Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings.

BACKGROUND: Understanding patient satisfaction with pharmacy services can help to enhance the quality and monitoring of pharmacy services. Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) is a valid and reliable instrument for measuring patient satisfaction with services from the pharmacist. The availability of the PSPSQ 2.0 in Nepalese version would facilitate patient satisfaction and enhance pharmacy services in Nepal. This study aims to translate the PSPSQ 2.0 into the Nepalese version, culturally adapt it and verify its reliability and validity in the Nepalese population.
METHODS: The methodological and cross-sectional study design was used to translate, culturally adapt it, and validate PSPSQ 2.0 in Nepalese. The Nepalese version of PSPSQ 2.0 went through the full linguistic validation process and was evaluated in 300 patients visiting different community pharmacies in Kathmandu district, Nepal. Exploratory factor analysis was carried out using principal component analysis with varimax rotation, and Cronbach's alpha was used to evaluate the reliability.
RESULTS: Three-hundred patients were recruited in this study. Participants ranged in age from 21 to 83 years; mean age was 53.93 years (SD: 15.21). 62% were females, and 34% educational level was above 12 and university level. Only 7% of the participants were illiterate. Kaiser-Meyer-Olkinwas found to be 0.696, and Bartlett's test of sphericity was significant with a chi-square test value of 3695.415. A principal axis factor analysis conducted on the 20 items with orthogonal rotation (varimax). PSPSQ 2.0 Nepalese version (20 items) had a good internal consistency (Cronbach's alpha = 0.758). Item-total correlations were reviewed for the items in each of the three domains of PSPSQ 2.0.
CONCLUSION: The PSPSQ 2.0 Nepalese version demonstrated acceptable validity and reliability, which can be used in the Nepalese population for evaluating the satisfaction of patients with pharmacist services in both community pharmacy and research.

Introduction

Patient satisfaction is an essential and widely used indicator for measuring the quality of healthcare services. The patients’ judgment on whether the service provided to them meet their need and expectations are usually collected when measuring patient satisfaction [1, 2]. The data obtained from the patient satisfaction survey helps in identifying the different factors which can be used to improve and implement quality healthcare services for the patient's comfort. It is also an essential measure that informs the healthcare providers or other relevant stakeholders as a predictor of health-related behaviours expected from the patients following any health interventions [3-6].

Different tools have been developed in the past to evaluate patient satisfaction of the services delivered at community pharmacies. In 1983, the Patient Satisfaction Questionnaire (PSQ) was developed to assess patient satisfaction with medical care [7]. Gourley et al. developed the Pharmaceutical Care Satisfaction Questionnaire (PCSQ) to measure consumer satisfaction with pharmacy services [8]. In 2015, Sakharkar et al. developed an instrument called "Patient Satisfaction with Pharmacist Services Questionnaire" (PSPSQ 2.0) for measuring satisfaction of patient with pharmacist delivered services that evaluated the quality of the services. This tool helped to improve the healthcare of patients and promote patient wellness in chronic diseases [9].

Pharmacy services have evolved from a state where the role of pharmacists was narrowly focused on dispensing medicines to an age where pharmacy services cover a wide range of pharmaceutical care services with a focus on patient-centred care [10, 11]. Although, the pharmacy services have advanced significantly in high-income countries; however, the same cannot be said in case of low-and middle- income countries like Nepal [12]. Pharmacy services in Nepal are still limited to the dispensing of medicines and counselling to a large extent. According to the Department of Drug Administration (DDA), at present (February 2020), around 14,000 pharmacies (community pharmacies) are registered with the DDA [13]. Despite the dismal state of pharmacy services, there is an increase in the number of pharmacy workforce in Nepal as a result of an increase in the number of pharmacy colleges, mainly in the private sector. This rise in the number of pharmacy workforce has led to more pharmacists and assistant pharmacists joining community pharmacies. So, the services provided in a community pharmacy sere will be an interesting area to explore and develop further. In recent years, some community pharmacies have already started providing services such as medication and lifestyle counselling, and management and reporting of adverse drug reactions (ADRs) [14-16]. This recent development in community pharmacy practice highlights the need for some standard instruments to measure the quality of services provided by community pharmacists. The majority of the people in Nepal speak and understand the Nepalese language so, translated and validated Nepaleseinstrument for measuring patient satisfaction about the pharmacy services can have a huge scope in research and also in quality improvement programs within those pharmacies.

Generally, many tools (questionnaires) are available in English. There is a common practice of translation, cultural adaption and validation of the questionnaire/instrument tools to a different language to suit the local context. There are some tools like the World Health Organization-Health-related quality of life, European Organization for Research and Treatment of Cancer, Functional Assessment of Chronic Illness Therapy, etc. which have been translated into many languages. This suggests that translating the questionnaire to the local language is very common and essential. The PSPSQ 2.0 instrument, developed by Sakharkar et al., has subsequently been translated and cross-culturally adapted in Malaysian language with acceptable measurement properties [17]. However, it has not been translated into Nepalese, and presently, there is no specific tool to measure patient satisfaction with pharmacist services available in the Nepalese language.

Nepal is a landlocked country situated between India and China, and the Nepalese language (also called the Nepali language) is an official and most commonly spoken language of Nepal. Nepalese language is spoken as a mother tongue by almost half of the total population (approximately 29 million) in Nepal [18, 19]. Around 5–7 million Nepalese language speakers are estimated to be living in India, and Nepalese language is one of the 22 scheduled languages of India [20]. Similarly, more than one-third of the whole Bhutanese population and few parts of Myanmar can speak Nepalese language [25]. Nepalese language is also the mother tongue of Bhutanese refugees living in Nepal. Nepal is a homeland to the people with unique culture, language, health literacy, socio-economic profile and health-seeking behaviour; and health practice in Nepal is very different from the English-speaking countries. For example, patients asking pharmacists for specific medicines may be a common thing in developed countries, as the population health literacy in those countries is higher. Contrary to that, pharmacists in developing countries like Nepal often receive requests from the patients for a medicine with a particular colour, brand and dosage form due to inadequate health literacy. Health literacy in the Nepalese people is one of the less explored areas [21].

To best of our knowledge, no evidence exists concerning patient satisfaction with pharmacy services in Nepal. Moreover, as explained earlier, there is an unavailability of the comprehensive, reliable and valid instrument for assessing patient satisfaction with pharmacy services in Nepalese. This study aimed to translate the Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version, culturally adapt it and verify its reliability and validity in the community setting.

Methods

Study design and settings

This study was a methodological and cross-sectional study designed to translate the tool, culturally adapt it and verify its reliability and validity to assess the patient satisfaction with pharmacy services (PSPSQ 2.0), using the tool developed by Sakharkar et al. [9], into a Nepalese version.

Study site and study duration

The study site included three different community pharmacies of Kathmandu city, Nepal. Kathmandu is a capital city, situated in Bagmati Province of Nepal. The services provided by these community pharmacies are only limited to dispensing and medication counselling. The data collection took place between April 2019 and October 2019. Pharmacists and assistant pharmacists working on those pharmacies were responsible for dispensing over-the-counter, and prescription medications and they were also providing medication counselling. They were also responsible for stock and inventory management. The community pharmacies in the study were not associated with any specialised clinics or general clinics such as diabetes and psychiatric clinics.

Study population, inclusion and exclusion criteria

Patients receiving pharmacy services from different community pharmacies were included in this study. Patients were included in this study if they met the following inclusion criteria: (a) native Nepalese, (b) able to understand Nepalese, (c) patients receiving pharmacy-related services for at least three months from the same pharmacist and community pharmacy, (d) aged over 18 years and (e) does not have a psychiatric illness. Patients receiving services from the pharmacists working at the hospital and clinical settings were excluded in this study.

Instruments

Original PSPSQ 2.0

PSPSQ 2.0 [9] developed by Shahakar et al., has been evaluated psychometrically. It is a validated and reliable instrument for measuring patient satisfaction with pharmacist services (see S1 File). This tool consists of 20 items and divided into three domains, i.e. quality of care, pharmacist-patient relationship and overall satisfaction using a four-point, Likert-type scale [9]. The first domain ‘quality of care’ comprised of 10 items. The second domain is the pharmacist-patient relationship which contains six items. The final domain is overall satisfaction which comprised of 4 items.

Demographic questionnaire

The questionnaire was developed, comprising of six items questionnaire that explored demographic and related information of patients: age, gender, educational level, working status, ethnicity and religion.

Translation, cultural adaptation and validation

The methods for translation, cultural adaptation, validation and reliability are described briefly under respective subheadings after a paragraph on PSPSQ (2.0).

Step 1—Translation procedures and cultural adaptation

The PSPSQ 2.0 was used as a study tool to translate it into the Nepalese version. Before translation, the formal permission to translate, culturally adapt it, verify its reliability and validity of the instrument PSPSQ 2.0 was taken from authors of Sakharkar et al. (2015) via email. The process of translation and cultural adaptation of PSPSQ 2.0 questionnaire was conducted according to standard translation guidelines, i.e. FDA PRO Guidance [22] and ISPOR Good Practice Guidelines for linguistic and cultural adaptation and validation [23] as prescribed. The research team did the translation with the help of accredited translators. The translation and cross-cultural adaptation process was done in five different stages–

At the first stage of the translation (forward translation) process, the PSPSQ 2.0 English version was sent to two independent bilingual translators who were born in Nepal and native Nepalese speakers to translate English to Nepalese.

The second stage is reconciliation stage where the two Nepalese forward translations by two different, forward translators were reconciled by research and translation coordinator (SS) along with study team member (ST), to deliver a single “reconciled version” of the translated questionnaire.

Third, the reconciled version was then sent to two independent bilingual translators blinded to the original English version and having English as their first language for the backward translations.;

Fourth, an expert committee was formed by the study team for cultural adaptation. The expert committee comprised of pharmacy academician, pharmacists from different settings, i.e. community, clinical and hospital, forward and backward translators). Experts were contacted by the research coordinator on personal approach within the country and after their consent committee was formed. This committee then compared the backward translations with the original English version and made relevant changes, improvements and cross-cultural adaptations in order to produce the version that was used in the pilot study. After reaching consensus, the committee approved an “intermediate version” of the translated Nepalese version;

In the last step, the version produced in the fourth stage was subjected to a pre-test to ensure proper comprehension of each question and cultural appropriateness testing of the intermediate version was done by the pre-testing and concluded with the “final version”, the final Nepalese version of PSPSQ 2.0.

Step 2—Validation and reliability analysis

Face validity

The face validation of the PSPSQ 2.0 was performed by collecting feedback from the participants of the pilot study (n = 15). During the pilot study, the intermediate version was administered to the fifteen patients comprised of native Nepalese speakers. Data collection form along with the demographic questionnaire and Nepalese version PSPSQ 2.0 developed was used to collect qualitative information following an interview with the pilot participants. Participants responded to the PSPSQ 2.0 Nepalese version and then evaluated it for intelligibility, appearance, clarity, and wording. Participants were asked if they encountered any difficulty and/or confusion on understanding the questions. They were also asked about any problematic or upsetting words which they might have found in the questionnaire. Participants were also encouraged to give suggestions for improvements and allowed to present the question in an alternative way where they considered it appropriate.

Content validity

This tool, in its original language, was already evaluated for content validity [9]. This questionnaire was already used by various experts to assess the satisfaction of the people on the pharmacists-delivered services. Hence, we assumed the tool is already validated for its content, and the questionnaire already contains items from the desired content domains. Therefore, we did not perform any content validity tests on our own.

Data collection process

A self-administered survey was conducted for evaluating the construct validity and the internal consistency of the tool. Patients visiting the community pharmacies and receiving the pharmacy services from the same pharmacies were approached, and the aim of the study was explained. Written informed consent from the participants was taken and was assured that their participation in this study was voluntary, and confidentiality of them will be maintained. Data collection form along with the demographic questionnaire and the Nepalese PSPSQ 2.0 was given to the patients receiving pharmacy services from different community pharmacies. The data collection form was distributed by one investigator of this study in each community pharmacy, and patients were given 15–30 minutes to fill with the questionnaire by themselves. The questionnaire was only given after patients left the community pharmacy. The investigator of the study assisted those patients who could not read and write by explaining when needed while filling up the questionnaire. Additional time was given to participants to fill with the questionnaire when required.

Sample size calculation for the survey

Using the item-response theory (IRT), the sample size required for the study was calculated [24]. Several studies have suggested different sample sizes. Some studies have recommended an item-to-respondent ratio of 1:5 up to 1:10, respectively [25, 26]. However, we have gathered data from 300 patients as PSPSQ 2.0 consisted of 20 items, thereby refining the ratio to 1:15. Three-hundred samples were sufficient for this study and were enough to produce reasonable factor solutions. However, at least 120 participants are required in conducting a factor analysis [27].

Sampling adequacy and sphericity

Before the performance of exploratory for its appropriateness in the factor analysis, the sampling adequacy was analysed using the Kaiser-Meyer-Olkin (KMO). KMO has to be more than 0.5 to be considered acceptable. Bartlett's test of sphericity was completed to figure out the common factors and to specify the appropriateness of the factor analysis model [28, 29].

Construct validity

The construct validity of the tool was checked with exploratory factor analysis (EFA) with varimax rotation on the 20 items of the questionnaire. It was intended to evaluate whether correlations among items were >0.3 and also to check the factorability of the correlation matrix using Bartlett's test of sphericity [30]. EFA with Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy and Bartlett's test of sphericity supported the validity of the PSPSQ 2.0 questionnaire. Eigenvalues were taken out first. The potential number of factors was determined by the number of factors with eigenvalues greater than one [30, 31] and by the visual inspection of the scree plot with the inflection in the slope. Eigenvalues associated with each factor before and after extraction, and after rotation were also analysed. The eigenvalues associated with each factor represented the variance explained by that particular factor: the eigenvalue was translated into the percentage of variance explained.

Reliability and internal consistency measurement

Cronbach's alpha coefficient was used to measure the internal consistency and reliability of the dimensions of the questionnaire. A coefficient value greater than 0.70 indicates a high level of internal consistency. Alpha values ≥0.7 were considered satisfactory [32].

Other statistical analysis

Data were entered, cleaned and analysed using the Statistical Package for Social Sciences (IBM SPSS Statistics, Armonk, NY, IBM Corp) Version 21.0.

Ethical consideration

The ethics approval was taken obtained from the Institutional Review Committee (IRC) of Nobel College, Kathmandu, Nepal (Reference number was EPY IRC 160/2018). Written consent was taken from the participants of the study and was assured that their participation in this study was voluntary, and confidentiality will be maintained. Consent from the participating experts was also taken to form an expert review committee in written form.

Results

Patients' socio-demographic characteristics

The socio-demographic characteristics of the patients are shown in Table 1. Participants ranged in age from 21 years to 83 years; the mean age was 53.93 years (SD: 15.21). Majority of the participants(62%) were females. Almost one-third of participants' educational level was above 12 and the university level, which was followed by primary level (22.7) and secondary level (22.3%). Only 7% of the participants were found to be illiterate. Regarding the working status of participants, the majority (81.7%) of participants' status was working.

Table 1

Socio-demographic characteristics of patients.

Study characteristics	N	Percent (%)
Age	Mean (SD): 53.93 (15.21)
	Minimum- Maximum: 21–83
Gender
Male	114	38.0
Female	186	62.0
Education Level
Illiterate	21	7.0
Informal education	42	14.0
Primary level (up to 5)	68	22.7
Secondary level (6–12)	67	22.3
Above 12 and University level	102	34.0
Working Status
Working	245	81.7
Not Working	55	18.3
Ethnicity
Brahmin / Chettri	141	47.0
Janjati	140	46.7
Others	19	6.3
Religion
Hindu	209	69.7
Buddhist	47	15.7
Christian	28	9.3
Muslim	16	5.3

Translation and cultural adaptation

The process of translation and cultural adaptation generated the Nepalese version of PSPSQ 2.0 (See S2 File). During the process, no significant difficulties were found. However, some negligible changes in grammatical structures were needed. The pilot testing showed that there was no any difficulty among participants regarding the understanding of all 20 items of the PSPSQ 2.0. The expert review committee performed a cultural adaptation.

R-matrix (i.e., the correlation matrix)

R-matrix (i.e., the correlation matrix)—the top half contained the correlation coefficient between all pairs of questions, and the bottom half one-tailed p-values of them (Shown in S1 Table). For the straightforward interpretation, only the columns for the first and last five questions in the questionnaire were displayed. Variables with very few correlations above 0.3 might not fit with the pool of items, and variables with correlations greater than 0.9 might be collinear. All questions correlated reasonably well with all; therefore, any questions from Q1 to Q20 were not eliminated at this stage.

Sampling adequacy and sphericity

The results of the KMO statistic test was found to be 0.696. This showed that the sample size was probably adequate for factor analysis. Bartlett’s test of sphericity was significant with a chi-square test value of 3695.415 (degree of freedom = 190, p<0.0005) indicating that factor analysis was adequate to the observed data.

In summary, a principal axis factor analysis (FA) with orthogonal rotation (varimax) was executed on all the 20 items. Six factors had eigenvalues greater than the Kaiser's criterion of 1 and overall explained 64.80% of the variance. As the sample size was sufficient as per the calculation, and scree plot and Kaiser's criterion converged on this value, six factors were retained. (Fig 1).

Fig 1

Scree plot.

Total variance explained

Table 2 shows the eigenvalues associated with each factor before and after extraction, and after rotation. All 20 factors were identified before extraction (i.e., as many eigenvectors as the variables). Eigenvalues associated with each factor represented the variance explained by that factor. Eigenvalue was then converted into the percentage of variance explained (e.g., factor 1 explained 21.84% of total variance). The first few factors explained a large amount of variance (especially factors 1 and 2) and the subsequent factors small amount. All factors with eigenvalues >1 were extracted, which gave six factors. Rotation also ensured the factor structure showing the importance of the six factors in the analysis. Factor 1 accounted for more variance (19.88%) than other five (12.46%, 6.27%, 5.08%, 3.44% and 3.23%) before rotation. After rotation it accounted for 15.99% of variance (compared to 8.71%, 8.71%, 6.28%, 6.06% and 4.61% of rest of the factors).

Table 2

Total variance explained.

Factor	Initial Eigenvalues			Extraction Sums of Squared Loadings			Rotation Sums of Squared Loadings
	Total	% of Variance	Cumulative %	Total	% of Variance	Cumulative %	Total	% of Variance	Cumulative %
1	4.368	21.840	21.840	3.977	19.884	19.884	3.198	15.990	15.990
2	3.007	15.034	36.874	2.492	12.461	32.345	1.743	8.713	24.703
3	1.787	8.936	45.810	1.254	6.270	38.616	1.742	8.710	33.412
4	1.487	7.437	53.247	1.017	5.083	43.698	1.256	6.281	39.693
5	1.251	6.254	59.501	.688	3.441	47.140	1.212	6.060	45.753
6	1.061	5.307	64.808	.646	3.230	50.369	.923	4.616	50.369
7	.980	4.900	69.707
8	.894	4.470	74.177
9	.824	4.121	78.298
10	.646	3.232	81.530
11	.630	3.151	84.681
12	.530	2.648	87.328
13	.479	2.395	89.724
14	.402	2.010	91.734
15	.385	1.927	93.660
16	.369	1.846	95.506
17	.305	1.524	97.031
18	.242	1.211	98.241
19	.209	1.045	99.286
20	.143	.714	100.000

Extraction Method: Principal Axis Factoring.

Reliability and validity

Cronbach's alpha for the reliability of all the 20 items was 0.758, which indicated very good reliability while that for each of the domains ranged from 0.621 to 0.845 (Shown in Table 3). Cronbach's alpha value was found to be 0.845, 0.683 and 0.621 for the domain quality of care, patient-pharmacist relationship and overall respectively.

Table 3

Item-total reliability statistics of quality of care, interpersonal relationship (pharmacist/patient) and overall domain and reliability analysis.

Domain	Items	Scale Mean if Item Deleted	Scale Variance if Item Deleted	Corrected Item-Total Correlation	Squared Multiple Correlation	Cronbach's Alpha if Item Deleted	Cronbach's Alpha
Quality of Care	Q1	27.24	27.515	.404	.432	.842	0.845
	Q2	27.11	26.984	.442	.384	.839
	Q3	27.31	25.220	.578	.547	.828
	Q4	27.42	22.801	.678	.656	.817
	Q5	27.53	22.794	.765	.763	.808
	Q6	27.45	24.413	.646	.636	.821
	Q7	27.29	27.204	.395	.376	.843
	Q8	27.38	23.000	.699	.580	.815
	Q9	27.34	27.940	.230	.364	.859
	Q10	27.13	25.921	.582	.502	.829
Interpersonal Relationship (pharmacist/patient)	Q11	15.98	6.532	.219	.190	.714	0.683
	Q12	15.80	5.943	.445	.301	.631
	Q13	15.74	6.372	.447	.332	.635
	Q14	15.77	5.985	.437	.341	.634
	Q15	15.85	5.548	.566	.432	.587
	Q16	15.76	6.189	.410	.329	.643
Overall	Q17	9.07	3.065	.518	.310	.491	0.621
	Q18	9.13	3.223	.476	.386	.522
	Q19	9.21	2.841	.452	.304	.513
	Q20	9.87	2.516	.285	.125	.705
Pooled (All 20 Items)							0.758

Discussion

PSPSQ 2.0 was successfully translated, culturally adapted, and its reliability and validity into Nepalese version were verified using the established methodology [22, 23]. The good comprehensibility and simplicity of completion of PSPSQ 2.0 Nepalese version were reinforced by the feedback from the participants included in the pilot study and reproduce the evaluation of the original English version in this regard [9]. This Nepalese version also demonstrated acceptable psychometric properties of reliability and validity for the evaluation. This research has produced a Nepalese version of the PSPSQ 2.0 which, after transcultural adaptation and validation has proven to be a discriminant, valid and reliable tool to assess patients' satisfaction with pharmacy services.

The practising pharmacists working in community settings of Nepal or specific geographical regions of other countries (e.g. part of India, Bhutan, and Myanmar) where Nepalese is spoken predominantly can be significantly benefitted by this translated, culturally adapted and validated reliable questionnaire. There are people with Nepalese ethnicity in India, Bhutan and Myanmar. They belong to the broader Nepalese community but citizens of a different country. While there might be some similarity in terms of culture, language, festival etc. when it comes to healthcare seeking practice or healthcare belief the culture or influence of culture might be different given the difference in context and access to resources and their standards of living. However, further studies are needed to comment on the overall culture and its effect on healthcare-seeking practice among Nepalese communities living Bhutan and Myanmar. Due to high mobility of people between Nepal and India, the Nepalese community living in a particular region of Northern, Eastern and North-Eastern India might have different cultural experiences when compared to the Nepalese community of Bhutan and Myanmar. Again, more studies are needed on their cultural experiences and the influence of their culture on healthcare-seeking practice or healthcare belief system.

Community pharmacies stand as the first point of contact for obtaining medicines and offer various services like counselling on diseases and medicines, dressing of wounds, administering injections etc [16, 33, 34]. Easy access, flexible opening schedule, free or minimum service charge are the reasons community pharmacies are preferred than other health care service centres. Community pharmacies in Nepal thus play a significant role in catering over the counter and prescription medicines, managing minor illness and referring patients to specialised care centres [33, 35, 36].

Patient satisfaction may not relate to consumer satisfaction, as we see it in the retail sector. In Nepal, community pharmacy is also known as a retail pharmacy. There may be two possibilities. The first possibility is that an unsatisfied consumer may not buy a product or service; it may be detrimental to business but not to patient's health. The second possibility maybe retail sectors other than community pharmacy do different things to satisfy all consumers' needs; however, the same may not be the case for healthcare or community pharmacies. For community pharmacies, an unsatisfied patient means he or she might not have enough information, may not like the pharmacy environment as there is no provision for privacy, in that case, the patient may not be able to express his concerns or his healthcare needs, and it may affect his health outcome.

Contrary to that, a pharmacist cannot dispense whatever a patient request over the counter to make him/her happy. Patient satisfaction is a unique issue when it comes to community pharmacy services; it is an important issue. However, it needs to be defined and measured. Assessing satisfaction of pharmacy is considered as a critical indicator of the quality of pharmacy services. It will also contribute to the indirect monitoring the patient prognosis, as it reflects whether the service provided by the pharmacist is meeting patients' expectations or values [37]. This is also useful for setting a standard when launching new pharmacist-delivered services or strategies [38]. This tool will ensure the availability of one of the essential evaluation tools to the researchers and policy stakeholders performing pharmaceutical health service research or implementing any such programs to improve the patient outcomes as a result of pharmacists delivered services. In the future, this tool can be integrated with services such as medication counselling, management of adverse drug reactions, pharmaceutical care services by a pharmacist. This research fulfils the need for the comprehensive, reliable and valid instrument for assessing patient satisfaction with pharmacy services in the Nepalese version.

The results of the confirmatory factor analysis supported the validity of the PSPSQ 2.0 questionnaire. Bartlett's test of sphericity was significant (p < 0.0001) with a χ2 value of 3695.415. This showed that the sample size was probably acceptable for factor analysis, which was supported by the recommendations of a minimum of 100 to 200 participants by several studies [25-27].

Based on the results of the reliability analysis, the internal consistency coefficient (Cronbach alpha) for the instrument of the PSPSQ 2.0 and its three domains was found to be good, demonstrating that it can generate reliable scores. Cronbach's alpha value exceeded the pre-set value (0.70) and illustrated excellent reliability within the constructs [32]. The findings of this study were similar to the study conducted by Hassali et al., where this tool was translated into Malaysian language [17], which showed Cronbach's alpha value as 0.907, 0.762 and 0.913 for the domain “Quality of Care”, 0.762 for the “patient-pharmacist relationship” and the pooled 16 items respectively. Comparing to the study by Hassali et al. [17] and our study, variability was found in Cronbach's alpha value in every domain. There were some discrepancies noted between the original English version and the Nepalese version. Cronbach's alpha was found below than the original instrument where the developer of the tool reported. Cronbach's alphas value of 0.95 in Veterans Affairs (VA) based clinics, 0.98 and 0.96 in two community-based clinics diabetes clinic and psychiatric clinic, respectively [9]. The eigenvalues and scree plot supported a 3-factorial nature of the translated questionnaire. Another discrepancy found in the study was a study site where the original study conducted at VA based clinics and community-based clinics. However, we collected data from the community pharmacies with no specialised or general clinics. A significant strength of this study is that it provided the first measure to assess the patient's satisfaction with pharmacy services in Nepal. Elaborated translations and cultural adaption procedures were conducted. Additionally, the sample size in this study is more extensive than many similar studies conducted in other countries.

This study has some limitations, as well. First, as this study was conducted among patients taking services from the community pharmacy, it could not include patient's receiving services in more diverse environments such as clinical pharmacy and hospital pharmacy. More studies in different settings, such as clinical and hospital pharmacy, is advisable. The second limitation, the patients in this study do not represent the target population, as patients were selected based on available extraction. This would be a limitation to generalising the results of this study. The time duration taken by the patients in this survey was about 15–30 minutes to complete the Nepalese version PSPSQ 2.0 questionnaire, which is acceptable as suggested by other studies. However, some of them needed assistance in completing the questionnaire, as they were illiterate and did not know how to read and write, thus one of the drawbacks of the tool. We have included patients receiving pharmacy services from the same pharmacy for at least three months, and due to the selection criteria for the patients, it was inevitable to avoid recall bias in the study.

Nonetheless, the validity and reliability of the Nepalese version of PSPSQ 2.0 were verified as adequate in this study. Thus, the findings of this study could help to assess patient satisfaction with pharmacy services in the future and be actively used in related studies. In future, this tool can be used in community settings to study and assess the patient's satisfaction with pharmacy services. Further revisions of this instrument can be done after taking into consideration the nature of pharmacy services provided by hospital pharmacies or clinical pharmacy.

Conclusion

The findings of the study found that the Nepalese version of PSPSQ 2.0, developed initially by Sakharkar et al.,. is a valid and reliable and useful tool to assess patient's satisfaction with pharmacy services. Accordingly, the Nepalese version of PSPSQ 2.0 could be used in the future to measure patient satisfaction with various services provided by community pharmacists among the Nepalese speaking population.

PSPSQ 2.0 original version.

(DOC)

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PSPSQ 2.0 Nepalese version.

(PDF)

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(XLSX)

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Correlation matrix.

(DOCX)

Click here for additional data file.

30 Jun 2020

PONE-D-20-14361

Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version

PLOS ONE

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We look forward to receiving your revised manuscript.

Kind regards,

Carl Richard Schneider, BN, BPharm (Hon), PhD

Academic Editor

PLOS ONE

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

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2. Please provide additional details regarding the consent of the expert reviewers employed to test the validation of this questionnaire. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If the need for consent was waived by the ethics committee, please include this information.

3. Please ensure that you have specified whether participant consent was informed. In addition, please refrain from stating p values as .000, either report the exact value or employ the format p<0.001.

4. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed:

https://fulltxt.org/article/957

https://mhealth.jmir.org/2018/1/e24/

In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed.

5. Thank you for stating the following in the Competing Interests section:

"The author(s) declare that they have no competing interests."

We note that one or more of the authors are employed by a commercial company: Jeevee Health Pvt Ltd.

5.1. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form.

Please also include the following statement within your amended Funding Statement.

“The funder provided support in the form of salaries for authors [insert relevant initials], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.”

If your commercial affiliation did play a role in your study, please state and explain this role within your updated Funding Statement.

5.2. Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc.

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6. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

In your revised cover letter, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

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We will update your Data Availability statement on your behalf to reflect the information you provide.

7. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: No

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: In the scarcity of the instrument of focus, the authors' aim to provide the need of validated and reliable questionnaire to measure patient's satisfaction towards pharmacy services is noble and this present study could be the answer.

However, the authors do not present the study satisfactorily and there are much room for improvement. Firstly, it seems that the manuscript was not adequately proofread before submission. The presence of basic grammatical errors in many parts of the article can be the evidence. For example, some sentences miss the full stop (for example, lines 154 and 242) and even a "sentence" is not a sentence, but just a phrase (for example, lines 146-147). The subheadings are not written consistently as well as some journal or publisher name(s) in the Reference section. The use of however and although in a sentence could be possible, but the authors seem to not use them properly and potentially create confusion for the readers (lines 96-97). Two sentences in the Introduction section are sequentially repeated in the Methods section, i.e. lines 90-93 vs 159-163. The reference number of ethical clearence presented in line 247 is slightly different from line 421.

Secondly, it seems that the authors want to provide a validated and reliable translated questionnaire that could be useful for all pharmacy settings, i.e. hospitals, clinics, and community pharmacies, but the sample was only taken from community pharmacies without sufficient details about the number of pharmacies, sampling method, and typical services provided by the pharmacies. The study may also be prone to recall bias as the defined recall period is 3 months. Providing more details on the data collection and giving more focus on community pharmacy settings (i.e specify the pharmacy setting in the title) may improve the quality of the manuscript.

Thirdly, in the Results section, there are many technical details to read the tables that usually are not supposed to be written in the paragraph. They should be put as a table caption.

Fourthly, the authors tend to repetitively report the KMO value and the adequate number of sample, especially in the Results and Disccusions sections while it may not be necessary.

Fifthly, in the construct validity analysis, the authors retained six factors in the final model, but the internal consistency reliability was calculated based on the three-factor solution like the original construct. No name was given for each of six factors retained in the model. No further discussion was given on the discrepancy of the number of domains found in the Nepalese version vs the original version. The authors also miss to report one important table, which is the distribution of each question to each factor with its corresponding factor loading. The questions should be displayed in its original language and the target language, while the authors only provide the Nepalese version in the Supplementary file.

Lastly, the authors also used visual inspection of the scree plot as it complemented the Kaiser’s criterion of 1 (K-1) to decide the number of factors retained. While they decided to use a six-factor solution, the inspection of scree plot shows that the kink of the plot is on the third eigenvalue. This result should suggest only two or three factors should be retained. Any alternative analysis, such as the parallel analysis, is recommended to support the decision for retaining six factors.

Reviewer #2: Title: Please revise; it can be shortened (remove abbreviations for instance).

Please be consistent; Napalese version vs Napalese language.

Some minor english editing of the manuscript is required.

The number of tables could be reduced.

Introduction:

Patient vs consumer satisfaction; patients needs in many ways to rely on the service; while consumers can easily disregard the service. Is this an issue when it comes to needs and whether or not to measure satisfaction?

Cultural differences between English and Nepalese what would be the most prominent ones?

Aim; I don't think as it is currently written encompass cultural adaption.

Methods:

Consistent and clearly stated.

But, from the introduction I get the impression that this tool can be used in all pharmacies; but you only collect data from community pharmacies: Perhaps it is wise to exclude some of the information provided about hospital pharmacies/clinical pharmacies; or at least this needs to be discussed thoroughly.

The sample size seems appropriate; and the statistics is well described.

Results:

The correlation matrix could be presented as a supplement in its full version.

Several of the correlation is way below 0.3, is this problematic, and should it be discussed?

Table 3, unessecary; information could be given in text.

Table 4. I suggest that you instead provide the percentages of explained variance from the different loadings.

It could also be an idea to present the scree plot before table 4; this will provide the reader with information about how many different factors one should include.

Discussion:

All data are collected by one pharmacist in community pharmacies: please discuss.

The cross cultural adaption; is the culture among Nepalese speaking people in India, Buthan and Myanmar similar?

The number of participants in the study is good. 300 is acceptable. Please do not repeat it.

Why is your sample not represenative; could you please elaborate on these characteristics. Please provide information about how many of the respondents that couldn't read or write. On p. 211 you state that patients filled out the questionnaire by themselves: pleas adjust wording.

Reference list:

Please adjust/provide adequate informartion; e.g., ref no. 33.

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6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: Kjell H. Halvorsen

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

13 Aug 2020

We are very grateful for the reviews provided by the editor and the reviewers on our manuscript. The comments are encouraging, and the reviewers appear to share our judgment that this study and its results are interesting and relevant. Please kindly see the attached file, in blue, our detailed response to comments.

All page numbers and line numbers refer to the revised manuscript with track changes.

Sunil Shrestha and co-authors.

Submitted filename: Response to Reviewers.docx

Click here for additional data file.

28 Sep 2020

Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings

PONE-D-20-14361R1

Dear Dr. Shrestha,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Carl Richard Schneider, BN, BPharm (Hon), PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for responding to my comments. Hopefully, the instrument will be useful for pharmacy practice in Nepal.

Reviewer #2: I think the authors have addressed my initial concerns appropriately, although there are still a few typos and minor errors in punctuation.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: Yes: Antonius Nugraha Widhi Pratama

Reviewer #2: No

1 Oct 2020

PONE-D-20-14361R1

Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings

Dear Dr. Shrestha:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Carl Richard Schneider

Academic Editor

PLOS ONE