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This study was approved by the Medical Ethics Committee of our hospital, and all patients signed informed consent forms. Because this was a retrospective review of clinical records, consent for the nursing intervention was obtained as part of routine care, and written informed consent for the use of anonymized clinical data for research purposes was obtained before data extraction.
Study Subjects
Clinical data from 132 patients with DM complicated by OP admitted to our hospital from March 2023 to December 2024 were retrospectively collected. The study period referred to the time when eligible patients initiated the recorded nursing pathway. The final analysis included only patients with complete baseline, 6-month, and 12-month follow-up records; patients who had not completed 12 months of follow-up by the time of data extraction were excluded during screening. Eligible patients met the diagnostic criteria for DM,11 met the diagnostic criteria for OP, defined as an L1–4 or femoral neck BMD T-score of ≤ -2.5,12 , had complete clinical data including intervention records, follow-up data, and relevant examination results, and were aged 40 years or older. Patients were excluded if they had severe dysfunction of major organs such as the heart, liver, or kidney; malignant tumors, hyperthyroidism, or other diseases affecting bone metabolism; mental illness or cognitive impairment preventing cooperation with interventions and follow-up; loss to follow-up or interruption of intervention due to other reasons during the follow-up period; or a history of fracture or anti-osteoporotic surgery within the past 6 months. Grouping was based on the predefined nursing pathway documented in the medical and nursing records, rather than randomization. Patients managed with routine nursing were included in the control group, whereas those managed with the symptom-psychology-society three-dimensional nursing pathway were included in the observation group. No propensity-score matching was performed because of the limited sample size. To reduce confounding, baseline characteristics were compared between groups, and sensitivity analyses were conducted with adjustment for age, sex, BMI, duration of DM, and baseline BMD.
Sample Size Calculation
The 12-month change in L1–4 BMD was used as the primary outcome measure for sample size estimation, the sample size calculation was performed using a statistical software. The assumed effect sizes were based on previously published intervention data in patients with type 2 diabetic osteoporosis and our preliminary clinical audit: the expected 12-month change in L1–4 BMD was 0.02 ± 0.08 g/cm2 in the routine nursing group and 0.08 ± 0.07 g/cm2 in the three-dimensional intervention group. Setting α = 0.05 (two-tailed) and β = 0.20 (statistical power = 80%), the minimum required sample size was calculated to be 132 cases, which was consistent with the sample size enrolled in this study.
Intervention Measures
The follow-up period for both groups of patients was 12 months.
Control group: routine nursing
Patients in the control group received routine nursing, including basic health education, routine medication guidance, basic dietary and exercise recommendations, and routine follow-up. Basic health education consisted of one group health lecture upon admission and another before discharge to explain knowledge about DM and OP, as well as medication precautions. Routine medication guidance informed patients of the method of taking treatment drugs, dosage, and common adverse reactions. Basic dietary and exercise recommendations were provided through dietary and exercise guidance manuals, and patients were advised to follow a low-sugar and low-fat diet and engage in moderate physical activities such as walking. Routine follow-up was conducted by telephone once every 3 months after discharge to assess medication adherence and remind patients of regular re-examinations.
Observation group: Symptom-Psychology-Society Three-Dimensional Intervention
On the basis of routine nursing, patients in the observation group received targeted symptom intervention, personalized psychological counseling, and hospital-family-community collaborative social support. Targeted symptom intervention involved individualized plans based on patients' specific symptoms. For blood glucose management, blood glucose levels were dynamically monitored, hypoglycemic drug dosages were adjusted by attending endocrinologists according to standardized treatment protocols and current clinical guidelines, and personalized dietary and exercise interventions were implemented with targets of FPG 4.4–7.0 mmol/L and HbA1c < 7.0%. Nursing staff were responsible for education, adherence support, follow-up documentation, and communication of abnormal findings to physicians. Baseline and follow-up use of hypoglycemic agents, calcium/vitamin D, bisphosphonates, and other anti-osteoporotic medications was extracted from medical records and compared between groups. For bone metabolism regulation, calcium supplementation at 1000 mg/d plus vitamin D at 800 IU/d was standardized, and anti-osteoporotic drugs, such as bisphosphonates, were adjusted according to BMD results.
Personalized psychological counseling was delivered by trained endocrinology nurses who had received standardized training in chronic disease psychological support and health education. Psychological status was assessed using the SAS and SDS before intervention. Patients with anxiety or depression, defined as SAS score > 50 or SDS score > 53, received personalized psychological counseling once a month for 30–60 min each session, including emotional catharsis guidance, disease-related cognitive education, and positive attitude cultivation. Patients with SAS ≤ 50 and SDS ≤ 53 received routine psychological education and emotional support during follow-up; structured monthly counseling was initiated only if subsequent assessments exceeded the predefined thresholds. Therefore, patients who met the SAS or SDS threshold throughout follow-up could receive up to 12 individualized counseling sessions over the 12-month period. When patients showed severe or persistent anxiety or depressive symptoms, referral to a psychiatrist or clinical psychologist was recommended according to routine hospital practice.
Hospital-family-community collaborative social support was established through linkage with patients' families and community health service centers. Families were educated about disease care and were guided to provide emotional support and daily living assistance. Community medical staff conducted monthly home visits to supervise implementation of intervention plans and promptly address problems encountered during home care. Completion of each scheduled home visit was recorded in the community follow-up form. Home-visit adherence was calculated as the number of completed visits divided by the number of scheduled visits, and adherence of ≥80% was considered acceptable. FRAX scores were calculated using the China-specific model of the web-based FRAX tool, with femoral neck BMD included. The 10-year probabilities of major osteoporotic fracture and hip fracture were recorded for analysis.
Observation Indicators and Follow-Up
The follow-up period was 12 months and combined outpatient visits with telephone follow-up. Outpatient follow-up was conducted at baseline, 6 months, and 12 months after intervention to complete indicator detection and scale assessment. Telephone follow-up was performed once a month during the follow-up period to record intervention adherence, symptom changes, and adverse events. All observation indicators were measured at the three aforementioned outpatient follow-up time points. Lumbar spine L1–4 and left femoral neck BMD were measured using dual-energy X-ray absorptiometry.
Five milliliters of early morning antecubital venous blood were collected, and serum was separated by centrifugation for laboratory testing. FPG was measured by the glucose oxidase method using an automated biochemical analyzer. HbA1c was measured by high-performance liquid chromatography using an automated glycosylated hemoglobin analyzer. TC, TG, LDL-C, and HDL-C were measured by enzymatic methods using an automated biochemical analyzer.
The SAS13 consists of 20 items with a 4-point scoring system, with a total score ranging from 20 to 80; higher scores indicate more severe anxiety, with a cut-off value of 50. The SDS13 includes 20 items with a 4-point scoring system, with a total score of 20 to 80; higher scores indicate more severe depression, with a cut-off value of 53. The Social Support Rating Scale (SSRS)14 comprises 10 items with a total score of 12 to 66; higher scores indicate higher levels of social support.
Statistical Analysis
Data were analyzed using statistical software. Continuous variables were tested for normality using the Shapiro-Wilk test and were expressed as mean ± standard deviation or median (interquartile range), as appropriate. Between-group comparisons were performed using the independent-samples t test or Mann-Whitney U test, and within-group changes over time were analyzed using repeated-measures analysis of variance or an appropriate non-parametric method. When multiple pairwise comparisons were performed, Bonferroni correction was applied. Count data were presented as n (%) and compared using the χ2 test or Fisher's exact test, as appropriate. Sensitivity analyses were performed with adjustment for age, sex, BMI, duration of DM, and baseline BMD where applicable. Correlation analysis was performed using Pearson's correlation analysis and was interpreted as exploratory. A two-sided P<0.05 was considered statistically significant. Because the present analysis included only patients with complete baseline, 6-month, and 12-month records, complete-case analysis was used and no imputation was performed.