A cross-sectional, general population survey was conducted from March 2013 to September 2015 among urban young adults of East Sikkim in the age group of 15-40 years.

Study site included an urban area in East Sikkim. The selected urban site was Gangtok, East Sikkim, the most important city in Sikkim. Identification of Gangtok as urban site was based on criteria provided by Urban Development and Housing Department (UDHD), Government of Sikkim, Gangtok.

Men and women in the age group of 15-24 years are defined as youth and young adults are considered up to the age of 40 years [10,11]. In this study only young adults (15-40 years of age; below and above this age group were excluded) of either sex were recruited as participants since these group presents with comorbid age-related chronic medical conditions that might lead to more use of analgesics, also they have a tendency to develop adverse outcomes of regular use of analgesics as well as might cause dependence over a period of time.

Sampling method and size: The population of Gangtok, when the study was designed, was 98,658, i.e., approximately 1,00,000 [12]. According to the population pyramid of India approximately 35% of the total population belongs to the age group of 15-40 years [13]. Hence, an approximate 35,000 people are expected to be in the age group of 15-40 years. Prevalence of regular analgesic use as reported from several European studies in age groups above 14 years has been reported in the range of 7.2-34.8%. In this study, for a younger age group of the study population (15-40 years) an estimated prevalence of 5% analgesic misuse with an acceptable lower limit of 2% were assumed. To detect the prevalence at a 95% Confidence Interval (CI), the study enrolled n=700 participants from Gangtok site. During recruitment for the study, stratification according to age groups and gender was carried out and was adjusted according to actual percentage of population of the same.

Sampling locations in each site were identified. Mostly schools were included where people in the age group of 15-17 years aggregate, colleges (18-22 years) and households where participants in the age group of 15-40 years were easily available. This study surmises more as an ethnographic one with strict inclusion criteria of age group, i.e., 15-40 years of either sex.

The case record form constituted the following:

A generic 21 item questionnaire on sociodemographics based on the age, gender, education, ethnicity, religion, marital status. It also focused on questions that deals with alcohol use and smoking.

A generic 21 item analgesic misuse questionnaire, which measured the use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and opioid analgesics without prescription [14].

SF-36 is a 11-item QoL questionnaire, which assessed the QoL in different domains. It is a highly reliable (Cronbach's alpha greater than 0.85, reliability coefficient greater than 0.75 for all dimensions except social functioning) and valid instrument in terms of distinguishing between the groups with significant health differences [15].

Ethical issues: The study protocol, instruments/questionnaire, informed consent was duly approved by Institutional Ethics Committee (IEC).

During data collection, the participants were well explained about the nature and objective of the study before beginning with the face to face interviews. Responses of the questionnaires were coded by numbers and at no time participant’s name/photo were associated with participant’s responses to the questionnaire (to encourage an honest approach to the questions asked) so that full confidentiality was maintained. Participation for this study was voluntary. At any time participant had complete freedom to withdraw from the study, if desired so.

Informed consent was obtained. The informed consent form used for data collection was made in three different languages of English, Hindi and Nepali.

They were given a copy of the signed informed consent. During interview local language (Nepali), Hindi or English was used as per the convenience of the participant. Questionnaire on QoL aspects and analgesic misuse were recorded on the printed paper questionnaire form from each of the study participants. Participants were not given any monetary or other compensation in lieu of participation in the study. Data were de-identified, coded, entered and encrypted in secure files.

Analgesic misuse was defined in this study as any current (past 30 days) use of analgesics (greater than or equal to 10 doses/month) for indications other than everyday kind of pain (e.g., minor headache, sprain, toothache, premenstrual syndrome) without medical advice [16-18]. Body Mass Index (BMI) was calculated and expressed in kilogram/square meter. SF-36 questionnaire was collated for an easy statistical use [6].

Data were fed in Statistical Package for the Social Sciences (SPSS), version 20.0, IBM Corp. All the data fed in the software were checked for incorrect or any missing values before beginning the analysis. Frequency distribution was used to describe nature, extent and patterns of analgesic use. Chi-square was run for non parametric data to show the significant difference, if any.

The [Table/Fig-1] shows QoL among urban young adults in the study. For parameters like general health and health now compared to one year ago showed maximum percentage for good to excellent health and about the same as one year ago. And, also maximum percentage was observed for variables: not limited at all and minimum for: limited a lot.

The [Table/Fig-2] shows QoL (problems faced due to physical and emotional problems) among the study participants. For most of the parameters, maximum percentage was observed for: none of the time at more than 60% and minimum for: most of the time at less than 15% and a medium range for: some of the time at 14-25%.

The [Table/Fig-3] shows comparison of QoL among participants having pain and no pain in the past four weeks statistical significant differences were observed like compared to one year ago, health condition now, moderate activities, emotional health-depression, emotional health-happy, emotional health-full of life, emotional health-worn out.

[Table/Fig-4] shows comparison of QoL among participants misusing analgesics and not misusing analgesics. There was significant difference among analgesic misusers and non misusers in measures like general health, compared to one year ago, health condition now, emotional health-depression, emotional health-full of life, emotional health-felt dumped, emotional health-energy, emotional health-worn out.

The present investigation explored predictors of low QoL in the young adult population of East Sikkim. Almost 25.57% of the population reported some pain which coincides with the observation of chronic pain reported in a relatively younger population [19,20].

As observed from the QoL (problems faced due to physical and emotional problems) among urban young adults, for most of the parameters, maximum percentage was observed for: none of the time at more than 60% and minimum for: most of the time at less than 15% and a medium range for: some of the time at 14-25%.

This study measured QoL in three main domains; general, physical and emotional. General health was found to be statistically significant in analgesic misusers. General health and compared to one year ago, health condition now and moderate activities carried out in the past four weeks were also found to be statistically significant in subjects having pain. Special emphasis was given to the emotional domain as low QoL in this domain predicted by chronic pain may increase the risk of future onset of substance use disorder and other psychiatric disorders in later life. The study identified few important measures of low emotional QoL with statistical significance in subjects having pain; depression in the past four weeks, happiness in the past four weeks, full of life in the past four weeks and worn out in the past four weeks. In misusers of analgesics, important measures of low emotional QoL with statistical significance were depression in the past four weeks, full of life in the past four weeks, felt dumped in the past four weeks, energy in the past four weeks and worn out in the past four weeks. There are higher levels of ill-health and physical impairment among substance misusers than in the general population as reported by Grant B and Pickering M [21]. Another study where patients from a managed care organisation who filled > or =1 NSAID use over a six month period were reported to have an easy accessibility of Over-the Count (OTC) medications, which may contribute to patients using more than one NSAID to manage pain. From the study it was reported the use of NSAIDs was associated with lower scores indicating poorer health related QOL [22].

Little background information was available on the prevalence of the prescription misuse problem in India, which was a limitation in designing the study. Also, this study was conducted only in one urban site in East Sikkim, i.e., Gangtok and therefore a limitation in generalisation of findings. We had restricted the age of the participants to 15-40 years and did not include participants in age groups below and above, which again limits the scope of present study. Ethnic disparity of enrolling more number of Nepalis in the study could have been decreased by enrolling more participants from other ethnic groups depending on the presence of the problem.

This study could identify a subset of participants in their youth with current pain and several measures of QoL in emotional domain like depression, full of life, energy etc; in the past four weeks in subjects misusing analgesics. Low QoL in more than one emotional domain also identifies possibility of future onset of mental and psychiatric impairments.

Since, this study provides an idea about the possible factors resulting in analgesic misuse, this shall provide baseline information to design further studies in the future and to detect risk factors of analgesic misuse and its impact on the QoL. Future studies shall aim to help formulate prevention measures and is expected to have a policy impact.

Moreover, studies can be conducted on a broader aspect in both the urban and rural different areas of Sikkim as well as in different parts of our country to understand the prevalence and the predictors causing analgesic misuse.