascertain if  there  is  any  significant difference between the two.

 

Alternatively,  children  can  be surveyed  in  households.   For further discussion, see Chapter 5 on Survey Methods.

 

Adults:  Pregnant and lactating women are of particular  concern.  Pregnant  women  are  a  prime  target  group  for  IDD   control activities  because  they are especially  sensitive  to  marginal iodine  deficiency.  Often they are relatively  accessible  given their participation in antenatal clinics.  Women of  childbearing age - 15-44 years - may be surveyed in households.

 

Technique

The  subject to be examined stands in front of the examiner,  who looks  carefully  at  the neck for any sign  of  visible  thyroid enlargement.  The subject is then asked to look up and thereby to fully extent the neck.  Thus pushes the thyroid forward and makes any enlargement more obvious.

 

Finally,  the  examiner palpates the thyroid  by  gently  sliding his/her  own  thumb  along the side of  the  trachea  (wind-pipe) between  the cricoid cartilage and the top of the sternum.   Both sides  of the trachea are checked.  The size and  consistency  of the thyroid gland are carefully noted.

 

If  necessary, the subject is asked to swallow (e.g. some  water) when  being examined - the thyroid moves up on  swallowing.   The size  of each lobe of the thyroid is compared to the size of  the tip  (terminal  phalanx)  of  the  thumb  of  the  subject  being examined.   Goitre  is  graded according  to  the  classification presented in Table 6.

 

 

Table 6:  Simplified classification of goitre* by palpation

 

     Goitre 0  No palpable or visible goitre

 

     Goitre 1  A goitre that is palpable but not visible when the

               neck is in the normal position, (i.e., the thyroid

               is  not visibly enlarged).  Thyroid nodules  in  a

               thyroid which  is otherwise not enlarged fall into

               this category.

 

     Goitre 2  A swelling  in the neck  that is  clearly  visible

               when  the  neck is in a  normal  position  and  is

               consistent with  an enlarged thyroid when the neck

               is palpated.

 

*  A thyroid gland will be considered goitrous when each  lateral lobe has a volume greater than the terminal phalanx of the thumbs of the subject being examined.

 

The specificity and sensitivity of palpation are low in grades  0 and 1 due to a high inter-observer variation.  As demonstrated by studies of experienced examiners, misclassification can be high.

 

 

Interpretation

 

Table  7 gives the epidemiological criteria for establishing  IDD severity, based on goitre prevalence in school-age children.  The terms  mild,  moderate,  and severe are relative  and  should  be interpreted in context with information from other indicators.

 

It  is recommended that a total goitre rate or TGR  (number  with goitres  of  grades  1 and 2 total examined) of  5%  or  more  in schoolchildren  6-12 years of age be used to signal the  presence of a public health problem.  This recommendation is based on  the observation  that  in  normal,  iodine-replete  populations,  the prevalence  of goitre should be quite low.  The cut-off point  of 5% allows both for some margin of error of goitre assessment, and for  goitre that may occur in iodine-replete populations  due  to other causes such as goitrogens and autoimmune thyroid diseases.

 

        Table 7.        Epidemiological criteria for assessing

the severity  of IDD based on the prevalence of goitre

                                in school-aged children

 

                                Degrees of IDD, expressed as percentage of

the total of the number of children surveyed

               

 

None

Mild

Moderate

Severe

Total goiter rate (TGR)    

0.0-4.9%

5.0-19.9%

20.0-29.9%

>-30% 

 

Finally in this connection, it is emphasized that thyroid size in the community may not return to normal for months  or years after correction of iodine deficiency.

 

 

Click to continue . . . .

 

TOP