In needs assessment, the discrepancy between the current and the desired situation in a given group of people is studied. The needs assessment was structured by the Precede-Proceed model (PRECEDE: predisposing, reinforcing, and enabling constructs in educational diagnosis and evaluation; PROCEED: policy, regulatory, and organizational constructs in educational and environmental development), which analyzes and correlates quality of life, health, behavior, and environmental factors in a certain population [50]. The current situation has shown a large discrepancy between expected duration of physical recovery and actual RTW after gynecological surgery (even laparoscopic), whereas there is strong evidence that long periods of sick leave can result in poorer general health, increased risk of mental health problems and work disability, and induces unnecessary costs for society [2,8] The most frequently performed gynecological surgical procedures with a considerable postoperative effect on recovery and RTW (accounting for more than 17,500 procedures in the Netherlands per year) are hysterectomy (abdominal, vaginal, and laparoscopic) or laparoscopic adnexal surgery on benign indication [51]. Because approximately 67% of women aged 25-65 are in the workforce, these large numbers of surgical procedures have a great impact on absenteeism [52]. Therefore, patients who underwent these types of surgical procedures were chosen as the target group for this intervention.

To clarify and find possible explanations for prolonged sick leave, a literature search in PubMed regarding behavioral and environmental conditions of prolonged sick leave and delayed RTW in the target group was performed.

The focus group technique was considered the most suitable supplement to the literature search for identification of patient’s needs, attitudes, and beliefs regarding postoperative recovery and resumption of work. In addition to supplementing the results of the literature search, it was assumed that focus group discussions would align the results to the Dutch context and give more insight into specific content requirements of the prospective eHealth intervention that could be used during the development process. The participatory technique of focus group discussions is widely used and scientifically accepted to gain insight into public views and needs through group interaction [53,54].

Participants for the focus group discussions were recruited from the patient files of the VU University Medical Center, an academic hospital in the Netherlands. To mirror the intended target group, inclusion criteria for participation in the focus group discussions were age 18-65, a history of a laparoscopic adnexal surgery and/or hysterectomy on benign indication in 2008, and a job (paid or unpaid) of at least 8 hours per week. To create homogeneity within the focus groups but heterogeneity among the groups, the patients were recruited by means of purpose sampling into 3 groups: fast RTW, intermediate RTW, and delayed RTW. All of the participants had already returned to work after surgery (range 1-36 weeks).

The aim of the focus group discussions was to identify patients’ needs regarding perioperative care and counseling in resuming normal and work activities. In addition, patients were specifically asked for the important requirements of a useful eHealth intervention. The identification of patients’ needs and requirements occurred in 3 different steps:

1. Identifying and prioritizing patients’ perceived shortcomings in and difficulties with received perioperative care and counseling in resumption of normal and work activities.

2. Inventory of possible solutions and improvements to overcome these shortcomings and difficulties, starting with the highest prioritized bottlenecks.

3. Brainstorming about favorable content, requirements, and specific tools that should be incorporated into an eHealth intervention that aims to empower patients during the perioperative period and resumption of work activities.

The focus group discussions were all recorded and transferred into verbatim transcripts that were analyzed by open coding using the ATLAS.ti software [55].

A detailed process evaluation of the focus group discussions will be published in a separate paper [Pittens et al, unpublished data, 2012]. The study design and procedures of the focus group discussions were approved by the Medical Ethics Committee of the VU University Medical Center (2009/42, February 9, 2009). Participants signed a privacy agreement to declare voluntary participation, to give permission for processing the information for the development of an intervention (such as an eHealth intervention), and to exclude transmittal of information to others.

As a starting point for the development of the intervention, the products of this first step were the main behavioral and environmental conditions of the chosen target group contributing to prolonged sick leave.

The purpose of this step was to transform the identified behaviors and environmental conditions causing prolonged sick leave into behaviors and conditions that prevent a prolonged sick leave. To achieve this, performance objectives were formulated. Performance objectives describe in detail patients’ behavioral and environmental outcomes that are necessary for patients to reach the formulated behavior objective of “timely RTW.”

To select a suitable theoretical framework to reach the performance objectives, a literature search regarding main determinants of recovery and RTW was performed in PubMed. To elucidate, a suitable theoretical framework provides appropriate determinants that could be influenced to reach the behavior objective. Based on this framework, the performance objectives of the target group were elaborated into matrices with change objectives, explaining how patients and their environment will change as a result of the eHealth intervention to reach the behavior objective.

In this step, theoretical methods and practical strategies to address the change objectives were searched for and applied. Research has shown that the effectiveness of interventions to change behavior can be increased by the use of theory-based methods [56]. A theory-based method is a method derived from theory and research that describes a process that influences changes in determinants of behavior and environmental conditions. A practical strategy is a technique for the application of the theory-based method in ways that fit the target group and the context in which the eHealth intervention will be applied. The required theoretical framework, theory-based methods, and translation into practical strategies were determined based on the book that describes the IM approach [42], a literature search in the PubMed database, the focus group discussions, and a brainstorm session of the researchers.

During this step, information obtained in previous steps was translated into specific tailored tools and information to empower gynecological patients by the eHealth intervention. Furthermore, to obtain evidence-based information and instruments necessary to fulfill patients’ needs, additional research was performed.

To verify if the eHealth intervention matched with the main target group and fitted the expectations of gynecologists, family physicians, and occupational physicians, the first concept version was evaluated by focus group participants (n = 21), physicians (n = 22), eHealth specialists (n = 3), and a representative of a patient organization (n = 1) through questionnaires. The eHealth intervention was scored on 8 main areas used to describe how the intervention functions, empowers, and can be modified to provide the best behavior change to obtain timely RTW and prevent work disability. The 8 areas included: appearance, behavior prescriptions, burdens of using the website, content, delivery, message, participation, and assessment and tailoring. Ritterband et al [57] describe these areas in detail. This model is meant to ground Internet intervention research within a scientific framework. The 8 different areas were covered in the evaluation questionnaires with 23 unique open- and close-ended questions (Appendices 4 and 5). In addition, participants were also encouraged to propose recommendations. The results of the evaluation were used to optimize the design and usability of the eHealth intervention, which resulted in the final version.

The focus of Step 5 is adoption of the intervention by the patients and relevant stakeholders, and the development of an implementation plan. With the input of patients and stakeholders during previous steps, the researchers identified facilitating factors and barriers regarding adoption and implementation of the eHealth intervention. With this information, an implementation plan to enable an extensive evaluation of the intervention was developed and an appropriate linkage system for future implementation was composed.

During Step 6, the main objective of this study (ie, to develop a feasible and generally accepted eHealth intervention that empowers gynecological patients during the perioperative period into returning to normal activities and work, to obtain timely RTW, and prevent work disability) was used to compose an evaluation plan. Although the eHealth intervention was based on both theory and evidence and was developed in collaboration with the main target group and relevant stakeholders, its adoption, barriers for usage, and implementation possibilities still had to be evaluated in daily practice. In addition, the effectiveness of this eHealth intervention regarding a timely RTW to prevent work disability had to be investigated. Therefore, the project group approached 7 gynecology practices (1 university-based and 6 hospital-based) about participation in the evaluation of this intervention through implementation of the eHealth intervention as a supplement to the standard perioperative care given at their hospital. In addition, the project group formulated inclusion and exclusion criteria for patients to participate in the study and developed appropriate outcome measures to evaluate the intervention’s effectiveness, adoption, usage, and implementation. Furthermore, a logistic plan to recruit patients and involve participating health care providers was developed.

In total, 12 performance objectives derived from the main behavior objective were formulated (see Table 1).

In addition to performance objectives for patients, there were also performance objectives formulated for gynecologists, family physicians, occupational physicians, and employers (Table 1). Nevertheless, the primary focus during the next steps of the IM protocol (the development of the eHealth intervention) will be on patients. Ideally, for each group (patients, gynecologists, family physicians, occupational physicians, and employers) an intervention should be developed specific to their needs, wishes, and behavior outcomes to minimize the risks of theory and/or program failure. However, a balance had to be found between the ideal situation and what was within reach of this study. Secondly, the performance objectives of gynecologists, family physicians, occupational physicians, and employers could be considered external determinants of patients’ behavior. These determinants can either be influenced by the patients or the patients can learn these skills through the intervention and how to handle them adequately. Finally, the performance objectives of gynecologists, family physicians, occupational physicians, and employers are relatively simple objectives to reach. The researchers are convinced that the main part of these objectives can be reached through making agreements with gynecologists, family physicians, occupational physicians, and employers and by involving them in the evaluation and implementation plan (IM Steps 4-6) without specifying determinants of their behavior and applying specific theoretical methods and strategies for them.

The literature search showed that the main determinants of recovery and return to normal activities and work (in addition to the physical condition of the patient, level of invasiveness of the surgical procedures, and related complications) are the patients’ attitude, social influence, and self-efficacy [60-65]. In addition, skills, barriers, and facilitators are important factors that influence RTW [66-68]. For these reasons, the Attitude-Social influence-self-Efficacy (ASE) model [69,70], adapted for recovery and return to normal and work activities, was used to affect behavior of patients (see Appendix 1). The ASE model is comparable to the theory of planned behavior [71], which describes the relation between attitude and behavior. The modified ASE model describes that the behavior of a patient after surgery regarding recovery and return to normal and work activities is determined by attitudinal beliefs, social influence, and self-efficacy beliefs, and is influenced by skills, barriers, and resources. The ASE model was used to create matrices with change objectives. To fill out the matrices, available literature regarding the performance objectives and determinants was studied together with the results of the needs assessment and expertise of the project group. Appendix 2 presents an example of the change objective “Patients develop a work-reintegration plan.”

Numerous practical methods and suitable strategies to affect all formulated determinants were identified and used for the development of tools and materials of the eHealth intervention. Appendix 3 presents some examples of these methods with preconditions for the method necessary for it to succeed [72] and final tool/materials of the eHealth intervention. References and footnotes explain the source and development process of each method, strategy, and tools/materials.

With the knowledge obtained in the previous steps of the IM protocol, the project group convened at several meetings to invent various appropriate tools for the eHealth intervention. A website producer specializing in eHealth interventions and a screenwriter were consulted at some of the meetings. In addition, an experienced gynecologist outside the project team was consulted to judge the medical content of one of the tools.

In close collaboration with the website producer, the eHealth intervention was developed with MODX, an open-source hypertext preprocessor (PHP) Web application framework with a capable built-in content management system (CMS). The Internet address of the eHealth intervention is “http://www.ikherstel.nl/www.ikherstel.nl,” which means, “I am recovering” (Appendices 6-10) [73]. The eHealth intervention was developed with special attention to colors, layout, navigation, and readability to create confidence and user-friendliness. For the patient, it consists of two main sections: an Action List to assist in resumption of activities and a central home page. Gynecologists, family physicians, and occupational physicians have access to a different section. Table 2 presents an overview of the tools in the eHealth intervention. For some tools, additional information about the development and functioning is described subsequently.

In this study, anticipation of adoption and implementation started with the involvement of patients (target group) in all stages of the intervention development and evaluation. Health care providers, occupational physicians, and eHealth specialists participated in the evaluation of the intervention during IM Step 4. In addition, a committee with representatives of the Dutch medical boards of gynecologists, occupational physicians, and family physicians, and a representative of an umbrella patient organization were involved during the development of all steps of the intervention and agreed to stay involved during the final implementation steps of this intervention. Through this committee, a linkage system was created by involving the future users and implementers of the intervention from the start of the intervention development process. Furthermore, an important target of this study was to develop an eHealth intervention that could be used by patients, doctors, and employers without any support to simplify implementation. Evaluation of self-reliant use by patients and important stakeholders was evaluated positively during the test phase of Step 4.

Within the context of a RCT with the eHealth intervention (Step 6), the project group will facilitate its implementation and maintenance. In collaboration with the relevant care providers, the eHealth intervention will be offered as a supplement to standard perioperative care and will involve minimal additional time investment for the care providers. Agreements about usage of the contents of the eHealth intervention will be made with the gynecologists of participating hospitals and the family physicians and occupational physicians of participating patients. Therefore, the main purpose of this step was to create familiarity and support for the eHealth intervention and convalescence recommendations by all prospectively involved users. To reach these purposes for all of the different user groups, information letters will be distributed among patients and care providers. In addition, presentations with background information about the development of the eHealth intervention, its contents, and how to use it will be given to the gynecologists during general teaching meetings at their hospitals. Employers will become familiar with the intervention through invitation for participation by the patients (ie, employees). The eHealth intervention will be primarily used during the period of sick leave after surgery. Therefore, no agreement with the patients’ employers to use the eHealth intervention during work hours will be made.

With the information gathered during the process evaluation (Step 6), in collaboration with the committee with representatives of the Dutch medical boards of gynecologists, occupational physicians, and family physicians, and the patient organization, a final implementation plan will be developed. In this plan, medical insurance companies and the Health Care Insurance Board (CVZ) will likely be involved for the final implementation of the eHealth intervention.

The evaluation of the eHealth intervention will be performed by a RCT, during which the eHealth intervention will be compared with usual given care at 7 participating medical centers [75]. A power calculation was performed on the primary outcome (sustainable RTW) and showed that a total participation of at least 212 patients, their health care providers, and employers should be the goal. Patients will be recruited to participate in the RCT when they are placed on a waiting list for a hysterectomy or laparoscopic adnexal surgery on benign indication in one of the 7 participating medical centers, are aged 18-65, and they work (either paid or unpaid) for at least 8 hours per week. The main exclusion criteria are malignancy, deep infiltrating endometriosis, concomitant surgical procedures, major comorbidity, sick-listed for more than 2 months, currently in a lawsuit against their employer, and not able to use the Internet or unable to understand the Dutch questionnaires. If a patient participates, the researchers will inform her family physician and occupational physician by letter about the content of the intervention, the group allocation, and what is expected of them regarding the provision of health care. Follow-up will take place approximately 26 weeks after surgery.

Patients willing to participate and who meet the inclusion criteria will be randomized to the intervention or usual care group (control group). Main outcome measures of the RCT are the effectiveness of the eHealth intervention compared to usual care with respect to RTW, general recovery, quality of life, pain intensity, and complications. Part of the RCT will be a process evaluation of the patients, their care providers, and employers in the intervention group. Main outcome measures of the process evaluation are the extent to which the eHealth intervention and convalescence recommendations are used and followed up (compliance); appreciation of the different tools of the eHealth intervention and advice; perceived effectiveness, usage, and implementation barriers; and suggestions for improvement.

The outcome measures will be obtained using questionnaires administered at baseline and at 2, 6, 12, and 26 weeks after surgery. Gynecologists will complete questionnaires 1 day after surgery for each patient and at the end of the study. Employers will be asked to evaluate the eHealth intervention 8 weeks after their employee’s surgery.

The study design and procedures of the RCT study were approved by the Medical Ethics Committee of the VU University Medical Center (#2009/218, October 22, 2009).

In this study, the IM protocol turned out to be a useful method to develop and tailor an eHealth intervention aimed at the empowerment of gynecological patients during the perioperative period including return to normal activities and work. By using available literature and focus group discussions, it became increasingly clear that to obtain timely RTW and prevent work disability, the intervention should target both behaviors of patients as well as environmental determinants. Performance objectives for obtaining timely RTW and prevention of work disability were formulated and matrices with change objectives, explaining how patients and their environment have to change as a result of the eHealth intervention to reach the performance objectives, were developed. Finally, based on the ASE model [69,70], theoretical methods and practical strategies, suitable tools, and materials for the eHealth intervention were developed. Most of the participating patients and stakeholders judged the intervention to be a promising eHealth tool to empower gynecological patients during the perioperative period to return to their normal activities, including work.

A primary strength of this study lies in the way the eHealth intervention was developed, tailored, and assessed. Both theory and evidence were combined and patients and most relevant stakeholders were involved, minimizing the risks of theory and/or program failure [72]. The frequent involvement of patients in several steps of the IM process resulted in an eHealth intervention that was specifically tailored to their needs and wishes and therefore more likely to be implemented successfully. In addition to information supply, which is the primary aim of most websites, this eHealth intervention distinguishes itself by monitoring the recovery process, giving tailor-made advice based on patients’ workloads, and informing patients when additional consultation of care providers is needed. By linking patients with their gynecologists, convalescence recommendations can be adapted and insecurities regarding consequences of the complications can be solved. Connecting patients and employers facilitates a dialogue and the joint effort to compose a reintegration plan. Furthermore, this eHealth intervention is developed to be used without support and with minimal effort of care providers. Therefore, use of the intervention costs little and implementation is expected to be relatively easy. Moreover, like most eHealth interventions, an important strength is the possibility to use it at the time, place, and pace that fits the patient, care provider, and employer [38]. Finally, the combined approach of encouraging and helping patients to participate in their consultation and empowering clinicians with skills to identify and adapt to the needs of their patients is thought to produce long-term benefits for patients [21].

Main limitations concerning the needs assessment of this study include a possible selection bias; patients assigned to the focus group discussions are a selection of the patients willing to discuss their perioperative problems. Patients less willing to discuss their problems may also experience different perioperative issues. However, through purposeful sampling and by proactively approaching all relevant patients for participation in the focus group discussions, we tried to minimize this selection bias as much as possible. In addition, the influence of dominant patients who might be overly influential cannot be excluded. On the other hand, specific observations on this matter showed that this rarely occurred [Pittens et al, unpublished data, 2012]. Furthermore, these patients already underwent the surgery, whereas the intervention is designed to be used both before and after surgery. It has to be determined whether this intervention is applicable to the entire target population and whether the intervention fits the needs of patients both before and after surgery. Due to practical reasons, not all stakeholders (eg, employers and health care providers) were involved in the needs assessment and development process of this eHealth intervention. As a consequence, the intervention might be less supported by these groups. However, results of prior focus group discussions with supervisors and care providers in another comparable IM study [47] were used and some of those stakeholders were also involved in the test phase. Because this was an exclusively Dutch study directed at the Dutch health care system, a final limitation is that external validity of the eHealth intervention has to be examined before the results may be applied internationally.

To our knowledge, this is the first study that tailors an eHealth intervention through the IM protocol to empower gynecological patients during the perioperative period to obtain timely RTW and prevent work disability. Therefore, comparison with other studies is limited. However, previous research showed several developmental and interventional characteristics. For example, it was demonstrated that IM is a successful method to tailor eHealth [45,76] as well as RTW [47,48] interventions. Moreover, Web-based interventions show positive effects on empowerment [25]. Furthermore, it is proven that tailoring an eHealth intervention influences usage positively (eg, time and frequency) and increases the effectiveness of the message [77,78]. In contrast to most eHealth interventions, this intervention aims at secondary and tertiary prevention. Therefore, further research is needed to determine whether the characteristics mentioned previously also apply to the present study.

Although comparable studies are lacking, the approach followed in this study—involving relevant stakeholders in the development of an eHealth intervention—is in line with an observed trend of multi-stakeholder involvement in health care in general [79,80]. Gained experiences in this study might contribute to additional insights for future initiatives on multi-stakeholder involvement in health care.

This study shows that the IM protocol can successfully be used for the development and tailoring of an eHealth intervention for gynecological patients. The protocol led to a systematic development of the intervention, it made sure that collaboration with the main target group was realized, and both theory and evidence was used to tailor the intervention.

Furthermore, through the detailed convalescence recommendations provided by the eHealth intervention, patients will be better informed about when it is thought to be medically safe to resume daily and work activities after gynecological surgery and it will give them the possibility to arrange workplace adaptations if necessary [74]. Prospective cohort studies exploring sick leave after general surgical procedures show that return to work is primarily influenced by the expectations of the patient and their supervisors rather than physical factors or the type of surgery [1,10,81]. Therefore, it is assumed that these tailor-made convalescence recommendations will help to accelerate recovery and stimulate patients to resume activities with increasing gradations of strain, which will presumably bring about a quicker recovery and RTW and prevent work disability [82-84]. Therefore, it is expected that this eHealth intervention fulfills patients’ needs and is able to empower gynecological patients during the perioperative period and return to normal activities and work [77]. However, its adoption, barriers for usage in daily practice, and implementation possibilities by patients and stakeholders still need to be evaluated more extensively in a process evaluation. Furthermore, a RCT will be needed to assess the effect of empowering gynecological patients during the perioperative period and return to normal activities and work by this eHealth intervention on work disability prevention, resumption of activities, and quality of life [75]. The results are important to assess this intervention’s true value and policy implications.

This eHealth intervention is developed for patients who underwent a hysterectomy or laparoscopic adnexal surgery. However, the strategy used to develop the intervention and the final result may also be used as a blueprint for other kinds of surgical procedures.

The development of an eHealth intervention according to the IM protocol to obtain timely RTW and prevent work disability by empowerment and improving communication after gynecological surgery resulted in an intervention based on both theory and evidence and involvement of patients and most stakeholders. This eHealth intervention is well accepted by patients and stakeholders and is considered to be a promising tool to obtain timely RTW and prevent work disability after gynecological surgery. Its effectiveness needs to be proven in a RCT [75].