Design
A convergent design scheme proposed by Creswell et al.[11]is adopted, i.e., quantitative and qualitative research data are collected and analyzed simultaneously, and data representing the same dimension in the results of the two types of research are compared during integration, so as to draw the final research conclusions. The quantitative research part of this study adopts a retrospective cohort study, while the qualitative research is a prospective study. The newly enrolled patients are selected for a semi-structured interview (Fig. 1).
Cohort
This study included patients with cervical spondylotic myelopathy who underwent laminoplasty in Peking University Hospital from January 2018 to November 2019. Patients who accepted early postoperative intensive rehabilitation were included in the intensive rehabilitation group, and others were included in the orthopedic treatment group.
Patients in the intensive rehabilitation group received rehabilitation treatment in hospital for 1 week under the guidance of a professional team composed of rehabilitation doctors, physiotherapists, occupational therapists, and nurses. From the second day after surgery, the training was conducted for approximately 90 minutes each time, twice a day. The nerve function training of the limbs and hands includes proprioceptive neuromuscular facilitation (PNF) practices, muscle strength training and hand function training, up to 40 minutes at a time. Cervical function training includes cervical range of motion training and cervical isometric muscle strength training, up to 20 minutes at a time. Training on transfers, balance and gait up to 30 minutes at a time.
In the orthopedic treatment group, no professional rehabilitation team intervened, and the patients were given routine discharge education and rehabilitation guidance by orthopedic doctors and nurses on the second day after surgery and performed rehabilitation exercises at home according to the guidance content.
Quantitative survey study
Sample
Clinical and follow-up data of patients with CSM (all aged ≥18 years) who underwent laminoplasty in the Department of Orthopedics, Peking University Third Hospital, from January 2018 to January 2019 were retrospectively analyzed. All patients underwent perioperative process management according to the ERAS protocol. Patients with major organic diseases, tumor history, secondary cervical surgery history, and severe osteoporosis were excluded.
Materials
The visual analogue scale (VAS) uses a 10-cm long straight line, of which one end is 0 and the other end is 10, which indicates “painless” and “most painful,” respectively. Patients draw a point on the straight line according to their pain intensity. The modified Japanese Orthopaedic Association (mJOA) score includes upper and lower limb motor and sensory functions, hand function, and sphincter function. It is currently recognized as the evaluation standard of cervical spinal nerve function[12]. The neck disability index (NDI) is a cervical function scale that evaluates the influence of neck pain on the patients’ activities of daily living. It is currently the most widely used evaluation scale for cervical spine function globally, with its reliability and validity effectively verified[13].
In this study, the VAS, mJOA, and NDI scores before surgery and at 3 months (±14 days) after surgery, as well as the scores before (2 days±1 day after surgery) and after (1 week±2 days after surgery) rehabilitation treatment were collected from patients in the intensive rehabilitation group. The VAS, mJOA, and NDI scores before surgery and at 3 months (±14 days) after surgery were collected from patients in the orthopedic treatment group.
Statistical analysis
Research data were processed using SPSS 23.0 software. For description of quantitative indicators, median, 25% quartile, and 75% quartile were calculated, which are expressed as “median (25%, 75% quartile).” Wilcoxon rank-sum test was used for intra-group comparison, and Mann-Whitney rank-sum test was used for inter-group comparison. A P-value < 0.05 was considered to indicate statistically significant differences.
Qualitative interview study
Sample
Patients with CSM (all aged ≥18 years) who underwent laminoplasty in the Department of Orthopedics, Peking University Third Hospital, from May 2019 to November 2019 were selected to participate in the study. All patients underwent perioperative process management according to the ERAS mode. They provided informed consent and signed relevant documents to allow on-site or telephone audio recording during interviews. Patients with major organic diseases, tumor history, secondary cervical surgery history, psychiatric disorders, mental retardation, communication disorders, and severe osteoporosis were excluded.
In the qualitative research, purposive sampling was adopted; patients in the intensive rehabilitation and orthopedic treatment groups were selected and the patients in the two groups corresponded to each other in sex and age. The determination of sample size was based on the principle of information saturation, i.e., contents of the respondents’ interview data were repeated, and data analysis no longer presented new topics[14]. Nvivo 12.0 software was applied to encode and integrate the interview data until no new topics appeared. Finally, 12 patients were included in the intensive rehabilitation group and 12 patients in the orthopedic treatment group.
Methods
In this study, the convergent design was adopted in the mixed methods research, so questions in the interview outline of qualitative research were generated, with a focus on the dimensions involved in quantitative observation indicators, namely, postoperative pain, cervical function, and nerve function. Patients were asked about changes in their postoperative symptoms, medical care experiences and feelings, and evaluation of the treatment effect. All questions were open, and the interview outline is shown in Tab. 1.
Tab. 1 Outline of the qualitative interview
Intensive rehabilitation group
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Orthopedic treatment group
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1. Why did you undergo the operation?
2. What improvements have you made in the rehabilitation department this week?
3. What symptoms remain?
4. What difficulties do you experience during postoperative rehabilitation?
5. How do you feel during the rehabilitation process?
6. How do you evaluate the rehabilitation effect in the rehabilitation department?
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1. Why did you undergo the operation?
2. What rehabilitation exercises and treatments do you perform at home?
3. How is your disease recovering?
4. What symptoms remain?
5. What difficulties did you experience in the week after you came home?
6. How are you feeling at home this week?
7. What other help do you need from me?
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Patients in the intensive rehabilitation group were interviewed face-to-face after 1 week of rehabilitation treatment (1 week±2 days after surgery), and those in the orthopedic treatment group were interviewed through telephone in the same time period after surgery. Semi-structured, in-depth interview was conducted for both groups. Before the interview, the researcher inquired about patients willingness to be interviewed, and asked them to sign the informed consent form[15]. In this study, all 24 patients successfully completed the interview, and the audio recording materials of the interview were retained. Within 24 hours after each interview, the researcher would personally check the recorded content, and after the privacy information was concealed, the recorded content was transcribed into a verbatim transcript using a third-party platform. After the transcription was completed, the researcher would personally correct and check the transcript and keep the data properly.
Statistical analysis
The qualitative research data were processed using Nvivo 12.0 software, and the transcription materials were coded and integrated to form topics. The analysis method employed was the thematic content analysis method recommended by Hsieh et al.[16] First, the researcher read the materials repeatedly and fully obtained the information in the data. Then, the researcher marked the important contents and concepts in the materials and encoded them in an open way. Finally, similar or related codes were classified to form the topic, and the researcher defined the topic and found corresponding excerpts from the materials to interpret the contents of the topic.
Mixed methods integration and analysis
In this study, data representing the same dimension in the quantitative and qualitative results were compared and analyzed so as to obtain the integrated results of the data on each dimension. The principle of integrated analysis is as follows: if the results of two types of data confirm each other, they will be recorded as “confirmation;” if the results of two types of data complement each other, they will be recorded as “expansion;” and if the results of two types of data contradict each other, they will be recorded as “discordance”[17].