Methodology and indicators for NBCAL monitoring in stores and health services: a multicenter study (Multi-NBCAL)

Boccolini, Cristiano Siqueira; Oliveira, Maria Inês Couto de; Toma, Tereza Setsuko; Peres, Patricia Lima Pereira; Santos, Evangelia Kotzias Atherino dos; Passos, Maria Cristina; Gubert, Muriel Bauermann; Sá, Naíza Nayla Bandeira de; Vianna, Rodrigo Pinheiro de Toledo; Gomes, Daniela Lopes; Silva, Talita Maria Alves Lopes da; Sally, Enilce de Oliveira Fonseca; Rea, Marina Ferreira

Cristiano Siqueira Boccolini

Instituto de Comunicação e Informação Científica e Tecnológica em Saúde, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.

http://orcid.org/0000-0002-4804-5641

Maria Inês Couto de Oliveira

Universidade Federal Fluminense, Niterói, Brasil.

http://orcid.org/0000-0003-0439-6295

Tereza Setsuko Toma

Instituto de Saúde, Secretaria de Estado de Saúde de São Paulo, São Paulo, Brasil.

http://orcid.org/0000-0001-9531-9951

Patricia Lima Pereira Peres

Faculdade de Enfermagem, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brasil.

http://orcid.org/0000-0001-7086-8970

Evangelia Kotzias Atherino dos Santos

Programa de Pós-graduação em Enfermagem, Universidade Federal de Santa Catarina, Brasil.

http://orcid.org/0000-0002-5970-020X

Maria Cristina Passos

Escola de Nutrição, Universidade Federal de Ouro Preto, Ouro Preto, Brasil.

http://orcid.org/0000-0002-8234-6827

Muriel Bauermann Gubert

Universidade de Brasília, Brasília, Brasil.

http://orcid.org/0000-0002-0103-4187

Naíza Nayla Bandeira de Sá

Instituto de Ciências da Saúde, Universidade Federal do Pará, Belém, Brasil.

http://orcid.org/0000-0002-1267-1624

Rodrigo Pinheiro de Toledo Vianna

Centro de Ciências da Saúde, Universidade Federal da Paraíba, João Pessoa, Brasil.

http://orcid.org/0000-0002-5358-1967

Daniela Lopes Gomes

Instituto de Ciências da Saúde, Universidade Federal do Pará, Belém, Brasil.

http://orcid.org/0000-0002-0092-3396

Talita Maria Alves Lopes da Silva

Centro de Ciências da Saúde, Universidade Federal da Paraíba, João Pessoa, Brasil.

http://orcid.org/0000-0003-2599-3144

Enilce de Oliveira Fonseca Sally

Universidade Federal Fluminense, Niterói, Brasil.

http://orcid.org/0000-0002-9506-3690

Marina Ferreira Rea

Instituto de Saúde, Secretaria de Estado de Saúde de São Paulo, São Paulo, Brasil.

http://orcid.org/0000-0003-1540-7973

Correspondence
C. S. Boccolini Laboratório de Informação em Saúde, Instituto de Comunicação e Informação Científica e Tecnológica em Saúde, Fundação Oswaldo Cruz. Rua Leopoldo Bulhões 1480, Rio de Janeiro, RJ 21040-900, Brasil. cristianoboccolini@gmail.com

Contributors

C. S. Boccolini coordinated the study, contributed to study concept and planning, data analysis and interpretation, bibliographic review, discussion of results, and manuscript writing. M. I. C. Oliveira, P. L. P. Peres and E. K. A. Santos contributed to study planning, data analysis and interpretation, bibliographic review, discussion of results, and manuscript writing. T. S. Toma contributed to fieldwork coordination, development of indicators, and manuscript revision. M. C. Passos and M. B. Gubert contributed to fieldwork coordination, data analysis and interpretation, bibliographic review, discussion of results, and manuscript writing. N. N. B. Sá, D. L. Gomes and T. M. A. L. Silva contributed to the construction of indicators and critical review of the manuscript. R. P. T. Vianna contributed to study planning, fieldwork coordination, data analysis and interpretation, bibliographic review, and manuscript writing. E. O. F. Sally contributed to study planning, data analysis and interpretation, bibliographic review, and manuscript writing. M. F. Rea contributed to bibliographic review and manuscript writing. All authors approved the final version for publication.

Additional informations

ORCID: Cristiano Siqueira Boccolini (0000-0002-4804-5641); Maria Inês Couto de Oliveira (0000-0003-0439-6295); Tereza Setsuko Toma (0000-0001-9531-9951); Patricia Lima Pereira Peres (0000-0001-7086-8970); Evangelia Kotzias Atherino dos Santos (0000-0002-5970-020X); Maria Cristina Passos (0000-0002-8234-6827); Muriel Bauermann Gubert (0000-0002-0103-4187); Naíza Nayla Bandeira de Sá (0000-0002-1267-1624); Rodrigo Pinheiro de Toledo Vianna (0000-0002-5358-1967); Daniela Lopes Gomes (0000-0002-0092-3396); Talita Maria Alves Lopes da Silva (0000-0003-2599-3144); Enilce de Oliveira Fonseca Sally (0000-0002-9506-3690); Marina Ferreira Rea (0000-0003-1540-7973).

VARIABLE	DESCRIPTION/CATEGORIES	REMARKS
(1) Product	Smallest unit of analysis for NBCAL monitoring. Each product is distinguished from the others by the following characteristics described on the labels: type, name and manufacturer.	The product can be displayed for sale in one or more places of the store and may present different NBCAL violations in those places. For instance, off-price and special display.
(2) Groups and types of products	Product grouping according to Law n. 11,265/2006¹¹11. Presidência da República. Lei nº 11.265, de 3 de janeiro de 2006. Regulamenta a comercialização de alimentos para lactentes e crianças de primeira infância e também a de produtos de puericultura correlatos. Diário Oficial da União 2006; 4 jan. as follows: I - Infant formulas (IF): (1) infant formulas for infants; (2) infant follow-up formulas for infants; (3) infant formulas for specific dietary needs. II - Formulas for young children (FYC): (4) infant follow-up formulas for young children. III - Nipples (NI): (5) baby bottles; (6) nipples; (7) pacifiers; and (8) nipple protectors. IV - Milks (MI): (9) fluid milk; (10) powdered milk; (11) modified milk and similar plant-based milk. V - Processed complementary foods (CF): (12) processed complementary foods and cereal-based foods suitable for infants or young children, as well as other milk-based foods or drinks or not, when marketed or otherwise presented as suitable for feeding infants and young children. VI - Dairy Compounds (DC): (13) dairy compounds are growing-up milks, they fit both the definition of “other milk-based foods or drinks” and the milk group.	1: Nutrient formulas, presented or recommended for high-risk newborns, cannot be marketed as only hospitals are allowed to use them, so they are not included in the list of product groups. Marketing of this group of products, when observed, must be registered separately, included as item 14). 2: Dairy compounds were grouped separately as the 6th group (VI), because they are frequently marketed, involving frequent infractions. These products, created after the enactment of Law n. 11,265/2006, although not mentioned by their names, are part of its scope as they are presented as suitable for feeding young children. They are regulated by MAPA Normative Instruction n. 28/2007³⁷37. Ministério da Agricultura, Pecuária e Abastecimento. Instrução Normativa nº 28, de 12 de junho de 2007. Diário Oficial da União 2007; 14 jun..
(3) Types of commercial promotion	- Special display (SD): defined as “any product display that makes it stand out from the others in the store, such as a shop window, shelf edge, products arranged as a pyramid or island, product crates, shelf ornaments, and others”. - Off-price (OP): discounts, special offer, discount coupons, progressive discounts, and other forms of price reduction. - Gifts or samples (GI): products, accessories or toys offered by the store, associated with product purchase. - Others (OT): any other system that induces consumers to buy the product.	Commercial promotion is defined by NBCAL as “a number of information and persuasion activities from companies that manufacture, handle, distribute and market products aiming to induce the acquisition or sale of a certain product”. For each product, one or more categories of commercial promotion can be observed. That is, multiple responses can be observed for each product.
(4) NBCAL violation	NBCAL violations can be divided into two major product groups: - Products with prohibited commercial promotion: include IF and NI. Any type of commercial promotion of products from these groups constitutes a NBCAL violation. - Products with permitted commercial promotion with a warning phrase: include FYC, CF, MI and DC. These products can have commercial promotion as long as they present a warning phrase from the Brazilian Ministry of Health. Absent or inadequate warning phrases constitute a NBCAL violation.	Calculation method: (a) observe if the product has any type of commercial promotion. (b) write down the product group, manufacturer name, product name, and type of violation(s). (c) if the product belongs to the group that allows commercial promotion (FYC, CF, MI, and DC), check if it presents a warning phrase: “The Brazilian Ministry of Health informs: breastfeeding prevents infections and allergies and is recommended up to 2 years old or older” - for MI and FYC products, or “The Brazilian Ministry of Health informs: after 6 months of age, keep breastfeeding your child and offer new foods” - in the case of CF products. For DC, accept either phrase, as it is a product not regulated by ANVISA. (d) then, if the product presents a warning phrase, observe whether it is highlighted, with auditory or visual evidence, whether it is legible, bold, framed, in a horizontal position, and close to the product being promoted. If these requirements are not met, the commercial promotion of the product violates NBCAL.

INDICATOR	DEFINITION	CALCULATION METHOD
(1) Number of products with NBCAL violation by store	Total number of distinct products with NBCAL violation in each store.	- Each product for sale in the store may have one or more NBCAL violations (see section: Type of commercial promotion). - Regardless of the variety of violations attributed to each product, this product will receive the “violation” attribute when one or more product-related violations are observed, constituting a binary variable (yes/no). - Each product with one or more NBCAL violations will be counted and the total number of products with infractions in each store establishment will be summed up, ranging from zero (store with no violation) to the total number of distinct products the store sells). - Each store now receives a value for this variable.
(2) Number of stores with NBCAL violation	Indicates the store has NBCAL violation. Presence or not of NBCAL violation in each store.	To obtain this indicator, a binary variable (yes/no) will be built, based on the “total NBCAL violations by store” in which yes refers to the store where at least one NBCAL violation has been observed in at least one product. Then, the number of stores with at least one NBCAL violation is summed up.
(3) Average number of products with NBCAL violation of by store	Average number of products with at least one NBCAL violation in each store.	Numerator: sum of the number of products marketed that present an NBCAL violation. Denominator: sum of stores that sell products covered by NBCAL. Note: this indicator can be stratified by product groups: IF, FYC, NI, MI, CF, and DC. In this case, the denominator varies according to the presence or not of products from that group in the store.
(4) Proportion of stores with NBCAL violation	Proportion of stores with at least one NBCAL violation.	Numerator: number of stores with NBCAL violations. Denominator: number of stores that sell products covered by NBCAL. Multiply the result by 100. Note: this indicator can be stratified by product groups: IF, FYC, NI, MI, CF, and DC. Then, the denominator will be the number of stores that sell each type of product. It can also be stratified by companies that produce infant formula, nipples, pacifiers and bottles (products with prohibited promotion). The denominator, in this case, must only include the stores that sell products from a specific company.
(5) Proportion of each type of commercial promotion with NBCAL violation	Percentage of each type of commercial promotion with NBCAL violation: (off-price/ special display/ gifts and samples/ others) by product category in the store.	Numerator: total number of each type of commercial promotion with NBCAL violation (SD, OP, GI). Denominator: total number of stores with NBCAL vioilation. Multiply the result by 100. This indicator can be presented in two different ways: - Frequency stratified by type of commercial promotion, where each type of promotion will present its frequency percentage. The sum of these frequencies may be higher than 100%, as one product may present more than one type of commercial promotion in disagreement with NBCAL. - Combined frequency of types of commercial promotion: SD, OP, GI, SD+OP, SD+GI, OP+GI, SD+OP+GI. The sum of the percentages for this indicator will be equal to 100%. This indicator can be stratified by product.

INDICATOR	DEFINITION/CATEGORIES	CALCULATION METHOD
(1) Proportion of managers or pharmacists with knowledge of NBCAL	Percentage of managers or pharmacists who know NBCAL. This question allowed 3 categories of answers: yes, more or less, no.	Numerator: number of managers or pharmacists interviewed who said they knew NBCAL. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(2) Proportion of managers or pharmacists that can name products covered by NBCAL	Percentage of managers or pharmacists that can name products covered by NBCAL.	Numerator: number of managers or pharmacists interviewed who were able to name at least 3 products covered by NBCAL. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(4) Proportion of managers or pharmacists with NBCAL training	Percentage of managers or pharmacists with NBCAL training.	Numerator: number of managers or pharmacists interviewed who reported NBCAL training or class. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(3) Proportion of managers or pharmacists with breastfeeding or infant food training	Percentage of managers or pharmacists with breastfeeding or infant food training.	Numerator: number of managers or pharmacists interviewed who reported breastfeeding or infant food training. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(5) Proportion of managers or pharmacists who advise mothers on infant food	Percentage of managers or pharmacists who improperly advise mothers on infant food.	Numerator: number of managers or pharmacists interviewed who reported providing infant food guidance to mothers. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(6) Proportion of managers or pharmacists who receive visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers	Percentage of managers or pharmacists who receive visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers.	Numerator: number of managers or pharmacists interviewed who reported visits of representatives from companies of infant foods and products. Denominator: total number of managers or pharmacists interviewed. Multiply the result by 100.
(7) Proportion of stores that receive visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers	Percentage of managers or pharmacists who receive daily, weekly, monthly or sporadic visits of representatives from companies of infant foods and products.	Numerator: number of managers or pharmacists interviewed who reported daily visits of representatives from companies of infant foods and products. Denominator: total number of managers or pharmacists who receive visits of representatives from companies of infant foods and products. Multiply the result by 100. Note: repeat the operation to calculate the percentage of weekly, monthly, and sporadic visits.

INDICATOR	DEFINITION	CALCULATION METHOD
(1) Proportion of maternity hospitals that received visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers	Percentage of maternity hospitals that received visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers .	Information provided by the health professional, but the unit of analysis is maternity hospital. The following steps were considered to build the indicator: (a) Each maternity hospital will receive ‘yes’ if at least one professional reports that one or more companies (or distributors) of infant food or products visited one or more health professionals in person in the maternity hospital. (b) Calculate the indicator: numerator = number of maternity hospitals that received in-person contact from companies; denominator = total number of maternity hospitals evaluated. Multiply the result by 100. The analysis of this indicator can be stratified by company. For ex.: companies X, Y, and Z visited #%, #% and #% of evaluated maternity hospitals that received an in-person visit of representatives from companies of infant foods or products. To qualify the indicator, stratify the visit frequency at least once a month and bimonthly or more, calculating the frequency percentage of the indicator for each of these two categories. Note: the questions related to this variable refer to the last 12 months.
(2) Proportion of maternity hospitals where health professionals receive visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers	Percentage of maternity hospitals where health professionals receive daily (weekly, monthly, sporadic) visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers.	Numerator: number of maternity hospitals where one or more health professionals reported receiving daily (weekly, monthly, sporadic) visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers. Denominator: total number of maternity hospitals where one or more health professionals reported receiving visits of representatives from companies of infant foods, nipples, baby bottles, and pacifiers. Multiply the result by 100. Note: repeat the operation to calculate the percentage of weekly, monthly, and sporadic visits. This indicator can be stratified by visiting company. For ex.: company X visits #% of maternity hospitals and company Y visits #% of maternity hospitals.
(3) Proportion of maternity hospitals where companies of infant foods, nipples, bottles and pacifiers commit NBCAL violation by offering incentives to health professionals	Percentage of maternity hospitals where companies of infant foods, nipples, bottles and pacifiers commit NBCAL violation by offering incentives to health professionals. Offering incentives constitutes NBCAL violation; it was identified through 5 questions: (a) offering informational or educational materials to be distributed to mothers; (b) offering gifts or giveaways (pens, notepads, USB sticks or other gifts); (c) offering sponsorship for activities or events outside the institution; (d) offering invitations to social events; (e) offering discounts at product purchase. Offering other materials must also be registered to be analyzed whether it constitutes an NBCAL violation.	Firstly, the proportion of maternity hospitals where one or more companies of infant foods, nipples, bottles and pacifiers offer incentives to health professionals is analyzed, which characterizes illegal contact from these companies with health professionals: (a) Each maternity hospital receives an attribute (yes/no) if one or more health professionals report the offer of incentive from companies of infant foods, nipples, bottles and pacifiers through their representatives. (b) Calculate the indicator: numerator = number of maternity hospitals where one or more health professionals reported the offer of one or more incentives by a company; denominator = total number of maternity hospitals. Multiply the result by 100. Note: this indicator can be stratified by company: numerator = number of maternity hospitals reporting incentive from company X; denominator = total number of maternity hospitals reporting incentive from companies of infant foods and products. Multiply the result by 100. Example: companies X, Y, and Z offered incentives to health professionals in #%, #%, and #% of all maternity hospitals evaluated, respectively.
(4) Proportion of maternity hospitals where companies of infant foods, nipples, bottles and pacifiers commit NBCAL violation by offering incentives to maternity hospitals	Percentage of maternity hospitals where companies commit NBCAL violation by offering incentives to maternity hospitals. Identification of product offer, where a product is offered free of charge or at a reduced price to the maternity hospital, of the following incentives from a company or distributor: (a) free supplies of infant formula or other baby food products; (b) nipples, pacifiers, bottles or nipple protectors; (c) breast pumps; (d) equipment or devices; (e) event sponsorship; (f) courses or workshops held at the maternity hospital; (g) office supplies; 9h) area renovations or improvements; (i) educational and informational materials; (j) discounts or subsidies for product purchases; (l) offering other materials not listed above.	The categories in this item are attributed to maternity hospitals where a listed incentive was offered to one or more health professionals by a company or distributor to the institution where they work, constituting a positive response (binary, yes/no answer) for each category of this indicator. (a) Each maternity hospital receives an attribute (yes/no) if one or more health professionals report the offer of incentives from companies to the maternity hospital. (b) Calculate the indicator. Numerator = number of maternity hospitals where one or more health professionals reported the offer of one or more incentives to the maternity hospital by a company; Denominator = total number of maternity hospitals. Multiply the result by 100. Note: the offer of each incentive is related to a specific company or distributor. The results of offering one or more incentives can be described by company or distributor. For ex.: company X offered one or more incentives to healthcare professionals in #% (n = #) of the maternity hospitals that received incentives from the companies of infant foods, nipples, pacifiers and bottles. Note: the questions related to this variable refer to the last 12 months.
(5) Proportion of maternity hospitals where post-partum mothers had contact with representatives from companies of infant foods, nipples, pacifiers and bottles in the maternity hospital	Percentage of maternity hospitals where post-partum had contact with representatives from companies of infant foods, nipples, pacifiers and bottles in the maternity hospital. Identification of contact from commercial representatives of a company or distributor with post-partum women in a maternity hospital. Subcategories of this variable: the name of the company that made such contact, type of contact and frequency of contact in the evaluated maternity hospital.	One or more positive answers to this question characterize the contact of commercial representatives of a company or distributor with post-partum women in the evaluated maternity hospital. (a) Each maternity hospital receives an attribute (yes/no) if one or more health professionals report a company’s contact with post-partum women in the maternity hospital. (b) Calculate the indicator: numerator = number of maternity hospitals in which one or more health professionals reported contact of a company’s representative with post-partum women in the maternity hospital; denominator = total number of maternity hospitals. Multiply the result by 100. Note 1: the companies or distributors that had contact with post-partum women in the maternity hospitals can be described. Note 2: the questions related to this variable refer to the last 12 months. Note 3: in case of direct contact of representatives from companies or distributors with post-partum women in the maternity hospitals, analyze the types of benefits offered: (a) promotional materials for specific products; (b) informational or educational materials; (c) samples of milk or other baby food products; (d) gifts or giveaways; (e) coupons; (f) other benefits not listed above.

INDICATOR	DEFINITION	CALCULATION METHOD
(1) Knowledge of health professionals about NBCAL	Proportion of health professionals who know NBCAL. The question allowed 3 categories of answer: yes, more or less, no.	Numerator: number of health professionals who reported they knew NBCAL (here only the answer “Yes, I know NBCAL” was considered - “More or Less” was not considered). Denominator: total number of health professionals interviewed. Multiply the result by 100.
(2) Ability of health professionals to name products covered by NBCAL	Proportion of health professionals that can name products covered by NBCAL.	Numerator: number of health professionals who could name at least 3 products covered by NBCAL. Denominator: total number of health professionals interviewed. Multiply the result by 100.
(3) NBCAL training of health professionals	Proportion of health professionals with NBCAL training.	Numerator: number of health professionals who reported participation in course, training or class about NBCAL. Denominator: total number of health professionals interviewed. Multiply the result by 100.
(4) Participation of health professionals in a congress or event sponsored by a company of infant foods or products	Proportion of health professionals who participated in a conference sponsored by a company of infant foods or products.	Numerator: number of health professionals who reported participation in a congress sponsored by a company of infant foods and products. Denominator: total number of health professionals interviewed. Multiply the result by 100.
(5) NBCAL violation due to personal incentive accepted by health professionals for the participation in congresses or events sponsored by a company of infant foods or products	Proportion of health professionals who received any of the personal incentives below at a conference or event sponsored by a company of infant foods or products: (a) congress registration; (b) ticket or transportation to the congress; (c) meal or party during the congress; (d) office supplies (pens, notepads, etc.); (e) gifts.	Numerator: number of health professionals who received a personal incentive for a congress sponsored by a company of infant foods or products. Denominator: total number of health professionals who participated in a congress sponsored by a company of infant foods or products. Multiply the result by 100.

[1] Correspondence
C. S. Boccolini Laboratório de Informação em Saúde, Instituto de Comunicação e Informação Científica e Tecnológica em Saúde, Fundação Oswaldo Cruz. Rua Leopoldo Bulhões 1480, Rio de Janeiro, RJ 21040-900, Brasil. cristianoboccolini@gmail.com