Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial

Background Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. Objective We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. Methods Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. Results A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; P=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; P=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; P=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (Ps=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (P=.003). Rehospitalization rates were similar between the 2 groups. Conclusions The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. Trial Registration Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901

yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed

其他:
Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Overall, was the app/intervention effective? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.

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Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "through a digital health platform."

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").

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Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "physician-pharmacist participation." subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 清除所选内容 Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "ambulatory cancer pain" Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients were randomly assigned to either an intervention group (InterG) or control group (CTLG). During the four-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every three days, and the Brief Pain Inventory (BPI) form every 15 days to patients in the InterG via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the CTLG received conventional care and did not receive reminders to fill out the forms. That being said, if CTLG patients filled out a form via MediHK, the pain management team (PMT) would review and respond the same way that they did for the InterG. The primary outcome included pain intensity and pain interference in daily life. Secondary outcomes included Patient-Reported Outcome Measures (PROMs), medication adherence, ADRs, and rehospitalization rates. "

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 清除所选内容 2021/6/25 CONSORT-EHEALTH (V 1.6.1) - subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "During the four-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every three days, and the Brief Pain Inventory (BPI) form every 15 days to patients in the InterG via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the CTLG received conventional care and did not receive reminders to fill out the forms. That being said, if CTLG patients filled out a form via MediHK, the pain management team (PMT) would review and respond the same way that they did for the InterG." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients were randomly assigned to either an intervention group (InterG) or control group (CTLG)." 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it)

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Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " A total of 100 patients were included, with 51 in the InterG and 49 in the CTLG. The worst pain scores, least pain scores, and average pain scores in the InterG and CTLG were statistically different, with a median value of 4 (IQR, 3-7) vs. 7 (IQR, 6-8) (P = 0.001), 1 (IQR, 0-2) vs. 2 (IQR, 1-3) (P =0.02), and 2 (IQR, 2-4) vs. 4 (IQR, 3-5) (P = 0.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationship with others, and interests reduced, but the difference was not statistically significant compared with the CTLG. The medication adherence rate increased from 43% to 63% in the InterG, compared to 33% to 51% in the CTLG (P <0.001). The overall number of ADRs increased at four weeks, and more ADRs were monitored in the InterG (P=0.003). Rehospitalization rates were similar between the two groups. "

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The joint physician-pharmacist team through MediHK can improve pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. "

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5)

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Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study established a physician-pharmacist collaboration team that participated in the self-management of ambulatory patients with cancer pain through a WeChat-supported platform-Medication Housekeeper (MediHK). We aimed to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain and optimize therapeutic outcomes."

清除所选内容
Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Pain is a common and challenging issue for cancer patients, affecting most at some stage of their disease. According to recent surveys, cancer pain management in China remains far from the ideal goal. Smartphones and application platforms, such as WeChat (the largest social networking application in China), provide additional value to obtain knowledge and information, and make it possible for patients and healthcare providers to communicate electronically. Several studies have reported the application of self-management of cancer pain based on the e-health model" Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We aimed to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain and optimize therapeutic outcomes." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Ambulatory patients with cancer pain in a tertiary hospital were included and assigned to either a control group (CTLG; joined in the MediHK only, no physician-pharmacist active intervention) or an intervention group (InterG; MediHK platform plus physician-pharmacist intervention) with an allocation ratio of 1:1 using a random number table." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes to methods after trial commencement.

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Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The inclusion criteria of participants included the following: 1) ≥18 years old; 2) diagnosed with malignant tumors by a pathological or cytological method; 3) met the cancer pain diagnostic criteria according to NCCN Guidelines and had moderate to severe pain (NRS ≥4); 4) patients or their families were able to read Chinese and use WeChat; 5) had a normal verbal ability and performance status; and 6) agreed to participate in the study and sign the informed consent form. "

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely webbased trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At the patients' first visit to the ambulatory clinic, the physician provided a detailed consultation, then determined a treatment plan after discussion with the pharmacist; an account was created for eligible patients to log in. Patients were observed for four weeks. At week four, the patients were required to complete and submit the PROMs through MediHK or report through phone calls within one day. Patients could continue to use MediHK after the completion of the study."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

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Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "After registration, the pharmacist demonstrated the use of each MediHK module to patients, including what information was collected in each form and how to fill it out, and how to switch the interface and send a form or question. Even though the operation of MediHK was simple enough, the training process took about 10 minutes. The specific time depended on patient understanding, ability, and proficiency in WeChat. " Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients were observed for four weeks. At week four, the patients were required to complete and submit the PROMs through MediHK or report through phone calls within one day. Patients could continue to use MediHK after the completion of the study." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

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Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At week four, the patients were required to complete and submit the PROMs through MediHK or report through phone calls within one day."

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 清除所选内容 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

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Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted three rounds of consensus building using Delphi methods [12] to determine patient-reported outcome measures (PROMs) that could be integrated into MediHK."

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No news feeds or changing content which may have an impact on the replicability of the intervention.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

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Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The pharmacist would first review patient demographic information, check the form regarding pain intensity and interference in daily life, conduct medication therapy reviews, and review ADRs and medication adherence. If the patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician. The physician was responsible for prescribing or adjusting pain medications. If no changes were needed, the pharmacist provided appropriate targeted education based on patient knowledge deficits. " 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Note that all screenshots of the app include translations that have been added for clarity of this manuscript. "

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At the patients' first visit to the ambulatory clinic, the physician provided a detailed consultation, then determined a treatment plan after discussion with the pharmacist; an account was created for eligible patients to log in."

清除所选内容
Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "MediHK contains two opening screens: the patient interface (Multimedia Appendix 1) and the medical interface (Multimedia Appendix 2). The former is for patients, and the latter is for the members of the pain management team (PMT), which consisted of physicians and pharmacists. The medical interface was designed to manage pain-related problems and provide consultation to patients in a timely fashion. Both interfaces included three modules: a user login module for inserting basic user demographics into MediHK; an e-consultation module for communicating between patients and medical providers; and an introductory module for MediHK education, which offers a quick response code for new users (Multimedia Appendix 3)."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patients could consult any questions about pain, and the PMT would receive real-time WeChat messages and respond as soon as possible. The acceptable response time was generally within 2 hours. When patients needed a change in drug/dosage or treatment of an ADR, pharmacists first reviewed the patients' historical records through MediHK, then made recommendations and reminded the physician. In China, pharmacists have no right to prescribe. If the physician had conflicting opinions, an agreement would be reached through offline contact; then, the physician could adjust drug therapy regimens."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Does your paper address subitem 5-x?

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The pharmacist would send daily 24-hour pain diaries, ADR forms every 3 days, and the BPI form every 15 days via MediHK. The pharmacist would first review patient demographic information, check the form regarding pain intensity and interference in daily life, conduct medication therapy reviews, and review ADRs and medication adherence. If the patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician. The physician was responsible for prescribing or adjusting pain medications. If no changes were needed, the pharmacist provided appropriate targeted education based on patient knowledge deficits."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

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Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "After registration, the pharmacist demonstrated the use of each MediHK module to patients, including what information was collected in each form and how to fill it out, and how to switch the interface and send a form or question. Even though the operation of MediHK was simple enough, the training process took about 10 minutes. The specific time depended on patient understanding, ability, and proficiency in WeChat." Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The primary outcome included pain intensity and pain interference in daily life. Secondary outcomes included PROMs, medication adherence, ADRs, and re-hospitalization rates." subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text "This study used the BPI (Chinese version) to assess cancer pain, and it has been widely used for its good construct and concurrent validity. e designed a list to record the medication history of ambulatory patients with cancer pain (Multimedia Appendix 4). The Morisky Medication Adherence Measure (MMAM) was used to assess adherence to analgesics because of its excellent reliability and validity in the Chinese cancer pain population. We designed a form (Multimedia Appendix 6) concerning WHO terminology for ADRs and classified it into several symptoms. We designed a pain diary to capture patients' daily pain in the home setting over time. The pain diary included the following five modules (Multimedia Appendix 7): 1) a pain score record, which combined the NRS, Face Pain Scale (FPS), and Verbal Rating Scale (VRS) to assess pain accurately; 2) a form that included the time of administration as well as medication name and dosage for patients taking medication within 24 hours; 3) a module that recorded the specific duration, pain score, treatment status and new pain location when the NRS >4; 4) a module that recorded detailed pain information; and 5) a final module that gave suggestions to physicians or pharmacists based on patient feedback." 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

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Does your paper address subitem 6a-iii?

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No changes to trial outcomes after the trial commenced.

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Our pre-experiment included 72 patients who met the criteria for inclusion. The preliminary results showed that the average NRS of patients in the CTLG was 5.85, and the standard deviation was 2.442. The average score of patients in the InterG was expected to be less than 4. Assuming a type I error of 5%, a type II error of 20%, and considering the design of similar sample content, the sample size required for each group was calculated to be 37 patients. Allowing for 20% attrition, 100 patients (50 participants per group) were planned to be enrolled.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 31/53 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No interim analyses and stopping.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " Ambulatory patients with cancer pain in a tertiary hospital were included and assigned to either a control group (CTLG; joined in the MediHK only, no physician-pharmacist active intervention) or an intervention group (InterG; MediHK platform plus physician-pharmacist intervention) with an allocation ratio of 1:1 using a random number table." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This was a two-arm, randomized controlled clinical trial." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dG… 32/53 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " Ambulatory patients with cancer pain in a tertiary hospital were included and assigned to either a control group (CTLG; joined in the MediHK only, no physician-pharmacist active intervention) or an intervention group (InterG; MediHK platform plus physician-pharmacist intervention) with an allocation ratio of 1:1 using a random number table." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Ambulatory patients with cancer pain in a tertiary hospital were included and assigned to either a control group (CTLG; joined in the MediHK only, no physician-pharmacist active intervention) or an intervention group (InterG; MediHK platform plus physician-pharmacist intervention) with an allocation ratio of 1:1 using a random number table."

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No one was blinded in this study.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "That being said, CTLG patients did not receive a reminder to fill out the forms. If they filled out the form via MediHK, the PMT would also review and respond the same way as for the InterG." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The pharmacist would send daily 24-hour pain diaries, ADR forms every 3 days, and the BPI form every 15 days via MediHK. The pharmacist would first review patient demographic information, check the form regarding pain intensity and interference in daily life, conduct medication therapy reviews, and review ADRs and medication adherence. If the patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician. The physician was responsible for prescribing or adjusting pain medications. If no changes were needed, the pharmacist provided appropriate targeted education based on patient knowledge deficits. Patients in the CTLG received conventional care. Before the patient was discharged from the hospital, the pharmacist conducted detailed medication education. That being said, CTLG patients did not receive a reminder to fill out the forms. If they filled out the form via MediHK, the PMT would also review and respond the same way as for the InterG." Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All data were analyzed by the statistical software SPSS (IBM SPSS Statistics 22.0), and all charts were made by the graphing software GraphPad (GraphPad Prism 8.0.2 (263)). For measurement data, the normality test adopted the Kolmogorov-Smirnov method. If normally distributed, the data were expressed as mean ± standard deviation (SD), and the comparison between the two groups used two independent sample t-tests. If not normally distributed, the data were expressed as the median and interquartile range (IQR), and the comparison between groups underwent a Mann-Whitney U test. Counting data were expressed as a frequency and percentage. A Chi-square (2)  12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).

Does your paper address subitem 12a-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No participants who did not use the application or dropped out from the trial.
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We introduced possible factors that contributed to pain intensity in each pain item in a multivariate linear regression analysis." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of Xiangya Hospital of Central South University (approval number 2017121139). All participants signed an informed consent form before participation."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "All participants signed an informed consent form before participation. "

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline)

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Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Even though the operation of MediHK was simple enough, the training process took about 10 minutes. The specific time depended on patient understanding, ability, and proficiency in WeChat." Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "A total of 100 patients joined and completed this study, with 51 in the InterG and 49 in the CTLG. Demographic (gender, age, height, and weight) and clinical information (diagnosis, pain type, and site of pain) of the two groups were not statistically different (P>0.05), nor was the intensity, pain interference, and adherence to pain medications at baseline ." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No losses and exclusions after randomisation.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "At the patients' first visit to the ambulatory clinic, the physician provided a detailed consultation, then determined a treatment plan after discussion with the pharmacist; an account was created for eligible patients to log in. At week four, the patients were required to complete and submit the PROMs through MediHK or report through phone calls within one day." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 清除所选内容 Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答 Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The trial was not stopped or ended early. analysis and whether the analysis was by original assigned groups Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Demographic (gender, age, height, and weight) and clinical information (diagnosis, pain type, and site of pain) of the two groups were not statistically different (P>0.05), nor was the intensity, pain interference, and adherence to pain medications at baseline (Table 1.)"

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.

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Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Demographic (gender, age, height, and weight) and clinical information (diagnosis, pain type, and site of pain) of the two groups were not statistically different (P>0.05), nor was the intensity, pain interference, and adherence to pain medications at baseline (

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.

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Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Demographic (gender, age, height, and weight) and clinical information (diagnosis, pain type, and site of pain) of the two groups were not statistically different (P>0.05), nor was the intensity, pain interference, and adherence to pain medications at baseline (Table 1.)"

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 您的回答 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Pain intensity in the InterG was significantly reduced compared with that in the CTLG. The worst pain scores, least pain scores, and average pain scores in the two groups were statistically different, with a median value of 4 (IQR, 3-7) vs. 7 (IQR, 5-8) (P = 0.001), 1 (IQR, 0-2) vs. 2 (IQR, 1-3) (P = 0.02), and 2 (IQR, 2-4) vs. 4 (IQR, 3-5), favoring the InterG (P = 0.001). The present pain score of the two groups did not reach a statistical difference. However, the score of the InterG was numerically lower than that of the CTLG. The number of forms submitted by InterG patients was much higher than that of the CTLG (710 vs. 95), with an average of 4.64 forms/person/day vs. 0.06 forms/person/day. The most common forms submitted by the CTLG were BPI (56%), Pain diary (18%), and Medication list (16%) ( Table 3). The complete adherence rate in the InterG increased from 43% to 63%, while that in the CTLG increased from 33% to 51% (P <0.001) (χ2 = 12.864) (Figure 1). The overall incidence of ADRs was 36% across the two groups at baseline and increased to 56% at week four. ADR incidence in the InterG was significantly higher than that in the CTLG (P = 0.003, 2 = 8.990). The two groups had a similar re-hospitalization rate within the four-week trial. There was no significant difference between the two groups within four weeks (P = 0.92, 2 = 0.010). The physician-pharmacist intervention through MediHK was an independent influencing factor for the most severe pain (β=-1.413, P = 0.005) (Multimedia Appendix 8) and average pain (β=-1.154, P = 0.003) (Multimedia Appendix 9). Aside from medication adherence, the intervention was significantly related to the least pain(β=-0.701, P = 0.02) (Multimedia Appendix 10). No factors significantly influenced the present pain (Multimedia Appendix 11). "

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

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17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study used the BPI (Chinese version) to assess cancer pain. The Morisky Medication Adherence Measure (MMAM) was used to assess adherence. We designed a form (Multimedia Appendix 6) concerning WHO terminology for ADRs and classified it into several symptoms. We designed a pain diary to capture patients' daily pain in the home setting over time. " Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Pain intensity in the InterG was significantly reduced compared with that in the CTLG. The worst pain scores, least pain scores, and average pain scores in the two groups were statistically different, with a median value of 4 (IQR, 3-7) vs. 7 (IQR, 5-8) (P = 0.001), 1 (IQR, 0-2) vs. 2 (IQR, 1-3) (P = 0.02), and 2 (IQR, 2-4) vs. 4 (IQR, 3-5), favoring the InterG (P = 0.001). The present pain score of the two groups did not reach a statistical difference. However, the score of the InterG was numerically lower than that of the CTLG. The number of forms submitted by InterG patients was much higher than that of the CTLG (710 vs. 95), with an average of 4.64 forms/person/day vs. 0.06 forms/person/day. The most common forms submitted by the CTLG were BPI (56%), Pain diary (18%), and Medication list (16%) ( Table 3). The complete adherence rate in the InterG increased from 43% to 63%, while that in the CTLG increased from 33% to 51% (P <0.001) (χ2 = 12.864) (Figure 1). The overall incidence of ADRs was 36% across the two groups at baseline and increased to 56% at week four. ADR incidence in the InterG was significantly higher than that in the CTLG (P = 0.003, 2 = 8.990). The two groups had a similar re-hospitalization rate within the four-week trial. There was no significant difference between the two groups within four weeks (P = 0.92, 2 = 0.010). The physician-pharmacist intervention through MediHK was an independent influencing factor for the most severe pain (β=-1.413, P = 0.005) (Multimedia Appendix 8) and average pain (β=-1.154, P = 0.003) (Multimedia Appendix 9). Aside from medication adherence, the intervention was significantly related to the least pain(β=-0.701, P = 0.02) (Multimedia Appendix 10 Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We introduced possible factors that contributed to pain intensity in each pain item in a multivariate linear regression analysis."

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Patient information was protected by encryption." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "In total, we took into account the universal applicability of MediHK when we developed it to ensure easy operation. The only complicated step was the switch between the interface. However, this was emphasized when training in the outpatient clinic."

19-ii)
22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This study included a joint physician-pharmacist team that managed ambulatory patients with cancer pain through a WeChat-supported platform, MediHK, with promising results. Even if the CTLG did not receive a reminder to fill out the forms, patients in this group actively contacted the PMT through MediHK to determine whether the medication plan needed to be adjusted due to either uncontrollable pain intensity, interference on daily life, or severe ADRs. The results revealed the patients' need to contact the professional team via MediHK for better pain management. The patients in the InterG reported more ADRs compared to CTLG patients primarily due to more reports obtained from InterG patients. More ADRs were not in conflict with improving pain. For example, the PMT added new drugs for pain treatment, which may have caused some ADRs, but most of them were tolerated after a few days and monitored closely by the pharmacist."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Regrettably, we did not record the impact of education status and age in keeping medical records. Patients who had never received education may take longer to keep records. However, since the patients or their families included were all able to use WeChat proficiently, we believed that MediHK was feasible; for patients who were too old or unable to record, family members or caregivers would help to send the form. In total, we took into account the universal applicability of MediHK when we developed it to ensure easy operation. The only complicated step was the switch between the interface. However, this was emphasized when training in the outpatient clinic."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.

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Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study has the following limitations: 1) this study had abnormally high participation, which will not necessarily reflect what would happen when patients use the platform independently, because pharmacists would send daily notifications, 2) it was prospectively powered and conducted in a randomized manner, but inevitable confounding factors can exist in the real world. Multivariate linear regression can only explain a small part of the influence of different pain intensity types, 3) being conducted in a single tertiary hospital, applying this approach in other clinical settings may require some individualization to meet specific needs, 4) the observation time of only four weeks limited the long-term application of the results, and 5) this study lacked further assessment about buy-in from both patients and the PMT."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 清除所选内容 Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "There are some strengths of this study. First, this study was a real-world randomized controlled trial conducted in a large ambulatory clinic of a tertiary hospital. All patients were clinically recruited and randomly assigned. The integration of PROMs has not been a feature of other eHealth and (web) application-related studies, allowing this digital health study to help advance this field. In addition, real-time reporting can facilitate just-in-time interventions based on an individual's current circumstance or environment. This study achieved real-time communication between ambulatory patients with cancer pain and healthcare providers through MediHK, extending medical service to ambulatory patients a pathway for the self-management in home settings. "

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study has the following limitations: 1) this study had abnormally high participation, which will not necessarily reflect what would happen when patients use the platform independently, because pharmacists would send daily notifications." Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This was a two-arm, randomized controlled clinical trial, and the study has been registered at http://www.chictr.org.cn/index.aspx (ChiCTR1900023075)." Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This was a two-arm, randomized controlled clinical trial, and the study has been registered at http://www.chictr.org.cn/index.aspx (ChiCTR1900023075

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

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Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?

您的回答
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * I spend about one day on going through the checklist INCLUDING making changes in my manuscript.
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