It was a pilot study which was conducted in SGT University, Gurugram. Ethical clearance was obtained from the Ethics Committee of Faculty of Physiotherapy, SGT University Gurugram Ref no (SGTU/FOP/2019/72). Permission was also sought from Medical Superintendent, SGT Hospital for conducting the survey during health camps. The data collection commenced in the month of September 2019 and continued till November 2019. Compilation of data, analysis and writing of report took around 4 months (March 2020).

Inclusion criteria: Postmenopausal women, age group of 45-60 years, residing in rural (Mankrola, Sultanpur, Chandu) and Urban (Basai, Farrukhnagar, Urban Gurugram) areas of North east region of Gurugram and willing to participate in the study, were included in the study.

Exclusion criteria: Women with history of surgical hysterectomy and age above 65 years were excluded from the study.

The purpose of study was explained to the subjects and informed consent was taken from all the participants.

The study was conducted in four steps. [Table/Fig-1] shows step by step procedure that was followed.

[Table/Fig-1]:

Flowchart showing steps followed for conducting the research.

Steps

Development of questionnaire: A total of 100 postmenopausal women from the above mentioned urban and rural areas of Gurugram were approached during regular health camps organised by our Institute. They were interviewed to understand different aspects of factors affecting their physical and mental health. With a view to assess risk factors for physical and mental health, all the enrolled women were interviewed regarding age at menopause, parity, medical and obstetric history, menopausal symptoms, personal habits, physical health issues, lifestyle regarding physical activity status and routine, psychological and social stressors. Along with this, an interview of the doctors including researchers from Departments of Obstetrics and Gynaecology, Medicine and Physiotherapy and Orthopedic Department of SGT Hospital Gurugram was carried out. A thorough literature search was also done by researchers.

First draft of questionnaire: The information that was collected in the first step was utilised to develop various items related to main objectives of the questionnaire. Different questions were prepared ranging from dichotomous questions to multiple choice questions where in the respondents have to select the best answer. The initial item pool consisted of 40 questions which were later reduced to 35 questions with only important, clear and specific questions included in it. Care was taken that the language was kept simple. Certain medical terminologies like Myocardial infarction, hypertension etc., were translated in Hindi and put in brackets as the sample included postmenopausal women with different levels of knowledge and understanding.

To ensure content and face validity of the questionnaire, evaluation of item pool of questionnaire was requested from 5 experts working on the health issues related to postmenopausal women. These included Professors and MD Doctors, one from Department of Community Medicine, one from Psychiatry, two from Obstetrics and Gynaecology and one from Physiotherapy. They were requested to examine the questionnaire with 35 questions for its relevance with respect to subject matter of study for accuracy and also evaluate for its strength and weakness. From the item pool of 35 questions, 28 questions were selected by experts. Based on these inputs first draft of questionnaire was prepared.

Second draft of questionnaire: A second review was also taken from another expert panel in which some changes were suggested which were incorporated into the second draft of questionnaire. The panel consisted of two senior Physiotherapy Professors working in the field of Obstetrics and Gynaecology and one senior Professor from Department of Orthopaedics. Content Validity Index (CVI) for each item was calculated [11]. Based on their response, 3 items were deleted. The second draft of questionnaire resulted into development of a self-structured questionnaire consisting of 25 questions. Questionnaire was divided into 4 sections. The first section included demographic details like name, age, occupation, employment status, number of children, education status, type of family etc. The second part of the questionnaire included medical history, third part consisted of physical health and fitness details like their exercise habits, frequency of exercising, type of physical activities they do etc. The last part of the questionnaire included factors affecting their psychological health [Annexure-1].

Conduction of pilot study: To evaluate the compatibility and appropriateness of second draft of questionnaire with the target population, a pilot study was conducted on 60 postmenopausal women from the same rural and urban areas of Gurugram from where the first sample population was taken and the selection criteria also remained the same. This sample of postmenopausal women was different from those that were initially interviewed for preparing rough draft of questionnaire. A sample of 30 each was taken from urban and rural areas of Gurugram by purposive random sampling. The purpose of study was explained to the subjects and they were requested to fill the questionnaire in the presence of researcher. On an average, respondents took 10-15 minutes to fill the questionnaire.

According to census of India, an urban area can be defined as an area with municipality corporation, with a minimum population of 5,000 of density 400 persons per square kilometer and with at least 75% of males working in non-agricultural pursuits and a rural area can be defined as an area with clear surveyed boundary but no municipal board with a population density of up to 400 per square kilometer and with >75% of male population involved in agricultural activities [13].

Reliability of questionnaire: To check the internal consistency of the questionnaire Cronbach alpha value was calculated. The value ranged from 0-1. A score of 0.7 or higher was considered acceptable. It was calculated for entire questionnaire. Five questions in section A (occupation, marital status, income, personal habits-smoking and alcohol), were excluded before measuring Cronbach’s alpha value as they had zero variance. But they were kept in questionnaire due to their relevance to the research area. Questions in the section B i.e., Physical health and Fitness Status were not included since a reply of NO (for e.g., answer NO to question “Do you exercise”) needs respondent to skip that question.

Numerical coding of the responses obtained from each participant was done. Responses were converted to 0, 1 and 2 depending upon codes assigned. SPSS software package version 20.0 was used to analyse the data. To ensure internal consistency of the questionnaire, Cronbach alpha value was calculated using SPSS software version 20. The value ranged from 0-1. A score of 0.7 or higher supported reasonable internal consistency.

The pilot study was conducted on 60 postmenopausal women. The average age in study group was 52±3.44 years and the mean age of onset of menopause was 46.38 years. Average Body Mass Index (BMI) was 27.3 Kg/m². Some other survey details have shown in [Table/Fig-2].

Questionnaire was sent to experts twice with request for comments. As suggested by experts, small amendments were done which included grammatical corrections. One question regarding caste details in section one was suggested by four reviewers to be of no significance whereas the section two sub heading was suggested by most of reviewers to be modified from chronic diseases to chronic diseases and Medical History. Overall, seven questions were removed from the questionnaire after first expert opinion as the questions were suggested by the reviewers did not pertain to health of postmenopausal women and 3 were deleted after second expert opinion as their CVI was less than 0.70. CVI evaluates clarity and relevance of each item of the questionnaire. A CVI of more than or equal to 0.79 was considered satisfactory for each statement. Current study had a mean CVI of 0.80.

Most of the respondents (90%) on whom pilot study was conducted said that they found it easy and were able to understand questions thoroughly and could answer it easily. Lay out of the questions, font size, questionnaire length was found appropriate by most. Question number 16 “Physical activity” in section C of questionnaire was modified to “How frequently you exercise?”

For confirming reliability of questionnaire, Cronbach’s alpha reliability coefficient was calculated as shown in [Table/Fig-3]. The Cronbach alpha value was calculated for total items (N=21) of the questionnaire, the value of which came 0.660 [Table/Fig-3]. One item i.e., “Living alone” was deleted from the questionnaire which improved the reliability of the questionnaire to 0.772 with total items N=20 [Table/Fig-4]. The final questionnaire consisted of 24 questions.

In the present study, a self-structured questionnaire was developed and was checked for its reliability and validity. The questionnaire was developed with aim to address multiple domains related to physical and mental health of postmenopausal women in a limited population of Gurugram, India. There is a difference of lifestyle in terms of physical activity behaviours, dietary intake and socio-economic factors in rural and urban areas which impacts overall health and quality of life of women [13]. With a significant number of women belonging to the status of menopause, it is crucial to understand the status of psycho-physical fitness, associated risk factors among postmenopausal women, so that a comprehensive health framework can be designed that would help in devising educational programmes to help them live an independent and healthier life in the later stages of their life.

Although there are many studies that have evaluated health of postmenopausal women in India, authors came across studies that have utilised different questionnaires factors affecting health of menopausal women. A recent hospital-based study by Senthilvel S et al., used 2 different questionnaires to assess menopausal symptoms and socioeconomic factors affecting health of postmenopausal women [14]. Similarly, a study by Ganapathy T and Al Furaikh SS utilised Menopause Specific Quality of Life questionnaire (MENQOL) to assess menopause related health issues and a self-structured questionnaire that evaluated socio demographic factors that did not include information like Medical history, physical and psychological health status [15]. MENQOL assess Menopause specific symptoms mainly vasomotor and physical health issues but it lacks information personal history, medical status and factors affecting physical fitness and mental health of postmenopausal women [16].

The study questionnaire had 4 sub sections which included all information like demographic details, medical health status, physical health status and psychological health status. To assess internal consistency of the questionnaire, Cronbach’s alpha value was calculated, the value of which was acceptable (0.772) so it can be considered a reliable tool to identify factors affecting health of menopausal women. Cronbach alpha value more than 0.9 is considered as excellent in terms of internal consistency of questionnaire and value less than 0.5 is considered unacceptable [17]. The internal reliability of the questionnaire is similar to a study by Pathak RA which studied reliability and validity of Menopausal Rating Scale in a population of Gujarat. The Cronbach alpha value of questionnaire is 0.738 which is considered as acceptable [18]. Also, similar results were seen in a study that assessed reliability and validity of menopause attitude assessment scale among women living in district of Mahmudiye. The questionnaire had 13 items and Cronbach’s alpha value of 0.744 [19]. Current study had a CVI of 0.80 which is similar with menopause symptoms severity inventory-38 with CVI 0.87 [20].

The study was done on a selected population of Gurugram. It’s generalisability beyond population of Gurugram was unknown and should be tested. Questionnaire did not include food habits of postmenopausal women.

Based on the results of the study it can be concluded that questionnaire possessed good content and face validity and acceptable reliability. As such, the questionnaire can be utilised to evaluate factors affecting physical and mental health status of postmenopausal women as it is a reliable and valid tool.