"I Just Assumed This Was Already Being Done": Canadian Patient Preferences for Enhanced Data Sharing for Precision Oncology.

PURPOSE: In Canada, health data are siloed, slowing bioinnovation and evidence generation for personalized cancer care. Secured data-sharing platforms (SDSPs) can enable data analysis across silos through rapid concatenation across trial and real-world settings and timely researcher access. To motivate patient participation and trust in research, it is critical to ensure that SDSP design and oversight align with patients' values and address their concerns. We sought to qualitatively characterize patient preferences for the design of a pan-Canadian SDSP. METHODS: Between January 2022 and July 2023, we conducted pan-Canadian virtual focus groups with individuals who had a personal history of cancer. Following each focus group, participants were invited to provide feedback on early-phase analysis results via a member-checking survey. Three trained qualitative researchers analyzed data using thematic analysis. RESULTS: Twenty-eight individuals participated across five focus groups. Four focus groups were conducted in English and one in French. Thematic analysis generated two major and five minor themes. Analytic themes spanned personal and population implications of data sharing and willingness to manage perceived risks. Participants were supportive of increasing access to health data for precision oncology research, while voicing concerns about unintended data use, reidentification, and inequitable access to costly therapeutics. To mitigate perceived risks, participants highlighted the value of data access oversight and governance and informational transparency. CONCLUSION: Strategies for secured data sharing should anticipate and mitigate the risks that patients perceive. Participants supported enhancing timely research capability while ensuring safeguards to protect patient autonomy and privacy. Our study informs the development of data-governance and data-sharing frameworks that integrate real-world and trial data, informed by evidence from direct patient input.

Athletes' perspectives on return to sport after anterior cruciate ligament reconstruction and their strategies to reduce reinjury risk: a qualitative interview study.

BACKGROUND: Insights derived from athletes who have completed the final phase of rehabilitation and successfully returned to their respective sports after anterior cruciate ligament (ACL) reconstruction could potentially contribute to the enhancement of therapeutic strategies. Therefore, the aim of this study was to explore athletes' experiences, thoughts, and behaviours of final phase rehabilitation and return to sport after ACL reconstruction and to describe their thoughts about the risk of reinjury. METHODS: This qualitative interview study included individual semi-structured interviews with 15 athletes after ACL reconstruction. All athletes were aged between 15 and 35 years (median, 23 years), had returned to their preinjury contact sport at elite or recreational competitive level, rehabilitated with different physioterapists (working in hospital, primary care or sport clinics), and had undergone primary ACL reconstruction between 14 and 59 months (median, 23 months) before the interviews. Data were analysed using qualitative content analysis. RESULTS: Analysis of the data resulted in the following 4 main categories related to athletes' experiences of the return to sport process and their thoughts about the risk of reinjury: Athletes' strategies for safe return to sport; Support during rehabilitation and return to sport; The rehabilitation journey was worthwhile to be able to play again; and Reinjury is beyond one's control. CONCLUSIONS: Athletes described strategies for a safe return to sport after ACL reconstruction, emphasizing continuous increased load, not forcing return to sport, injury prevention exercises, and seeking support from professionals and coaches. Despite loving their sport, the athletes had mixed feelings about undergoing additional rehabilitation if reinjured. The athletes recognized the high reinjury risk, attributing it to fate. These findings enhance understanding of athletes' return to sport experiences after ACL reconstruction, their strategies to minimize reinjury risk, which might help optimizing care for this patient group.

The effect of neck-specific exercise and prescribed physical activity on headache and dizziness in individuals with cervical radiculopathy: Further analyses of a randomized study with a 1-year follow-up.

OBJECTIVE: To evaluate the effect of neck-specific exercise (NSE) compared to prescribed physical activity (PPA) on headache and dizziness in individuals with cervical radiculopathy (CR). Also, to investigate associations between headache or dizziness and pain, neck muscle endurance (NME), neck mobility, physical activity, and fear avoidance beliefs. METHODS: Individuals randomized to either NSE or PPA were selected to a headache subgroup (n = 59) and/or a dizziness subgroup (n = 73). Data were evaluated, according to headache and/or dizziness outcomes at baseline and at 3, 6, and 12-month follow-ups. RESULTS: No significant between-group differences were found between NSE and PPA in either subgroup. In the headache subgroup, significant within-group improvements were seen at all follow-ups for NSE (p < .001) and from baseline to 3 (p = .037) and 12 (p = .003) months for PPA. For dizziness, significant within-group improvements were seen from baseline to 3 months for NSE (p = .021) and from baseline to 3 (p = .001) and 6 (p = .044) months for PPA. Multiple regression models showed significant associations at baseline between headache intensity and neck pain (adjusted R-square = 0.35, p < .001), and for dizziness with neck pain and dorsal NME (adjusted R-square = 0.34, p < .001). CONCLUSION: NSE and PPA show similar improvements in headache intensity and dizziness in individuals with CR. Headache intensity is associated with neck pain, and dizziness with neck pain and dorsal NME, highlighting the importance of these factors when evaluating headache and dizziness.

A more than 20-year follow-up of pain and disability after anterior cervical decompression and fusion surgery for degenerative disc disease and comparisons between two surgical techniques.

BACKGROUND: Follow-ups more than 20 years after neck surgery are extremely rare. No previous randomized studies have investigated differences in pain and disability more than 20 years after ACDF surgery using different techniques. The purpose of this study was to describe pain and functioning more than 20 years after anterior cervical decompression and fusion surgery, and to compare outcomes between the Cloward Procedure and the carbon fiber fusion cage (CIFC). METHODS: This study is a 20 to 24-year follow-up of a randomized controlled trial. Questionnaires were sent to 64 individuals, at least 20 years after ACDF due to cervical radiculopathy. Fifty individuals (mean age 69, 60% women, 55% CIFC) completed questionnaires. Mean time since surgery was 22.4 years (range 20,5-24). Primary outcomes were neck pain and neck disability index (NDI). Secondary outcomes were frequency and intensity of neck and arm pain, headache, dizziness, self-efficacy, health related quality of life or global outcome. Clinically relevant improvements were defined as 30 mm decrease in pain and a decrease in disability of 20 percentage units. Between-group differences over time were analyzed with mixed design ANOVA and relationships between main outcomes and psychosocial factors were analyzed by Spearman´s rho. RESULTS: Neck pain and NDI score significantly improved over time (p < .001), with no group differences in primary or secondary outcomes. Eighty-eight per cent of participants experienced improvements or full recovery, 71% (pain) and 41% (NDI) had clinically relevant improvements. Pain and NDI were correlated with lower self-efficacy and quality of life. CONCLUSION: The results from this study do not support the idea that fusion technique affects long-term outcome of ACDF. Pain and disability improved substantially over time, irrespective of surgical technique. However, the majority of participants reported residual disability not to a negligible extent. Pain and disability were correlated to lower self-efficacy and quality of life.

Physiotherapists' experiences of internet-based neck-specific exercises for patients with chronic whiplash-associated disorders.

Objective: Neck-specific exercises for individuals with chronic whiplash-associated disorders (WAD) have shown promising results, but there is also a need for more efficient and flexible ways of rehabilitation, such as use of digital health tools. Understanding physiotherapists' experiences of an internet-based tool may help to improve digital tools within physiotherapy. The purpose of this study was to describe how physiotherapists' experience an internet-based neck-specific exercise program for patients with chronic WAD. Methods: This study has a qualitative design. Focus group discussions were held with physiotherapists who have been treating patients with chronic WAD, using an internet-based neck-specific exercises program in a randomized controlled multi-center trial in south and central Sweden. Three focus groups were held with three participants in each group. Phenomenography was applied as a research approach for data analysis. Results: One main category was identified as "internet-based program as a complement to regular rehabilitation," with five descriptive sub-categories: (a) support in patient work; (b) usefulness based on a patient's prerequisites and preferences; (c) physiotherapist and patient interaction; (d) increasing efficiency in rehabilitation; and (e) enabling patient participation, autonomy and self-management. Conclusions: From a physiotherapy perspective, an internet-based program could work as a method of complementary support to the standard rehabilitation treatment for patients with chronic WAD, as long as it is interactive and adjustable to the individual. The internet-based program could lead to increased autonomy and self-efficacy, and save resources and time for physiotherapists and patients. Further, more research is needed to strengthen these digital tools within the healthcare system.

Dizziness and balance outcomes after two different postoperative rehabilitation approaches following neck surgery: analyses of a multicenter randomized controlled trial.

BACKGROUND: Dizziness and balance problems are common symptoms in patients with cervical radiculopathy. OBJECTIVE: To evaluate the effect of neck surgery postoperatively combined with either structured rehabilitation or standard approach in patients with cervical radiculopathy and dizziness and/or balance problems, and investigate factors influencing dizziness and balance at 6-month follow-up. METHODS: Individuals (n = 149) with cervical radiculopathy and dizziness and/or balance problems were randomized preoperatively to structured postoperative rehabilitation or standard postoperative approach. Outcomes were intensity of dizziness and subjective balance, and clinical measures of balance. RESULTS: Self-reported measures improved at three months (p ˂ 0.001 to p = .007) and the standing balance at six months (p = .008). No between-group differences. Baseline values, neck pain, and physical activity level explained 23-39% of the variance in 6-month outcomes for self-reported measures. Baseline values and physical activity level explained 71% of the variance in walking balance, and lower baseline scores were significantly associated with standing balance impairments (OR 0.876). CONCLUSION: Patients improved significantly in dizziness and subjective balance intensity shortly after surgery, and in standing balance at 6 months, independent of postoperative rehabilitation. Neck pain, physical activity, and neck muscle function influenced dizziness and balance, although preoperative values and neck pain were of most importance for 6-month outcomes.

Developing Data Sharing Models for Health Research with Real-World Data: A Scoping Review of Patient and Public Preferences.

For researchers to realize the benefits of real-world data in healthcare requires broader access to patient data than is currently possible given siloed data systems. To facilitate evidence generation, infrastructure must support integrated data collection and sharing enabled by patient consent. Critical to the success of data sharing is to design secured data sharing platforms around patient preferences and expectations. The objective of this review was to characterize patient and public preferences for secured data sharing platforms and incentives to share real-world data for health research. We conducted a scoping review of the data sharing and health informatics literature capturing patient and public values for data sharing platforms and incentivization. We searched Embase and Medline (OVID) databases for primary data studies. Two reviewers participated in study selection and data abstraction. Findings were summarized according to preference frequency within each major theme. The final search produced 253 articles. After screening, 12 articles were included for data extraction. Two studies discussed preferences for data sharing platforms, 7 discussed incentives preferences, and 3 addressed both. We identified considerable variation of patient and public preferences according to preferred consent mechanisms and level of control, willingness to trade off risks and benefits, and the type of incentivization appropriate to offer for participation. This preference variation informs the conditions under which individuals may be willing to engage with secured data sharing platforms to support research. Our findings indicate that platforms will need to be flexible to meet the diverse preferences of users and facilitate uptake.

Neck-Related Headache in Patients With Cervical Disc Disease After Surgery and Physiotherapy: A 1-Year Follow-up of a Prospective Randomized Study.

STUDY DESIGN: A prospective randomized multicenter trial. OBJECTIVE: To investigate the effects of surgery with either structured postoperative physiotherapy or standard postoperative approach on neck-related headache in patients with cervical radiculopathy. Secondary, to investigate associations between change in neck-related headache and change in neck muscle endurance, neck mobility, or neck pain. SUMMARY OF BACKGROUND DATA: The effect of physiotherapy on individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease is unknown. METHODS: One hundred six patients with neck-related headache and participating in a randomized controlled trial evaluating the additional effects of physiotherapy after surgery for cervical radiculopathy were included. Patients were randomized preoperatively to structured postoperative physiotherapy (n = 51) or the standard postoperative approach (n = 55). Outcome measures were headache intensity and neck pain intensity, neck muscle endurance, and neck mobility. Measures were obtained preoperatively and at 6 weeks, 3 months, 6 months, and 1 year postoperatively. RESULTS: Headache intensity significantly changed from baseline to 1 year postoperatively (P < 0.001) in both groups. Post-hoc tests showed a significant difference between baseline and 6 weeks (P ≤ 0.05). No significant differences were found between groups (P > 0.05) or between-group differences in changes over time (P > 0.05). The change in current headache intensity over time was associated with a change in current neck pain intensity over time (P = 0.003, ß = 0.40). CONCLUSION: There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time. Change in current headache intensity was only associated with a change in current neck pain intensity. LEVEL OF EVIDENCE: 2.

Balance problems and dizziness after neck surgery - associations with pain and health-related quality of life.

Introduction: Symptoms of dizziness or imbalance are often present in individuals with a variety of neck-disorders. The aims of this study were to determine the prevalence of patient-reported balance problems and dizziness 10-13 years after surgery for cervical degenerative disc disease; evaluate associations with neck pain and health-related quality of life; and investigate how these individuals described dizziness. Material and methods: Sixty-eight individuals, 10 years or more after anterior cervical decompression and fusion surgery, who previously participated in a randomized controlled trial were included. Participants completed questionnaires including ratings of dizziness and balance problems, the Dizziness Handicap Inventory, and an open-ended question regarding their experience of dizziness. Secondary outcomes were neck pain and quality of life. Results: Seventy-two percent experienced occasional or daily symptoms of unsteadiness and/or dizziness. Intensity ratings for dizziness during movement and for balance problems were similar and rather low, but had an impact on quality of life. Ratings of dizziness at rest were even lower. Dizziness ratings were associated with neck pain. Strenuous activities were related to dizziness and dizziness was primarily described as intermittent and non-rotatory. Conclusions: Dizziness or balance problems in the long-term after surgery for cervical degenerative disc disease are common and have an impact on daily life. Ratings of problem frequency and intensity were usually low. Dizziness and balance problems may affect quality of life. Patients' descriptions of these problems are in line with common symptoms of cervicogenic dizziness.

Physiotherapy after anterior cervical spine surgery for cervical disc disease: study protocol of a prospective randomised study to compare internet-based neck-specific exercise with prescribed physical activity.

INTRODUCTION: Patients suffering from remaining disability after anterior cervical decompression and fusion (ACDF) surgery for cervical disc disease may be prescribed physical activity (PPA) or neck-specific exercises (NSEs). Currently, we lack data for the success of either approach. There is also a knowledge gap concerning the use of internet-based care for cervical disc disease. The scarcity of these data, and the high proportion of patients with various degrees of incapacity following ACDF, warrant increased efforts to investigate and improve cost-effective rehabilitation. The objective is to compare the effectiveness of a structured, internet-based NSE programme, versus PPA following ACDF surgery. METHODS AND ANALYSIS: This is a prospective, randomised, multicentre study that includes 140 patients with remaining disability (≥30% on the Neck Disability Index, NDI) following ACDF for radiculopathy due to cervical disc disease. Patient recruitment occurs following attendance at routine clinical appointments, scheduled at 3 months postsurgery. Patients are then randomised to one of two groups (70 patients/group) for a 3-month treatment programme/period of either internet-based NSE or PPA. Questionnaires on background data, pain and discomfort, physical and mental capacity, satisfaction with care, and health and workplace factors are completed, along with physical measures of neck-related function conducted by independent test leaders blinded to randomisation. Measures are collected at inclusion, after the 3-month treatments (end of treatment) and at a 2-year follow-up. Radiography will be completed at the 2-year follow-up. Preoperative data will be collected from the Swedish Spine Registry. Data on healthcare consumption, drug use and sick leave will be requested from the relevant national registers. ETHICAL CONSIDERATIONS: This study was approved by the Regional Ethical Review Board in Linköping Ref. 2016/283-31 and 2017/91- 32. The scientists are independent with no commercial ties. Patients are recruited after providing written informed consent. Patient data are presented at group level such that no connection to any individual can be made. All data are anonymised when reported, and subject to the Swedish Official Secrets Health Acts. The test leaders are independent and blinded for randomisation. Exercises, both general and neck-specific, have been used extensively in clinical practice and we anticipate no harm from their implementation other than a risk of muscle soreness. Both randomisation groups will receive care that is expected to relieve pain, although the group receiving NSE is expected to demonstrate a greater and more cost-effective improvement versu s the PPA group. Any significant harm or unintended effects in each group will be collected by the test leaders. All questionnaires and test materials are coded by the research group, with code lists stored in locked, fireproof file cabinets, housed at the university in a room with controlled (card-based) access. Only individuals in receipt of a unique website address posted by the researchers can access the programme; patients can neither communicate with each other nor with caregivers via the programme.Study participation might lead to improved rehabilitation versus non-participation, and might therefore be of benefit. The results of this study should also contribute to more effective and flexible rehabilitation, shorter waiting times, lower costs and the possibility to implement our findings on a wider level. DISSEMINATION: If effective, the protocols used in this study can be implemented in existing healthcare structures. The results of the study will be presented in scientific journals and popular science magazines of relevance to health. The findings will also be presented at local, regional, national and international conferences and meetings, as well as in the education of university students and at public lectures. Information about the results will be communicated to the general population in cooperation with patient organisations and the media. TRIAL REGISTRATION: NCT03036007.

Women's experiences of daily life after anterior cervical decompression and fusion surgery: A qualitative interview study.

OBJECTIVE: To explore and describe women's experiences of daily life after anterior cervical decompression and fusion surgery. DESIGN: Qualitative explorative design. SUBJECTS: Fourteen women aged 39-62 years (median 52 years) were included 1.5-3 years after anterior cervical decompression and fusion for cervical disc disease. METHODS: Individual semi-structured interviews were analysed by qualitative content analysis with an inductive approach. RESULTS: The women described their experiences of daily life in 5 different ways: being recovered to various extents; impact of remaining symptoms on thoughts and feelings; making daily life work; receiving support from social and occupational networks; and physical and behavioural changes due to interventions and encounters with healthcare professionals. CONCLUSION: This interview study provides insight into women's daily life after anterior cervical decompression and fusion. Whilst the subjects improved after surgery, they also experienced remaining symptoms and limitations in daily life. A variety of mostly active coping strategies were used to manage daily life. Social support from family, friends, occupational networks and healthcare professionals positively influenced daily life. These findings provide knowledge about aspects of daily life that should be considered in individualized postoperative care and rehabilitation in an attempt to provide better outcomes in women after anterior cervical decompression and fusion.

Evaluation of physical function in individuals 11 to 14 years after anterior cervical decompression and fusion surgery--a comparison between patients and healthy reference samples and between 2 surgical techniques.

OBJECTIVE: The purpose of this study was to evaluate neck-related physical function in individuals 11 to 14 years after anterior cervical decompression and fusion (ACDF) surgery for degenerative cervical disk disease and to compare the long-term outcome of 2 surgical techniques, including the Cloward procedure and cervical intervertebral fusion cage. METHODS: In this cross-sectional study, 51 individuals, 11 years or more after ACDF, underwent testing of cervical active range of motion, hand-grip strength, static and dynamic balance, neck muscle endurance, and completed pain ratings. The participants' values were compared with values of age- and sex-matched healthy individuals to evaluate impairments. Correlations between different test scores and pain were performed. Group differences were analyzed between the 2 surgical techniques. RESULTS: Sixty-five percent and 82% exhibited impairment in ventral and dorsal neck muscle endurance, respectively. Impairment rates of 18% to 39% for cervical active range of motion, 27% to 43% for hand-grip strength, 37% for standing balance, and 35% for dynamic balance were recorded. Twenty-nine percent of the participants had impairment (>30 mm visual analog scale) in pain. There were no significant differences in physical function between the 2 surgical treatment groups (Cloward procedure or cervical intervertebral fusion cage) (P = .10-.92). CONCLUSIONS: In those studied, a large percentage of patients who had anterior cervical decompression and fusion surgery have impairments in neck-related physical function when compared 11 to 14 years after surgery with age- and sex-matched healthy reference individuals. Neck-specific function, but not balance, was statistically correlated to pain. Neck muscle endurance was most affected, and balance impairments were also present in one-third of the individuals. There were no differences in long-term physical function between the 2 surgical techniques.

Positive predictive factors and subgroup analysis of clinically relevant improvement after anterior cervical decompression and fusion for cervical disc disease: a 10- to 13-year follow-up of a prospective randomized study: clinical article.

OBJECT: The main purpose of this 10- to 13-year follow-up of a prospective randomized study was to identify preoperative factors that predicted good long-term outcome after anterior cervical decompression and fusion (ACDF) with the Cloward procedure or the cervical intervertebral fusion cage. A second purpose was to investigate subgroup differences at the 10-year follow-up between patients with and without clinically relevant improvement (CRI) and between men and women. METHODS: To evaluate clinically meaningful outcomes, good outcome was defined as CRI in neck-related pain intensity (≥ 30-mm improvement on a visual analog scale), and CRI in neck-specific disability (≥ 20% improvement in the neck disability index [NDI]) from preoperative measurements to the 10-year follow-up. A total of 73 patients (77% of the original study sample) completed questionnaires at least 10 years after ACDF. RESULTS: High preoperative neck-related pain intensity and preoperative nonsmoking status were predictors of CRI in neck-related pain intensity, and male sex was a predictor of CRI in neck-specific disability; however, no additional predictive factors were identified for good outcome after ACDF. The surgical procedure, number of operated levels, and radiological factors such as healing status did not influence the prediction models. Individuals without CRI in neck-specific disability (75%) and pain intensity (43%) reported a worse outcome for several psychosocial outcome variables compared with those with CRI. At the 10-year follow-up, women reported significantly greater neck- and arm-related pain intensity than men, and women also reported more disability and worse psychosocial status. Women reported CRI on the NDI less frequently than men (p = 0.01). CONCLUSIONS: Preoperative predictive factors of good outcome 10-13 years after ACDF included initial high neck-related pain intensity, nonsmoking status at the time of surgery, and male sex. There were greater improvements in pain intensity than in neck-specific disability, and the latter showed a greater association with psychosocial factors. These results suggest the need for multimodal postoperative rehabilitation for patients who do not have a satisfactory outcome after ACDF.

A comparison between the carbon fiber cage and the cloward procedure in cervical spine surgery: a ten- to thirteen-year follow-up of a prospective randomized study.

STUDY DESIGN: Ten- to 13-year follow-up of a prospective randomized study. OBJECTIVE: To compare the 10- to 13-year outcomes of anterior cervical decompression and fusion (ACDF) with a cervical intervertebral fusion cage (CIFC), and the Cloward procedure (CP) using a broad clinical and patient-centered assessment. SUMMARY OF BACKGROUND DATA.: There are few prospective studies and none with a follow-up of 10 years or more. METHODS: Patient questionnaires completed 10 years or more after ACDF. Seventy-three patients (77%) responded. Radiographs were obtained at 2 years. RESULTS: Apart from greater fulfillment of preoperative expectation (P = 0.01) and less headache (P = 0.005) in the CIFC group compared with the CP group, there were no significant differences in the outcomes of the two surgical methods. Pain intensity improved in comparison with preoperative levels in both the CIFC and CP groups (P < 0.0001), but the Neck Disability Index (NDI) only improved in the CIFC group (P = 0.04). Only those with a healed fusion benefited from an improved NDI (P = 0.02). There was no deterioration in pain intensity or NDI after the 2-year follow-up. CONCLUSION: The outcomes of the two surgical methods, with a few exceptions, were equal at 10- to 13-year follow-up, and there was no deterioration in outcome after the 2-year follow-up. Pain intensity improved more than disability, which may indicate that further improvement of physical function requires early more extensive postoperative rehabilitation. Despite persisting disability, repeat surgery was relatively uncommon.